A Hard Look At What We're Eating · 1983, to March 5, 1984, to give FDA time to eval uate...

A Hard Look At What We're Eating

Consumer

V O L . 1 8 N O . 3 A P R I L 1 9 8 4

S e a l i n g T e e t h T o P r e v e n t C a v i t i e s 4A group of experts recently agreed that sealants can beeffective in protecting teeth of youngsters, particularlythose teeth that are pitted and have fissures.

A H a r d L o o k A t W h a t W e ' r e E a t i n g 8In its ongoing study of American diets, FDA gathers dataon several hundred chemicals, including some that posec o n t a m i n a t i o n c o n c e r n s .

Q u e s t i o n s O f S u b s t a n c e ( s ) C o n c e r n C o s m e t i c U s e r s 1 4Judging from letters to FDA, people worry about the ingredients that go into the various beauty aids. This articleprovides the answers to some of the more commonquestions.

D o Y o u r s e l f A F l a v o r 1 6With herbs and spices, you can gain a reputation as agourmet cook. The curator of the U.S. National Arboretum 's herb garden offers some tips for using those flavoring agents. They're particularly good for people trying toa v o i d s a l t .

B e e P o l l e n A s A H e a l t h F o o d 2 0Promoters claim that bee pollen is a good health foodbecause it's full of nutrients and has therapeutic powers.That may be true—for bees.

F o o d P r e s e r v a t i v e s : A F r e s h R e p o r t 2 3Man's quest for extending the shelf life of foods is never-ending. In its new look at preservatives in long use, FDAhasn't yet passed judgment on the safety of some.

H e a t U s e d T o F i g h t S o m e C a n c e r s 2 6A recently approved device offers a new way to treat fourtypes of cancer. In a process called hyperthermia, cancercells are destroyed by microwave-type heat.

Updates

T h e N o t e b o o k

2

2 8

I n v e s t i g a t o r s ' R e p o r t s 2 9

S u m m a r i e s o f C o u r t A c t i o n s 3 3

When winter raged outdoors, it was into the greenhouse for tender herbssuch as these, either to tide them over to spring or to use for cooking.For more about cooking herbs, see Do Yourself A Flavor beginning onpage 16.

Margaret M. HecklerSecretary, U.S. Department ofHea l th and Human Serv ices

Roger W. Mil ler/Editor

Harold C. Hopkins/Editorial Director

J e s s e R . N i c h o l s / A r t D i r e c t o r

F D A C o n s u m e r / A p r i l 1 9 8 4 / I

updates

C a n c e r P a i n k i l l e r

A new, higher concentration of Dilaudid, a morphine-type drug, has been approved by FDA toease the pain experienced by some patients witha d v a n c e d c a n c e r.

The new dosage form, a 10 milligram-per-cubic-centimeter concentration, will provide pain reliefas great as can be attained with any other narcotic, including heroin, and can be delivered in avery small volume.

Previously the drug was available in concentrations of one, two, three and four milligrams percubic centimeter for intramuscular or intravenousinjection. Use of these concentrations requiredrelatively large injections to achieve therapeuticdoses in patients who had become tolerant of thedrug. This posed a problem for terminally illpatients who often do not have the muscle massneeded to take large injections.

In response to the need in this group of patientsfor a more concentrated dose of a potent painki l ler, FDA worked with Knol l Pharmaceuticals ofWhippany, N.J., to develop safety data for thenew dosage form, which is called Dilaudid-HP.

117 On Carcinogen List

Twenty-two of the 117 entries in the ThirdAnnual Report on Carcinogens are "known carcinogens." This means that evidence from humanstudies indicates there is a causal relationship between exposure to the substance (or process) andh u m a n c a n c e r .

The 22 entries include substances, groups ofsubstances, and technological processes:• 4-Aminobiphenyl• Arsenic and certain arsenic compounds• A s b e s t o s• A u r a m i n e m a n u f a c t u r e• B e n z e n e• B e n z i d i n e• N,N-Bis (2-chloroethyl)-2-naphthylamine(Chlornaphazine) *• Bis (chloromethyl) ether and technical gradechloromethyl methyl ether• C h l o r a m b u c i l *• Chromium and certain chromium compounds• C o k e o v e n e m i s s i o n s• Cyclophosphamide*

• Diethylst i lbestro l*• Hematite underground mining• Isopropyl alcohol manufacture (strong-acidprocess)• Melphalan*• Mustard gas• 2-Naphthy lamine• Nickel refining• Soots, tars and mineral oils• T h o r i u m d i o x i d e• Vinyl chloride

Those marked with an asterisk are therapeuticsubstances. The remaining 98 entries in the reportare substances "which may reasonably be anticipated to be carcinogens" based on limited evidenceof carcinogenicity in humans or sufficient evidenceof carcinogenicity in experimental animals.

Of all the entries in the report, two are naturalsubstances not used or produced commercially(anatoxins and cycasin); two are food or cosmeticadditives (saccharin and safrole); 12 are pesticides;and 15 are therapeutic substances, including thefive on the "known carcinogen" list.

The remaining substances are various industrialchemicals and byproducts.

The Third Annua! Report on Carcinogens wasprepared by the National Toxicology Program,U.S. Public Health Service, Department of Healthand Human Services. It was released in December1983. Summaries of the report may be obtained atno charge from the Public Information Office,NTP, B2-04, P.O. Box 12233, Research TrianglePark, N.C. 27709. The complete report can bepurchased for $32.50 from the National TechnicalInformation Service, 5285 Port Royal Road,Springfield, Va. 22161. The order number is PB8 3 - 1 3 5 8 5 5 .

Ultrasound Safety Questioned

Ultrasound imaging in pregnancy should be usedonly when there is an accepted medical reason forit, concluded a panel of experts meeting at theNational Institutes of Health in February. Thepanel said it could not endorse routine ultrasoundscreening of pregnant women because there is notenough evidence of benefit to either the mother ort h e f e t u s .

Ultrasound imaging uses high-frequency soundwaves to produce an image of the fetus and its

2 / April 1984 / FDA Consumer

surroundings on a screen. Doctors use the procedure for evaluation of fetal growth and activity,for detection of multiple pregnancies and physicalabnormalities, for determination of fetal age, andfor many other purposes. The use of ultrasound inobstetrics has grown rapidly in the United States.The procedure is now available in nearly all hospitals, and many obstetricians have ultrasoundequipment in their offices. (See 'The UnknownsO f U l t r a s o u n d " i n t h e M a r c h 1 9 8 3 i s s u e o f F D AConsumer,)

Concerns about the safety and effectiveness ofthe procedure prompted FDA and the NationalInstitutes of Health to sponsor a consensus development conference to assess the use of ultrasoundduring pregnancy. The conference was held Feb. 6to 8 in Bethesda, Md., after a year's preparationby the panel.

The panel concluded that ultrasound evaluationcan improve the outcome of high-risk or complicated pregnancies, but its effectiveness as a routinescreening procedure has not been proved. Use ofu l t r a s o u n d t o d e t e r m i n e t h e s e x o f t h e f e t u s o r t osee or obtain a picture of the fetus should be discouraged, the panel said.

The panel also concluded that there is notenough information to reliably assess the risks ofultrasound. Although it is encouraging that noh a r m f u l e f f e c t s t o e i t h e r m o t h e r o r f e t u s h a v ebeen reported in more than 20 years of use, thepanel said, it is nevertheless likely that any ille f f e c t s w o u l d b e s u b t l e a n d w o u l d n o t b e i m m e

diately apparent.Many of the studies on the safety of ultrasound

in humans have been "inadequate," the panelmembers said. They noted, however, that severalhave shown there is no association between exposure of fetuses to ultrasound and subsequent lowbirth weight or hearing loss of the newborns.

Some animal and cell culture studies have suggested that ultrasound exposure can retard fetalgrowth, impair the immune response, and producecell damage and chromosomal changes. Most ofthese studies involved higher levels of ultrasoundenergy than are used in diagnostic evaluations andsome of the findings could not be reproduced byother investigators. Nevertheless, the panel said,the reported effects cannot be ignored.

To help answer questions about the safety ofultrasound in pregnancy, the panel called for

animal studies designed to detect the long-termeffects of in utero ultrasound exposure.

Reprints Available

Reprints are available of "Back Pain: Ubiquitous, Controversial," an article that appeared int h e N o v e m b e r 1 9 8 3 i s s u e o f F D A C o n s u m e r ,

Single copies of reprints can be obtained from theFood and Drug Administration, HFE-88, 5600Fishers Lane, Rockville, Md. 20857. Multiplecopies are available from FDA, HFW-40, at theRockville address. Copies of reprints are alsoavai lable from FDA's consumer affairs officers,who are located in 30 cities around the country.

Gumming Up The Habit

Cigarette smokers who are participating in anorganized program to kick the habit may get anassist from Nicorette, a new nicotine chewing gumrecently approved by FDA as a prescription drugproduct.

Each buff-colored, flat square of gum containstwo milligrams of nicotine identical to that foundin tobacco. The color and shape of the new product differentiate it from ordinary gum.

Nicorette does not eliminate the desire for cigarettes but can provide a short-term alternativesource of nicotine for dependent persons whoabruptly stop smoking during an organized smok-ing-cessation program. In behavior modificationprograms, the effectiveness of Nicorette was demonstrated to be significantly greater than plainchewing gum.

According to the labeling approved by FDA,smokers who have a high physical dependence onnicotine are most likely to benefit from use ofNicorette. Such persons typically smoke more than15 cigarettes a day, prefer brands of cigaretteswith more than 0.9 milligrams of nicotine each,inhale, and find the first cigarette in the morningthe hardest to give up.

Pregnant women and some heart patients shouldnot use the product, nor should they smoke. TheU.S. Public Health Service regards cigarette smoking as "the single most important preventablecause of illness and early death" in the U.S.

Nicorette is a product of Merrell Dow Pharmaceuticals Inc., Cincinnati , Ohio.

FDA Consumer / April 1984 / 3

Sealing Teeth To Prevent Cavitiesby Annabel Hecht

Fluorides in drinking water andtoothpaste have played a majorrole in reducing the number of cavities in the teeth of children and youngadu l t s i n t he Un i t ed S ta tes . Bu t t heproblem of cavities hasn't beenlicked. By age 16, American childrenhave an average of nearly 10 decayedor missing (extracted) teeth or filledt o o t h s u r f a c e s .

What's interesting is that the locations of the cavities have changed.Now they're occurring mainly on thechewing surfaces of the molars instead of the smooth tooth surfaces,where they predominated before thea d v e n t o f fl u o r i d e s . T h e m o l a r s a n d

premolars (the teeth directly in frontof the molars) have always been particularly susceptible to decay becausetheir surfaces contain pits and fissures where food and bac te r i a can be

trapped, eventually leading tocav i t i e s .

In young people 50 percent of cavities develop in these pits and groovesof the chewing surfaces, which areleast benefited by fluorides. (Plaque,not easily cleaned from these surfaces, prevents the fluoride fromdoing its job.)

Fortunately, such damaging toothdecay can be prevented by sealing theteeth with a plastic resin to protectt h e m f r o m b a c t e r i a i n t h e o r a l e nvironment, according to participantsa t a r e c e n t N a t i o n a l I n s t i t u t e s o fHealth consensus development conference. Unfortunately, dental sealants have been under-used by dentists

and overlooked by or unknown toparents, the panel of experts said.

Concern about pit and fissure cavities predates the advent of fluorides.As early as 1923 some dentists advocated recontouring the tooth surfaceand filling the ground-out fissureswith restorative material, techniquesthat were neither preventive norwidely accepted.

Surface sealing got its start in themid-1950s when a dental scientist, D.Michael Buonocore, discovered thatby etching the tooth surface with adilute solution of phosphoric acid ad u r a b l e b o n d c o u l d b e e s t a b l i s h e dbetween the tooth and a plastic resin.It was not until 1965, however, thatBuonocore and his colleagues reported on clinical trials with the newprocedure.

T h e fi r s t s e a l a n t s w e r e m a d e o fcyanoacrylates and polyurethanes,plastics that proved to be difficult tohandle, and dental researchers in thelate 1960s sought better materials.Today sealants are composed ofpolymethylmethacrylate resins similart o t h o s e u s e d i n s o m e o t h e r d e n t a lprocedures, such as repairing brokenedges of teeth, attaching orthodonticdevices, and splinting loose teeth tofi r m o n e s .

Currently there are three classifications of dental sealants, which aredesignated by the manner in whichthey are cured (hardened):• Chemically or self-cured sealantsc o n s i s t o f t w o m a t e r i a l s t h a t a r emixed together just before applica

tion, with one material serving as an" a c t i v a t o r " t h a t c a u s e s t h e m i x t u r eto harden quickly.• Ultraviolet-light-cured sealantsharden to a glossy finish after beingexposed to small amounts of ultraviolet light from a hand-heldi n s t r u m e n t .• Visible-light-cured sealants hardenwhen exposed to a high-intensitywhite light from a hand-heldi n s t r u m e n t .

FDA regulates both the sealantsand the ultraviolet and visible lightdelivery systems under the authorityo f t h e M e d i c a l D e v i c e A m e n d m e n t so f 1 9 7 6 .

The procedure for applying sealants is relatively simple. First thetooth to be sealed is isolated by ar u b b e r d a m o r c o t t o n r o l l s t o i n s u r ethat saliva won't get on the surface(contamination by saliva is one ofthe primary causes of sealant failure). After being thoroughly cleanedand dried, the surface is etched byapplication of a 30 to 50 percentphosphoric acid solution for aboutone minute. The etching creates aporous surface into which the sealantc a n p e n e t r a t e .

When the acid is washed away andthe tooth is once again dried, thesealant is placed on the tooth surf a c e . T h e t i m e n e e d e d f o r t h e s e a l a n tto harden varies, depending on whichmethod is used. Generally it takesa b o u t a m i n u t e .

T h o s e w h o c a n m o s t b e n e fi t f r o mthis preventive treatment are children


6 / A p r i l 1 9 8 4 / F D A C o n s u m e r

Dental sealants appear as white patcheson the chewing surface of the molars towhich they have been applied (pictureat top left), The effectiveness of thesealants is evident in the photo below(left). The tooth on the left in the picture was treated a year after it appeared in the patient's mouth. Fiveyears later the tooth is still protected,while its untreated neighbor developeda cavity that required filling.

(Photos by Richard J. Simonsen,D.D.S., National Institute of DentalResearch, National Institutes ofHealth.)

with newly erupted first and secondprimary molars and newly eruptedfirst and second permanent molars.S e a l a n t s a r e n o t a s u b s t i t u t e f o rfluorides, the panel stressed. Sealantsshould be used along with fluoridesi n t h e i r v a r i o u s f o r m s .

In the last several years clinicalt r i a l s o n s e a l a n t s i n s e v e r a l c o u n t r i e shave resulted in findings that areremarkably consistent and positive.T h e t r i a l s s h o w e d t h a t t h e o c c u r r e n c eof pit and fissure cavities was reduced by approximately 95 percent atthe end of one year and at least 50percent at the end of five years.

As far as safety is concerned, theconsensus conference panel found noevidence that the sealant materials,the acid used for etching, or the ultraviolet light used to harden dentalsealants are harmful to the patient orthe dentist. The group warned, however, that looking at the unshieldedultraviolet light reflected from thetooth and surrounding tissues forlong periods without ultraviolet-absorbing glasses could have deleterious effects on the eyes of the dentalpersonnel applying sealants. (FDA isalso concerned about the possiblehazard of exposure to the blue partof the spectrum in the visible-light-cured sealant system.)

Despite a record of effectivenessand safety that spans more than 15years of clinical study, many dentistsin private practice and in publicdental health-care programs aren'tusing dental sealants to prevent cavities. Among the reasons for thisunder-use, cited by the panel, areunfamiliarity with the technique,early failures of the sealants to stayin place, and difficulties in explainingthe procedures to patients andp a r e n t s .

D e n t i s t s h a v e b e e n c o n c e r n e d t h a tcavities might develop underneath thesealant. They don't, according to theconsensus panel's findings. In fact,the process of tooth decay seems tobe a r res ted because the bac te r ia a resealed off from their nutrient supply.E v e n w h e n t h e s e a l a n t w e a r s o f f o rcomes off, treated teeth are no more

susceptible to cavity formation thanuntreated teeth. According to onereport presented to the conference,the sealant penetrates the pores oft h e e n a m e l a n d c o n t i n u e s t o s e r v e a sa protectant even though the sealantappears to be lost.

The public has not been well informed about this preventive procedure, added the panel. Cost may alsohave played a part in parents' reluctance to accept sealants for theirchildren. The sealing of tooth surfaces is not covered by most insurance plans and other third-partypayment agencies, including Medic a r e .

Gathering more information on thecost effectiveness of using sealants incommunity dental health programsw a s o n e o f t h e r e c o m m e n d a t i o n s o fthe consensus panel. The group alsourged continuing research to improvesealant technology.

The Consensus Development Conf e r e n c e o n D e n t a l S e a l a n t s i n t h ePrevention of Tooth Decay was helda t t h e N a t i o n a l I n s t i t u t e s o f H e a l t hin Bethesda, Md., Dec. 5 to 7, 1983.The panel, chaired by James W.Bawden, D.D.S., The University ofNorth Carolina, Chapel Hill, N.C.,included D. Walter Cohen, D.D.S.,University of Pennsylvania, Philadelphia; Durward R. Collier, D.D.S.,Tennessee Department of Health andEnvironment, Nashville; Gay-wynnPitcher Cooper, R.D.H., Albuquerque, N.M.; Irving W. Eichenbaum,D.D.S., University of ConnecticutHeal th Center, New Br i ta in, Conn.;Caswell A. Evans Jr., D.D.S., Seattle-King County Department of Public Health, Seattle; Marilyn C.Farray, J.D., Children's DefenseFund, Washington, D.C.; Joseph L.Fle iss, Ph.D., Columbia Univers i ty,New York ; E lverne M. Tonn,D.D.S., Universi ty of the Pacific,San Francisco; and Robert M.Veatch, Ph.D., Georgetown University, Washington, D.C.

Annabel Hecht is a member ofFDA's publications staff


A H a r dL o o kA t W h a tWe're Eating by Louise Fenner

What were chemicals once used ine l e c t r i c a l t r a n s f o r m e r s a n d c a rbonless "carbon paper" doing in thebreakfast cereal? Chemists testing thecereal as part of a study of contamin a n t s i n t h e A m e r i c a n d i e t w e r e

puzzled. Where had the polychlori-nated biphenyls (PCBs) come from?

Further testing showed that thePCBs were migrating into the cerealfrom the cereal boxes. Although thequantities were minute, it was import a n t t o fi n d t h e i r s o u r c e b e c a u s ePCBs can cause liver damage andother toxic symptoms in humans.

Investigation by the Food andDrug Administration revealed thatthe cereal boxes were produced fromrecycled paper containing, amongother materials, carbonless carbonpaper. At one time PCBs were usedin making carbonless carbon paper.

The laboratory's finding ultimatelyled to the writing of an FDA regulation limiting the amount of PCBsallowed in paper food packaging.Although no longer used in carbonless carbon paper, PCBs still turn up

occasionally in recycled paper madef r o m d i s c a r d e d fi l e s t h a t i n c l u d e t h e

old-style carbonless carbon paper.The FDA regulation assures thatexcess i ve l eve l s o f PCBs w i l l no t endup in any more cereal boxes—orother paper food packaging.

FDA's Total Diet Laboratory,meanwhile, continues to check forcontaminants in America's food supply. Located in Kansas City, Mo., itis responsible for the analytical endof the agency's Total Diet Study.The 20 chem is t s and t echn i c i ans as

signed to the Total Diet laboratoryanalyze chocolate milkshakes, quarter-pound hamburgers, beer, bologna, lasagna, frozen pizza, dillpickles, watermelon, chocolate chipcookies, and more than 200 otherf o o d s A m e r i c a n s h a n k e r f o r e a c hyear. They are interested in whats h o u l d n ' t b e i n t h o s e f o o d s : u n s a f eamounts of pesticides, industrialchemicals, and toxic elements such asarsenic, lead, cadmium and mercury.On the positive side, they also measure the quantities of several essential


The Total Diet Study begins with the purchase of foodin several cities around the country. FDA inspector

Michelle Barry loads the first of several carts.

m i n e r a l s i n f o o d s .

Experts at FDA headquarters theninterpret the data and compare theresidue findings with daily intakelevels of contaminants found acceptable by the Food and AgriculturalOrganization of the United Nationsand by the World Health Organization. (An "acceptable" daily intakeis one that appears to present no appreciable risk.) Although residues of70 to 80 pesticides, pesticide metabolites (breakdown products), and industrial chemicals are frequentlyfound, they are always well belowF A O / W H O l i m i t s .

Only once has a residue reached alevel considered of health significance: In 1966 the pesticide dieldrinapproached the FAO limit. Since thattime, dieldrin has been banned foruse on food crops and residue levelshave declined steadily.

The Total Diet Study was inaugur a t e d i n 1 9 6 1 t o m e a s u r e l e v e l s o fvarious substances in kitchen-prepared foods. It is unlike most otherFDA food survei l lance programs

because it analyzes table-ready foods(as purchased or prepared) ratherthan raw or unprocessed commodi t i e s . S i n c e t h e a m o u n t o f c h e m i c a lr e s i d u e s a n d m i n e r a l s i n f o o d c a n b eaffected by processing, cooking,washing, peeling and other forms ofpreparation, table-ready foods give amore accurate picture of the actualA m e r i c a n d i e t .

The Total Diet laboratory is specially equipped and staffed to finda n d m e a s u r e l o w l e v e l s o f s e v e r a lhundred chemicals that might bepresent in food. Unfamiliar chemicalsfrequently show up, so a special research team established in 1981, theTotal Diet Research Center, assists inidentifying unknowns and in developing new and improved analyticalmethods for the program. Severalmethods originated in the Total Dietprogram have been published for useby the scientific community at large.

Once a year, food samples are alsosent to FDA's Winchester Engineering and Analytical Center in Massachusetts, where they are analyzed for


A forest of separators funnels marks a corner of theTotal Diet laboratory where technician Kevin dineprepares extracts from food samples that will be

analyzed for chlorphenoxy acid herbicides.

radioactive isotopes.The Total Diet program supple

ments FDA's routine and specialfood surveillance programs, servingas a backup and occasionally anearly warning system for contaminat i o n i n c i d e n t s .

In one instance, fish meal intendedfo r use i n ch i cken f eed became cont a m i n a t e d i n a w a r e h o u s e w h e r e afire had vaporized PCBs in a largee l e c t r i c a l t r a n s f o r m e r . C h i c k e n s t h a thad ea ten the feed were la te r co llected for analysis in the Total DietStudy. The laboratory discoveredrelatively high PCB levels and alertedFDA headquarters. It happened thatthe contamination had just been discovered in the course of a separateFDA investigation—but it was clearthat the warning system wasw o r k i n g .

Several years ago residues of PCP(pentachlorophenol) were detected inunflavored gelatin, a product madefrom collagen derived from animalh i d e s a n d o t h e r t i s s u e s . P C P w a sonce used in slaughterhouses as a

fungicide to retard spoilage of animalhides awaiting shipment (sometimesto gelatin manufacturers), but thisuse of PCP had long been stopped inthe United States. FDA investigatedthe gelatin manufacturer and discovered he was producing a mixtureof domestic and imported gelatin.The foreign gelatin was found toc o n t a i n P C P a n d w a s d i v e r t e d f r o mf o o d u s e .

Over the years the Total DietStudy has tracked residues fromseveral groups of pesticides, includingorganochlorine or chlorinated pesticides (DDT, dieldrin, heptachlor); or-ganophosphates (parathion, mala-thion); chlorophenoxy acids (herbicides such as 2,4-D and 2,4,5-T); andcarbamates (from an important, relatively new family of pesticides thatincludes such compounds as carbaryland carbofuran).

The Total Diet Study has shown asteady decline in the levels of chlorinated pesticide residues over the pastdecade. DDT, once widely used butnow banned, shows up today only at

to / April 1984 / FDA Consumer

Chemist Kent Fan! enters data into an inductivelycoupled plasma spectrometer, a device that measures

quantities of essential minerals in food.

very low levels and almost always inproducts of animal instead of plantorigin. However, low levels of DDE,a breakdown product of DDT, arefound in about 40 percent of samplescurrently being analyzed. Since thesechemicals can accumulate in the fattytissues of animals exposed to them,the findings indicate that environm e n t a l c o n t a m i n a t i o n c o n t i n u e s b u tis declining. Low-level, decreasingd i e l d r i n r e s i d u e s a l s o c o n t i n u e t o b efound in products of animal origin.

A t t h e s a m e t i m e t h a t l e v e l s o fchlorinated residues are diminishing,the Total Diet Study is showing anincrease in the frequency of low-levelresidues of organophosphate pesticides. Most common is malathion,today being found in approximately20 percent of food items analyzed.

About a dozen previously undetected pesticides have been found sincethe revised Total Diet Study began in1982 (see accompanying article).More r es i dues have a l so been de tec ted in potatoes and peanuts as a result of analyzing foods individually

instead of in composites, which wasd o n e b e f o r e 1 9 8 2 . T h e s e r e s i d u e s a r eusually metaboli te and breakdownproducts of sprout-suppressant chemicals in potatoes and soil fungicidesin peanuts.

E s s e n t i a l m i n e r a l s e v a l u a t e d i n t h eTotal Diet Study are iron, calcium,phosphorus, copper, manganese,magnesium, potassium, sodium,iodine, selenium and zinc. Two ofthese, iodine and sodium, seem to bemore than plentiful in the U.S. diet.T h e m i d - 7 0 s ' To t a l D i e t d a t a i n d i c a t et h a t i n t a k e o f i o d i n e i s t w o t o fi v etimes the U.S. Recommended DailyAllowance (RDA) for all groups, andthat dairy and grain and cereal products are proving extremely frequents o u r c e s o f t h a t m i n e r a l . I o d i n e c a n

get into dairy products via feed supplements, iodized salt blocks, someveterinary medications, and productsused to sanitize equipment and housing for animals. Iodine can be addedto cereal and grain products via certain dough conditioners, and it turnsup in some food colorings and other


Technician Betty Davis monitors the ashing of foodsamples in preparation for lead and cadmium analysis.

additives. There is growing beliefthat iodine, once deficient in manyareas, is now excessive in U.S. diets(see "Iodine: Going From Hypo ToHyper" in the April 1981 FDA Consumer).

Grain and cereal products are thelargest sources of sodium amongfoods studied in the Total Diet Studyexcept for salt added directly by thec o n s u m e r. O t h e r r e s e a r c h h a s s h o w nthat the average American's dailyintake of sodium is 4 to 5 grams,considerably higher than the 1.3 to3.3 grams per day estimated by theN a t i o n a l R e s e a r c h C o u n c i l t o b e a n"adequate and safe intake." Sodiumis also added to many foods as salt(sodium chloride) and in other ingredients during processing. The datagenerated by the Total Diet Studyhelped support FDA's decision topropose voluntary sodium labelingfor foods and to encourage foodprocessors to reduce sodium contentin the products they manufacture.

FDA's Total Diet Study continuesto be the most comprehensive anal

ysis of the American diet. Total Dietfindings are used by the Environmental Protection Agency and other government agencies, nutritionists andother health professionals, industryand consumers in evaluating levels ofc h e m i c a l c o n t a m i n a n t s a n d s o m e e ss e n t i a l n u t r i e n t s i n t h e U . S . d i e t .Other governments have establishedsimilar programs to survey their foodsupply, and FDA has trained a number of foreign chemists in Total Dietanalytical procedures.

Louise Fenner is a member of FDA'spublications staff.


H o w Yo u r D i e tIs Analyzed

At one time the Total Diet Studyevaluated three standard projecteddiets: those of a typical teen-age boy(considered the family's biggest eater),a 2-year-old toddler, and a 6-month-old infant. (The normal caloric intake of the teen-age boy, 2,800 to3,000 calories, was raised to almost4,000 calories as an added safetymargin.) The diets were based on the1965 Household Food ConsumptionSurvey of the U.S. Department ofAgriculture. Every year FDAanalyzed 30 "market baskets" offood bought in supermarkets. Ofthese, 20 baskets were geared to theadult (teen) diet and 10 to infantsa n d t o d d l e r s . O n e m a r k e t b a s k e t

encompassed a two- to four-weeksupply of food, depending on thediet being studied.

E a c h a d u l t m a r k e t b a s k e t c o nt a i n e d a b o u t 1 2 0 i t e m s . T h e f o o dwas divided into 12 groups andblended into composites of similartypes of items, such as root vegetables, dairy products, or grains andcereals .

In spring 1982 the Total DietStudy was modified to account forchanges in American eating habitsand to provide more specific inform a t i o n a b o u t i n d i v i d u a l f o o d s . F D Aturned to an updated version of theUSDA food consumption survey donein 1977-78, and to the Second Nat i o n a l H e a l t h a n d N u t r i t i o n E x a m i n ation Survey (HANES) of the NationalCenter for Health Statistics, done in1976-80. Together these surveys queried some 50,000 people and collectedinformation on 3,700 foods Americans are eating. From these, FDAse lec ted 234 food i t ems fo r a rev i sedmarket basket. In addition to stapleitems, the new market basket includes convenience products such asa frozen dinner and frozen pizza, afew fast-food items purchased fromrestaurants, some homemade dishes

such as lasagna and spaghetti withmeat sauce, and—for the f irst t ime-alcoholic beverages.

The revised Total Diet Study evaluates the diets of eight groups ofA m e r i c a n s i n s t e a d o f t h r e e . A m a t he m a t i c a l m o d e l t a k e s i n t o a c c o u n tthe amount and types of foods typically eaten by various populationgroups. Using this model, data fromt h e 2 3 4 - i t e m m a r k e t b a s k e t c a n b e

applied to the diets of infants, toddlers, teen-age females and males(age 14 to 16), adult females andmales (25 to 30), and older femalesand males (60 to 65).

Another important change is theswitch to analyzing individual foodsinstead of composites. Compositespresented the problem of dilution—that is, contaminants or mineralswere mixed throughout the entirecomposite and were diluted duringanalysis.

In the current study, four marketbaskets are collected and analyzedeach year, one each from the eastern,western, central and southern regions

of the country. FDA employees visitsupermarkets in three cities withinthe same region, purchase exactly thesame 234 items, pack them with dryice if necessary, and ship them toKansas City. Each market basket iscollected over a four-week period.

Foods ready to eat—such as freshfruit or quarter-pound hamburgers—are analyzed as is, after suitable laboratory preparation. The rest of thefood goes to the home economicsdepartment of St. Mary College innearby Leavenworth, Kan., where,under a contract with FDA, it isprepared as it would normally bee a t e n . H e r e c a k e m i x e s a r e t u r n e dinto cakes, pancake mixes into pancakes, and ingredients from the supermarket into lasagna, homemadepork chow mein, beef stew, and thel i k e . T h e n b a c k t o t h e F D A l a b o r a

tory, where identical foods collectedin the three cities are combined intoa single sample. If unusual findingsturn up, analyses are performed onreserve portions of the samples whenpossible (e.g., nonperishable items).


Questions Of Substance(s)Concern Cosmet ic Users

73 ousseau once said, "Man can be cured of every folly but vanity. " FromJ\ the amount of money spent on cosmetics these days, it's safe to say thattimes haven't changed much. Last year more than $10 billion was spent onhair preparations, mouthwash, makeup, shaving cream and perfume. Butalong with our love for looking pretty is a need to reassure ourselves aboutthe safety of cosmetic products. To help people who are concerned aboutwhat's in the cosmetics they use, here are some answers to typical questionsreceived in the mail by the Food and Drug Administration. The answers wereprepared by experts in FDA's cosmetics division.

of this and the complexity of mostfragrance formulas, these substancesmay be listed as "fragrance" on thel a b e l .

Thus, the designation "and otheringredients" on the label of thispolish remover is an FDA-approvedway to describe ingredients that arerecognized as trade secrets and which

QI want to inquire about a. substance called BHT foundin some soap products. Is it a carcinogen?

A BHT is used at very low. l e v e l s a s a n a n t i o x i d a n t t h a tprotects against rancidity or discoloration. We are not aware of any information that indicates BHT may beh a r m f u l o r c a n c e r o u s w h e n s o u s e din soap.

9p o n s ,

A t t ached t o t h i s l e t t e r i s alabel from a bottle of nail

polish remover. I call your attentionto the contents: acetone, water, otheringredients. What are other ingred i e n t s ?

A Cosmetics labeled after April. 15, 1977, must declare theiringredients. Ingredients must be listedby uniform names in descending order of predominance. This means thefirst ingredient shown must be present in the largest amount. Ingredientsthat constitute less than 1 percent ofthe product need not be listed inorder of predominance, andcolor ingredients may belisted in any order, regardlesso f t h e a m o u n t u s e d i n t h e

p roduc t .The ingredient list

is not requiredt o i n c l u d e t h e n a m e sof specific fragrances orflavors used in a product.These may be listed simply as"fragrance" or "flavor." Someingredients used in cosmetics areclaimed by the manufacturer to betrade secrets. If FDA agrees that aspecific ingredient is a trade secret, itneed not be carr ied on the l is t . Because

]4 / April 1984 / FDA Consumer

the manufacturer is not required torevea l .

Does using cosmetics such aseye liner, eye shadow, blush,

foundation, or any other cosmeticfor that matter, have any long-termeffects?

A Very little is known about• the long-term effects of cosmetics. A long-term effect may besystemic and not just an irritation onthe surface of the skin. Many ingredients can penetrate the skin. Skinpenetration studies are now underway to determine likely chronic effects of some cosmetic ingredientsfrom long-term use.

9f m o

A highly advertised bodyspray product contains the

following ingredients: SD alcohol40B, isobutane, propane, fragrance,propylene glycol. While the advertising of this product entices consumersto buy it because of its seeminglysensuous smell, it contrasts with thewarning on the label that states: "Intentional misuse by deliberately concentrating and inhaling contents canbe harmful or fatal. " Which of thelisted ingredients would cause harmful or fatal consequences if inhaleddirectly and why would the manufacturer put a dangerous chemical in theproduc t?

A The problem is not one of• toxicity of any particular ingredient under usual use conditionsbut of misuse causing oxygen deprivation. Such a warning is requiredfor self-pressurized containers inwhieh the agent used to expel theproduct is partially or wholly a halo-carbon or hydrocarbon. Such propel-lants have been responsible for thedeaths of persons, usually juvenilesand adolescents, who concentratedthe vapors from such products andinhaled them to induce a euphoriceffec t , or "h igh. "

According to reports of thesecases, the sprays have been concentrated in a number of ways, often byspraying the contents of the con

tainer into a plastic bag.The required warning statement is

intended to caution against deliberater a t h e r t h a n a c c i d e n t a l m i s u s e . F D Adoes not have any information thatinjuries or deaths have ever resultedfrom normal use of the productsi n v o l v e d .

QAre too many permanent• waves bad for the health? Dotney have any relationship to cancer?

A Generally speaking, perma-• nent wave products presentn o h a z a r d t o t h e c o n s u m e r w h e nused according to directions onnormal healthy hair and scalp, although some consumers may occasionally experience minor itching andscalp reddening or, in some cases, anallergic reaction.

QAn advertisement for a cos-m m e t i c c r e a m c l a i m s t h a t i t" h a s b e e n F D A - c l e a r e d a s a m u l t i -

faceted moisturizing, oxygen-trans-porting cosmetic preparation. " Is thist r u e ?

A The advertisement mentions« that this product has been"cleared" by FDA. This statement isu n t r u e . F i r m s t h a t m a n u f a c t u r e c o smetics are neither required to registertheir company nor to obtain premar-ket FDA approval for their formulas.

Some statements made for products are in the nature of "puffery"

to promote the product. Cosmeticmanufacturers often claim their products contain some secret ingredientthat is superior to the ingredientsused by other brands or some magicformula that will accomplish extraordinary results. But the great majorityof cosmetic products in any category—lipstick, face creams, etc.—basically are similar in composition.A popularly priced cream or lotionusually is just as effective in keepingthe skin soft as the most expensiveface cream. In the expensive creamthe buyer may be paying for a prettyjar, an appealing fragrance, or afeeling and aura of exclusivity.

/ am interested in obtaining• the name of a hair coloringwould be nonallergenic and

would not contain any coal-tar hairdye.

A As a regulatory agency, the. F o o d a n d D r u g A d m i n i s t r ation is not permitted to recommendbrand-name products. Even if permitted, it would be unwise to do so,since any ingredient in any productmay cause a reaction in some sensitive person.

Coal-tar hair dyes are exemptedf r o m t h e a d u l t e r a t i o n a n d c o l o r a d d itive provisions of the Food, Drug,a n d C o s m e t i c A c t i f t h e l a b e l s b e a r acaution statement alerting consumerst o t h e r i s k o f s k i n i r r i t a t i o n .

The warning label is as follows:"Caution—this product contains

certain ingredients which may causes k i n i r r i t a t i o n o n c e r t a i n i n d i v i d u a l sand a preliminary test according toaccompanying directions should firstbe made. This product must not beused for dyeing the eyelashes oreyebrows; to do so may causeb l i n d n e s s . "

If a label bears this warning statement, the additional measures thatFDA can take to protect the publicare severely limited unless Congressrepeals the exemption for coal-tarproducts. In the past, many billshave been proposed by Congress, butnone has passed.

F D A C o n s u m e r / A p r i l 1 9 8 4 / 1 5

Do \burself A Flavorby Holly H. Shimizu

"Take one bay leaf" is good recipe advice for many soups, stews, casseroles andthe like. Here the author, who is curator of the national herb garden, clips abasketful of leaves from the cooking bay, Laurus nobilis, a.k.a. the classic laurelof antiquity. She's just reducing the foliage to keep the plant from outgrowing itsgreenhouse space.

1 6 / A p r i l 1 9 8 4 / F D A C o n s u m e r

Herbs can provide creative, tasteful alternatives to salt for flavoring foods.Through the skillful use of herbs and spices, imaginative flavors can becreated and simple foods made into gourmet delights.

Herbs and spices differ only in that herbs tend to be plants grown intemperate areas while spices grow in tropical regions. Many people prefer togrow their own herbs to have a fresh supply throughout the growing season,thereby assuring top quality. Professional cooks prefer fresh herbs, ifavailable. But fresh herbs are less concentrated, and two to three times asmuch should be used if a recipe calls for dried herbs.

If growing herbs for drying, the harvesting should be done in the morningafter the dew has evaporated but before the sun is very bright. The essentialoils in herbs will evaporate into the atmosphere during the day, so it is important to collect them when flavor is at its peak. Cut only the amount to beused in one day.

The herbs should be dried in bunches or laid on screens in a warm, dark,well-ventilated spot. An attic is ideal although closets or dry basements willsuffice. Ideally, the temperature should not be over 90 degrees. If it's toohot, the herbs will cook. The length of time required for drying will varyaccording to the thickness of the plant parts. Herbs should be stored awayfrom direct sunlight to prevent bleaching. Be sure they're well labeled. Mostdried herbs will keep for at least one year in glass or plastic containers. Buteventually they lose most of their potency and should then be thrown out.Certain herbs, such as chives, parsley, French tarragon, mint, basil, lovage,and sorrel, keep well in the freezer. Put them into individual plastic bags orsmall plastic jars and freeze them.

There are no strict limits to the use of herbs. A good general rule is not tomix two very strong herbs together, but rather one strong and one or moremilder flavors to complement both the stronger herb and the food.

Here are some tips for cooking with herbs and spices:• In general, the weaker the flavor of the main staple item, the lower thelevel of added seasoning required to achieve a satisfactory balance of flavorin the end product.• Dried herbs are stronger than fresh, and powdered herbs are stronger thancrumbled. A useful formula is: 1/4 teaspoon powdered herbs = 3/4 to 1teaspoon crumbled = 2 teaspoons fresh.• Leaves should be chopped very fine because the more cut surface exposedt h e m o r e fl a v o r w i l l b e a b s o r b e d .• A mortar and pestle can be kept in the kitchen to powder dry herbs whenn e c e s s a r y .• Scissors are often the best utensil for cutting fresh herbs.• Be conservative in the amount of an herb used until you're familiar with itsstrength. The aromatic oils can be strong and objectionable if too much is used.• The flavoring of herbs is lost by extended cooking. Add herbs to soups orstews about 45 minutes before completing the cooking. But for cold foodssuch as dips, cheese, vegetables and dressings, herbs should be added severalhours or overnight before using.• For casseroles and hot sauces, add finely chopped fresh or dried herbsdirectly to the mixture.•To become familiar with the specific flavor of an herb, try mixing it withbutter and/or cream cheese, let it set for at least an hour, and spread on aplain cracker.• Beware when purchasing herbal salt blends. Many are merely herbs addedto salt. Read the ingredients carefully or just blend your own combinations.• Dried herbs should be stored in plastic bags, boxes or tins rather thancardboard containers. Keep the containers out of the direct sunlight (becausethat will bleach their color and reduce their strength) and don't place themtoo near the stove (to avoid the high humidity).

Heading back excessive growthwith pruning shears is one wayto keep this plant of cardamom(Elettaria cardamomum) healthy.Although its leaves look lush,it's actually grown for its spicyseeds, prized in wanner countries for curries and such.


Strengths of HerbsStrong or Dominant Flavors: These should be used with care since theirflavors stand out—approximately one teaspoon for six servings. They includebay, cardamom, curry, ginger, hot peppers, mustard, pepper (black), rosemary, and sage.M e d i u m F l a v o r s : A m o d e r a t e a m o u n t o f t h e s e i s r e c o m m e n d e d — o n e t o t w o

teaspoons for six servings. They are basil, celery seed and leaves, cumin, dill,fennel, French tarragon, garlic, marjoram, mint, oregano, savory (winter andsummer), thyme, and turmeric.Delicate Flavors: These may be used in large quantities and combine wellwith most other herbs and spices. This group includes burnet, chervil, chives,and parsley.H e r b B l e n d s

Herbs can be combined for specific foods. Having the combinations onhand will speed cooking and enhance one's reputation as a gourmet. Theycan be added loosely or wrapped in cheesecloth and removed before serving.Following are some suggested herb blends :

F i sh he rbs :

Some herbs grow well in thegreenhouse or on a sunny win-dowsill, need plenty of sun andair circulation, and may have insect and disease problems. Theseare mint (left foreground), prostrate rosemary (left background),thyme (right foreground), andanother variety of thyme (pot incenter).

Poultry herbs:

Sa lad herbs :

Tomato sauce he rbs :

Vegetable herbs:

I t a l i a n b l e n d :

B a r b e c u e b l e n d :

F r e n c h h e r b a l c o m b i n a t i o n s :

• F ines he rbes :

• Bouquet garni mixtures:

Bas i c he rb bu t te r :

Herb vinegars:

basil, dill weed (leaves), garlic, parsley

basil, bay leaf (crumbled), French tarragon,lemon thyme, parsley (options: fennel, sage,savory)

lovage, marjoram (two parts), sage (threeparts)

basil, lovage, parsley, French tarragon

basil (two parts), bay leaf, marjoram,oregano, parsley (options: celery leaves,cloves)

basil, parsley, savory

basil, marjoram, oregano, rosemary, sage,savory, thyme

cumin, garlic, hot pepper, oregano

parsley, chervil, chives, French tarragon(sometimes adding a small amount of basil,fennel, oregano, sage or saffron)

bay, parsley (two parts), thyme. The herbsmay be wrapped in cheesecloth or theparsley wrapped around the thyme and baylea f .

one stick unsalted butter, one to three tablespoons dried herbs or two to six tablespoonsfresh herbs, 'A teaspoon lemon juice, andwhite pepper. Combine ingredients and mixuntil fluffy. Pack in covered container andlet set at least one hour. Any of the culinaryherbs and spices may be used.

Heat vinegar in an enamel pan and pour itinto a vinegar bottle and add one or severalculinary herbs (to taste). Do not let thevinegar boil. Let the mixture set for twoweeks before using. Any type of vinegarmay be used, depending on personal prefe rence .


Herb Blends To Replace Salt

(These can be placed in shakers and used instead of salt.)

Saltless surprise:

Pungent salt substitute:

Spicy saltless seasoning:

2 teaspoons garlic powder and 1 teaspooneach of basil, oregano, and powderedlemon rind (or dehydrated lemon juice).Put ingredients into a blender and mixwell. Store in glass container, label well,and add rice to prevent caking.

3 teaspoons basil, 2 teaspoons each ofsavory (summer savory is best),celery seed,ground cumin seed, sage and marjoram,and 1 teaspoon lemon thyme. Mix well,then powder with a mortar and pestle.

1 teaspoon each of cloves, pepper, and coriander seed (crushed), 2 teaspoons paprika,and 1 tablespoon rosemary. Mix ingredients in a blender. Store in airtight cont a i n e r .

Th is he rb cen te r i nc ludes herbs

drying and stored in jars, herbjelly, mortar and pestle forgrinding or pulverizing leaves orother plant parts, and a bottleof vinegar. Dried plant partswill release more of the essentialoils or flavor if crushed just before using in a recipe.

W h a t G o e s W i t h W h a t

Soups: bay, chervil , French tarragon, marjoram.parsley, savory, rosemary

P o u l t r y : garlic, oregano, rosemary, savory, sage

Beef: bay, chives, cloves, cumin, garlic, hot pepper, marjoram, rosemary, savory

L a m b : garl ic, marjoram, oregano, rosemary.thyme (make little slits in lamb to beroasted and insert herbs)

P o r k : coriander, cumin, garlic, ginger, hot pepper, pepper sage, savory, thyme

C h e e s e : basil, chervil, chives, curry, dill, fennel.garlic chives, marjoram, oregano, parsley.sage, thyme

F i s h : chervil, dil l, fennel, French tarragon.garlic, parsley, thyme

F r u i t : anise, cinnamon, coriander, cloves, ginger.lemon verbena, mint, rose geranium, sweetcicely

B r e a d : caraway, marjoram, oregano, poppy seed.rosemary, thyme

Vegetables: basil, burnet, chervil, chives, dill, Frenchtarragon, marjoram, mint, parsley, pepper.t hyme

S a l a d s : b a s i l , b o r a g e , b u r n e t , c h i v e s , F r e n c h t a rragon, garlic chives, parsley, rocket-salad,sorrel (these are best used fresh or added tosalad dressing. Otherwise, use herb vinegarsfor extra flavor).

Holly H. Shimizu is curator of the herb garden at the U.S. NationalArboretum in Washington, D.C.


Bee PollenA s AHealth Food

by Tim Larkin

It seems there's always someonewilling to consider unlikely substances as capable of curing an illnessor promoting better health. In thecase of bee pollen, the philosophyseems to be that what's good forbees w i l l be be t t e r f o r humans .

Bee pollen is flower pollen gathered by the common honeybee andcarried to the hive on the bee's legsas tiny pods formed by mixing thepollen with nectar. The pollen is usedas food by the bees.

But some bees don't get their foodb e c a u s e h u m a n s h a v e i n t e r v e n e d t oclaim the supply for themselves.Humans get into the act by placingdevices in the hive that strip the beeof her pollen before she can deliver.The purloined pollen is collected intrays, processed into several forms,and marketed as an extraordinarilynutritious food, often accompaniedby claims of therapeutic qualities.

The idea of what's good for thebee is good for the beekeeper needsexamination. Following are some ofthe principal claims made for beepollen, along with scientific evidencea n d o t h e r f a c t s a s s o c i a t e d w i t h t h o s ec l a i m s .

Claim: Pollen is a ''giant germk i l l e r i n w h i c h b a c t e r i a c a n n o te x i s t . "

T h e m o s t a u t h o r i t a t i v e s c i e n t i fi c

study of the biology, biochemistryand management of pollen {Pollen,by R.G. Stanley and H.F. Linskens)shows that pollen, when exposed toair, is rapidly attacked by bacteria,yeast and other fungi. Therefore,consumers should use the same precautions when storing pollen as with

any other perishable food product.C l a i m : P o l l e n i s n a t u r e ' s m o s t

perfect food.There is no one perfect food, only

t h o s e t h a t a r e b e t t e r f o r v a r i o u sforms of life. The perfect food forthe sea cucumber is organic debrissucked up from the ooze at theocean's bottom. To larva of the sil-phid beetle, decaying meat is a perfect food. For the hookworm, there'snothing better than blood. Accordingto studies by the National Academyof Sciences, the best dog food differsf r o m t h e b e s t c a t f o o d w h i c h d i f f e r sfrom the best guinea pig food, anda l l o f t h e m d i f f e r f r o m t h e i d e a lhuman diet. Thus, because pollenmay be the best food for bees (or atleast the best they can lay their hindlegs on), there is no basis for a conclusion that it is the best, or anywhere near the best, food for humanbeings.

Claim: Pollen retards aging, aswitness the longevity of natives ofthe mountains of Russian Georgiawho owe it all to their pollen-richd i e t .

According to a study of the eatinghabits of elderly persons in the Caucasus region of Soviet Georgia, "Sixty percent ate a mixed diet of milk,vegetables, meats, and fruits. Seventypercent of the calories were of vegetable origin and the remainder frommeat and dairy products. Seventy to90 grams of protein were included int h e d i e t s . M i l k w a s a m a i n s o u r c e o f

protein." Although honey (whichdoes contain some pollen) was sometimes included in the breakfast menu,along with cheese, bread and tea, thescientists conducting the study madeno mention whatever of bee pollen,even though they were looking forsome dietary clue that might explainwhy these people live so long. Onecentenarian's recipe might be lesst h a n a t t r a c t i v e t o t h o s e m e n w h obelieve bee pollen wards off old age.Gabriel Chapnian, estimated to be117, gave his prescription for longevity as: "Active physical work, and am o d e r a t e i n t e r e s t i n a l c o h o l a n d t h el a d i e s . "

C l a i m : P o l l e n i s t h e r i c h e s t s o u r c eof protein known to science.

The major constituent of pollen iscarbohydrate, not protein. And theprotein quality of pollen varies, depending on the plant from which itcomes. As pointed out by Dr. Hachi-

ro Shimanuki, director of the BeeLaboratory at the U.S. Departmentof Agriculture Research Center inBeltsville, Md., the protein contentvaries, ranging from 5 to 28 percent.A study by the United Nations Foodand Agriculture Organization showsthat many foods contain more protein than even the bee pollen with thehighest protein content. For example,soybean cake contains 46 percentprotein; raw soybeans, 38 percent;dry pumpkin seed, 29 percent; brewer's yeast, 39 percent. For comparison, round steak is about 20 percentprotein.

The gross amount of protein doesnot give the full picture, however.Some protein sources contain all theessential amino acids in the properbalance needed by humans, butothers do not. Thus, dry gelatin,which is about 86 percent protein,has a low biological value because itis very low in some essential aminoacids. Most bee pollen does containall the essential amino acids, but thea m o u n t s o f i n d i v i d u a l a c i d s w i l l a l s o

vary with the climatic and nutritionalconditions of the plants on which thepollen matures.

Biological value means the amountof protein actually digested andt r a n s f o r m e d i n t o f o o d v a l u e . Te s t son rats by several researchers haveproduced information on weight gainrelated to protein intake of variouskinds. This ratio—called the "proteinefficiency ratio"—ranges from a highof 3.80 for eggs and 3.55 for fish toa low of -1.25 for gelatin. Legumes(beans and peas) are good proteinsources, having protein efficiencyr a t i o s o f a b o u t 1 . 5 . N o t e s t s o f t h i sk i n d h a v e e v e r b e e n c a r r i e d o u t f o rbee pollen. Indeed, we do not reallyknow what percentage of ingestedbee pollen, if any, is actually capableof being absorbed by the human digestive system. It should be noted,however, that the amounts usuallycontained in a capsule of bee pollenprovide an insignificant amount ofp ro te in .

It should also be pointed out thateven if bee pollens were rich in biologically available protein, there arefar less expensive protein sources, including fi let mignon.

Claim: Bee pollen relieves allergies,asthma and hay fever.

T h e r e a r e n o s c i e n t i fi c s t u d i e s t osupport this claim. On the contrary.


scientists believe that bee pollen isespecially hazardous for persons withallergies, asthma or hay fever. Dr.M. D. Levin, director of the CarlHayden Bee Research Center inTucson, Ariz., warns pollen users

. .to be aware of its potential totrigger an allergic reaction."

This view is supported by cases inscientific studies. In one instance, 15minutes after a 46-year-old man witha history of seasonal allergy took beepollen he developed anaphylacticshock and required emergency treatm e n t .

Dr. Steven Cohen, an allergy specialist conducting research on stinging insects and bee pollen at theMilwaukee County Medical Complex,tested two women who experiencedacute allergic reactions after eatingsmall quantities of bee pollen. Hestated that bee pollen can be deadlyto persons with allergies. ''Somepeople are sensitive enough that oralexposure to it will cause a significantreaction," he said. An entomologistwith the Mississippi Cooperative Extension Service, Dr. James Jarratt,also pointed out that, "If you werenot aware of a specific allergy, onethat you didn't notice due to the lowlevels of the allergen you encounterin day-to-day behavior, you might ingest a pretty good-sized slug of it inbee pollen and have an allergic reaction." This is fair warning for the 10to 20 percent of the U.S. populationt h a t s u f f e r s f r o m s o m e f o r m o f

allergy.C l a i m : Va r i o u s a t h l e t e s s t a t e t h a t

bee pollen has improved their perform a n c e .

Assuming the person making sucha statement is not doing it for a fee,such claims, called testimonials, arebased on personal belief, not evid e n c e o f e f f e c t i v e n e s s . M e d i c a l h i s

tory (as well as the history of foodfads) is crammed with instances ofpeople claiming various types of benefit from useless, and sometimes evenharmful, substances, primarily fromthe plant world.

During a high point of the quackpatent medicines era, just before the1906 Food and Drugs Act, magazinesand newspapers were full of testimonials about the curative powers of" m e d i c i n e s " t h a t w e r e l i t t l e m o r et h a n a l c o h o l a n d c o l o r e d w a t e r . S u c hads, then and now, capitalize on anoddity of human nature: People are

often (temporarily) helped, not bythe food or drug being touted, butby a profound belief it will help. Therenowned physician Sir William Osierh a d t h i s i n m i n d w h e n h e a d v i s e dphysicians . .to treat as many patients as possible with a new drugwhile it still has the power to heal."Some testimonials are sincere expressions of erroneous belief, and thestill mysterious translation of hopemagnified by belief into benefit, buto t h e r s a r e f r a u d u l e n t . A n d s o m e a r e

purchased. Noting how people lendtheir names to preposterous claims,one cynical newspaper editor said,"If your brains won't get you intothe papers, sign a 'patent medicine'testimonial. Maybe your kidneysw i l l . "

Claim: Scientific tests prove thatbee pollen enhances athletic perf o r m a n c e .

In a 1975 test sponsored by theN a t i o n a l A s s o c i a t i o n o f A t h l e t i c

Trainers, the Louisiana State University swimming team participated in asix-month experiment in which halfthe team took 10 pollen tablets aday, one-quarter received 10 placebotablets (externally identical to thepollen tablet but devoid of pollen),and the other quarter received fivepollen and five placebo tablets. Therewas no measurable difference in performance among the three groups.

The test later was repeated with 30swimmers and 30 high school crosscountry runners. As one of the researchers, Dr. John Wells of LSU,said, the bee pollen was "absolutelynot a significant aid in metabolism,workout training or performance."

Claim: Bee pollen can alleviate avirtual encyclopedia of ailments,including sexual malfunction and tendencies toward suicide. (One promotional pamphlet listed 80 separateafflictions, from "growing pains" tocancer, which it claimed bee pollenhad treated successfully.)

T h e r e i s n o v a l i d s c i e n t i fi c e v i d e n c efor any therapeutic benefit from beepollen. In view of what's knownabout bee pollen, compared withwhat's claimed, the conclusion of theauthoritative Stanley-Linskens studyis worth repeating. "While pollen, orits equivalent, may be irreplaceablein the bee diet," the study said, "wefail to see a correlation with suggeste d b e n e fi t s t o m a n "

What is the position of the Food

and Drug Administration regardingbee pollen? Under the law, since thepollen has not been shown to beharmful other than to those sufferingfrom an allergy, bee pollen may bemarketed as a food, provided no nutrition or therapeutic claims are madeor implied regarding it.

Thus, if the labeling (includingpamphlets or advertising associateddirectly with the product) does notsuggest that it is intended for useother than as food, bee pollen marketed as a food need meet only thesame general labeling requirements asother foods, and be prepared, packedand held in a sanitary manner.

Although FDA has legal authorityto require that new food additivespass certain tests before being allowed on the market, it cannot demand the same proof of foodstuffs,such as bee pollen. This is not thecase with drugs.

If those selling bee pollen, or anything else, claim it can cure or alleviate any illness or produce sometherapeutic benefit, the law says theproduct is a drug and must meetrigid scientific requirements for bothsafety and effectiveness. The exactlanguage of the law is strict andprecise. To gain approval as a newdrug, a product must support itsclaims by "adequate and well-controlled investigations, including clinical investigations, by experts qualifiedby scientific training and experiencet o e v a l u a t e t h e e f f e c t i v e n e s s o f t h e

drug involved, on the basis of whichit could be fairly and responsiblyconcluded by such experts that thedrug will have the effect it purportsor is represented to have under theconditions of use prescribed, recommended or suggested in the labelingor proposed labeling."

Obviously, some bee pollen distributors have been making drug claims.In a recent instance, FDA asked thatall shipments of a particular productand its promotional literature be immediately recalled by the manufacturer. The firm responsible swiftlycomplied, possibly aware that FDAcan take other steps. These includeseizure, injunction, and criminalprosecution where the law is violatedregarding sale of an unapproved drugor a product classified as a drug dueto therapeutic claims made for it.

Tim Larkin is a freelance writer.


Food Presen^tives:A Frcsh Reportby Chris Lecos

The 20th century has seen vast changes in agriculturaltechnology and food production and enormous demands upon the food industry. Food today is producedin massive quantities and transported not only coast-to-coast but to all parts of the world. It would be impossible for many foods to be processed, packed, shipped,stored and stacked on supermarket shelves safely for longperiods without chemical preservatives.

W i d e u s e o f c h e m i c a l a d d i t i v e s i n f o o d s i s o f c o n c e r nto many people, however, and it is the task of regulatoryagencies such as the Food and Drug Administration toprotect public health through enforcement of the nation'sfood safety laws.

Of the array of chemicals used in foods, some areadded to improve nutritional content; some to give color;some to impart or enhance flavor; and others to extendthe food's shelf life and stability. Some are added tokeep food from spoiling or from becoming rancid andpoor tasting. It is this last group—the preservatives—withwh ich we a re he re conce rned .

Humans have always sought ways to make food lastlonger and still be edible. Salt, sugar, acids, and smoke(for meat and fish) have been employed in the past topreserve food, in treatments usually done on the farm ori n t h e h o m e k i t c h e n .

Preservatives used by the modern food industry perform either or both of two major functions: As antimicrobial agents, they keep food from spoihng; and asantioxidants, they keep foods from becoming rancid ordeveloping off-colors and flavors.

Antimicrobial agents are added to food formulations toinhibit or prevent the growth of molds, yeasts and bacteria that spoil foods. Antioxidants are used in a widevariety of food products—particularly the large numberthat contain fats and oils—to prevent rancidity.

Antioxidants slow the development of off-flavors andodors and color changes, caused by chemical reactionsthat take place when foods are exposed to oxygen, moisture, heat, or certain enzymes present in many naturalfats. The time it takes for fats and oils to become rancidvaries with the particular fat and storage conditions.Unsa tu ra ted f a t s have l ess r es i s t ance t han sa tu ra ted f a t sto rancidity. Vegetable oils contain more unsaturatedfats, but also small amounts of naturally occurring antioxidants such as tocopherols. Although animal fats aremore saturated, they have fewer naturally occurring antioxidant substances. Therefore, animal fats generallyrequire added or higher levels of antioxidants than dovegetable oils.

T h e c h e m i c a l r e a c t i o n t h a t o c c u r s w h e n a f o o d b e

comes rancid is either oxidative or hydrolytic. In a hydro-lytic reaction, enzymes speed the reactions of the fat withother chemical elements of a food to produce foul-smelling fatty acids. An oxidative reaction results when foodsare exposed to oxygen.

Foods high in carbohydrates and protein also are subject to microbial deterioration that can affect flavor.Those with large amounts of carbohydrates also mayundergo changes in color instead of developing off-odorsand off-tastes. This change in color is sometimes referredto as the ''browning effect." Consumers are used to seeing this cosmetic defect in some fresh fruits and produce,after they are cut.

Since so many foods contain fats and oils, which aresusceptible to oxidative and other reactions that causerancidity and off-odors, the food industry considers itimportant to inhibit these reactions so as to extend theshelf life of the food products.

The 1938 Food, Drug, and Cosmetic Act gave FDAbroad authority to move against any chemicals in foodthat are unsafe for human consumption. This power wasstrengthened 20 years later with the passage of the FoodAdditives Amendment, which required those in the foodindustry desiring to add a substance to food to first demonstrate its safety. The 1958 amendment, however,applied only to new additives. Hundreds of substanceshad been in common use by the food industry at thetime. Many of those had a long history of use and wereconsidered safe. They were placed on what is known asFDA's GRAS (generally recognized as safe) list.

Starting in the early 1970s, FDA contracted with theFederation of American Societies for ExperimentalBiology (FASEB) to review the scientific literature todetermine which additives on the GRAS list could retaintheir status as GRAS substances. There are more thant w o d o z e n a n t i m i c r o b i a l s a n d a n t i o x i d a n t s o n F D A ' sGRAS list. There also are many other additives—including antimicrobial and antioxidant agents—that have comeinto use since 1958 and are regulated by FDA.

Of the more than two dozen GRAS antimicrobials andantioxidants, FDA has reaffirmed that six may continueto be safely used. These are benzoic acid, methylparaben,propyl gallate, propylparaben, sodium benzoate, andstannous chloride. Of the remainder, FDA has either notfinally acted on its published proposals to reaffirm theirsafety or is still evaluating data before taking finalaction. The two most widely used antioxidants still beingreviewed by the agency are butylated hydroxyanisole(BHA) and its related compound, butylated hydroxy-toluene (BHT).

BHA and BHT are used in a large number of productsthat contain fat and oil. Other substances often used incombination with BHA and BHT include propyl gallateand sometimes citric acid, phosphoric acid and ascorbicacid. These substances help enhance the effectiveness ofB H A a n d B H T .

A brief summary of these GRAS substances, their fooduses, and their status in FDA's continuing evaluationsf o l l o w s :

Ascorbates and erythorbates (ascorbic acid, ascorbyl pal-mitate, calcium ascorbate, erytborbic acid, sodium ascor-bate, sodium erytborbate)—FDA has proposed that all of


these antioxidants except calcium ascorbate be reaffirmeda s G R A S s u b s t a n c e s . FA S E B c o n c l u d e d i n 1 9 7 9 t h a t

using these substances in food presents no health hazard.In general, they are used in small concentrations to inhibit enzymatic browning and/or as preservatives in manyfoods and beverages, including concentr^^.ted milk products, some meat products, pickling brine for pork andbeef cuts, baked goods, soft and hard candies, fats andoils, gravies, breakfast cereals, and processed fruits andvegetables.

Ascorbic acid (vitamin C), a natural constituent inmany products and an essential nutrient, has many fooduses. It is used mostly as an antioxidant but is an antimicrobial in some foods. It is often used with other majorantioxidants—BHA, BHT and propyl gallate—to maket h e m m o r e e f f e c t i v e .

Ascorbyl palmitate is a fat-soluble antioxidant made bycombining ascorbic acid with palmitic acid. Calcium ascorbate and ascorbyl palmitate are derivatives of ascorbicacid but have more limited uses in foods. Erythorbic acida n d i t s s o d i u m s a l t a r e e f f e c t i v e a n t i o x i d a n t s b u t c o nt r i b u t e l i t t l e v i t a m i n C t o f o o d .

B e n z o i c a c i d a n d s o d i u m b e n z o a t e — B e n z o i c a c i d a n d i t ssodium salt, sodium benzoate, have been used as antimicrobial preservatives most of this century, particularly inhighly acidic foods. They are especially effective againstyeasts and bacteria, less so against molds. The GRASs t a t u s o f b e n z o i c a c i d a n d s o d i u m b e n z o a t e w a s a f fi r m e d

by FDA after FASEB reported there was no evidence ofa hazard to public health at the levels used by industryi n f o o d s .

Benzoic acid occurs naturally in some foods, includingraspberries, cranberries and other berries, prunes, cinnamon, cloves, tea, and anise. It is used mainly in condiments and relishes, sugar substitutes, imitation dairyproducts, nonalcoholic beverages, soft candy, chewinggum, baked goods, alcoholic beverages, frozen dairyproducts, fats and oils, gelatins and puddings, andcheese. Sodium benzoate, sometimes identified as benzoate of soda, is also used as an antimicrobial agent insweet sauces, baked goods, condiments and relishes,processed vegetables, salted margarine, seasonings andflavors, jams and jellies, fats and oils, gelatins andpuddings, frosting, processed fruit, imitation dairy products, gravies, alcoholic and nonalcoholic beverages, fruitices, milk products, soft candy, frozen dairy products,instant coffee and tea, meat products, breakfast cereals,hard candy, and cheese. By FDA regulation, the maximum level permitted in food for both ingredients is0.1 percent.

BHA (butylated hydroxyanisole and BHT (butylated hydroxy toluene)—BHA and a chemically similar compound,BHT, are antioxidants used for more than 40 years toretard rancidity in a wide array of food products containing fats and oils as well as in certain processed meatproducts. They are both direct additives and indirectadditives put into defoaming agents, food packagingmaterials, adhesives, and lubricants that come intoc o n t a c t w i t h f o o d .

T h e m o s t c o m m o n a n t i o x i d a n t f o r m u l a t i o n s c o m b i n e

BHA, BHT and/or propyl gallate with citric acid, according to the second edition of the Handbook of FoodAdditives (published by CRC Press, a division of theChemical Rubber Co.). These additives are consideredmore effective than other antioxidants to prevent rancidity in fats and oils. Potency, ability to prevent off-flavors and odors, and low cost are among the factorst h a t m a k e a n a n t i o x i d a n t a t t r a c t i v e o r u n a t t r a c t i v e t o

industry for use in food.BHA and BHT generally are used in breakfast cereals,

chewing gum, convenience foods, vegetable oils, shortening, potato flakes, enriched rice, potato chips, andcandy—to name some. Their ability to intercept oxygenbefore it gets to fat molecules is what makes them effective in keeping food from becoming rancid. FDA limitst h e i r u s e i n f o o d — a l o n e o r i n c o m b i n a t i o n w i t h o t h e rantioxidants—to no more than 0.02 percent of the totalf a t a n d o i l c o n t e n t . B H T i s u s e d l e s s t h a n B H A b e c a u s ethe former is less stable at high temperatures.

Parabens (methyl paraben and propyl paraben)-Used inmany foods for more than 50 years, these two antimicrobial agents were affirmed as GRAS by FDA. Closely rel a t e d t o b e n z o i c a c i d — w h i c h i s m o r e e f f e c t i v e i n a c i d i c

foods—methyl and propyl paraben are used to inhibitmolds and yeast in various foods but are not as effectiveagainst bacterial spoilage. Yeasts and molds are more ofa spoilage problem in foods high in acid and can be controlled better with the less costly sodium benzoate. Thetwo parabens are sometimes used to extend the effectiveness o f benzo ic ac id .

Both are listed as GRAS for addition directly to food,and they are permitted as indirect food additives in foodpackaging materials when used in adhesives for packaging, transport, or holding of food. Generally, these additives are used in such products as processed vegetables,baked goods, fats and oils, seasonings, sugar substitutes,frozen dairy products, processed fruit, jams, jellies,preserves, olives, pickles, syrups, soft candy, gelatins andpuddings, grain products, alcoholic and nonalcoholic beverages, cheese, and sweet sauces.

Propionic acid and its salts (calcium propionate, sodiumpropionate, dilauryl thiodipropionate, thiodipropionicacid)—Propionic acid and its salts, calcium propionateand sodium propionate, generally described as propionates, have been used extensively for many years in bakedgoods and in processed and blended cheese products. Thepropionates blend well with emulsifying agents used incheese and dough products and are effective againstfungi, but not against yeasts, and against organisms thatcause ''rope" in doughs. Characterized by gelatinousthreads in the center of a loaf of bread, rope is causedby a bacterium that contaminates dough and survivesbaking. The bacteria multiply and digest the bread, causing off-flavors, discoloration and softening. Baking destroys most molds but contamination can occur in thehumid environment within the bread wrapper if the addit i ves a re no t used .

Calcium propionate is commonly used in bread products. Sodium propionate is often used with pies andcakes. Many dairy products contain propionic acid as a


naturally occurring ingredient. It is partly responsible forthe aroma of butter and cheese, especially Swiss cheese.FDA regulations also permit propionic acid as an optional ingredient in artificially sweetened jams, jellies andp r e s e r v e s .

Dilauryl thiodipropionate and thiodipropionic acidwere approved as GRAS substances for use in productswith edible fat, but they are not considered as effectiveas BHA, BHT and other antioxidants. These two sulfur-containing compounds tend to cause odor and flavorproblems. FASEB's 1979 report revealed no use of thesesubstances in foods and said they were of "limitedvalue." However, FASEB said they may serve a moreimportant role in food-packaging film. FDA is considering whether to affirm their GRAS status. FDA at presentlimits their use, along with any other antioxidants, to atotal of 0.02 percent of the fat and oil content of foodand to 0.0005 percent in food when they migrate to itfrom the food package.

Propyl gallate—This widely used antioxidant was affirmed as a GRAS substance after FASEB concluded in1973 that present levels of commercial use posed nohealth hazard. Used in foods since 1948, propyl gallateo f t e n i s c o m b i n e d w i t h B H A a n d / o r B H T a n d e v e n o t h e radditives and put into fats, oils and fat-containing foodssusceptible to rapid rancidity and other oxidative reactions that could affect taste and color. Besides fats andoils, it is added to meat products, snack foods, bakedgoods, nuts, grain products, frostings, chewing gum, softcandy, frozen dairy products, gelatins and puddings, andalcoholic and nonalcoholic beverages.

Sorbic acid and its salts (calcium, potassium and sodiumsorbate)—Used in foods for more than 30 years, sorbicacid and its salts—often called sorbates—are used as antimicrobial preservatives and as sprays, dips or coatings onwrapping materials. A 1975 FASEB report found no evidence of potential harm to public health when sorbic acidand its salts are used at present or anticipated levels.FDA has proposed that they be affirmed as GRAS substances. FDA food standards, however, limit the amountso f s o r b a t e s a d d e d t o v a r i o u s f o o d s .

Sorbic acid and potassium sorbate are the only sorbates used as preservatives. They may be found in bakedgoods, fats and oils, milk products, cheese, frozen dairyproducts, processed vegetables and juices, condiments,soft candy and other confections, jams and jellies, sweetsauces, nonalcoholic beverages, and gravies. Potassiumsorbate also is used with processed fruits, juices anddrinks, fruit ices, meat and fish products, snack foods,alcoholic beverages, and seasonings and flavors.

Sorbic acid, a potent inhibitor of molds and fungi,generally is more effective over a wide range of acidlevels in foods and thus has broader uses than sodiumbenzoa te .

Sodium sorbate is considered too unstable for use as afood preservative, but it and potassium sorbate are listedas GRAS for paper and paperboard food-packaging materials. Calcium sorbate is employed mainly in margarine.

Stannous chloride (tin chloride)—Described as a chloride

salt of metallic tin, stannous chloride prevents oxygenfrom combining with chemicals in foods and causingcolor changes and offensive odors. It was affirmed as aGRAS substance by FDA after FASEB reported in 1974that it posed no health hazard. Its use in food cannotexceed 0.0015 percent, calculated as tin, under FDAregulations. Its main food uses are in processedvegetables, processed fruits, and nonalcoholic beverages.

Sulfiting agents (potassium bisulfite, potassiummetabisulfite, sodium bisulfite, sodium metabisulfite,sodium sulfite, sulfur dioxide)—Sulfiting agents such assodium bisulfite and sodium metabisulfite, marketed as"vegetable fresheners" or "potato whitening" agents, areused by the food service industry—restaurant salad barsare a major example—to keep lettuce and other vegetables fresh and crisp and to prevent discoloration offruits and other produce when cut or peeled.

In March 1983, after receiving reports of adverse reactions to sulfites among certain segments of the population, particularly asthmatics, FDA advised the stateagencies responsible for overseeing the food service industry that consumers should be informed when sulfitingagents are used through display of "conspicuous andeasily readable labels, signs, placards, menu statements"or by other means. FDA added that foods treated withsulfiting agents would not be considered safe unlessconsumers were properly informed of their use. The National Restaurant Association has since reported thatmany of its members have stopped using sulfiting agents.

Sulfur dioxide is a colorless gas that has been used formany years to sanitize food containers and fermentationequipment, to inhibit microbial spoilage, and as an antioxidant. Sulfur dioxide is not to be used in meats or otherfoods that are substantial sources of thiamine (vitaminB,) because of its adverse effects on this vitamin.

In 1982, FDA proposed to affirm the GRAS status ofsulfur dioxide, sodium bisulfite, and sodium and potassium metabisulfite, with limitations on their use, but notsodium sulfite and potassium bisulfite because of a lackof information about their current food uses. When FDAbecame aware of the more recent data on adverse reactions to sulfites in some people, the agency undertookfurther review and is reevaluating its earlier proposal.

Tocopherols—The tocopherols are a group of chemicallyrelated substances that, depending on the form of tocopherol, contribute varying amounts of vitamin E to thediet. There are eight known forms that occur naturally inanimal tissues and in vegetable oils, cereals, nuts, andleafy vegetables. Six other tocopherol derivatives are prepared commercially for use as antioxidants in foods,mainly to prevent fats and oils from becoming rancid.Alpha tocopherol is the most potent vitamin E compound. Mixed tocopherol concentrates have been used asantioxidants in food since 1949. These include bakedgoods and mixes, breakfast cereals, milk products,poultry products, gelatins, puddings, fillings, soups, soupmixes, snack foods, nonalcoholic beverages, seasonings,flavorings, and infant formulas.

Chris Lecos is a member of FDA's publications staff.


Heat Used To Fight Some Cancersby Richard C. Thompson

A medical device that uses controlled microwave energy tot rea t ce r ta in k inds o f cancer has been

approved by the Food and Drug Administration for marketing by them a n u f a c t u r e r .

With this approval, a techniqueknown as hyperthermia (hyper =excessive; thermia = heat) hasmoved from the experimental closerto the clinical, and prospects formanagement of four particular cancers is improving.

The approved device and proced u r e a r e f o r t r e a t m e n t o f t h e s e m a

lignant tumors: melanoma, a rare butvery malignant and likely fatal skincancer; squamous (basal cell) carcinoma, a less threatening but stilldangerous and fairly common skincancer that can spread into and beneath the skin; adenocarcinoma, asoft-tissue cancer that can grow andspread rapidly, with often fatalresults; and sarcoma, a bone andorgan cancer that also grows andspreads with fatal results. Hypert h e r m i a t r e a t m e n t i s l i m i t e d t opatients who have recurrent or regressive cancers of those types despite conventional therapy.

Hyperthermia is a palliative treatment, meaning that it suppresses andperhaps halts the growth of the cancer, but it is not a cure. It will beused to treat cancer sites followingthe present standard treatments ofradiation, chemotherapy and surgery.

FDA's approval was for a machineproduced by BSD Medical Corp. ofSalt Lake City.

Clinical studies sponsored by thefirm began in 1981 and involved 10institutions, including the Universityof Utah, Loma Linda University inCalifornia, Presbyterian MedicalCenter in Denver, Swedish TumorInstitute in Seattle, and the University of Wisconsin.

In the course of the two-yearstudy, researchers treated 179 pa

tients who had late-stage tumors,using hyperthermia combined withradiation. Some additional patientswere treated with hyperthermia only,some with hyperthermia and othertherapies.

After 1,640 hyperthermia treatments on these patients, researcherse v a l u a t e d 2 1 8 t u m o r s i t e s a n d f o u n dthat 81 tumors showed full regression, another 60 showed at least 50percent regression, and another 40showed partial regression. The netresult was full to partial regression of83 percent of the tumors.

Hyperthermia devices radiate energy,m u c h l i k e t h a t o f a m i c r o w a v e o v e n .This energy enters body tissue andsilently bombards the cell molecules,causing the tissue to heat up. In living tissue, heat is carried away by theblood that flows through (perfuses) thetissue. Solid malignant tumors have amuch smaller blood supply than thato f n o r m a l t i s s u e a n d t h e r e f o r e l e s sability to have heat carried away.When hyperthermia is applied, tumorswill reach a relatively higher temperature than surrounding normal tissueand that destroys the tumor cells.

To administer hyperthermia, thepatient is positioned beside themachine, and the physician directs abeam of microwave energy from asmall, horn-like applicator to thet u m o r. T h e b e a m h e a t s t h e c a n c e rcells to 108 to 113 degrees Fahrenheit(42 to 45 degrees Celsius), in effect''cooking" the malignant tumor andcausing cells to die. Repeatedlyheating such tumors for up to anhour can cause the tumor to shrink,o r r e g r e s s .

During treatment the machine continually monitors the temperature ofthe tumor and the surrounding tissuethrough needle-like probes insertedinto the body. It automatically adjusts power to maintain the temperature set by the operator. This ensuresthat the tumor is receiving the in

tended dose of thermal energy andthat surrounding healthy tissue is noto v e r h e a t e d .

The possibility of using heat tosuppress the growth of cancer cells inthe body has long intrigued medicalr e s e a r c h e r s . T h e r e a r e n u m e r o u sa n e c d o t e s i n m e d i c a l l i t e r a t u r e -

many of them confirmed—of a tumormysteriously disappearing after thepatient had a high fever. Appliedhyperthermia had to wait, however,until the technology was more fullydeveloped and its medical uses betteru n d e r s t o o d .

Hyperthermia will be used chieflyby oncologists—physicians who specialize in cancer—and by certainradiologists and others who havesimilar specialization. It is not anoffice procedure but will be offeredin those medical centers throughoutthe country where such specialists arelocated and where the equipment isi n s t a l l e d .

F D A ' s N a t i o n a l C e n t e r f o r D e v i c e sand Radiological Health, which isresponsible for the approval of thehyperthermia machine, will continuemonitoring the performance of thisnew technology. The center's staff isproviding technical support to theN a t i o n a l C a n c e r I n s t i t u t e f o r e v a l u ation of equipment for hyperthermiatreatment of cancer and is assistingin the selection and analysis of thermometry (measuring) equipment needed with hyperthermia. The center hasdesigned a calibration system for thethermometer probes used in hyperthermia and also has developedmater ia ls known as "phantoms,"which are foam and plastic shapesthat have the same density as humant i s s u e . T h i s a l l o w s m a n u f a c t u r e r s t otest their machines without usinghuman subjects.

Richard C. Thompson is a memberof FDA's publications staff.


T h e N o t e b o o k

The Notebook: a potpourri of items of interestgathered from FDA news releases, other newssources, and the Federal Register (designated PR,with date of publication). The Federal Register isavailable in many large public libraries.

■ The week beginning April 23 has been design a t e d N a t i o n a l C o n s u m e r s W e e k w i t h t h e t h e m e"Consumers Mean Business" {PR Jan. 6).

■ C o n s u m e r s i n t h e D i s t r i c t o f C o l u m b i a w i l lhave better protection during 1984, thanks to anagreement between the district's Department ofConsumer and Regulatory Affairs and FDA's Baltimore district office. The agreement provides for acooperative response to public health emergencies,coordination of consumer complaint investigations,joint training efforts, analytical assistance, andmutual exchange of inspection information {PRJan. 16).

■ An index to the compilation of FDA AnnualReports, 1950-1974, is available for $4.00 postpaidfrom the American Institute of the History of Pharmacy, Pharmacy Building, University of Wisconsin,Madison, Wis. 53706.

■ The Department of Defense is proposing toallow coverage of trans-telephonic monitoring ofpacemakers under the Civilian Health and MedicalProgram of the Uniformed Services (CHAMPUS)(PR Jan. 18).

■ The Nuclear Regulatory Commission proposesto require that licensees use the services of personnel dosimeter processors accredited by the NationalVoluntary Laboratory Accreditation Program of theNational Bureau of Standards. The proposal stemsfrom concern that personnel dosimeters, devicesworn by workers to measure radiation exposure, arenot being processed accurately (PR Jan. 10).

■ Paragon Optical Inc. wants the color addit iveregulations amended to allow use of D&C Red No.1 7 a n d D & C Ye l l o w N o . 1 0 t o c o l o r c o n t a c t l e n s e s .... The closing date for the provisional listing ofD&C Yellow No. 10 was postponed from Nov. 1,1983, to March 5, 1984, to give FDA time to evaluate objections to permanently listing the coloradditive (PR Jan. 6, Jan. 3).

■ Market-testing of grated cheese containing powdered cellulose as an anti-caking agent is due tobegin this month under temporary permits issued byFDA to Pace Dairy Foods, Rochester, Minn.; Cal

ifornia Cheese Co., San Jose, Calif.; and SchreiberFoods Inc., Green Bay, Wis. Cheese made by PaceDairy Foods and Schreiber Foods will be distributednationwide, while the California Cheese Co. productwill be tested in 13 western states (PR Jan. 26).

■ About 10 to 20 grants, ranging from $20,000 to$70,000, will be made by FDA this year to supportclinical trials of the safety and effectiveness oforphan drug products. Grants of over $70,000 willbe considered by the agency if the trial extends overa two- to three-year period (PR Jan. 30).

■ FDA has stayed the final decision on ingredients in egg bread and has granted petitions for

r e c o n s i d e r a t i o n o f t h e s e a m e n d m e n t s t o t h e s t a ndard of identity for bakery products (PR Jan. 17).

■ Rules governing the export of investigationalnew drugs and biological products not covered byan investigational new drug application (IND) havechanged. Export will be allowed if a written requestfrom the exporting firm satisfies FDA that theproduct is appropriate for investigational use, wouldbe used for such purposes only, and could be legally used in the importing country. Exports willalso be authorized if the requests come from anauthorized official of the importing country andadequate information about the product's use isprovided. Previously, requests were processedthrough the State Department (PR Jan. 18).

■ The United States voted to schedule pentazocine under Schedule III and 18 benzodiazepinesunder Schedule IV of the Convention on Psychotropic Substances at a February meeting of theUnited Nations Commission on Narcotic Drugs. Thec o n v e n t i o n w a s e s t a b l i s h e d i n 1 9 7 1 t o c o n t r o l"mind-altering" drugs according to their actual orpotential level of abuse. Control requirements involve licensing of manufacturers, record keeping,security measures, warning labels, and export andimport author izat ion. Adopt ion of in ternat ionalscheduling does not require rescheduling of drugsm a r k e t e d i n t h e U n i t e d S t a t e s .


Investigators'Reportsm

On CabbagesA n d C a n c e r

"Cabbage, Brussels Sprouts, Carrots, Cauliflower, Spinach and Brocc o l i v s . C a n c e r . "

That was the banner display lineon a magazine ad that appeared lastspring for Daily Greens, green ovalpills sold by PharmTech Research,San Francisco. According to the ad.Daily Greens "are concentrated servings of cruciferous and carotene-richvegetables shaped into tablets andgiven a protective vegetable coating."

Why all the fuss about vegetablesreduced to pill form? Well, said thead, the National Academy of Sciencesreports that a regular diet of cruciferous and carotene-rich vegetables isassoc ia ted w i t h a reduc t i on i n t heincidence of certain cancers. Therefore, the ad continued, "Daily Greensallow you to eat cruciferous vegetables regularly, with the convenienceof a food supplement." The adclosed with the exhortation: "Helpyour body defend itself."

These claims for the product raisedeyebrows at two government agencies: the Federal Trade Commissionand the Food and Drug Administration. The former began investigatingthe Daily Greens promotion mediacampaign in magazine, newspapera n d t e l e v i s i o n a d s . F D A ' s S a n F r a ncisco district sent an investigator toinspect the corporate headquarters ofPharmTech Research on MontgomeryStreet .

The investigator interviewed thecompany president and collectedsamples of the product, its labeling,and promotional literature. She wasdenied access to the shipping records.

The labeling collected by the investigator included the statement, "Youcan take steps to reduce the risk ofcancer... .Eat more fruits, wholegrains, and vegetables, particularlythose contained in Daily Greens.Daily Greens, taken once a day, isdesigned to deliver the cruciferous

by Carol Ballentine

vegetables that have been found tobe protect ive."

The investigator informed the president that making unsubstantiatedmedical claims for a food productsuch as Daily Greens was a violationof the Food, Drug, and CosmeticAct. The president denied that thelabeling included medical claims. He

s a i d t h a t t h e i n f o r m a t i o n o n t h e l a

beling and promotional literature wastaken from a National Academy ofSciences report titled "Diet, Nutrition, and Cancer." He gave the investigator three copies of the report.

Next the investigator paid a visit toPacific Coast Service Co., the publicstorage warehouse in South San

' i m .


Francisco that was storing and ship- to appear on the labeling of food preventive until the court ruled onping bulk quantities of Daily Greens products seems to be in conflict with the deceptive advertising complaintfor PharmTech. The warehouse, in the 1st Amendment. If information the agency had lodged against thebusiness some 25 years, primarily about disease-related matters is pre- company. In that complaint, FTCstored nonperishable items, such as sented truthfully, then this commer- said that PharmTech's ads misrepre-furniture, household goods, and elec- cial information should come within sented information in the 1982 NAStronic equipment. The stocks of the protection of the First Amend- report ''Diet, Nutrition, and Can-D a i l y G r e e n s w e r e o n e o f o n l y a f e w m e n t . " c e r . " T h e f o l l o w i n g i s e x c e r p t e dfood i t ems i n t he wa rehouse . The San F ranc i sco d i s t r i c t con - f r om tha t r epo r t :

Storage conditions were good, the sidered this response inadequate and . .There is sufficient epidemio-investigator reported, and the owner recommended that the product be logical evidence to suggest that con-cooperative. He provided shipping seized. At about the same time, on sumption of certain vegetables,records for Daily Greens that showed the opposite coast, the Philadelphia especially carotene-rich (i.e., darkrecent shipments to New York, New district was also requesting seizure of green and deep yellow) vegetablesJ e r s e y, M a r y l a n d , a n d W e s t V i r g i n i a . D a i l y G r e e n s . a n d c r u c i f e r o u s v e g e t a b l e s ( e . g . , c a b -

The San Francisco district sent a The Pennsylvania Department of bage, broccoli, cauliflower, and brus-regulatory letter to the president of Health had found approximately sels sprouts), is associated with aPharmTech stating FDA's position $8,200 worth of Daily Greens at reduction in the incidence of cancerthat Daily Greens was both a mis- Allen Drug Inc., in Allentown, Pa. A at several sites in humans. A numberbranded food and a misbranded and state inspector had told the store's of nonnutritive and nutritive com-unapproved new drug. The letter proprietor that the product was mis- pounds that are present in these vege-requested that the firm act promptly branded and should not be sold or tables also inhibit carcinogenesis int o c o r r e c t t h e v i o l a t i o n s . s h i p p e d b a c k t o P h a r m Te c h . T h e l a b o r a t o r y a n i m a l s . I n v e s t i g a t o r s

At about the same time, the Fed- proprietor agreed to hold the ship- have not yet established which, iferal Trade Commission issued an ment. The state agency notified the any, of these compounds may beadministrative complaint against Philadelphia district office, which responsible for the protective effectPharmTech, charging the firm with sent an investigator to Allen Drug. observed in epidemiological studies,two counts of false advertising. FTC The investigator collected samples of . .These recommendations applysaid that the firm was misrepresent- the product and labeling to support only to foods as sources of nutrients—ing the findings of the Nat ional the distr ic t 's request for seizure. not to d ietary supplements TheAcademy of Sciences as they apply to The two pending seizures weren't committee is unable to predict theDaily Greens. The agency also sought the only bad news for PharmTech. health effects of high and potentiallya preliminary injunction in a U.S. Many consignees were returning bulk toxic doses of isolated nutrients con-District Court to halt the product's shipments of Daily Greens to the sumed in the form of supplements."nationwide print and broadcast ad- South San Francisco warehouse be- Early in 1984, FTC obtained ave r t i s i ng campa ign . cause the p roduc t wasn ' t se l l i ng we l l . consen t dec ree pe rmanen t l y ba r r i ng

PharmTech responded to FDA's In Pennsylvania, the Department of PharmTech from misrepresentingregulatory letter by saying that Daily Health had created more trouble for scientific tests or articles and fromGreens was a "food for special diet- the company by making misbranding making health claims without "re-ary use" and not a drug. The com- charges against PharmTech. The liable and competent scientificpany did agree to change some of the company agreed to send a letter to evidence." Both of FDA's seizurelabeling statements. But it refused to all distributors and retailers in Penn- requests were approved and fileddelete the references to the NAS sylvania advising them to remove all with the appropriate district attor-findings on foods and cancer, stating the labeling from the product that neys. PharmTech Research has filedthat "since the FTC has initiated an bore the objectionable claims. This for bankruptcy,investigation under the FTC Act, this included the chore of removing theFTC i nves t i ga t i on shou ld p rec lude bo t t l es f r om the boxes . Ca ro l Ba l l en t i ne i s a member o fa n y a c t i o n b y t h e F D A . " F T C o b t a i n e d a f e d e r a l c o u r t i n - F D A ' s p u b l i c a t i o n s s t a f f

The letter added: "FDA's policy junction barring PharmTech fromof not allowing disease-related claims advertising Daily Greens as a cancer

Tidying UpO h i o B l o o d P l a s m a I n c . o f C i n c i n

na t i i s back in bus iness a f te r i t slicense was suspended and it recalledsome products because of faulty record keeping and other violations ofplasmapheresis operation regulations.

An investigation by FDA's Cincinn a t i d i s t r i c t o f fi c e r e v e a l e d t h a t t h e

firm's employees failed to obtain therequired medical histories from plasma donors; to properly identify andlabel donor red cells; to correctlyperform saline infusions; and to correctly measure the physical propertiesof donor plasma. The firm falsifiedrecords to concea l these m is takes .

In an attempt to correct inadequacies of its record keeping system.

the plasma center employees relabeled plasma in such a way that amixup could occur between hepatitisnegative plasma and hepatitis positiveplasma. On one occasion, a donorwas mistakenly infused with anotherd o n o r ' s r e d b l o o d c e l l s .

After the FDA investigation revealed the deficiencies, Ohio BloodP l a s m a I n c . s h u t d o w n a n d r e t r a i n e d


all employees. It was then allowed toreopen on a limited basis and acceptdonors, but no shipments of bloodproducts were permitted until FDAhad reinspected the operation andlifted the suspension. This was done,and the firm is now in compliancewith Good Manufacturing Practicesfor such centers .

Plasmapheresis is a process byw h i c h b l o o d i s t a k e n f r o m d o n o r sand the plasma (liquid portion) removed . The red ce l l s a re re tu rned tothe donor unharmed in an injectedsaline solution. The plasma is used inmedical research and drug manufacture and to treat patients with various illnesses. Proper operation ofplasmapheresis centers is essential toboth donors and patients, and labelsand records are an important part ofthat operation.

P e r s u a d e d

Farmers' Supply Co. of BunkerHill, 111., apparently had problemskeeping its pesticide chemicals separated from its feed products. Evenafter three inspections by FDA'sChicago district, the firm continuedto store and mix pesticides in thes a m e w o r k a r e a w h e r e i t s t o r e d a n dmixed animal feed. As the inspectorspointed out, this could easily lead toc o n t a m i n a t i o n o f t h e f e e d .

Samples of the seized productswere sent to the district laboratory,where analysis showed the feed cont a i n e d t h e t o x i c h e r b i c i d e t r i fl u r a l i n .

Finally, with Farmers' Supply notconvinced that its feed handling wasfaulty, FDA obtained a court orderinstituting seizure of the firm's entirestock of minerals, concentrates, andf e e d b l o c k s . T h i s a m o u n t e d t o 1 4tons (62 lots) of bagged and uncovered feed products valued at $4,000.T h o s e l o t s t h a t w e r e c o n t a m i n a t e dwere destroyed under a consentdecree.

When Barges Bump

It was like something out of aLaurel and Hardy comedy, whereone disaster inevitably leads toa n o t h e r. A s r e c o n s t r u c t e d — b e c a u s e i twas a dark night and no one witnessed the en t i re cha in o f even ts—thetugboat City of Greenville waspushing a string of barges down the

Mississippi River when one of thebarges struck an abutment of thePoplar Street Bridge at St. Louis.

The impact broke several bargesloose from the string and theyfl o a t e d f r e e d o w n t h e r i v e r . S o m e o fthe runaways crashed into a fleet ofbarges moored on the Illinois side oft h e r i v e r. T h e s e w e r e l o a d e d w i t hcrude oil and grains, and somecaught fire. This collision set morebarges free, and soon a flotilla ofbarges was drifting down the river.

Downstream from St. Louis, atSauget, 111., is a 300-foot-long pipeline structure suspended over thesurface of the water and terminatingin a floating loading dock. The pipeline is used to transport chemicalsbetween barges on the river and achemical plant nearby.

Three of the barges from the upstream collisions plowed into thepipeline bridge, part of which collapsed on one of the errant barges.This barge contained 45,000 bushelsof soybeans, worth $300,000. Thepipeline broke through the fiberglasshatch cover protecting the cargo, andl e a k e d s o m e o f i t s c o n t e n t s i n t o t h ehold where the soybeans were stored

(the entire pipeline structure fell afew days later).

The barge with the tainted soyb e a n s w a s m o v e d t o t h e M i s s o u r iside of the river, where investigatorsf r o m F D A ' s S t . L o u i s s t a t i o n s u r

veyed the condition of the soybeansand collected some samples to beanalyzed by the agency's Kansas Citydistrict laboratory. Bad news. Thesoybeans were contaminated withb e n z e n e a n d t o l u e n e .

Because of the accident, the consignee of the soybeans refused toaccept the shipment. The damagedcargo now became the responsibilityof the barge line transporting thesoybeans.

Knowing that the contaminatedsoybeans were subject to seizure byFDA, the barge line proposed reconditioning, and presented several poss i b l e m e t h o d s t o t h e S t . L o u i s s t a t i o nf o r c o n s i d e r a t i o n .

T h e f i r s t m e t h o d — a v e n t i l a t i o nand aeration process—proved unsatisfactory. After some discussion, thebarge line proposed roasting thebeans in the hope that heat wouldv o l a t i l i z e a n d r e m o v e t h e c o n t a minants. With FDA's approval , a pi lot


b a t c h w a s r o a s t e d a n d t e s t e d . T h ebatch tested negative, so the entire45,000 bushels were roasted. Samplesw e r e e x a m i n e d a n d n o u n s a f e c o nt a m i n a n t s w e r e f o u n d . T h e c o s t o f

reconditioning was some $90,000.Moral of the story: Be extra care

ful pushing barges under the PoplarStreet Bridge on dark nights whensoybean-loaded barges are nearbyand a chemical pipeline bridge is justd o w n s t r e a m .

Airport 1983

F o r w a n t o f s o m e v a l v e s t h e w a t e r

supply at Volpe International Term i n a l i n B o s t o n w a s o u t — a t l e a s t

temporarily. Airlines using that terminal were being serviced by generalaviation companies, who were providing potable water by truck.

Volpe International Terminal iso n e o f fi v e t e r m i n a l s a t B o s t o n ' s

Logan Airport. Like all facilitiesserving international carriers—buses,trains, airplanes—the terminal's foodand water supplies are routinely inspected by FDA under the International Travel Sanitat ion Program.

During an inspection in September1983, an investigator from FDA'sBoston district found problems withthe terminal's "back-flow preventiondevices" in the water system. Waternormally flows from a point of highpressure to low pressure. A drop inpressure at the point where the hosesconnect to the potable water lockerscan cause the water to reverse d i rect i o n a n d c a n d r a w c o n t a m i n a n t s s u c ha s c h e m i c a l s o r w a s t e m a t e r i a l s i n t othe c l ean wa te r sou rce . Th i s i s ca l l ed" b a c k - fl o w . "

To prevent back-flow, the connecting hoses are equipped with valvesthat close to prevent the water fromreversing direction should the pressure drop. It was these valves thatwere missing at Volpe InternationalTerminal. The investigator thus assigned the facility a "provisional"rating. This meant the facility shouldimmediately correct the problem andwould be reinspected in 30 days.

Unfortunately, the air l ine companies and Massport Authority (whichruns the airport) could not agree onwho was responsible for correctingthe problem. When the investigatorrevisited the site in October, the

valves were still missing. He therefore classified the facility as "notapproved."

Massport Authority locked thepotable water lockers at the terminaland shut off the water supply. Whenthe back-flow valves are replaced, thewater supply can be reopened.

Cleanliness Reports Ordered

For some people, writing reports isa t e r r i b l e c h o r e . F o r o n e b a k e r i t ' s at a s k t h a t c a n ' t b e a v o i d e d . U n d e r aconsent decree of permanent injunction, the owner of a bakery in Springfield, Mo., has to report to FDA'sKansas City district office everyother month to certify that his plantis free from any insect or rodentac t i v i t y.

This unusual court-ordered requirement was imposed because of thecontinuing failure of Roy-El WayProducts Inc. to keep the bakery andan adjacent warehouse clean.

Roy-El Way Products Inc., whichd o e s b u s i n e s s u n d e r t h e n a m e " B r e a dfor Li fe," manufactures naturalbread products and peanut butterand distributes a line of granolaproducts that are sold in nine states.

In January 1983 investigators fromt'DA and the Springfield Health

Department inspected Roy-El WayProducts and found rodent and insect filth in the firm's "Seven GrainB r e a d . " T h i s w a s n o t t h e fi r s t t i m ethis problem had appeared. The January visit was a follow-up to an earlier inspection that had resulted in awritten warning to the firm to cleanup the facilities.

After the January inspection thefirm destroyed approximately 3,500pounds of whole grain under thesupervision of the Springfield HealthDepar tment .

In subsequent visits, the FDA investigators found more evidence ofsanitation problems at Roy-El WayProducts. They photographed rats inbroad daylight eating grain from theoutside storage area. This is unusualsince rats usually feed at night. Adrainage ditch next to the buildingwas overgrown with weeds andbushes, providing an ideal home forr o d e n t s . M i c e w e r e s e e n i n s i d e t h e

bakery. One family of mice was nesting in the insulating material arounda h o t w a t e r h e a t e r.

FDA sent several letters outliningwhat should be done to improve sanitary conditions in and around thebakery. Although the owner didmake some improvements, his sanitation problems persisted and FDAhad to go to court.

In April 1983, in the U.S. DistrictC o u r t f o r t h e W e s t e r n D i s t r i c t o f

Missouri, Springfield Division, theowner of Roy-El Way Productssigned the consent decree. The decreeprohibits the firm from manufacturing bakery products that are not incompliance with the sanitation requirements of the Food, Drug, andCosmetic Act; it also requires thefirm to certify, in writing to FDA ona bimonthly basis, that its self-inspection program is maintainingoperations free from any insect orrodent act ivi ty.

After the consent decree was signed,the firm closed down for several daysw h i l e c o r r e c t i o n s w e r e m a d e . I t d e

stroyed 2,700 pounds of baked bread,rice, cornmeal, and repacked food.

— This small sample of reports fromthe field was compiled and edited byAnnabel Hecht, Carol Bal lent ine,Richard Thompson and EvelynZ a m u l a .


Summaries of Court Actions are given pursuant to section705 of the Federal Food, Drug, and Cosmetic Act. Summariesof Court Actions report cases involving seizure proceedings,criminal proceedings, and injunction proceedings. Seizureproceedings are civil actions taken against goods alleged tobe in violation, and criminal and injunction proceedings areagainst//rffw or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, orcosmetics which were alleged to be adulterated or misbrand-ed or otherwise violative of the law when introduced into andwhile in interstate commerce, or while held for sale after shipment in interstate commerce. Full court opinions for thesecases are published by either the West Publishing Companyor the Commerce Clearing House Inc. Texts can be obtained'from Commerce Clearing House at 1301 Pennsylvania Ave.,N.W., Washington, D.C. 20004.

Summaries of Court Actions are prepared by the Food andDrug Division, Office of the General Counsel, HHS.

Published by direction of the Secretary of Health andH u m a n S e r v i c e s .

S E I Z U R E A C T I O N S

F o o d s / P o i s o n o u s a n d D e l e t e r i o u s S u b s t a n c e s

PRODUCT: Let tuce, F.R.C. Brand, at Seat t le , W. Dis t .Wash.; Civil No. C82-1478M.CHARGED 12-15-82: When shipped by Fisher Ranch Corp.,Blythe, Calif., the article bore and contained the pesticidechemical chlorpyrifos, and no tolerance or exemption froma tolerance had been granted for such pesticide chemical inor on lettuce—402(a)(2)(B).DISPOSITION: Default—ordered destruction. (F.D.C. No.63935; S. No. 83-347-158; S.J. No. 1)

Foods/Contamination, Spoilage, Insanitary HandlingPRODUCT: Mole en pasta, and Mexican hoi sauce, atLaredo, S. Dist. Texas; Civil No. L-82-50.CHARGED 8-13-82: When imported from Mexico, the articles, labeled in part "Mole En Pasta San Luis.. .Made inMexico.. .Productos Dona Lupe, S.A... .San Luis Potosi,S.L.P." and "Bufalo.. .Mexican Hot Sauce.. .EmpacadoraBufa lo , S.A. Mexico 19, D.F. , " conta ined insect f i l th—402(a)(3).D I S P O S I T I O N : C o n s e n t — a u t h o r i z e d r e l e a s e t o V i c t o rPadilla, McAllen, Texas, for export to original foreign supplier. (F.D.C. No. 63762; S. Nos. 82-122-556/7; S.J. No. 2)

PRODUCT: Swiss cheese blocks, at Monticello, W. Dist.

Wis.; Civil No. 82-C1048-S.CHARGED: 12-10-82: When shipped by Pleasant ValleyCheese Cooperative, Winslow, 111., the article had beenprepared, packed and held under insanitary conditions—402(a)(4).DISPOSITION: Default—ordered destruction. (F.D.C. No.63909; S. No. 83-298-749 et al.; S.J. No. 3)

Foods/Economic and Labeling Violations

PRODUCT: "Apple concentrates," five lots, at Skokie, N.Dist. 111.; Civil No. 82C-7206.CHARGED 11-23-82: When shipped by Food Complex, Inc.,Woodside, N.Y., the valuable constituent, apple juice, hadbeen in part omitted from the articles (analyses showed littleor no chlorogenic acid, which is a natural constituent of applejuice); and the articles' name, "apple concentrate," was falseand misleading as to the articles' content (analyses showedthat the sugar ratios [fructose to glucose ratios] were notcharacteristic of apple juice concentrates, and demonstratedthe presence of added sugar instead)—402(b)(1), 403(a)(1).DISPOSITION: Default—ordered destruction. ̂ .D.C. No.63901; S. No. 82-249-808 et al.; S.J. No. 4)

PRODUCT: Pepper, black, ground, at New Orleans, E. Dist.La.; Civil No. 82-5969.CHARGED 12-29-82: While held by Foltz Coffee, Tea &Spice Co., New Orleans, La., who ground the article andpacked the article in tins labeled "Yogi Brand.. .GroundBlack Pepper NET WEIGHT 4 OUNCES.. .Arnaud CoffeeCorporation, New Orleans, La.," the article was shortweight—403(e)(2).D I S P O S I T I O N : C o n s e n t — d e a l e r a u t h o r i z e d t o r e c o n d i t i o n .(F.D.C. No. 63924; S. Nos. 83-383-7/8; S.J. No. 5)

PRODUCT: "Sesame oil," at Honolulu, Dist. Hawaii; Civi lN o . 8 1 - 0 2 6 2 .CHARGED 7-28-81: While held for sale, a valuable constituent, sesame oil, had been in part omitted or abstracted—402(b)(1); soybean oil had been substituted for sesameoil—402(b); the article's labels, which read "Mum's SesameOil.. .contains a high volume of vitamin E.. .Packed forTaisei Trading Co., Ltd., Kobe, Japan," contained false andmisleading claims as to consisting wholly of sesame oil—403(a)(1); and the labeling of a number of lots of the product misleadingly failed to reveal certain facts material in lightof the "high volume of vitamin E" statement (i.e., all nutrientquantities in relation to the average or usual serving or port ion)—403(a)(1).D I S P O S I T I O N : C o n s e n t — a u t h o r i z e d r e l e a s e t o M u m ' s Ta isei of Hawaii, Inc., Honolulu, Hawaii, for relabeling. (F.D.C.


No. 63512; S. No. 81-219-792; S.J. No. 6)

Drugs/Human Use

PRODUCT: Caffeine, phenylpropanolamine HCl & theophylline combination tablets, and caffeine, phenylpropanolamine HCl & ephedrine sulfate tablets, at Grand Rapids,W. Dist. Mich.; Civil No. 082-843 CAl.CHARGED 10-29-82: When shipped by B.T. Products, St.Petersburg, Fla., the articles were new drugs without effective approved New Drug Applications, and the articles' labeling lacked adequate directions for use—505(a), 502(f)(1).DISPOSITION: Default—ordered destruction. (F.D.C. No.63868; S. No. 82-309-437; S.J. No. 7)

PRODUCT: Cough syrups, and cough syrup concentrate, atLinden, Dist. N.J.; Civil No. 82-2242.CHARGED 7-13-82: When shipped by Anything and Everything, Brooklyn, N.Y., those articles which were labeled inpart "Piso's For Coughs... Active Ingredients: Chloroform. .. Pinex Company, Inc., New York, N.Y ... 5 [or '3']Oz." and "Regular Pinex Cough Syrup For Coughs ActiveIngredients.. .Chloroform.. .8 Fl. Oz Pinex Company,New York, N.Y.," were new drugs without effective approvedNew Drug Applications—5p5(a); and, while held for sale,those articles labeled in part "Wild Cherry Pinex Cough Syrup[or 'Super Pinex Cough Syrup,' 'Pinex Concentrate,' or'Regular Pinex Cough Syrup'] chloroform.. .3 Fl. OzPinex Co., New York, N.Y." had false and misleading labeling because their labels represented that the drugs containedspecific amounts of chloroform when chloroform was notpresent in the labeled amount—502(a).DISPOSITION: Default—ordered destruction. (F.D.C. No.63733; S. No. 82-287-133; S.J. No. 8)

PRODUCT: Hair shampoos and conditioners, with drug-typeclaims, at Philadelphia, E. Dist. Pa.; Civil No. 79-315.CHARGED 1-24-79 and amended 1-31-79: While held byAlfonso Products, Inc. (a/k/a A&W Products Co.), Philadelphia, Pa., who manufactured the articles using interstatecomponents, the circiunstances used for the articles' manufacture, processing, packing and holding failed to conformwith current good manufacturing practice—501(a)(2)(B); andthe label of the article Vigor-Tex was false and misleadingin declaring "1% Phenol" when the article did not containphenol—502(a).DISPOSITION: The articles were claimed by the manufacturer, who denied the charges. After the claimant entered intoa consent decree of permanent injunction (q.v., S.J. No. 14of this issue of FDA Consumer), the seizure action wasdismissed. (F.D.C. No 62083; S. No. 79-143-283 et al.; S.J.No. 9)

PRODUCT: Hydralazine HCl, hydrochlorothiazide & reser-pine tablets, U.S.P., Zenith, two lots, at Northvale, Dist.N.J.; Civi l No. 82-119.CHARGED 1-14-82: While held by Zenith Laboratories, Inc.,Northvale, N.J., who had manufactured both lots of thearticle using imported reserpine, the strength and quality ofboth lots of the article fell below the standard for contentuniformity of the U.S.P. (analysis of 30 tablets showed arange of approximately 60 to 125 percent of the declaredamount of reserpine, and 12 tablets were outside the U.S.P.limits for content uniformity)—501(b).DISPOSITION: Default—ordered destruction. (F.D.C. No.63598; S. No. 81-273-643 et al.; S.J. No. 10)

M e d i c a l D e v i c e s

PRODUCT: Muscle stimulators, electrical, at Orange, Dist.Conn.; Civi l No. N81-132.CHARGED 3-4-81: The accompanying labeling of the articles, specifically the operator's manual titled "P-8 PortableProfessional Muscle Exerciser.. .Rev. 3 Dated 7/25/80,"contained false and misleading claims for trimming the waistand for use for adipose tissue deposits—502(a); and the articles' labeling lacked adequate directions for use, since neitheradequate directions for lay use nor adequate information foruse by licensed practitioners could be provided for the intended purposes of the devices—502(f)(1).DISPOSITION: The articles were claimed by Total Approach, Inc., Orange, Conn. The claimant moved for returnof the seized articles and for dismissal of the complaint.Ultimately, a consent decree of condemnation ordered delivery of the devices to FDA for evaluation and other disposition and ordered destruction of the accompanying labeling.(F.D.C. No. 63268; S. No. 80-190-868 et al.; S.J. No 11)

PRODUCT: Vaporizer devices, Respirizer, and in-processvaporizer components, at Gettysburg, M. Dist. Pa.; Civil No.C V - 8 2 - 1 6 3 2 .CHARGED 12-28-82: The articles, which were being manufactured by Respirizer Co. (Div. of Campillary Systems, Inc.),Gettysburg, Pa., were accompanied by a brochure titled "Advanced Technology In Respiratory Therapy," which contained the following false and misleading claims: (1) that thedevices were adequate and effective for emphysema, asthma,allergies, sinusitis and sinusitis headaches, bronchitis, colds,flu, migraine headaches, respiratory and sinus illnesses, hayfever, and tensions caused by stress; (2) that the vapor generated by the Respirizer was more effective than the vaporfrom complicated and expensive hospital equipment; that theRespirizer vapor penetrated areas in the sinus and respiratorytract not reached by the vapor from hospital treatment; thatuse of the Respirizer was the only known method of natural-


ly treating sinuses and lungs; that moisture was restored todry tissues; (3) that Respirizer therapy was the safest and mosteffective single means of treating practically all respiratoryailments without adverse effects; and (4) that the therapeuticvalue of moisture in a warm gaseous state had been demonstrated by a recent clinical evaluation of the Respirizer at aU.S. government medical center—502(a); and the articles'labeling lacked adequate directions for lay use for the articles'intended purposes; and such directions could not be writtenand the articles were not exempt from such directions becausethe articles lacked the prescription legend—502(0(1).D I S P O S I T I O N : T h e m a n u f a c t u r e r c l a i m e d t h e a r t i c l e s . A

partial consent decree of condemnation authorized release ofthe in-process components for bringing them into compliance.After successful reconditioning of the in-process components,another partial consent decree of condemnation authorizedrelease of the finished devices for bringing into compliance.(F.D.C. No. 63780; S. No. 82-226-939; S.J. No. 12)

C I V I L C O N T E M P T A C T I O N S

DEFENDANTS: Bec ton , D ick inson & Co . (Ba rd -Parke rDivision), and Kenneth J. Summa, plant manager, Hancock,N. Dist. N.Y.; Misc. No. 112.CHARGED on or about 9-1-77 in a petition for an order toshow cause in civil contempt: That the defendants, withknowledge of the court's Warrant for Inspection, disobeyedand violated the warrent by refusing to permit inspection ofall records, files and papers respecting restricted devices andbearing on violation of the Federal Food, Drug, and CosmeticAct; and that, by reason of such refusal, the defendants werein civil contempt of the warrant for inspection.D I S P O S I T I O N : T h e c o u r t i s s u e d a n o r d e r t o s h o w c a u s e .Meanwhile, the government also filed an injunction action.The defendants countered by filing a declaratory judgmentaction petitioning the court to declare that FDA lacked authority to inspect, and to forbid such inspection. They alsomoved for dismissal of the government's petition and for summary judgment in favor of Becton, Dickinson & Co. and theother defendant. (See S.J. Nos. 15 and 16 of this issue.) Thet h r e e a c t i o n s w e r e c o n s o l i d a t e d f o r t r i a l . T h e c o u r t r u l e d

against the government, with respect to the civil contempt,because the warrent in question had been vacated and the matter became moot. Accordingly, the petition was denied. (Inj.No. 791; S.J. No. 13)

I N J U N C T I O N A C T I O N S

DEFENDANTS: A lphonso ' s P roduc t s , I nc . , a / k /a A&WProducts Co., and Laval L. Hillsman, vice president of production, Philadelphia, E. Dist. Pa.; Civil No. 80-4095.CHARGED 10-22-80 in a complaint for injunction: That the

defendants manufactured and sold various hair products, including Hair Medicine Grow Aid, Hair Medicine Grow AidShampoo, Roots Protein Hair <&. Scalp Food, Sulfur X, TarGrow Aid Conditioner, and Old Fashioned Tar ConditionerShampoo', that such hair products were drugs because theirlabeling represented them for the cure, mitigation, treatmentand prevention of disease, and for affecting the structure andfunction of the body of man; that such hair products had beenmanufactured, processed, packed and held under circumstances that failed to conform with current good manufacturing practice—501(a)(2)(B); that FDA inspections discloseda number of specified deviations from current good manufacturing practice—501(a)(2)(B); and that the defendants werew e l l a w a r e t h a t t h e i r a c t i v i t i e s w e r e i n v i o l a t i o n o f t h e l a w.DISPOSITION: The defendants had initially been claimantsin a seizure action (q.v. S.J. No. 9). That action was concluded with the filing of the complaint for injunction and aconsent decree of permanent injunction. The defendants wereenjoined from the complained of violations and were enjoinedfrom specified operations involving any drug labeled for orintended for hair or scalp use whose labeling or promotionalmaterial made any therapeutic claims unless and until prescribed conditions of current good manufacturing practicewere established, a qualified expert certified compliance, andall drugs on hand were destroyed or otherwise brought intocompliance. (F.D.C. No. 62083; S. No. 79-143-283 et al.; S.J.No. 14)

DEFENDANTS: Becton, Dickinson & Co. (t /a Bard-ParkerDivision), and Wesley J. Howe, president, William L. Clark,division vice president and general manager, James A. Levy,vice president for manufacturing, and Kenneth J. Summa,plant manager, Hancock, N. Dist. N.Y.; Civil Nos. 77 CV-337and (on appeal) 78-6137.CHARGED 9-2-77 in a complaint for injunction: That thedefendants, at the Hancock, N.Y., plant, manufactured, processed, packed, held and distributed in interstate commercevarious devices; that a number of such devices were restricteddevices because of their potentiality for harmful effect, themethod of their use, and/or the collateral measures necessaryfor their use (i.e., devices restricted to sale, distribution and/oruse only upon the written or oral authorization of a practitioner licensed by law to administer or use such devices ormeasures necessary for their use); that, during a plant inspection, permission to inspect a number of production and control records had been denied; that the defendants' refusal topermit inspection of records, files and papers bearing onwhether res t r ic ted dev ices were in v io la t ion was a lso a v io lation of the law; that, subsequently, the court had issued awarrant for inspection that authorized inspection and copying of all records bearing on whether restricted devices manufactured, processed, packed, transported or held by the


defendants were in violation of the law; that, after serviceof the warrant for inspection, FDA investigators were deniedaccess to some records and were refused permission to copyrecords and to take photographs; and that the defendants wereaware that their activities were in violation of the law—301(0.

In addition to the above injunction action, the governmentinitiated a civil contempt action for the continued refusal toinspect, and the defendant corporation brought a declaratoryjudgment action against the government (see S.J. Nos. 13 and1 6 o f t h i s i s s u e o f F D A C o n s u m e r,DISPOSITION: The court dismissed the government's complaint and granted summary judgment to the corporation andits co-parties. In the court's opinion of April 11, 1978, thecourt described the three companion cases as having arisenfrom the following simple undisputed circumstances: a routineFDA inspection of the defendants' plant; FDA's request forthe production of records under section 704(a), upon FDA'sassertion that the plant manufactured restricted medicaldevices; the denial of FDA's request; the subsequent issuanceof an inspection warrant; and the ultimate refusal of accessto Bard-Parker records and files.

In the 1976 Medical Device Amendments, Congress hadgiven FDA expanded inspectional authority over recordsregarding restricted medical devices, and had required FDAto promulgate regulations to classify appropriate medicaldevices as ''restricted" devices. FDA asserted that its existingregulation which defined prescription devices met the requirements of the new law concerning restricted devices.Although the court could not condone the action of the defendants in refusing to abide by a lawfully issued warrant (thewarrant's ultimate invalidity being no defense), and althoughthe resistance to the warrant could have subjected the defendants to criminal contempt, the civil contempt was mooted;the warrant was vacated; and the government's complaint forinjunction was dismissed—because Congress intended FDAto promulgate new regulations for restricted devices.

The government appealed the decision of the district courtas to the injunction action. Upon appeal, the governmentargued that FDA had published a Federal Register notice oneweek after the Medical Device Amendments became law,which notice informed the industry that "restricted devicesinclude all prescription devices."

However, on Dec. 27, 1978, the court of appeals found thatsuch notice was not adequate for two reasons: 1) Congresshad provided for a rulemaking procedure in which all participants were to have a full opportunity to present their viewsand analyses of data; and 2) Congress had intended that FDAdetermine that the particular restrictions on sale, distributionor use were justified by the risks presented by the device.Although broad, categorized regulations could be developedfor restricted devices, the rulemaking proceedings leading to

the earlier prescription device regulation addressed differentcircumstances; and a new regulation was required. The opinion of the district court was accordingly affirmed. (Inj. No.791; Misc. No. 435; S.J. No. 15)

M I S C E L L A N E O U S A C T I O N S

SUBJECT: Establishment inspection authority of FDA concerning "restricted devices," and the designation of restricteddevices, N. Dist. N.Y.; Civil Nos. 77 CV-181 and (on appeal)7 8 - 6 1 0 9 .CHARGED 5-17-77 by Becton, Dickinson & Co., Hancock,N.Y., against the Food and Drug Administration, FDA Commissioner Donald Kennedy, and FDA investigators WilliamC. Lubas and Richard N. James, in a suit for declaratoryjudgment, injunction and vacation of an inspection warrant:That the Bard-Parker division of Becton, Dickinson & Co.,Hancock, N.Y., manufactured medical devices such as surgical blades, scalpels, suction products and tubing; that,although FDA had not promulgated final regulations implementing medical device establishment registration, the corporation completed and filed a medical device establishmentinspection form; that Section 520(e) of the Medical DeviceAmendments required that the conditions affecting the sale,distribution or use of "restricted devices" be prescribed byadministrative regulation; that a June 4, 1976, FDA noticerestated certain statutory duties (stated to be imposed directly by the Medical Device Amendments and to be not dependent on the issuance of regulations) including a notice definingrestricted devices as defined in 21 C.F.R, 801.109 (i.e., prescription devices); that, because FDA had failed to complywith Section 520(d) of the Food, Drug, and Cosmetic Act andwith Section 4 of the Administrative Procedures Act, FDAhad failed to adopt a valid and lawful regulation restrictingthe sale, distribution or use of any device—its notice of June1976 notwithstanding; that plaintiff demanded judgment declaring that FDA lacked authority to inspect records, files,papers and other documents relating to "restricted devices"until a regulation had been promulgated under Section 520(e)of the FDC Act and Section 4 of the APA; that FDA be enjoined from such inspection until such regulation had beenpromulgated; and that the Warrant for Inspection, which hadbeen issued by the court, be vacated.DISPOSITION: The government moved to dismiss the plaintiff's complaint. Subsequently, the government moved for aninjunction against the corporation and for civil contempt (seeS.J. Nos. 13 and 15 of this issue of FDA Consumer). Thisaction (together with the companion cases arising out of acentral set of facts) was heard by the court, which decidedfor the plaintiff; and that decision was sustained by the courtof appeals. (Misc. No. 435; S.J. No. 16)

36 / April 1984 / FDA Consumer U . S . G O V E R N M E N T P R I N T I N G O F F I C E 1 9 8 4 - 4 2 1 - 1 7 4 / 1 1 2

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