Bill Osmunson DDS, MPH121-112th Ave NE Ste BBellevue, WA 98004428.455.2424

April 29, 2008

DEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration21 CFR Part 101[Docket No. FDA–2008–N–0040] (Formerly Docket No. 2006N–0168)

Food Labeling: Revision of Reference Values and Mandatory NutrientsAGENCY: Food and Drug Administration,HHS http://www.regulations.gov

Dear Sirs:

I am Food Manufacturer (www.chezgourmet.biz), Public Health Nutritionist with Masters in PublicHealth and Dentist (www.smilesofbellevue.com).

Greater disclosure of substances in foods is needed and possible.

Three Requests:

A. The “NUTRITION FACTS” section can be expanded to include “ADDED SUGAR”.By distinguishing between the products inherent sugars and the refined sugars wouldbe easy for the manufacturer and provide better differentiation between items suchas candy bars and dried fruit and fruit juices.

B. Foods which have been genetically manufactured should be listed.

C. An “Upper Limits” needs to be added for substances like fluoride, mercury, lead,pesticides, etc. These can be expressed in ppm (parts per million) or ppb.

Some of my patients report severe sensitivities and allergies to almost every known substanceand the more information available, the better.

The following is and example of why fluoride content should be listed, but not as a substance of“value” but rather as a concern for excess exposure.

Fluoride Summary:

I. We are ingesting too much fluoride from many sources. Extensive increases in fluoridepesticide residues on food crops, fluoride post-harvest pesticide residues on grains,fruits, vegetables, mechanically de-boning of meat which incorporates significantfluoridated bone, fluoride medications and fluoride dental products, resulting in manypeople, especially children, ingesting an excess dosage of fluoride.

II. Fluoridated communities no longer show a reduction in dental decay or reduction indental expenses and communities which stop fluoridating do not show an increase indental decay.

III. Risks, both medical and dental, from excess ingested fluoride are serious.

Professionals at the US Environmental Protection Agency (EPA) are concerned about theexcess fluoride exposure. "In summary, we hold that fluoridation is an unreasonable risk.That is, the toxicity of fluoride is so great and the purported benefits associated with it are sosmall - if there are any at all – that requiring every man, woman and child in America to ingestit borders on criminal behavior on the part of governments."

I. APPLICABLE WASHINGTON STATE STATUTES:

Fluoride is defined as a poison.“RCW 69.38.010 “Poison” defined. As used in this chapter "poison" means:

(1) Arsenic and its preparations; (2) Cyanide and its preparations, including hydrocyanic acid; (3) Strychnine; and (4) Any other substance designated by the state board of pharmacy which, when introducedinto the human body in quantities of sixty grains or less, causes violent sickness or death.”

60 grains is 3,888 mg. There is no dispute that 60 grains of fluoride will cause violent sickness ordeath. The probable toxic dose (PTD) of fluoride if swallowed at one time is considered 5 mg/kg1

or about 250 to 350 mg for an adult and much less for a child. 3,888 mg of fluoride is lethal. Asdefined by RCW 69.38.010.

1. Fluoride is a Legend Drug. Read a fluoridated toothpaste tube. It says, "DrugFacts". Fluoride in toothpaste is over-the-counter and is clearly labeled as a “not to be ingested”substance. Fluoride for ingestion is defined by the FDA as a Drug and defined by WashingtonCode as a Legend Drug.

2. When I went to the Pharmacist and requested fluoride for ingestion, I was deniedand told I was required to get a Doctor's prescription. The levels of “poisons” and “legend drugs”should be listed on food labels.

3. Fluoride is not a food, mineral or nutrient. Remove a nutrient from the diet and theabsence will be a disease. For example, remove Vitamin C and the patient will develop scurvy. Remove fluoride and the patient will not develop any disease. Fluoride is an attempt to preventtooth decay, but tooth decay is not caused by the absence of or inadequate intake of fluoride. There is no "RDA" Recommended Daily Allowance for fluoride and there never should be one. The American Dental Association has promoted the term "Optimal" amount of fluoride, but thetrade/marketing term is not a scientific term and is flawed.

4. The FDA in Congressional Hearings 2001 clearly stated that fluoride as used for thetreatment or mitigation of disease is a drug. When I called the FDA Dental Divisionlast month, the FDA confirmed that ingested fluoride for mitigation of disease is adrug.

5. Fluoride should not be compared to Iodine as a trace element. The absence ofIodine causes goiter but the absence of fluoride does NOT cause dental decay.Iodine is considered lethal at 4,000 to 8,000 mg, slightly higher than defined byRCW 69.38.010 and far less toxic than fluoride.

B. Centers for Disease Control (CDC) does not determine total exposure and at what levelsfluoride would be safe. “It is not CDC’s responsibility to determine what levels of fluoride in waterare safe” http://www.cdc.gov/fluoridation/safety.htm

C. 90+% of European Governments and Dental Associations have rejected, banned, orstopped fluoridation due to environmental, health, legal, or ethical concerns. Only six countries inthe world continue to fluoridate. Both the Nobel and Pasteur Institutes have rejected fluoridation.

II. EXPOSURE OF FLUORIDE HAS INCREASED, WE ARE INGESTING TOOMUCH FLUORIDE: Fluoride from water represents about half of fluoride exposure.

A. Everyone agrees too much fluoride can be toxic and the toxic amount for many is verylittle.

B. The strongest evidence of increased exposure of fluoride is the increased prevalenceof dental fluorosis in children, found in the middle of the 20th Century to be less than10%, in the mid 1990’s to be 22% and early 2000’s increased to 32%. The only causeof dental fluorosis is an excess exposure to fluoride. Listing the fluoride content onpackaging would be helpful to those wanting to have less fluoride.

C. Fluoride is not a nutrient. Dental decay is caused to a large degree by poor diets, lackof careful daily cleaning of the teeth, lower socioeconomics, general health, geneticsand more. With a good diet and cleaning, dental decay, gum disease, and many otherdiseases are reduced, mitigated. The only theoretical benefit from fluoridation is areduction in one disease and the side effects of fluoride have not been adequatelystudied. Early reviews indicate a possible increase in bone and tooth fracture withhigher levels of fluoride exposure.

D. Nature filters out the fluoride for infants and is a good indication of Nature’s “opinion”on the optimal level of fluoride, almost zero. Mother’s milk contains almost no fluoride,about 250 times less fluoride than fluoridated water. Man’s laws fluoridating water donot change Nature’s laws of toxicity.

E. The most definitive current review of fluoride exposure can be found between pages19-70 of the National Research Council’s 2006 committee report requested by theEPA, “Fluoride in Drinking Water: A Scientific Review of EPA’s Standards” 576 pages(NRC 2006). The unanimous conclusion by these 12 scientists is that the EPA’smaximum contaminant level of fluoride, 4 ppm is not protective. Note: 4 ppm hasbeen determined as not safe, and the Water District uses police powers to medicateeveryone at 1 ppm. An adequate margin of safety would be a factor of 10 becausedifferent people have different reactions to chemicals and not everyone drinks thesame amount of water or ingests the same amount of fluoride from other sources andsome people are more sensitive to chemicals such as fluoride.

F. The EPA in 2004 and 2005 permitted sulfuryl fluoride as a post-harvest fumigantpesticide with significant amounts of fluoride pesticide residue on most foods. Forexample 850 ppm of fluoride for egg and 900 ppm of fluoride on dried egg, 125 ppm offluoride in wheat. Toothpaste has about 1,000 ppm and should not be swallowed.2

Not all foods have the maximum residue permitted by law; however, if an EPAapplication was made for specific levels, we can be confident those levels willoccasionally be reached. When sulfuryl fluoride is applied to foods, the followingwarning is required.

I. Increases in fluoride pesticide residues in 1997 further increase total exposure.For example, an increase permitted pesticide residue of Cryolite (52% fluoride) from 7 ppm to 180ppm in lettuce.3

J. New medications and Dental products further increase exposure of fluoride.When fluoridation started over 60 years ago fluoride toothpaste was not available. Fluoride inwater is now excess fluoride and the most logical place to reduce fluoride exposure.

Listing fluoride content of a food on packaging should be done, but not as a “value”.

III. BENEFITS OF FLUORE:

The best way to evaluate the benefits of fluoride is to evaluate fluoridation. Over 60% of the USpopulation receives fluoridated water. By comparing communities which fluoridate with thosewho do not, provides an indication of what is happening for those who are ingesting greater levelsof fluoride.

As a Dentist who promoted fluoridation for 25 years, looking once again at the benefits and risksof fluoridation, I was shocked to discover that current scientific research on fluoridation no longershows evidence of reducing tooth decay.

“Evidence for whether an intervention works when applied in the community at large is referredto as its effectiveness. . . . Effectiveness studies more accurately reflect results that may beexpected from the implementation of interventions.”4 For example, if one community vaccinatedeveryone with a polio vaccination and another did not, we should be able to measure a reductionof polio disease in the polio vaccinated community.

Claims of a reduction in dental decay by 20% to 40% are flawed and certainly historical.References for those huge benefits are from data taken 20 or more years ago. If the first decayon a tooth can be prevented, then replacement costs for that filling, or subsequent crown, rootcanal, extraction, bridge, implant would not be necessary. A 20-40% reduction of initial decaywould translate into a reduction in total life time dental expenses of more than 50%. However,the glaring problem of why dental expenses are similar in both fluoridated and non fluoridateddeveloped communities must be answered. Does fluoridation no longer reduce dental decay,does fluoridation cause other dental expenses or is the evidence flawed? Dentists are puzzled asto the lack of reduction in dental expenses in fluoridated communities.

A. Ingestion of fluoride is not likely to reduce tooth decay (CDC 1999 MMWR, 48(41); 933-940, October 22).

B. National Institute of Health (NIH) evidence for fluoridation is “incomplete”. 2001Consensus Development Conference Conclusion.

C. Data from the World Health Organization of dental decay over the last 4 decadesindicates those developed countries which do NOT fluoridate have reduced tooth decay as much

as those which predominantly do fluoridate. http://www.fluoridealert.org/health/teeth/caries/who-dmft.html

D. Data from the National Survey of Children’s Health when graphed ranking the 50 USStates according to the percentage of their whole populations fluoridated, does not show a benefitof improved dental health for either the rich or poor. A state could fluoridate everyone or no oneand the percentage of people reporting very good and excellent teeth would be the same. TheWater District does not improve dental health by fluoridating water.http://www.fluorideresearch.org/404/files/FJ2007_v40_n4_p214-221.pdf

E. Washington State fluoridates 59% of residents on public water and Oregon only 19%.However, surveys indicate Oregonians have similar or better dental health and confoundingfactors are in Washington’s favor. The evidence for benefit from fluoridation is lacking.

GOOD TEETH AND FLUORIDATION

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% WholePopulationFluoridated

% High incomechildrenreportinggood/excellentteeth

% Low incomechildrenreportinggood/excellentteeth

Linear (% Highincomechildrenreportinggood/excellentteeth)Linear (% Lowincomechildrenreportinggood/excellentteeth)

F. In 1996, Leroux (UW) in the Journal of Dental Research listed the counties ofWashington and the dental decay prevalence and the percentage of people fluoridated. Again,any benefit from fluoridation is not detected by comparing the prevalence of dental decay incounties that fluoridate and those that do not. Water Fluoridation did not reduce tooth decay.

G. Dentists are puzzled as to why fluoridation no longer appears to reduce dental expensesor decay. Perhaps it was poor historical studies failing to include confounders such associoeconomic differences or delay in tooth eruption caused by fluoridation. In any case,after 60 years of fluoridation, evidence for the effectiveness of fluoridation cannot bedemonstrated. Several studies have been done where fluoridation has been stopped and acessation of fluoridation does not result in an increase in dental decay.

Fluoride, the only mass medicated drug without the patient’s consent must have currentevidence for effectiveness in reduction of dental expenses and decay or fluoridation shouldbe stopped.

IV. RISKS FROM OVER EXPOSURE OF FLUORIDE

Fluoride is an enzymatic reactor. It reacts and interferes with various chemical functions of thebody. Fluoride at levels of 5 mg/kg can be lethal, but low levels of fluoride over long periods oftime will cause or contribute to serious long term health damage.

dfs+DFS Caries Prevalence and % of people Fluoridated

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The most definitive source of risks from too much ingested fluoride is the NRC 2006 with theconclusion that the EPA’s Maximum Contaminant Level if water of 4 ppm is not protective ofdisease. The Committee did not review fluoridation, the intentional adding of fluoride to water atlevels of 1 ppm. However, the scientific evidence selected clearly shows fluoride at much lowerlevels than 4 ppm can be harmful to many.

Some of the dental and medical risks of violent sickness and death from too much fluoride raisedby the NRC 2006 report included:

• Tooth Damage• Rheumatoid and Osteoarthritic-like Pain• Bone Cancer• Bone Fractures• Thyroid Reduction• Diabetes• Obesity• Kidney damage• Reproductive problems• Lower IQ and increased Mental Retardation• Allergies (overactive immune system)• Gastrointestinal disorders, etc.

Let’s look at some of these diseases. The NRC 2006 report found, “The primary endocrineeffects of fluoride exposure in humans and animals include thyroid function decrease” (whichcontributes to obesity, skin disorders, lower basal metabolic rate, feeling tired, increasedheart disease, etc. The medication to treat hypothyroidisum is the 2nd most common USprescription (1999).

A. The NRC 2006 report continues “Diabetes and impaired glucose tolerance” (there is asix-fold increase in diabetes since 1958 when fluoridation started, 7% of US population, sixthleading killer, $132 Billion medical expense, and estimates place 50% of children born after2000 are at high risk of diabetes,5 and “Early Puberty onset”.6

B. These risks are sometimes difficult to fully understand and have several contributingfactors. To illustrate the NRC 2006 concerns, I ranked the 50 US states in order of thepercentage of their whole population fluoridated. The least percentage of people are on theleft and the greatest on the right (see the chart below). The other graphs have the statesranked in this same order.

% OF WHOLE STATE FLUORIDATED

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C. The NRC 2006 is correct, states with more people on fluoridated water (fluoridation ofwater contributes to the dosage, total exposure of ingested fluoride) finds more people withdiabetes.7

D. The NRC 2006 report is correct, the more the fluoride intake, the higher the obesity rate.8

DIABETES AND FLUORIDATION

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MALEDiabetesAdult 45-64yr old

FEMALEAdult 45-65yr old

Linear(FEMALEAdult 45-65yr old)

Linear(MALEDiabetesAdult 45-64yr old)

OBESITY AND FLUORIDATION

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E. The NRC report is correct with concerns of damage to intelligence. For example,reasonable evidence in each state on intelligence is found for those with below 70 IQ for SpecialEducation. Data for higher IQ levels was not found for each state and could not be compared.However, studies finding a decrease in IQ are of serious concern for everyone.9 States with morefluoridation have a higher prevalence of mental retardation.10 The costs of Special Education,decreased IQ are a life time of suffering and sorrow not only for the person but also for parentsand tremendous expense for schools, welfare, and employers. The doubling of the percentageof mentally retarded in more fluoridated states11 (at 1 ppm) is consistent with other literaturefinding a seven-fold increase of mentally retarded persons when comparing similar communitieswith 0.3 ppm to 3.4 ppm fluoride.

Fluoride is attracted to calcium and areas of the body high in calcium are obvious targets such asnerves, teeth, and bones.

MENTAL RETARDATION 6-17 YR OLD

AND FLUORIDATION

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% WholePopulationFluoridated

MR Children6-17 yr old/10,000

Linear (MRChildren 6-17yr old /10,000)

F. Fluoridation seems to increase heart disease for males more than females.12

HEART DISEASE AND FLUORIDATION

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G. The NRC is correct in their concern for an increased rate of cancer from fluoride,especially bone cancer. There does appear to be an increased rate of cancer for males andblack males.13 Although Osteosarcoma is a rare cancer, it has been shown to be between 300 to500% higher in boys on fluoridated water during growth spurts

H. Blood Lead levels are higher in children on fluoridated water.14 No amount of lead can beconsidered safe. The Water District should have an immediate cessation of fluoridation due to anincreased blood level of lead even if no other risks were considered.

CANCER & FLUORIDATIONAfrican American Adult Males

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Fluoridated

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AfricanAmericanAdult Male

Linear(AfricanAmericanAdult Male )

CANCER AND FLUORIDATION

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MaleCancerRate

FemaleCancerRate

Linear(MaleCancerRate)Linear(FemaleCancerRate)

Average Blood Lead NHANES III - Children 3-5

(Counties over 500,000)

0123456789

Race of Child

SiF < 10%SiF > 80%

I. Increased Violent Crime has been found in fluoridated communities.15

Thank you for the opportunity to provide input for your decision on food product labeling.

Sincerely,

Bill Osmunson DDS, MPHAesthetic Dentistry of Bellevue121-112th Ave NE Ste BBellevue, WA 98004425.455.2424bill@smilesofbellevue.com

smilesofbellevue.com

1 "it may be concluded that if a child ingests a fluoride dose in excess of 15 mg F/kg, then death is likely to occur. Adose as low as 5 mg F/kg may be fatal for some children. Therefore, the probably toxic dose (PTD), defined as thethreshold dose that could cause serious or life-threatening systemic signs and symptoms and that should triggerimmediate emergency treatment and hospitalization, is 5 mg F/kg."SOURCE: Whitford G. (1996). Fluoride Toxicology and Health Effects. In: Fejerskov O, Ekstrand J, Burt B, Eds.Fluoride in Dentistry, 2nd Edition. Munksgaard, Denmark. p 171."

2 http://www.epa.gov/EPA-PEST/1996/May/Day-08/pr-685.html3

http://mbao.org/2004/Proceedings04/064%20WelkerJ%20UPDATE%20ON%20THEWelkerJ%20DEVELOPMENT%20AND%20COMMERCIALIZATION%20OF%20PROFUME.pdf4 McDonagh MS, Whiting PF, Wilson PM, Sutton AJ, Chestnutt I, Cooper J, et al. Systematic review ofwater fluoridation. BMJ 2000;321:855-9. Full report available from: http://www.york.ac.uk/inst/crd/fluorid.htm. Analysis and comment available from: http://www.fluoridealert.org/york.htm.

5 http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm#76 Schlesinger J Am Dent Assoc 1956, NRC 2006 p.26

http://www.nationalacademies.org/morenews/20060322.html

SilicofluorideWater&Lead Pollution as Predictors of 1991

Violent Crime Rate (All US Counties)

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% of Population with Water Treated with Silicofluorides

Signif: SiF: p< .0001; Pb: p<.0001;

Interaction p=.067

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VIOLENT CRIMEper 100,000

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7 2004 data, Behavioral Risk Factor Surveillance System, CDC http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.html http://www.unitedhealthfoundation.com/shr2005/components/obesity.htmlhttp://apps.nccd.cdc.gov/giscvh/map.aspx8 2004 data, Behavioral Risk Factor Surveillance System, CDC http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.html http://www.unitedhealthfoundation.com/shr2005/components/obesity.htmlhttp://apps.nccd.cdc.gov/giscvh/map.aspx9 21.6% mental retardation @ 3.14ppm F3.4% mental retardation @ 0.37 ppm FTianjin, Fluoride Vol. 33 No. 2 49052 2000, Editorial 49 Fluoride 33 (2) 2000http://www.fluoride-journal.com/00-33-2/332-49.pdfNRC 2006 p 6Lu Y, Sun ZR, Wu LN, Wang X, Lu W, Liu SS. Effect of high-fluoride water on intelligence in children. Fluoride2000; 33:74-8.Li XS, Zhi JL, Gao RO. Effect of fluoride exposure on intelligence in children. Fluoride 1995;28:189-92.Zhao LB, Liang GH, Zhang DN, Wu XR. Effect of a high fluoride water supply on children’s intelligence. Fluoride1996;29:190-2.www.Fluoridealeart.org10 http://apps.nccd.cdc.gov/giscvh/map.aspx http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.htmlhttp://www.cdc.gov/mmwR/preview/mmwrhtml/00040023.htm11 http://apps.nccd.cdc.gov/giscvh/map.aspx http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.htmlhttp://www.cdc.gov/mmwR/preview/mmwrhtml/00040023.htm12 http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://www.unitedhealthfoundation.com/shr2005/components/obesity.htmlhttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.html13 See NRC 2006 Reporthttp://apps.nccd.cdc.gov/nohss/FluoridationV.aspwww.cdc.gov/cancer/npcr/uscs/pdf/2002_USCS.pdfhttp://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.html14 Coplan, Neurotoxicology. 2007 For NHANES III Children 3-5, mean blood lead is significantly associated withfluoridation status (DF 3, F 17.14, p < .0001) and race (DF 2, F 19.35, p < .0001) as well as for poverty incomeratio (DF 1, F 66.55, p < .0001). Interaction effect between race and fluoridation status: DF 6, F ;3.333, p <.0029;15 http://apps.nccd.cdc.gov/nohss/FluoridationV.asphttp://pubs.usgs.gov/circ/2004/circ1268/htdocs/table05.html http://www.unitedhealthfoundation.comMasters, R.D. (2002). (Westport: Praeger), pp. 275-296 (Ch. 15