New food and drug administration health claim requirements get mixed response
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practice applications FOR YOUR INFORMATION New Food and Drug Administration Health Claim Requirements Get Mixed Response N ut aficionados may have been surprised, perhaps even con- fused, by the qualified health claim that appeared on some of their favorite walnut products. “Supportive but not conclusive re- search shows that eating 1.5 ounces per day of walnuts as part of a diet low in saturated fat and choles- terol may reduce the risk of heart disease.” After more than a decade of heavy health claim evaluating, the US Food and Drug Administration (FDA) recently decided to create a subcategory of qualified health claims. The FDA says it gets infor- mation to the consumer faster and encourages healthier products. In theory, it would give producers the opportunity to spur sales. However, according to the New York Times, the California Walnut Commission, the first beneficiary of the new claims, found that its claim was too vague to increase sales. Si- multaneously, the Center for Sci- ence in the Public Interest (CSPI) and Public Citizen have initiated a lawsuit against the FDA, claiming that qualified health claims violate the Nutrition Labeling and Educa- tion Act of 1990 (1). Regardless of criticism, the new rules create a brave new world for dietetics professionals and, most im- portantly, for consumers. BRIEF HISTORY OF HEALTH CLAIMS In 1985, the United States was the first country to enact a law allowing health claims for nutrients naturally contained in conventional foods. (Be- fore that, Japan was the first country to permit health claims for functional foods.) The FDA health claim pro- gram allowed health claims for con- ventional foods without premarket approval. In 1990, Congress passed the Nutrition Labeling and Education Act, permitting only health claims ap- proved by the FDA and setting the foundation for today’s system (2). However, food companies and groups began lobbying to have a more flexible, timely health claim process, especially in light of the less stringent process required of supplements. As the Journal noted in April 2003, “The International Tree Nut Council (ITNC) or any or- ganization asking for FDA backing must go through four steps to get its health claim supported, an entire process that legally can take no more than 540 days” (3). The health claim process would require significant scientific agree- ment, meaning that the bulk of the scientific community believes that the food or contained ingredient is healthful. “It doesn’t necessarily mean that the scientific community understands the mechanism, but it agrees that it is healthful,” says the FDA. Under the significant scientific agreement system, only 12 health claims were approved by the FDA. NEW RULES In spring 2003, the FDA began allow- ing temporary placeholder claims, a process that gives companies permis- sion to use a qualified health claim while the significant scientific agree- ment claim is being evaluated. “It’s a qualified health claim not in the sense that you qualify,” says an FDA spokesperson, “but that there is a qualifying term.” Now a company can petition for a health claim, which the FDA pub- licly files within 45 days. The FDA then rules on it within 270 days (the previous 45 days are within the 270), a shorter process than the 540 days previously needed. Claims con- sidered unworthy at the end of the evaluation process are removed. The FDA uses evidence-based medicine to determine what quali- fied claims are most appropriate. Joanne Lupton, PhD, professor of nutrition at Texas A&M University, College Station, worked with the FDA in 2002 to create an efficient evaluation process, and consulted ADA Nutrition Scientist Esther F. Myers, PhD, RD, FADA, about the ADA evidence-based method. “The ADA has been a leader in this area and has been using the method so dietitians know the strength of rec- ommendations for their clients,” Lup- ton says. “The dietary guidelines com- mittee recently used evidence-based medicine, which was completely new to us, and now the FDA is using it. Now it’s the way of the world, partic- ularly within the government.” “[Qualified health claims are] an effort to get more information out there to consumers . . . because [sig- nificant scientific agreement] is a high standard to meet,” according to the FDA. “There are a few, very well-controlled and designed stud- ies, but sometimes it depends on the nature of the type of research. Sometimes it takes a while to get there. However, along the process of getting a [significant scientific agreement], we can sometimes see where scientists are pointing us. And if we are seeing that, why would we withhold it from the pub- lic, especially if there are no clear downsides?” CONSUMER IMPACT Most agree that the health claim change will put more responsibility in the hands of the consumer, not unlike the number of fortified foods has re- quired more sophisticated shopping. “The danger is not the increase in This article was written by Damon Brown, a freelance writer in New Orleans, LA. doi: 10.1016/j.jada.2004.11.013 © 2005 by the American Dietetic Association Journal of the AMERICAN DIETETIC ASSOCIATION 19
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Transcript of New food and drug administration health claim requirements get mixed response
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ut aficionados may have beensurprised, perhaps even con-fused, by the qualified health
laim that appeared on some of theiravorite walnut products.
“Supportive but not conclusive re-search shows that eating 1.5 ouncesper day of walnuts as part of a dietlow in saturated fat and choles-terol may reduce the risk of heartdisease.”
After more than a decade of heavyealth claim evaluating, the USood and Drug Administration
FDA) recently decided to create aubcategory of qualified healthlaims. The FDA says it gets infor-ation to the consumer faster and
ncourages healthier products. Inheory, it would give producers thepportunity to spur sales.However, according to the New
ork Times, the California Walnutommission, the first beneficiary of
he new claims, found that its claimas too vague to increase sales. Si-ultaneously, the Center for Sci-
nce in the Public Interest (CSPI)nd Public Citizen have initiated aawsuit against the FDA, claiminghat qualified health claims violatehe Nutrition Labeling and Educa-ion Act of 1990 (1).
Regardless of criticism, the newules create a brave new world forietetics professionals and, most im-ortantly, for consumers.
RIEF HISTORY OF HEALTH CLAIMSn 1985, the United States was therst country to enact a law allowingealth claims for nutrients naturallyontained in conventional foods. (Be-ore that, Japan was the first countryo permit health claims for functional
This article was written byDamon Brown, a freelancewriter in New Orleans, LA.
pdoi: 10.1016/j.jada.2004.11.013
2005 by the American Dietetic Associat
oods.) The FDA health claim pro-ram allowed health claims for con-entional foods without premarketpproval. In 1990, Congress passedhe Nutrition Labeling and Educationct, permitting only health claims ap-roved by the FDA and setting theoundation for today’s system (2).
However, food companies androups began lobbying to have aore flexible, timely health claim
rocess, especially in light of theess stringent process required ofupplements. As the Journal notedn April 2003, “The Internationalree Nut Council (ITNC) or any or-anization asking for FDA backingust go through four steps to get itsealth claim supported, an entirerocess that legally can take noore than 540 days” (3).The health claim process would
equire significant scientific agree-ent, meaning that the bulk of the
cientific community believes thathe food or contained ingredient isealthful. “It doesn’t necessarilyean that the scientific communitynderstands the mechanism, but itgrees that it is healthful,” says theDA.Under the significant scientific
greement system, only 12 healthlaims were approved by the FDA.
EW RULESn spring 2003, the FDA began allow-ng temporary placeholder claims, arocess that gives companies permis-ion to use a qualified health claimhile the significant scientific agree-ent claim is being evaluated. “It’s a
ualified health claim not in the sensehat you qualify,” says an FDApokesperson, “but that there is aualifying term.”Now a company can petition for a
ealth claim, which the FDA pub-icly files within 45 days. The FDAhen rules on it within 270 days (the
revious 45 days are within theion Jour
70), a shorter process than the 540ays previously needed. Claims con-idered unworthy at the end of thevaluation process are removed.The FDA uses evidence-basededicine to determine what quali-
ed claims are most appropriate.oanne Lupton, PhD, professor ofutrition at Texas A&M University,ollege Station, worked with theDA in 2002 to create an efficientvaluation process, and consultedDA Nutrition Scientist Esther F.yers, PhD, RD, FADA, about theDA evidence-based method.“The ADA has been a leader in this
rea and has been using the methodo dietitians know the strength of rec-mmendations for their clients,” Lup-on says. “The dietary guidelines com-ittee recently used evidence-basededicine, which was completely new
o us, and now the FDA is using it.ow it’s the way of the world, partic-larly within the government.”“[Qualified health claims are] an
ffort to get more information outhere to consumers . . . because [sig-ificant scientific agreement] is aigh standard to meet,” according tohe FDA. “There are a few, veryell-controlled and designed stud-
es, but sometimes it depends on theature of the type of research.ometimes it takes a while to gethere. However, along the process ofetting a [significant scientificgreement], we can sometimes seehere scientists are pointing us.nd if we are seeing that, whyould we withhold it from the pub-
ic, especially if there are no clearownsides?”
ONSUMER IMPACTost agree that the health claim
hange will put more responsibility inhe hands of the consumer, not unlikehe number of fortified foods has re-uired more sophisticated shopping.
“The danger is not the increase innal of the AMERICAN DIETETIC ASSOCIATION 19
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FOR YOUR INFORMATION
2
ualified health claims, but that theonsumer will focus on one healthlaim and forget about the rest,” saysinda McDonald, MS, RD, owner andublisher of Supermarket Savvy. “TheDA has tried to encourage balancey setting qualified nutrient levels forll health claims, but with so manyutrients and health claims to dealith it’s easy to focus on one nutrientnd forget about the others.”McDonald says that, for instance,
f you recommend that a client eatore high-fiber cereals, he or sheay only look at the fiber amount
nd overlook high calories due to fatnd sugar content.In September 2003, two nonprofit
rganizations, CSPI and Public Citi-en, sued the FDA for violation of theutrition Labeling and Educationct of 1990, the mandate that saysignificant scientific agreements areequired of all food health claims.Consumers don’t want wishy-washyealth advice from the federal gov-rnment,” CSPI Legal Director Bruceilverglade told the Washington Post.Putting out shaky scientific adviceoes against 100 years of publicealth tradition” (4).At the same time, food companies
elieve that the health food claimson’t go far enough, agreeing withonsumer watchdog groups thatualified language only serves toonfuse the consumer.According to the New York Times,
he walnut industry tested severalifferently worded claims with con-umers and found little impact onheir intent to buy:
Dennis A. Balint, chief executive ofthe California Walnut Commission,recalled being ‘elated’ when heheard that the right to make a claimhad been granted. But the elationsoon wore off as Mr. Balint began tofret over the wording that theagency was allowing.
Now, 8 months after the approval,ew if any walnut products carry arinted health claim. Consumer re-earch by the Walnut Commission,hich represents more than 5,000rowers and handlers, suggested thathe hedged claim would do little toromote sales. “When you tell the con-umer ‘supportive but not conclusive’nd ‘may’—with all those qualifiers,he claim is not very meaningful,” Mr.
alint said (1).0 January 2005 Volume 105 Number 1
HE FUTUREhe FDA says it stands behind theew health claim system despite theending lawsuit and complaints to-ards it, namely because of two po-
ential benefits. One, it wants to giveonsumers more tools so they canake better dietary choices. Sec-
ndly, it hopes to provide incentive forompanies to make more healthfulroducts, believing that productsith a health claim will sell more.“For instance, instead of saying my
everage has 20% more cherry, theyill say ours is healthier than an-ther brand,” says an FDA spokesper-on. “That’s the underlying logic.”
eferences. Alster N. New food labels winning
few fans. The New York Times.March 28, 2004; sect 3:4.
. The Center for Science in the Pub-lic Interest. CSPI Reports Interna-tional, Functional Foods: PublicHealth Boon or 21st CenturyQuackery? Available at: http://www.cspinet.org/reports/functional_foods/usa_bckgrnd.html. AccessedSeptember 10, 2004.
. Brown D. FDA considers healthclaim for nuts. J Am Diet Assoc.2003;103:426.
. Edelstein J. Qualified HealthClaims for Walnuts Receives FDAApproval. Available at: http://ceb.ucop.edu/newsletter/Business1.htm. Accessed September 10, 2004.
Counting Carbs
The FDA is taking action to clarifycarbohydrate health claims, par-tially in reaction to the low-carbo-hydrate trend.
“The way the law is written rightnow, you shouldn’t see a label thatsays ‘low-carb chips,’ but it can sayit is part of a low-carbohydrate life-style,” says an FDA spokesperson.“A carb is a nutrient and we havespecific nutrient claims, but thereare no nutrient claims for carbs.”
The FDA says that, unless usedwithin terms defined by regulation,carbohydrate claims are prohibitedunder section 403 of the FederalFood, Drug, and Cosmetic Act. Ac-cording to a spokesperson, thereare eight terms a manufacturercannot pair with carbohydrate la-bels on its products:
● Free● Low● Less● Reduced● Light● Good source● High● More
“Some companies are in viola-tion, but many have sound phras-ing,” the FDA says. “Many of thebig manufacturers are aware of theissue and have been responsive tothe warning letters we’ve sent out.”
Kraft, ConAgra, and the GroceryManufacturers of America are cur-rently petitioning for carbohy-
