FDA Opens Health Claim Field, Plans Increased Enforcement ofDSHEA

FDA Opens Health Claim Field, Plans Increased Enforcement ofDSHEA

"We are committed to improving opportunities forconsumers to get scientifically accurate information about the healthconsequences of the foods they consume, and to enhancing our enforcement effortsagainst those who would make false or misleading claims for theirproducts." -- Mark B. McClellan, M.D., commissioner, Food and DrugAdministration

WASHINGTON--The Food and Drug Administration (FDA)made several major announcements Dec. 18 impacting the natural products anddietary supplement industries. Mark B. McClellan, M.D., commissioner of food anddrugs, presented the Consumer Health Information for Better NutritionInitiative. According to McClellan, the goal of the program is to encourage foodand dietary supplement companies to make accurate, science-based label claimsabout products, and to eliminate fraudulent and misleading claims currently onthe market.

In his announcement, McClellan covered three major areas. First,the agency issued guidance about qualified health claims for conventional foodsand dietary supplements. Second, FDA established a task force charged withdeveloping a framework to ensure consumers get health information they can useand understand. Finally, FDA released an enforcement report outlining an"aggressive enforcement strategy" against dietary supplement companiesviolating the Dietary Supplement Health and Education Act (DSHEA).

Qualified Health Claims Guidance

"Guidance for Industry: Qualified Health Claims in theLabeling of Conventional Foods and Dietary Supplements" appeared in theDec. 20 Federal Register. The guidance is part of FDA's effort toimplement the Pearson court decision, which found that FDA could notreject health claims unless the claims were both misleading and that nodisclaimer would clear the misunderstanding. In October 2000, FDA released a FederalRegister notice discussing "enforcement discretion." This amountedto permitting dietary supplement companies to use qualified health claims aslong as the scientific evidence supporting the claim outweighed that against theclaim, and the claim was appropriately qualified.

In the new guidance, FDA broadened the scope of the Pearsondecision to allow conventional foods to also carry qualified health claims.

Health claims will still be subject to preapproval by FDA andmust meet a "weight of the evidence" standard. FDA will respond tohealth claim petitions in one of three ways. If the claim meets the"significant scientific agreement" standard, FDA will authorize theclaim and consider expediting publication to permit faster use in the market. Ifthe claim does not meet the "significant scientific agreement"standard but does meet a "weight of the evidence" standard, underwhich supporting evidence outweighs negative evidence, FDA will exercise"enforcement discretion," allowing companies to use the claim with anappropriate qualifier. If the claim does not meet either standard, FDA will denythe petition.

Current qualified health claims include folic acid and neuraltube defects, omega-3 fatty acids and coronary heart disease (CHD), and Bvitamins and CHD. Many national news articles speculated the authorizedqualified omega-3 claim could be the first to appear on food products, as fattyfish such as salmon could carry claims promoting consumption of omega-3 fattyacids to reduce the risk of CHD. It is also worth noting that ingredients usedin foods must be generally recognized as safe (GRAS). "This doesn't changethe safety requirement, so you'll likely still see claims for supplements thatwon't apply to foods," said Diane McEnroe, partner with Sidley &Austin, legal counsel to the National Nutritional Foods Association (NNFA).

"This is a very positive move by FDA, which will help foodcompanies to provide more accurate, science-based information on the healthbenefits of food products to consumers," said Rhona Applebaum, executivevice president of the National Food Processors Association (NFPA) (www.nfpa-food.org).NFPA and the Grocery Manufacturers Association (GMA) have long urged FDA toexamine its criteria for health claims and to expand the qualified health claimcategory beyond supplements.

However, the health claim news was not universally cheered."The supplement claims standard has led to a marketplace free-for-all ofmisleading claims that we fear will now spread to the much larger foodindustry," said Bruce Silverglade, legal affairs director of the Center forScience in the Public Interest (CSPI) (www.cspinet.org).

Consumer Information Task Force

To assist FDA in making this change to the health claimparadigm, FDA announced the formation of a task force to review issues involved.Headed by FDA Deputy Commissioner Lester Crawford, Ph.D., and Joseph Levitt,director of FDA's Center for Food Science and Nutrition (CFSAN), the task forcehas a six-month timeline to report back on a framework for facilitating consumeraccess to accurate, scientifically based health information.

Its first charge will be considering the "weight of theevidence" standard FDA will use in evaluating health claim petitions. AsFDA noted, it is not only the number of studies, but "whether the pertinentdata and information presented in those studies are sufficiently scientificallypersuasive."

DSHEA Enforcement

"FDA is committed to enforcing DSHEA in a manner thateffectuates Congress's intent," the agency wrote in its DietarySupplement Enforcement Report. "Congress's intent in passing [DSHEA]was to strike a balance between consumer access to dietary supplements and FDA'sauthority to act against supplements that present safety problems or bear falseor misleading labeling."

FDA stepped up enforcement operations in this area in 2002,including carrying out more than 80 manufacturing facility inspections, seizingmislabeled product, seeking court injunctions and pursuing criminalprosecutions. It plans to continue with these operations in the coming year, aswell as use the new CFSAN Adverse Event Reporting System (CAERS), due to comeonline in June 2003, to monitor dietary supplement safety and claims. McClellanspecifically mentioned seizure actions, saying, "We're puttingmanufacturers on notice about what is coming. We had a major seizure this week,and you can expect more coming."

The recent seizure involved U.S. marshals in California seizing$100,000 worth of product from Halo Supply Co. Its EverCLR capsules containedherbal extracts including echinacea, burdock and ashwaganda, and were promotedas having the ability to "restore your body's resistance to viruses."FDA said the products were unapproved new drugs because of labeling and weremisbranded.

It also outlined certain products that are "clearlyproblematic" and will draw the agency's close scrutiny in the comingmonths. These include:

Finally, FDA noted it "recognizes the need for dietarysupplement current Good Manufacturing Practice (cGMPs) requirements;"dietary supplement cGMPs are, in fact, mandated as part of DSHEA. Industryassociations were informed in October that publication of the proposed GMPswould happen before the end of 2002. At this point, however, there has been nofurther word on when the cGMPs may be published in the Federal Register.In its enforcement document, FDA asked industry to develop "bestpractice" guidelines. According to representatives from NNFA, such"best practices" may refer to cGMPs in place from organizations suchas NNFA, U.S. Pharmacopeia and NSF International that are practiced in theabsence of established federal regulations.

On the whole, industry associations said they were pleased withFDA's decisions. "We applaud FDA for saying they will enforce DSHEA,"said David Seckman, executive director and chief executive officer of NNFA (www.nnfa.org)."This is good for the industry and will offer more reliable information forconsumers to make educated decisions."