FDA Opens Health Claim Field, Plans Increased Enforcement of DSHEA

"We are committed to improving opportunities for consumers to get scientifically accurate information about the health consequences of the foods they consume, and to enhancing our enforcement efforts against those who would make false or misleading claims for their products." -- Mark B. McClellan, M.D., commissioner, Food and Drug Administration

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

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

Qualified Health Claims Guidance

"Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements" will appear in the Dec. 20 Federal Register. The guidance is part of FDA's effort to implement the Pearson court decision, which found that FDA could not reject health claims unless the claims were both misleading and that no disclaimer would clear the misunderstanding. In October 2000, FDA released a Federal Register notice discussing "enforcement discretion." This amounted to permitting dietary supplement companies to use qualified health claims as long as the scientific evidence supporting the claim outweighed that against the claim, and the claim was appropriately qualified.

In the new guidance, FDA broadened the scope of the Pearson decision to allow conventional foods to also carry qualified health claims. In a statement from Emord & Associates, the legal firm that represented the Pearson plaintiffs, Jonathan Emord cheered FDA's decision. "The decision is nothing short of revolutionary [and] is an abrupt departure from the agency's long held view that no nutrient-disease claims should be allowed for foods or dietary supplements unless proven to a near conclusive degree," it read. "Far more information about the actual and potential health benefits of dietary supplements and foods will reach consumers than ever before."

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

Current qualified health claims include folic acid and neural tube defects, omega-3 fatty acids and coronary heart disease (CHD), and B vitamins and CHD. Many national news articles speculated the authorized qualified omega-3 claim could be the first to appear on food products, as fatty fish such as salmon could carry claims promoting consumption of omega-3 fatty acids to reduce the risk of CHD. It is also worth noting that ingredients used in foods must be generally recognized as safe (GRAS). "This doesn't change the safety requirement, so you'll likely still see claims for supplements that won'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 food companies to provide more accurate, science-based information on the health benefits of food products to consumers," said Rhona Applebaum, executive vice president of the National Food Processors Association (NFPA) (www.nfpa-food.org). NFPA and the Grocery Manufacturers Association (GMA) have long urged FDA to examine its criteria for health claims and to expand the qualified health claim category beyond supplements.

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

Consumer Information Task Force

To assist FDA in making this change to the health claim paradigm, 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 Force has a six-month timeline to report back on a framework for facilitating consumer access to accurate, scientifically-based health information.

Its first charge will be considering the "weight of the evidence" standard FDA will use in evaluating health claim petitions. As FDA noted, it is not only the number of studies, but "whether the pertinent data and information presented in those studies is sufficiently scientifically persuasive." The Task Force will also:

* Propose a strategy to ensure FDA reaches decisions on health claim petitions in a timely fashion;

* Propose improvements in FDA's capability to identify false, misleading and/or unsubstantiated claims;

* Propose a strategy for FDA to prevent dissemination of such fraudulent claims; and

* Develop a research agenda to investigate how consumers view scientific information to help companies present such information in a non-misleading way.

DSHEA Enforcement

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

FDA stepped up enforcement operations in this area in 2002, including carrying out more than 80 manufacturing facility inspections, seizing mislabeled product, seeking court injunctions and pursuing criminal prosecutions. It plans to continue with these operations in the coming year, as well as use the new CFSAN Adverse Event Reporting System (CAERS), due to come online in June 2003, to monitor dietary supplement safety and claims. McClellan specifically mentioned seizure actions, saying, "We're putting manufacturers 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 contained herbal extracts including echinacea, burdock and ashwaganda, and were promoted as having the ability to "restore your body's resistance to viruses." FDA said the products were unapproved new drugs because of labeling and were misbranded. A company spokeswoman told INSIDER the company had no public statement.

Such seizures are dramatic, and usually come at the end of discussions between FDA and companies. In its enforcement notice, FDA laid out a variety of examples of enforcement action taken against different companies, such as warning letters asking for voluntary corrections of problems or legal action enjoining product sale. It also outlined certain products that are "clearly problematic" and will draw the agency's close scrutiny in the coming months. These include:

* Products that purport to treat life-threatening diseases such as cancer, HIV/AIDS and lupus--"These products are ineffective and rely on unsubstantiated claims."

* Weight-loss products--"There is no evidence supporting the products' effectiveness." These products were just the subject of a Congressional hearing, and have been under the microscope by the Federal Trade Commission (FTC) as well.

* Products targeting children's conditions, such as autism, attention deficit disorder, mental retardation and Down's syndrome.

* Colloidal minerals and colloidal silver.

* Supplements for smokers and for drinkers.

Finally, FDA noted it "recognizes the need for dietary supplement current Good Manufacturing Practice requirements (cGMPs);" dietary supplement GMPs are, in fact, mandated as part of DSHEA. Industry associations were informed in October that publication of the proposed GMPs would happen before the end of 2002. At this point, however, there has been no further word on when the GMPs may be published in the Federal Register. In its enforcement document, FDA asked industry to develop "best practice" guidelines. According to representatives from NNFA, such "best practices" may refer to cGMPs in place from organizations such as NNFA, U.S. Pharmacopeia and NSF International that are practiced in the absence of established federal regulations.

On the whole, industry associations said they were pleased with FDA'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 for consumers to make educated decisions."

Annette Dickinson, Ph.D., vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN)(www.crnusa.org), agreed with the assessment. "We support efforts by the regulatory agencies to reign in companies that are engaging in misleading dietary supplement advertising," she said. "The dietary supplement industry is regulated ... and companies that do not comply with the legal requirements for truthful advertising do a grave disservice to both consumers and the responsible companies providing quality products."