FDA Releases DSHEA Implementation Strategy, Guidance on Claims

WASHINGTON--The Food and Drug Administration (FDA) announced Nov. 4 regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act (DSHEA). FDA unveiled a strategy governing its regulatory plans in the dietary supplement arena and released a draft guidance document outlining substantiation requirements for structure/function claims. In addition, the agency is placing a great deal of emphasis on the meeting it previously scheduled for Nov. 15, which will examine the issue of new dietary ingredients (NDIs), what the agency has termed a "safety net" in the law. Finally, in announcing these initiatives, FDA again promised to release final GMP (good manufacturing practice) as soon as possible.

FDA gave industry a head's up on the plan during the Council for Responsible Nutrition's (CRN) annual conference held here the last week of October. Lester Crawford, Ph.D., acting commissioner of FDA, discussed the agency's "umbrella" strategy covering monitoring and evaluation of product and ingredient safety; assurance of product quality; and ongoing monitoring and evaluation of product labeling. "We have been taking a comprehensive look at DSHEA, and we want to satisfy the intent of the regulation," Crawford told the CRN attendees. "We're committed to going ahead with DSHEA and ensuring consumers of the safety of products and the truthfulness of the claims."

FDA's regulatory strategy report is divided into three sections following those Crawford outlined in his presentation. During a press briefing, Michael Landa, deputy director of regulatory affairs for FDA's Center for Food Safety and Applied Nutrition (CFSAN), reiterated the agency's goal is to increase transparency of the regulatory process. "We think if we're clear and consistent in setting and enforcing our expectations, we will facilitate greater compliance with the law by industry, resulting in better consumer protection and better public health benefits because of the greater degree of confidence that claims are substantiated under an appropriate scientific standard," he said.

In the area of monitoring product and ingredient safety, FDA focused on both the issue of NDIs as well as how to determine safety of ingredients already on the market. During his presentation at CRN, Crawford noted the Nov. 15 NDI meeting will "set the stage for what will happen in the next few years." And in its Q&A document online, FDA noted in addition to holding the meeting, the agency plans to begin bringing enforcement actions against dietary supplements that contain NDIs for which a notification has not been received and against supplements containing NDIs that FDA believes are unsafe.

"Old" dietary ingredients are also being reviewed by FDA as part of the new strategy. FDA contracted the Institute of Medicine (IOM) to develop a framework for evaluating the safety of dietary supplements; that report was released in early 2004 (for more information, visit www.naturalproductsinsider.com/articles/441news02.html). In addition, the agency plans to use signals from consumer groups, adverse event reports and other sources to identify possible safety concerns; FDA will then evaluate the risks and benefits of the ingredient before determining an appropriate regulatory action.

While Crawford and Landa both said FDA was not anticipating any immediate changes to its enforcement process, they emphasized FDA planned to take vigorous action against products and ingredients that may pose a public health concern, whether new or old ingredients.

On the labeling side, FDA noted it plans to expand its postmarket labeling surveillance beyond the Internet, which has been its primary focus for several years, into products marketed at the retail level. In addition, the agency is planning to take enforcement action against products where labels fail to reveal "material facts" that could pose risks to consumers. Among the situations that could lead to enforcement action are failure to disclose known drug interactions, possible adverse effects or contraindications. Finally, FDA plans to take further enforcement actions against products marketed with unsubstantiated claims.

To help clarify the issue of claims substantiation, FDA released a draft guidance document, focused exclusively on what types of substantiation could be used for making structure/function or general well-being claims; the guidance does not discuss differentiating between disease and structure/function claims. In the introduction, FDA noted, "We recommend that dietary supplement manufacturers carefully draft their labeling claims and carefully review the support for each claim to make sure that the support relates to the specific product and claim, is scientifically sound, and is adequate in the context of the surrounding body of evidence."

FDA sets forth four issues for companies to consider in making claims: the meaning of the claim (both express and implied), the relationship of the evidence to the claim, the evidence quality and the totality of the evidence. Several examples are provided under each area to provide further clarification of the issues discussed. The document also discusses different types of studies--in vitro, animal, human, intervention, observational, etc.--and how each may relate to the strength of a structure/function claim. It sets the randomized, double blind, parallel group, placebo-controlled trial as the "gold" standard and places the greatest weight on human studies using the ingredient and/or supplement being marketed. Other types of information--animal studies, historical use or in vitro--"may not be adequate to substantiate a claim."

During the press briefing, Bob Moore, Ph.D., team leader for compliance and enforcement within CFSAN's Division of Dietary Supplement Programs, said the guidance is not designed to set a benchmark. "The guidance tries to lay out the different types of evidence that are available and provide an overlay of the strengths and weaknesses," he said. "These are factors firms should consider to see if there is a strong link between that evidence and their claim."

In a public show of support, Deborah Platt Majoras, chairman of the Federal Trade Commission (FTC), announced its support for FDA's substantiation guidance document. "Today's FDA action leaves no doubt that our two agencies are united in our efforts to combat false or unfounded claims," she said. "We look forward to continuing our close collaboration with FDA to attack deceptive and unsubstantiated claims in the dietary supplement market."

Both Crawford's address to CRN and Landa's discussion with the press only briefly addressed GMPs. Landa noted, "Issuance of a final GMP rule is CFSAN's highest priority regulation, bar none." And Crawford assured industry members publication of dietary supplement GMPs is "one of the agency's highest priorities."

At press time, industry associations and stakeholders were still reviewing FDA's flood of documents. However, most groups were actively preparing comments for the Nov. 15 meeting and planned further comments to address the substantiation guidance and regulatory initiative.

Annette Dickinson, Ph.D., president of the Council for Responsible Nutrition (CRN), said the association is pleased FDA is working to implement DSHEA, and hopes to work with the agency to ensure the intention of the law is maintained through implementation. "I expect the substantiation document will make companies more cognizant of the need to have adequate substantiation, and this is consistent with the requirements of DSHEA," she said. "Its intent is to reel in unsubstantiated claims and this is appropriate; however, we will want to review the document in more detail. Also, the NDI meeting and the issues surrounding the definition of old and new dietary ingredients and the kind of evidence needed to establish safety are absolutely critical to the future of the industry and to the agency's ability to appropriately implement DSHEA." Dickinson added CRN was working on comments on the NDI issue and is requesting a speaking slot at the Nov. 15 meeting.

The American Herbal Products Association (AHPA) is also closely following the NDI issue, in particular. Together with CRN, the National Nutritional Foods Association (NNFA), the Consumer Healthcare Products Association (CHPA) and the Utah Natural Products Alliance (UNPA), AHPA filed with FDA a request to extend the comment period on the NDI issue from Dec. 3, 2004, to Feb. 1, 2005. Among the reasons cited for the time extension were the need for assessing the issue in context of the small businesses it will affect, the number of specific questions posed in the NDI notice and the need to review comments from the Nov. 15 meeting.

Jonathan Emord, an industry attorney who has headed up several health claim cases including Pearson v. Shalala, was still reviewing the guidance document, but said the fact that FDA was following FTC's lead was not necessarily good news for supplement marketers. "The FTC standard is ambiguous, and FDA's reliance on that FTC standard tends to obscure the requirements," Emord said. "It could have a chilling effect on companies that were making claims in good faith based on their understanding of the substantiation requirement, which has now been changed to a different standard."

FDA's documents are available online. The regulatory strategy can be found at www.cfsan.fda.gov/~dms/ds3strat.html. The substantiation draft guidance is available at www.cfsan.fda.gov/~dms/dsclmgui.html. And the NDI public meeting notice and questions from the Federal Register are at www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.htm.