HerbalEGram: Volume 6, Number 2, February 2009
FDA Publishes Final Guidance on Substantiation
of Supplement Claims
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The US Food and Drug Administration (FDA) released its final guidance on the substantiation of dietary supplement claims in December 2008.1 The guidance, which describes the amount, type, and quality of evidence that FDA recommends that manufacturers of dietary supplements have to substantiate nutritional deficiency, structure/function, or general well-being claims, is available here.
The FDA’s guidance document recommends that manufacturers possess adequate substantiation for each reasonable interpretation of any claim and stresses that the agency will apply a standard of “competent and reliable scientific evidence” to substantiate a claim. The document notes several factors that could help establish the type of information that would meet the definition of “competent and reliable scientific evidence,” and it gives 21 examples of situations that manufacturers might encounter in the process of determining claims substantiation. The recommendations within the guidance document are not legally enforceable responsibilities.
This final guidance was preceded by a draft guidance published in the Federal Register in November of 2004.2 Interested parties were able to submit comments to the FDA until mid-January of 2005. According to some dietary supplement trade organizations, the final guidance is substantively identical to the draft guidance.3,4
The American Herbal Products Association (AHPA) announced in January that the organization had submitted comments regarding the draft guidance that were not addressed in the final guidance.3 AHPA had requested that the agency acknowledge that information about traditional use should represent competent and reliable evidence for claims so long as the marketed product is in the form or dosage consistent with traditional use and that there is not significant emerging information that contradicts traditional use.
“The Federal Trade Commission (FTC), the Commission on Dietary Supplement Labels and many international regulatory agencies acknowledge and have developed systems to allow information about traditional use systems, and specifically herbal products, to serve as substantiation for contemporary claims that are consistent with traditional use,” said AHPA President Michael McGuffin.3 “It is a significant disappointment that the agency has neither addressed nor acknowledged our thoughtful comments on this important issue.”
According to Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association (NPA), NPA had also submitted comments to the draft guidance recommending that the FDA allow information on traditional use as evidence for claims (oral communication, January 26, 2009). Dr. Fabricant explained that NPA supports the document and is happy that the final guidance has been released, but NPA maintains that the document could use further clarification in some areas. For instance, example 3 of the guidance states that “recommended by scientists” implies general scientific agreement or consensus regarding a claim and states that the opinion of a small group of scientists would not support the claim. A number of questions remain or need to be qualified, such as: what would the agency consider to be a “small group of scientists,” number of institutes/universities, etc.? Is there a way to qualify statements along these lines that are acceptable to the agency so the claim would not imply consensus? Further, in example 14, the guidance indicates that a statement that a particular grain “has been used effectively for centuries to promote gastrointestinal health” may not be adequate, even if substantiated by historical evidence, because there is no objective scientific evidence to confirm its effectiveness. This would appear to limit most claims based on traditional uses, which seems at odds with the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA was to supply the consumer with more information and is reflected in the FTC advertising guide for industry, where FTC discusses traditional use statements.5
The Council for Responsible Nutrition (CRN) submitted comments to the draft guidance in 2005, in which the organization overwhelmingly agreed with the guidance. “The final guidance reinforces the long-standing thinking of the agency and echoes the FTC guidelines for advertising, to ensure that the two agencies are saying the same thing,” said Andrew Shao, PhD, CRN’s vice president of scientific and regulatory affairs (e-mail, January 28, 2009). “The guidance is also a validation of CRN’s voluntary advertising initiative with the [National Advertising Division], which requires that companies be able to substantiate the advertising claims of their products. This final guidance helps create consistency across all regulatory areas—whether FDA, FTC or voluntary regulation—to ensure that dietary supplement claims are able to be substantiated and helps to level the playing field for the entire industry.”
—Courtney Cavaliere
References
1. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act. December 2008. US FDA Center for Food Safety and Applied Nutrition Web site. Available at: http://www.cfsan.fda.gov/~dms/dsclmgu2.html. Accessed January 23, 2009.
2. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act; Availability. 74 Federal Register 21; January 5, 2009. Available at: http://www.cfsan.fda.gov/~lrd/fr090105.html. Accessed January 23, 2009.
3. FDA releases final claims substantiation guidance; AHPA comments not addressed. AHPA Update. January 8, 2009. American Herbal Products Association Web site. Available at: http://www.ahpa.org/Default.aspx?tabid=69&aId=507&zId=1. Accessed January 23, 2009.
4. Updated: FDA’s “Substantiation for Dietary Supplements Claims” final guidance offered. January 5, 2009. Natural Products Association Web site. Available at: http://www.naturalproductsassoc.org/site/News2?abbr=pc_&page=NewsArticle&id=10245. Accessed January 23, 2009.
5. Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry. Washington, DC: Federal Trade Commission, 2001. Available at: http://www.ftc.gov/bcp/edu/pubs/business/adv/bus09.shtm. Accessed February 3, 2009. |
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