03.01.05
The American Herbal Products Association (AHPA), Silver Spring, MD, along with the National Nutritional Foods Association (NNFA), Washington, D.C., submitted comments to FDA on January 10th regarding claim substantiation for dietary supplements.
Focusing on “traditional use,” AHPA suggested FDA recognize the value of credible information on the traditional use of herbs in substantiating structure/function claims for products that contain herbs. As the draft guidance reads, FDA will apply a standard for substantiating dietary supplement claims that is consistent with the FTC’s standard of “competent and reliable scientific evidence.” To this, AHPA’s president Michael McGuffin stated, “FDA should acknowledge that countries all over the world…have developed policies to allow traditional use claims for herbal products.” He continued, “Substantiation of a traditional claim for an herbal product should not require new clinical data so long as the product formulation, dose and claim conform to established traditional use records.” In its comments, AHPA provided specific examples of monographs and “core-data” files that have been prepared by these international government agencies.
AHPA also supported FTC, which believes there should be an option for “confirming scientific evidence” for claims based on historical or traditional use. This way claims are presented in such a way that consumers understand that the basis for the claim is a history of use of the product for a particular purpose. FTC’s role in this respect would be to make sure that the marketing of a product is consistent with the product as traditionally administered. AHPA also backed the Commission on Dietary Supplement Labels, which recommended in its final report that “the composition of the [traditional use] product correspond with the material for which such claims of historical use may be made,” and would need to be “carefully qualified to prevent misleading consumers.”
NNFA also submitted comments on claim substantiation, and while it applauded FDA’s efforts to implement and enforce DSHEA, it had reservations about how exactly those initiatives would be carried out with regard to dietary supplement labels. For example, NNFA agreed with FDA’s position that claims on labeling should be substantiated by scientific evidence, but felt the agency’s position may be too narrow. Additionally, NNFA noted FDA’s position that labels must bear “material facts” is not supported by DSHEA and it remains unclear how the agency expects companies to provide such information. NNFA also expressed concern that such a move may have potential product liability implications.
Focusing on “traditional use,” AHPA suggested FDA recognize the value of credible information on the traditional use of herbs in substantiating structure/function claims for products that contain herbs. As the draft guidance reads, FDA will apply a standard for substantiating dietary supplement claims that is consistent with the FTC’s standard of “competent and reliable scientific evidence.” To this, AHPA’s president Michael McGuffin stated, “FDA should acknowledge that countries all over the world…have developed policies to allow traditional use claims for herbal products.” He continued, “Substantiation of a traditional claim for an herbal product should not require new clinical data so long as the product formulation, dose and claim conform to established traditional use records.” In its comments, AHPA provided specific examples of monographs and “core-data” files that have been prepared by these international government agencies.
AHPA also supported FTC, which believes there should be an option for “confirming scientific evidence” for claims based on historical or traditional use. This way claims are presented in such a way that consumers understand that the basis for the claim is a history of use of the product for a particular purpose. FTC’s role in this respect would be to make sure that the marketing of a product is consistent with the product as traditionally administered. AHPA also backed the Commission on Dietary Supplement Labels, which recommended in its final report that “the composition of the [traditional use] product correspond with the material for which such claims of historical use may be made,” and would need to be “carefully qualified to prevent misleading consumers.”
NNFA also submitted comments on claim substantiation, and while it applauded FDA’s efforts to implement and enforce DSHEA, it had reservations about how exactly those initiatives would be carried out with regard to dietary supplement labels. For example, NNFA agreed with FDA’s position that claims on labeling should be substantiated by scientific evidence, but felt the agency’s position may be too narrow. Additionally, NNFA noted FDA’s position that labels must bear “material facts” is not supported by DSHEA and it remains unclear how the agency expects companies to provide such information. NNFA also expressed concern that such a move may have potential product liability implications.
