The American Herbal Products Association (AHPA) has asked the FDA to take into account relevant information on the traditional use of herbs when substantiating claims for products that contain them.
The industry association's comments are in response to the publication of the FDA's draft guidance on dietary supplement claims in November 2004. This set out the amount, type, and quality of evidence that it recommends a manufacturer have, in order to substantiate a structure/function claim.
The agency also stated that it intends to apply a standard for substantiating dietary supplements claims that is consistent with its standard of "competent and reliable scientific evidence".
"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 usage records," said Michael McGuffin, AHPA's president.
Other US bodies are more open to taking historical or traditional use of herbs into account, according to the association.
The Federal Trade Commission (FTC) has suggested that claims based on this could be presented "in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose".
This approach would depend on ensuring that the product is marketed in ways consistent with traditional uses - a caveat also issued by the Commission on Dietary Supplement Labels, which added that such claims would need to be "carefully qualified to prevent misleading consumers".
McGuffin noted that other countries, such as Canada, Australia and countries in the EU, allow for traditional use claims for herbal products within their policies.
The FDA is also soliciting comments regarding the premarket notification period for new dietary ingredients (NDIs). The notice was originally published on 20 October with a 45-day comment period, but this was extended until early February following requests from the AHPA and four other trade associations. A spokesperson for AHPA confirmed that it plans to submit comments.