United States: trade organizations submit comments to FDA on claim substantiation & new dietary ingredients (NDIs).
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 As the draft guidance reads, FDA will apply a standard for substantiating dietary supplement claims that is consistent with the FTC's standard of "competent and reliable scientific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.
New Dietary Ingredients (NDIs)
In other developments, AHPA, the Council for Responsible Nutrition (CRN), Washington, D.C., and the American Botanical Council (ABC), Austin, TX, also recently filed comments regarding new dietary ingredients (NDIs). According to AHPA, since the passage of DSHEA in 1994, FDA has posted online 260 NDI notification reports; some of those NDI notifications were incomplete or for old ingredients that did not need review. AHPA's input includes pragmatic suggestions to winnow out dietary ingredients that are not new, including recognizing AHPA's Herbs of Commerce, 2nd edition as a source document; suggests that a botanical's Latin binomial, author, and part be identified; and opposes FDA's contention that the "chemical composition" or "active components" needs to be disclosed. AHPA urged FDA to reject filings for new dietary supplements, foods, and old, or already known, ingredients; and to allow a company to withdraw a notice. AHPA also outlined key factors to define the standard for "reasonably expected to be safe."
Also submitting comments was the ABC, which said "In order to help determine which ingredients were NDIs, shortly after DSHEA was passed, several dietary supplement industry trade organizations began developing lists of "Old Dietary Ingredients" (ODIs) (or "grandfather" lists as some were called). Even though these lists were used as reference points by industry and were not considered "authoritative" by the FDA (i.e., each ingredient on the lists had not been verified to have been sold prior to October 15, 1994 with formal evidence, e.g., an invoice, bill of lading, catalog listing, etc.), ABC's suggested that FDA officially recognize the lists developed AHPA, CRN and the Utah Natural Products Alliance (UNPA) as positive lists of ODIs." ABC stated that since 10 years has lapsed since the passage of DSHEA, it does not believe that it should be necessary to create a new "authoritative" list in which all ingredients are confirmed as ODIs with such confirmatory evidence as FDA might have required previously, particularly since some of the records needed for such confirmation are probably no longer extant.
ABC also noted that FDA recently stated in correspondence that an ingredient must have been "lawfully marketed" prior to October 15, 1994 for it to qualify as an ODI. In the comments it filed, ABC objected to this stipulation, noting that this term does not appear in DSHEA and was thus was not the intent of Congress. ABC noted that in the pre-DSHEA regulatory environment there was considerable confusion about the legal and regulatory status of most botanicals and FDA tried unsuccessfully to remove some herbs from the market by declaring them "unapproved food additives." FDA was stopped by two highly publicized federal court decisions from doing so, and these cases, among other issues, became a primary impetus supporting the passage of DSHEA.
The definition of a dietary supplement has also been a point of contention. To this point, CRN suggested FDA keep the broad definition of dietary supplement intact, regardless of the essentiality in human nutrition. In the case of minerals, for example, CRN said essentiality in human nutrition is not a condition of inclusion as a mineral, for purposes of definition. "Minerals such as nickel, silicon, tin and vanadium are commonly included in many national brands and store brands of multivitamin/multimineral supplements and are grandfathered ingredients, having been present in such products for many years," CRN said. "Yet they are not recognized as 'essential' in human nutrition." It also addressed the term "dietary substance." "CRN views the term 'dietary substance' to refer to anything in food, whether the food itself is commonly consumed by most people or only rarely consumed by a small subgroup of consumers, whether the food is consumed in the U.S. or only elsewhere in the world, and whether the particular substance is a major or minor trace constituent of the food," the trade organization said, adding, "We also view the term as encompassing synthetic equivalents of the naturally-occurring substances."
CRN also says NDIs that have been "present in the food supply as an article used for food in a form in which the food has not been chemically altered" should not require notification to FDA. And it believes the class of NDIs that do not require notification is large, including all components or constituents of previously marketed foods. Examples of new dietary ingredients that would not require notification might include a newly identified isoflavone that is a natural constituent of blackberries or blueberries, a particular carotenoid naturally occurring in red and orange peppers, or a newly isolated polysaccharide from mushrooms.
CRN also mentioned the possibility of instituting an industry-sponsored safety review panel. "In order to reduce the burden on FDA and increase the credibility of the NDI submissions, industry could provide valuable assistance by establishing an independent safety review body, similar to the CTFA Cosmetic Ingredient Review, but in this case focused on the review of new dietary ingredients," it said. "Such a review panel could also perform the service of reviewing the safety of ODIs (grandfathered ingredients) about which safety concerns may arise for any reason. CRN said its members have discussed the feasibility of supporting an expert review panel, but consensus has not yet been reached on this undertaking.
CRN agreed with FDA that providing information regarding a new dietary ingredient's intended use (including the serving size or dose, as well as frequency and duration of recommended use) in finished product form should be required of companies. However, it did not believe that it was necessary for company to submit product labels. "The label and labeling for a product may be considered confidential by the manufacturer at the time the notification is filed, and in many cases the NDI submission
may be made by the supplier of the bulk ingredient, prior to the development of actual products and labels.
As for the information needed to establish a "reasonable expectation of safety," CRN had several reservations about where it thinks FDA might be headed. First, it pointed out that in examining FDA's description of the studies that might be considered there seemed to be a lot of similarities with the requirements set forth for food additives and generally recognized as safe (GRAS) petitions, as well as the information required for a new drug application (NDA). According to CRN, DSHEA deliberately excluded dietary ingredients from the definition of food additives and then established a separate notification procedure, and there should be no appearance in the current proceeding that the agency is tending back toward a food additive model. It also disagreed with FDA that the safety standard for dietary ingredients is similar to that for food additives or GRAS substances, which are positioned as having a "reasonable certainty of no harm." The language describing the safety standard for ingredients in DSHEA was altered deliberately to say that the ingredient will "reasonably be expected to be safe." CRN said further that there are models other than the food additive and NDA models that may be useful in developing ways to demonstrate a reasonable expectation of safety for dietary ingredients. It suggested FDA take a look at the GRAS self-determination process, as well as the model used by the Environmental Protection Agency (EPA) for new chemicals. In addition, it said Canada's Natural Health Products Directorate warrants review as it may also prove to be a valuable model.
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|Title Annotation:||INTERNATIONAL REGULATORY UPDATE|
|Date:||Mar 1, 2005|
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