FDA Regulation Changes Threaten the Supplement Industry

November 18, 2008
Category: Uncategorized

Urgent Action Needed. The Time to Send Comments to the FDA is Now: comment period whether section 301 should be extended to include dietary supplements has been extended to November 25.
In the November 11, 2008 issue of Pulse of Health Freedom, AAHF mentioned an FDA request for comment from industry and consumers regarding regulation changes that threaten to stifle the supplement industry.

Specifically, the FDA is implementing the Food and Drug Administration Amendments of 2007. These include a provision that amends the Food, Drug, and Cosmetic Act (FDCA).  Depending on the interpretation of this new provision, products may be barred from being marketed as dietary supplements if they include substances that have been subject to clinical investigations that have been made public.  In fact, all food items that include substances that have been subject to clinical investigations would be barred from interstate commerce.  For example, the natural sweetener Stevia has been targeted under this provision for regulation as a drug. This provision has created a conflict between two federal statutes. To listen to a brief description of what Section 912 is, click here.
The interstate shipment of foods to which certain substances have been added is prohibited by § 301 (ll). The issue in question is whether § 301 (ll) should extend to dietary supplements, which are currently subject to the provisions of § 201 (ff) of the FDCA. If § 301 (ll) is interpreted to apply to dietary supplements, it will be in direct conflict with the preexisting standard for dietary supplements set under § 201 (ff). Industry trade groups including the Natural Products Association and the Council for Responsible Nutrition are seeking clarification that § 201 (ff) remains in effect and sets the supplement standards and that § 301 (ll) does not apply to dietary supplements.
Under section 201, a substance cannot be marketed as a dietary supplement if it has undergone clinical studies that were made public and which were conducted in accordance with an investigational new drug application (IND).  This current standard permits supplement manufacturers to do important scientific research necessary to develop the best supplements, while still marketing the products as dietary supplements, as long as the studies are not conducted in accordance with an IND.  Section 301 (ll), on the other hand, prohibits the addition of substances to food that have been the subject of clinical studies, whether or not as part of an IND, providing those studies were made public.
If FDA determines that § 301 (ll) applies to dietary supplements, this would strangle innovation. It would create a “Catch 22” situation in which supplement producers who do scientific research on new supplements will find that the very fact of the research will lead to a ban on the proposed supplement. This is totally senseless. This is too senseless even for the FDA.
AAHF is sending comments to the FDA in partnership with its international affiliate, Alliance for Natural Health.
Concluding comment to FDA
There is a real risk, given the existing legal uncertainty surrounding section 301(II), that the provision would contravene DSHEA, deny consumers access to dietary supplements, as well as massively impact companies which have invested in clinical research, or those wishing to market new products based on substantiated evidence.
Additionally, the imposition of barriers to interstate trade would differentially impact residents of different states, thereby interfering with equal rights to access dietary supplements and related products, such as medical foods. In order to avoid such inequalities and adverse impacts, it is of paramount importance that dietary supplements and medical foods be exempted from the prohibition.

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