FDA should not subject dietary supplements to an FDA Amendment Act of 2007 provision that, if interpreted broadly, would block supplement sales, restrict innovation and discourage pre-market safety and efficacy tests, industry leaders say.

If applied to dietary supplements, the new law - FDAAA Sec. 912 - would "impose a severe chilling effect on research into the safety and efficacy of new ingredients," and cause "chaos in the marketplace," ingredient supplier Sabinsa says in Nov. 25 comments to FDA.

FDA in July 2008 solicited comments on implementing Sec. 912, which amends Sec. 301 of the Food, Drug and Cosmetic Act to prohibit interstate sale of foods with an added approved drug, licensed biological or a product that underwent publicly disclosed substantial clinical investigation (¹ 'The Tan Sheet' Aug. 11, 2008, In Brief).

Sabinsa CEO Jeff Lind said Congress did not intend for the provision to apply to supplements in part because it goes against "fundamental considerations of public policy."

For example, he said, the provision would prevent firms from researching ingredients thoroughly before going to market because doing so might bar their introduction altogether. As a result, some firms might push under-researched ingredients to market, or launch products prematurely.

This reaction would make the provision "entirely incompatible with the public interest in encouraging dietary supplement companies to invest resources in ensuring the safety and efficacy of the product," according to Sabinsa's comments.

The law appears to impose the "opposite" of what firms should do to develop new ingredients, Lind added. "The more substantial the investigations, the easier the path to market should be."

Further, the law contravenes existing regulations and could limit public access to supplements because it threatens ingredients already on the market, Sabinsa says. The Piscataway, N.J.-based company explains that the evidence firms must submit to FDA under Sec. 413 of the FDC Act to show ingredients are safe could trigger Sec. 912 enforcement, which would force them to pull from store shelves products that contain new dietary ingredients.

Under Sec. 912, firms also may need to pull food products that contain ingredients filed under FDA's generally recognized as safe notification program, the American Herbal Products Association says in its Nov. 25 comments submitted to FDA. Research requirements for GRAS status also could trigger enforcement under the new law, AHPA explained.

Like Sabinsa, AHPA argues that applying the provision to supplements violates Congress' intent. The trade group says it "cannot conceive of any congressional intent to prevent, prohibit or discourage clinical investigations of ingredients that are added to food."

However, FDA officials have said Congress' intent is unclear because there is no legislative history to guide the agency's application of the provision (² Also see "FDA Stymied By Reauthorization Terms That May Slow Ingredient Development" - Pink Sheet, 10 March, 2008.).

The Council for Responsible Nutrition and the Consumer Healthcare Products Association counter that FDA should look at other related regulations to determine congressional intent, according to joint comments submitted Nov. 25.

For example, the trade groups say FDA should "establish the proper interpretation and implementation of this provision," by comparing it to a similar provision in the Dietary Supplement Health and Education Act, which specifically references dietary supplements.

DSHEA Sec. 201(ff) prohibits firms from including drugs or biologics in dietary supplements only if the investigation is "authorized." The new law is broader and bans the addition to foods of drugs or biologics under any investigation.

CHPA and CRN argue the DSHEA provision overrules FDAAA Sec. 912 concerning supplements because it existed first and it specifically mentions dietary supplements, unlike the new provision.

The trade groups also note that if Congress wanted Sec. 912 to supersede DSHEA it would have amended or repealed the relevant provision. "The absence of such action by Congress indicates that this was not its intent," they say.

- Elizabeth Crawford (e.crawford@elsevier.com)

Congress Did Not Intend FDAAA Sec. 912 To Apply To Supplements – Industry

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