Senate appropriators say FDA must decide how it will implement a provision of the FDA Amendments Act of 2007 that could substantially stifle innovation in the dietary supplement industry.

Sec. 912 of FDAAA would amend the Food, Drug and Cosmetic Act to prohibit interstate sale of foods that have an added approved drug, licensed biological or a product -- such as supplement ingredient -- that underwent publicly disclosed substantial clinical investigation.

In the Senate Appropriations Committee's report for FDA's fiscal 2010 spending, the members recommend the agency decide how Sec. 912 will apply to dietary supplements.

Under a "definition of food" heading, the report says the agency closed the comment window on the question in October 2008, but "more than eight months later, FDA still has not resolved the issue."

"The committee directs FDA to dispose of this issue," according to the report, though it did not set a deadline.

Supplement industry stakeholders are concerned that, if interpreted broadly, Sec. 912 would stifle innovation by preventing firms from researching ingredients because doing so might bar their introduction to the marketplace. Some substances are exempted -- those marketed in foods before a clinical trial began, for example (¹ Also see "Congress Did Not Intend FDAAA Sec. 912 To Apply To Supplements – Industry" - Pink Sheet, 8 December, 2008.).

FDA, which extended the comment period by a month to November, acknowledges it is wrestling with a regulatory quandary in Sec. 912 (² 'The Tan Sheet' Nov. 3, 2008, In Brief).

Center for Food Safety and Applied Nutrition Director Stephen Sundlof said the provision "causes some problems" at FDA because it could make illegal any food substance originally evaluated, but not approved, as a drug.

Further, an attorney in the Department of Health and Human Services general counsel's office said action probably would wait until after the Obama administration settled in at FDA.

The possible ramifications of Sec. 912 came to the industry's attention in October 2008 when Washington-based law firm Coburn & Coffman filed a citizen petition asking FDA to consider steviol glycosides natural sweeteners to be drugs, and thus illegal when present in food products under the FDAAA provision (³ Also see "Stevia Nearing Sweet Taste Of Success, But Citizen Petition Could Spoil Party" - Pink Sheet, 3 November, 2008.).

However, the petition is rendered irrelevant as FDA has sent no-objection letters to firms seeking generally recognized as safe status for stevia as a food product (⁴ Also see "Supply's The Limit As Stevia-Based Sweeteners Gain In Popularity" - Pink Sheet, 6 July, 2009.).

Senate Bill Matches Administration's Request

While the report on the House bill with FDA's appropriation, H.R. 2997, does not refer to Sec. 912 of FDAAA, the reports on both bills include directions for FDA to use funding provided in the legislation to cover "start-up costs" associated with launching the agency's regulation of tobacco products, as authorized in a recently enacted law (⁵ Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 June, 2009.).

The Senate committee's bill with FDA's appropriation, S. 1406, matches President Obama's overall budget request for the agency, with a direct appropriation of $2.34 billion and $687 million in user fees for a total of $3.02 billion. The agency's total fiscal 2009 appropriation was $2.7 billion.

The bill also matches the administration's request for direct appropriations for FDA's food and human drug activities. It includes $783 million for food activities, with $236 million going to CFSAN and $546.5 million for field activities by the center and other FDA offices.

For human drugs, the bill sets a direct appropriation of $458 million, including $330 million for the Center for Drug Evaluation and Research and $128 million for field activities.

FDA's fiscal 2009 appropriation for CDER and human drug field activities was $413.5 million and for CFSAN and food field activities it was $648.7 million.

The Senate committee marked up the bill July 7, but no date for a floor vote has been set.

The House July 9 approved H.R. 2997, which increases FDA spending by 14 percent from fiscal 2009 to $2.995 billion, including user fees. Of that, $873.1 million would go to CDER and $782.9 million would go to CFSAN.

-- Malcolm Spicer (m.spicer@elsevier.com)

Senate Puts FDA On Notice To Solve FDAAA Sec. 912 Puzzle

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