Senate members say FDA must decide whether the agency will implement a provision of the FDA Amendments Act of 2007 in a way 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 an 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 FDA 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 does 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 altogether. "The Tan Sheet" reported industry's misgivings about the provision here and here.
FDA acknowledges it is wrestling with a regulatory quandary in Sec. 912. CFSAN Director Stephen Sundlof has said the provision "causes some problems for us" 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 was settled in at FDA.
The Senate committee marked up the bill with FDA's appropriation, S. 1406, on July 7. S. 1406 matches President Obama's overall budget request for FDA, 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 the Center for Food Safety and Applied Nutrition and $546.5 million for field activities by CFSAN 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 House was scheduled to vote today on its appropriations bill including FDA's spending, H.R. 2997.
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-- Malcolm Spicer (m.spicer@elsevier.com)
