The U.S. Food and Drug Administration is extending the comment period on section 912 of the Food and Drug Administration Amendments Act enacted on Sept. 27, 2007. Trade groups such as the Council for Responsible Nutrition and the Natural Products Association called for the extension, citing inconsistencies and vague language introduced by the provision, which some fear could muddy the distinction between conventional foods, including dietary supplements, and drugs. The comment period was originally set to expire this week, but the FDA has agreed to continue accepting comments through Nov. 25.
Concerns stem from possible interpretations of the provision that could prohibit the marketing of products as conventional foods or dietary supplements if they contain a substance that has undergone clinical investigation that has been made public. Most insiders do not believe that section 912 is meant to be interpreted this way, but the wording of the provision is broad enough to warrant fears that any product containing a new ingredient—one requiring testing for scientific substantiation—would be removed from store shelves once the results of those tests were released.
According to Andrew Shao, Ph.D., vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, the notion that Congress intended to completely stifle innovation by pulling any product containing a clinically tested new ingredient is "ludicrous." But the broad language is enough to get some in the industry concerned.
According to the Federal Register: "Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public."
Currently, the dietary supplement exclusionary clause established in section 201 (ff) of FDAAA rules that a product cannot be marketed as a dietary supplement if it has been authorized for investigational new drug research. Critics point out that, if section 301(II) is meant to include dietary supplements, then it contradicts the existing definition established by 201 (ff).
"What has everyone worried is that it just says 'food,' which legally includes dietary supplements," Shao said. But, he added, it was likely not Congress's intent to contradict the existing provisions set forth in the Dietary Supplement Health and Education Act of 1994. If they had meant to redefine the law, Shao said, Congress would have negated the current provision. "This law does not preempt the provisions in DSHEA," he said. "If that had been the intent, then Congress would have stricken [the existing provision]."