Recently ramped-up enforcement against synthetic botanicals means FDA needs to readdress synthetic botanicals in the draft guidance even before revising other parts, CRN wrote.
Synthetic botanical ingredients should not be disqualified as dietary ingredients in FDA’s new dietary ingredient (NDI) draft guidance, stated dietary supplement association the Council for Responsible Nutrition (CRN; Washington, DC) in a letter sent yesterday to FDA Commissioner Margaret Hamburg, MD. In the letter, CRN president and CEO Steve Mister asked the agency to reverse its NDI draft guidance position on synthetic botanical constituents.
A recent wave of increased enforcement against synthetic botanical constituents means FDA needs to readdress synthetic botanicals in the draft guidance even before the agency revises other parts of the guidance, said Mister in the letter. (FDA has indicated that it intends to revise the NDI draft guidance, issued in July 2011, although the agency has not provided a timeline for doing so.) According to CRN in a press release:
Despite ongoing discussions between the industry and FDA on other aspects of the NDI Draft Guidance, FDA’s district offices and port inspectors continue to detain ingredients at the border, issue warning letters to manufacturers, request recalls, and threaten seizures of synthetic botanical constituents, and to allege they are not legitimate dietary ingredients.
Mister further stated, “FDA’s actions an comments are having an immediate chilling effect on the industry and are irrevocably damaging commerce, innovation, and investment.”
CRN also says that FDA’s stance against synthetic botanical constituents opposes the “congressional intent” of the Dietary Supplement Health and Education Act of 1994 (DSHEA) as well as the Food, Drug, and Cosmetic Act, which makes no distinction between synthetic and natural dietary ingredients. Moreover, the association says, past FDA precedent has considered synthetic botanical constituents as dietary ingredients. The association quotes Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), who wrote last year to FDA that the agency’s position on synthetic botanicals is “wholly without statutory basis, and in fact contradicts longstanding FDA policy.”
CRN also points to the longstanding historical presence of synthetic dietary ingredients and says that botanicals have been synthesized long before even vitamin, mineral, and amino acid ingredients have been synthesized. Moreover, the association says, “dietary ingredients are defined by their biological activity, not by their source or chemical structure.”
Referring again to recent enforcement actions against botanicals, Mister wrote, “Because such enforcement actions are not grounded in the law, they exceed FDA’s statutory authority and must be ceased.
Mister concluded in his letter to FDA that “…CRN asks FDA to reverse its position, to cease taking or threatening enforcement action against synthetic botanical constituents, and to stop asserting…that such substances are not lawful dietary ingredients.”