The Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, yesterday called on FDA to reverse its current position that synthetic constituents of botanicals cannot be dietary ingredients. In a letter to FDA Commissioner Margaret Hamburg, M.D., CRN advised the agency’s position is contrary to the congressional intent behind the Dietary Supplement Health and Education Act of 1994 (DSHEA); stands in stark conflict with decades of FDA precedent; and is neither scientifically justified nor in the interest of the public health.
Further, CRN President and CEO Steve Mister requested in the letter that this issue be resolved without having to wait for resolution on other aspects of the NDI Draft Guidance, given the association’s concern that FDA has recently increased enforcement activities related to synthetic botanical constituents. “Because such enforcement actions are not grounded in the law, they exceed FDA’s statutory authority and must be ceased,” Mr. Mister wrote. “FDA’s actions and comments are having an immediate chilling effect on the industry and are irrevocably damaging commerce, innovation and investment.”
CRN’s position as outlined in the 26-page document is based on seven key areas:
· the Food, Drug and Cosmetic Act makes no distinction between synthetic and natural dietary ingredients;
· botanical constituents that are used in the food supply have been synthesized long before vitamins, minerals or amino acids were synthesized;
· dietary ingredients are defined by their biological activity, not by their source or chemical structure;
· synthetic botanical constituents lawfully may be dietary ingredients under the statute;
· decades of FDA precedent make it clear that synthetic botanical constituents can be dietary ingredients;
· public health, safety and environmental considerations all counsel in favor of permitting synthetic botanical constituents;
· FDA’s definitional bar for synthetic botanical constituents is not consistent across the entire food category.
CRN further pointed out that Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) wrote to FDA last year to remind the agency its position that synthetic botanical constituents do not qualify as dietary ingredients is “wholly without statutory basis, and in fact contradicts longstanding FDA policy.” Despite ongoing discussions between the industry and FDA on other aspects of the NDI Draft Guidance, FDA’s district offices and port inspectors continue to detain ingredients at the border, issue warning letters to manufacturers, request recalls and threaten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.
Mr. Mister concluded, “…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.”