WASHINGTON, D.C., April 9, 2012―The Food and Drug Administration (FDA) must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN) just published in Regulatory Toxicology and Pharmacology1, the official journal of the International Society of Regulatory Toxicology and Pharmacology.
“The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to include many changes that were not foreseen in the Congressional Record in 1994,” wrote the commentary’s co-authors Steve Mister, president and CEO, CRN and John Hathcock, Ph.D., senior vice president, international and regulatory affairs, CRN. “Through these misinterpretations, FDA attempts to impose a food additives-like safety standard, and gain de facto premarket approval against the overt wishes of Congress.”
The article points out that FDA’s effort to impose pre-market approval on dietary supplements is not a new occurrence. In the 1970s and 1990s, before the passage of DSHEA, FDA made two attempts, both of which were rejected by Congress and the courts. In the current NDI draft guidance, the agency attempts yet another end-run around the law by proposing the following:
- Re-characterizing many existing dietary ingredients as new dietary ingredients by expanding the definition of “chemically altered” to classify innovations in manufacturing as being chemical alterations;
- Requiring physical proof with “material evidence” that an ingredient was actually available in the market before 1994, and thus exempt from the NDI requirements;
- Prohibiting bio-identical synthetic versions of botanical compounds from being classified as dietary ingredients at all;
- Requiring a separate notification for each new product, as opposed to just the dietary ingredient; and
- Declaring The Redbook, the official textbook for evaluating food additives which has a “significantly higher threshold” for safety than the “reasonable expectation of safety” established under DSHEA, as “authoritative for demonstrating the safety of NDIs.”
Additionally, FDA wants to impose a risk-benefit standard for determining the safety of new ingredients, similar to what it used to remove ephedra from the market, which would allow FDA to evaluate the benefits of a product claimed by the manufacturer against the perceived risks—another attempt to challenge Congress’ intent for the law.
“It is time for FDA to reconsider its efforts to redistribute the safety burdens allocated by Congress in DSHEA, and to recognize that the pre-market paradigm of food additives is not what Congress intended for dietary supplements,” the authors concluded.
Regulatory Toxicology and Pharmacology presents articles concerned with regulatory decisions and with the interpretation of scientific knowledge as influencing regulatory decisions. Its international readership includes scientists, program managers, research directors, attorneys and business professionals.