Senator McCain to Introduce Legislation Regarding “FDA’s Current Regulations on Dietary Supplements”

Senator John McCain (R-AZ) has announced his intention to introduce legislation amending the Federal Food, Drug and Cosmetic Act in areas that would affect dietary supplements, including the sports nutrition category. The bill would: establish new facility registration requirements to identify all brands, products, and ingredients; redefine “new dietary ingredients” based on a FDA list of permissible ingredients; broaden adverse event report (AER) requirements; enhance record-keeping obligations for downstream manufacturers and retailers.

“Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” noted Michael McGuffin, president of the American Herbal Products Association (AHPA). “And at least in the case of the proposed policing responsibility for retailers, it appears to be more stringent than retailer requirements in current drug laws.”

The bill would also replace the definition of “new dietary ingredients” by creating a list of “Accepted Dietary Ingredients” prepared, published, and maintained by FDA, and define a new dietary ingredient as any ingredient not included on such list. Revisions would also be made to the current new dietary ingredient notification process, such that even ingredients that are presently used in food and would be used for the first time in dietary supplements are subject to notification.

In announcing today’s press conference, Senator McCain’s office identified several groups that support the yet-to-be-introduced legislation. These include USADA, as well as Major League Baseball, the National Basketball Association, the National Football League, the National Hockey League, the United States Olympic Committee, the American College of Sports Medicine, National College Athletic Association and the PGA Tour. (Adapted from AHPA update.)

The draft bill is available here: http://www.ahpa.org/Portals/0/pdfs/10_0202.