FDA shown to be a strict gatekeeper.

An article authored by Michael McGuffin, president, American Herbal Products Association (AHPA), Silver Spring, MD, and Anthony Young, partner, Kleinfeld, Kaplan and Becker, LLP, Washington, D.C., in a recent issue of Food and Drug Law Journal, pointed to FDA as a gatekeeper, ensuring new dietary ingredients (NDIs) are safe prior to coming to market. In the first nine-and-a-half years since DSHEA was passed, FDA received 145 unique notices of proposed new ingredients, according to the article. FDA has objected to 68--or 47%--of these notifications, either because the submissions were incomplete or provided inadequate data to support safe use of the ingredient, or because the ingredient itself or the product that would contain it did not fall within strict legal definitions. "FDA has developed some consistency in implementing the regulations for new dietary ingredients," said Mr. McGuffin. "At the same time, the agency needs to make information more available more promptly, and marketers of new dietary ingredients need to better understand the detailed application of these regulations."