CFSAN, CDER Divvy Up DSHEA Enforcement ActionsCFSAN, CDER Divvy Up DSHEA Enforcement Actions

WASHINGTON--The Food and Drug Administration (FDA) and two of its agencies have hammered out an agreement to divvy up some of the enforcement actions for implementing the Dietary Supplement Health and Education Act (DSHEA). The Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN) will coordinate specific activities depending on how the products are marketed. In its release of the agreement, FDA wrote that the agreement will assist FDA in implementing DSHEA by "improving the Centers' coordination of regulatory actions and clarifying their roles and responsibilities related to products that bear structure/function and/or disease claims." The Agreement will take effect on April 30, 2001. (Click here to review a copy of the document. It is scheduled to be posted by FDA later this week.)

CFSAN, for example, will take the lead on enforcement activities against products marketed as dietary supplements but that carry "disease" claims. It will also head up regulatory action against conventional foods and medical foods, regardless of whether claims made are "disease" oriented or structure/function claims.

CDER, meanwhile, which is the branch that regulates OTC and prescription drug products, will now have lead enforcement authority on products that contain hormones (including their metabolites) and products that have "long standing" use as drugs. It will continue to be primarily responsible for regulating products not intended for ingestion, "street drug alternatives," and products that contain a component that is part of an Approved New Drug. This final area is a nod to the recent court decision concerning red yeast rice marketed for its lovastatin content (for more, see www.naturalproductsinsider.com/hotnews/14h1013303.html).

What does the agreement mean to the natural products industry? David Seckman, executive director of the National Nutritional Foods Association (NNFA), noted that on first read the document makes sense in many ways. "In particular, the section about CDER specifically regulating products `not intended to supplement the diet', such as GBL, will help further distinguish between drugs and dietary supplements," he said. "If CDER is responsible, perhaps we can get help getting our message to the public that street drug alternatives and products like GBL are not supplements."

Marc Ullman, partner in New York's Ullman, Shapiro & Ullman, added that the document may signal increased enforcement activity out of FDA in the near future. "At a minimum, this document indicates that FDA feels that there is a need for increased enforcement activity in these areas," Ullman said. "When, and how aggressive this action will be when it comes, remains to be seen."