FDA Issues Warning Letters on Combination Dietary Supplement/OTC Drug Products

Kelley Drye Client Advisory

On October 28, 2008, the Food and Drug Administration (“FDA”) issued two warning letters regarding over-the-counter (“OTC”) products that combine aspirin with a dietary supplement into a single pill. One product combined low-dose aspirin and phytosterols, while the other combined low-dose aspirin with calcium. In the two letters with similar legal arguments, the FDA took the following positions:

  • The products are unapproved new drugs.”
  • Because use of the products requires physician supervision, OTC sales are not appropriate.
  • The products are misbranded.

Kelley Drye & Warren’s Food and Drug Practice Group has prepared the Client Advisory below discussing the FDA’s positions.