November 12, 2008
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.
KDW Client Advisory: FDA Warning on Combination Dietary Supplement/OTC Drug Products (PDF, 103.15 K)
