On October 16, 2001 FDA sent Warning Letters to two companies marketing combination dietary supplement/OTC drug products, stating that those products were “unapproved new drugs” and requesting “corrective action” within 15 days. Pharmaceutical giant Bayer Healthcare, LLC has recently launched a combination aspirin phytosterol product. Have the rules changed?

This afternoon, my colleague Tony Young (General Counsel for the American Herbal Products Association and Partner in Washington’s Kleinfeld Kaplan & Becker) suggested that I might want to look at the new home page for Bayer Aspirin because it featured a very unusual product.  Because I take Tony seriously, I immediately went to www.bayeraspirin.com and was amazed to see an announcement for Bayer’s newest product, Bayer Aspirin with Heart Advantage:  81 mg aspirin plus cholesterol lowering phytosterols.  The product claims to be both an over-the-counter-drug and a dietary supplement and utilizes both a Drug Facts and a Supplement Facts Box.  While this might seem like a really good, innovative idea for a new product, the problem is that FDA has spent the last 6 and a half years saying that it’s an illegal innovative idea.  Bayer, however, seems not to care.  (Bayer also doesn’t seem to care about the GRAS status of aspirin, which it lists as an “other ingredient” under its supplement facts box).

In October of 2001 FDA issued warning letters to BF Ascher & Company and Omni Nutraceuticals, Inc. objecting to the marketing of similar products.  Ascher was marketing “Melagesic” to promote "Promote natural, restful sleep and relieve pain."  It was a combination of 500 mg of acetaminophen and 1.5 mg of melatonin.  Omni was marketing two combination products; one acetaminophen and glucosamine, and the other acetaminophen with glucosamine and chondroitin.  Both were utilized claims for the temporary relief of “minor pain of arthritis” and “for long term joint health”.  

While the Warning Letters to both companies cited health issues relating to the long-term use of acetaminophen that might not be of such concern with Bayer’s aspirin/phytosterol product, FDA also informed both companies in unequivocal terms that their products were Unapproved New Drugs.  FDA stated that it reached this conclusion because of the presence of an unapproved active ingredient (the supplement) in a drug product.

The question now is, “Will Bayer get the same treatment?”