Warning Letters Confirm That FDA Views Combination OTC Drug/Dietary Supplement Products As Unapproved New Drugs

By Ricardo Carvajal & Kurt R. Karst –    

On October 28, 2008, FDA announced that the Agency issued Warning Letters to Bayer HealthCare contending that two of Bayer’s products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage (Heart Advantage), are unapproved new drugs and are misbranded.  Copies of the Warning Letters are available here and here.  The Heart Advantage Warning Letter further contends that the cardiovascular claims in the labeling of that product are not entitled to First Amendment protection because they are false, misleading, or concern illegal activity.  In the alternative, FDA argues that its objections to the claims are permissible under the First Amendment because: (1) FDA’s interest in protecting public health by ensuring that drugs are safe, effective and properly labeled is substantial; (2) the drug approval process, OTC drug review, and associated labeling requirements directly advance FDA’s substantial interest; and (3) that process and those requirements are no more extensive than necessary to serve FDA’s interest.

The FDA Warning Letters come on the heels of October 14, 2008 letters from Representatives John Dingell (D-MI) and Bart Stupak (D-MI) of the House of Representatives Energy and Commerce Committee to Bayer and the U.S. Department of Health and Human Services asking for information about the marketing of Bayer’s products as part of the Committee’s investigation of direct-to-consumer advertising of drug products.  The letters cite FDA’s May 2000 letter to industry, which recommends against the marketing of combination OTC drug/dietary supplement products.  More recently, the American Herbal Products Association sent FDA a letter that referenced Bayer’s Heart Advantage and asked for clarification of the Agency’s current policy on the marketing of combination OTC drug-dietary supplement combination products.