FDA sends warning to Bayer about drugmaker’s OTC-supplement combo products

The U.S. Food and Drug Administration sent warning letters to Bayer AG on Oct. 27 stating that the German drugmaker is in violation of FDA regulations for selling two aspirin medications that contain dietary supplements without getting approval first.


The products in question are Bayer Aspirin with Heart Advantage (which contains phytosterols) and Bayer Women’s Low Dose Aspirin Plus Calcium.

In its warning letter regarding the Bayer Heart Advantage product, the FDA wrote: “Notwithstanding your attempt to market this product as a combination drug-dietary supplement, the presence of aspirin in this product, with its intended uses as an analgesic and to mitigate, treat, and prevent heart disease, renders the entire product a drug. The phytosterols in this product could be marketed separately as a dietary supplement if the claims, ‘Plus Cholesterol Lowering Phytosterols’ and ‘Phytosterols, to help lower bad cholesterol,’ were removed and no other cholesterol-lowering claims were made, except as provided for in 21 C.F.R. § 101.83 as part of an explanation of the mechanism by which phytosterols reduce the risk of heart disease.”

Regarding the aspirin plus calcium product, the FDA had this to say: “The calcium carbonate in this product could be marketed separately as a dietary supplement if the claims about fighting osteoporosis were removed and no osteoporosis-related claims other than the authorized health claim for calcium and reduced risk of osteoporosis (see 21 C.F.R. § 101.72) were made in the product’s labeling. Alternatively, the calcium carbonate could be combined as a buffering agent with aspirin as long as no osteoporosis-related claims were made for the product. However, when, as here, a drug and a dietary ingredient are combined into a single dosage form, the combination becomes a ‘drug’ under section 201(g) of the Act (21 U.S.C. § 321(g)).”

Adding dietary supplements to already-approved drugs renders them new products that must be subject to FDA review before being sold, the FDA said.

Although the agency officials warned Bayer that it must take “prompt action” regarding its two over-the-counter drug and supplement combination products, the FDA did not call for the immediate recall of the products. Bayer has 15 days to respond to the agency’s concerns.

Nutrition Business Journal will explore this issue in our upcoming Raw Material and Ingredient Supply issue, which publishes in December. To order your copy of the issue or to subscribe to NBJ, go to go to www.nutritionbusinessjournal.com.

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