FDA WARNING_LETTER - Bayer HealthCare LLC

The FDA issued a Warning Letter to Bayer HealthCare L.L.C. regarding "BAYER WOMEN'S Low Dose Aspirin + CALCIUM," marketed as a combination OTC drug-dietary supplement. The product, containing 81 mg aspirin and 300 mg elemental calcium, is labeled for pain relief, aspirin regimen, and calcium supplementation to strengthen bones and fight osteoporosis.

The FDA determined the entire product is an unapproved new drug under sections 201(g)(1)(B), 201(g)(1)(C), and 201(g)(1)(D) of the Federal Food, Drug, and Cosmetic Act (the Act). Its intended uses for mitigating, treating, or preventing cardiovascular diseases and osteoporosis, combined with aspirin and calcium carbonate as active drug ingredients, render it a new drug not generally recognized as safe and effective (section 201(p) of the Act) and lacking an approved new drug application (section 505(a) of the Act).

The product is also misbranded under section 502(f)(1) of the Act due to inadequate directions for use, as osteoporosis treatment and cardiovascular indications require professional supervision. Furthermore, it is misbranded under sections 502(f)(2) and 502(a) of the Act because its labeling contains inadequate and misleading warnings. The "Drug Facts" panel warnings (e.g