The line between regulated drugs and food supplements just got a little closer today, which leads me to question how long before the non regulated food supplements will also fall under more scrutiny from the FDA, as stated below, a combination pill becomes a horse of a different color. BD
By law, dietary supplements get little scrutiny from the FDA. But mix a dietary supplement with a drug — even if the drug is nothing more than aspirin — and the combo pill is considered a new drug by the agency, subject to approval and plenty of regulation.
That’s what got Bayer into trouble today, as the FDA wrote to the company to say that two of its aspirin products are being unlawfully marketed. The products — Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, which contains the supplement phytosterols — are clearly an effort by the company to tap into the big-bucks supplement market. But that involves jumping through some regulatory hoops. Or at least it was supposed to.