Bayer is illegally marketing two aspirin products by claiming that the over-the-counter medications are effective in battling heart disease and osteoporosis. These effective health claims are unproven and against FDA regulation. Because of this marketing, FDA warned Bayer by sending them two warning letters for never submitting proof that its pills are effective in battling the heart disease and osteoporoses. The two products Bayer marketed were Bayer Women’s Low Dose Aspirin & Calcium and Bayer Aspirin with Health Advantage.
According to the FDA, the products were never approved new drugs. A company marketing new drugs are required to submit a new drug application in order to be marketing legally. FDA never approved these products for reducing risks of heart disease or fighting osteoporosis. In fact, these types are drugs, according to the FDA, require a health care professional’s diagnosis—making it the reason why they are not sold over-the-counter.
FDA has claimed they are not aware of any significant adverse events occurring with these products—they are concerned that neither product has been approved by FDA for the intended market uses. Check out the warning letter here.
According to Jacob Goldstein, Bayer’s marketing of these products “are clearly an effort by the company to tap into the big-bucks supplement market.” As a consumer, hearing that a major company like Bayer, (as Jacob Goldstein put it) jumped “through some regulatory hoops. Or at least it was supposed to,” upsets and concerns me.
Apparently, Bayer said it would reply to the FDA letters in the next 15 business days. FDA requested this response. Bayer should immediately respond in order to have the products approved or changed. The warning letters written by FDA are not binding. However, FDA can sue Bayer if the warnings are ignored.