Conner Mansfield, Mercer University College of Pharmacy 2016
The FDA regularly posts press releases on behalf of manufacturers recalling dietary supplements. 15 recalls of products described as dietary supplements have been posted in 2014. The reasons for these recalls are both alarming and unsurprising.
Manufacturers recalled 14 out of the 15 products after the detection of at least 1 undeclared active ingredient. Another manufacturer recalled their product after fears that their product was contaminated with Salmonella. We won’t focus upon that case.
The undeclared active ingredient(s) in all 14 of the remaining products were related to the dietary supplements’ labeled claims. Alarmingly, certain undeclared active ingredients appeared repeatedly. The following table lists the frequency of each ingredient’s inclusion:
The FDA tested and included the amounts of undeclared active ingredients contained in one product. That product contained 2.4mg of chlorzoxazone, 0.78mg of nefopam, 2.5mg of diclofenac, 7.7mg of ibuprofen, 2.1mg of naproxen, and 1.9mg of indomethacin. I have no idea how this particular product was manufactured, so I won’t comment further, but it doesn’t seem particularly hard to bring a dietary supplement to market, which invites tainted raw materials.
A quick search of the B2B, e-commerce website Alibaba returns 7,548 results for “supplement bulk powder” listed for sale by foreign wholesalers. Though the FDA requires manufacturers to register their facilities with the FDA prior to producing dietary supplements, the manufacturer doesn’t have to seek approval from the FDA prior to producing and marketing their product.
Undeclared active ingredients frequently make their way into dietary supplements. Certain ingredients repeatedly show up in press releases recalling these products. While it’s unclear if these ingredients are related to the same or separate raw ingredient suppliers, the continuous inclusion of active pharmaceutical ingredients should invite further regulation at the fringes of the dietary supplement industry.