In the research letter “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls,” researchers analyzed dietary supplements that were recalled due to adulteration with pharmaceutical ingredients between Jan. 1, 2009 and Dec. 31, 2012. These products were available for purchase in July or August of 2013 directly from websites of supplement manufacturers or retailers (not e-commerce sites); and included a supplement name, manufacturer and distributor that was identical to the information in the FDA recall. Analyses were performed using the same methods as FDA’s field laboratories.
FDA recalled 274 dietary supplements within the timeframe analyzed, of which 27 (9.9%) met the study’s inclusion criteria. Supplements were purchased at a mean (SD) of 34.3 (11.5) months after being recalled (the range being 8-52 months), and 74% (20 of 27) were manufactured in the U.S.
Analysts found one or more pharmaceutical adulterants were present in 66.7% of the recalled supplements still available for purchase (18 of 27). According to findings, 85% of those supplements marketed for sports nutrition (11 of 13), 67% for weight loss (6 of 9), and 20% (1 of 5) for sexual enhancement still contained adulterants. Of those produced by U.S. manufacturers 65% (13 of 20) still contained unauthorized ingredients.
Also, 63% (17 of 27) of the reviewed products still contained the same adulterant that led to its initial recall from FDA. Additionally, six of the 27 supplements examined contained one or more additional banned substances after recall.
Authors identified several limitations in the study, including testing for only those adulterants commonly found in supplements based on marketing claims; and failure to detect recently introduced analogs of banned substances. The researchers also said that while they made every effort to purchase recently manufactured substances, it was not known if all substances were made post-FDA recall date.
Regardless, the authors concluded that FDA has not been sufficiently successful in preventing banned and potentially dangerous substances from making it into the U.S. marketplace.
Natural Products Association’s (NPA) CEO and Executive Director Daniel Fabricant, PhD, former director of the Division of Dietary Supplement Programs at FDA, said the organization supports FDA’s efforts to crack down on manufacturers illegally selling adulterated supplements. “Selling drugs masquerading as supplements is a crime and tarnishes the solid reputation of our members who follow the rules,” he said. “We also inform our members immediately of FDA actions so products can be taken off the shelf or out of the e-marketplace as soon as possible. While it is not the obligation of the retailer to do so, it is the right thing to do and we are always putting consumer safety first. We’ll continue to work with our members and FDA to explore ways to ensure recalled or adulterated products don’t ever reach consumers. Our member companies are in a very good position to identify wrongdoing and report it to officials, which we do on a regular basis.”
American Herbal Products Association (AHPA) President Michael McGuffin said, “The authors’ latest effort to convince the public and policymakers to change the laws that regulate dietary supplements misses the mark because the products used in their study are not dietary supplements, they are illegal, adulterated drugs. These are not cases of enterprising individuals or organizations exploiting a loophole in the Dietary Supplement Health and Education Act (DSHEA). These are cases of criminals breaking existing law. Passing new laws won’t make these activities any more illegal.”
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), also commented on the JAMA letter, stating, “Any time adulterated health products get to consumers or remain on the market after the FDA has determined they are potentially unsafe illustrates a weakness in the enforcement of the nation’s food and drug laws. Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients (APIs). We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk.”
However, Mr. Mister said the study misinterprets its findings, and in doing so undermines the success that FDA has had in regulating dietary supplements. “We agree with the authors that FDA must increase the aggressiveness by which it enforces the drug laws targeted to illegal products. But the study found that of the 274 products that were recalled over the three-year period, only 27 remained on the market—meaning that FDA’s action successfully rid consumers of 90% of the implicated products. Of the 27 remaining, 18 of the products were identified as containing APIs after being recalled; the other nine had been reformulated. In other words, the FDA’s recall efforts had a more than 93% success rate (256 out of 274),” he noted.