Researchers Pieter Cohen, Gregory Maller, Renan DeSouza, and James Neal-Kababick from institutions including Harvard Medical School and Cornell University have released a research letter in the Journal of the American Medical Association on the presence of banned drugs in supplements available on retail shelves. The researchers have discovered that two-thirds of the recalled supplements which remained on shelves up to 6 months after their FDA recall possessed banned substances which can be hazardous to consumers’ health.
Unapproved or adulterated drugs masquerading as lawful supplements is a threat to public health and to consumer confidence in the supplement industry,” said Scott Melville, CEO of the Consumer Healthcare Products Association.
Of the 247 supplements banned in the period between January 1, 2009 and December 31, 2012, 27 were still available for purchase from manufacturers and retailers more than 6 months later. Dr. Cohen and associates tested these 27 supplements for the banned drugs which were associated with the effects claimed by the supplement; as in supplements that advertised for weight loss were tested for drugs associated with weight loss. The researchers found that 66.7 percent of the recalled supplements still available for purchase remained adulterated with unauthorized drugs. In addition, most of the supplements contain the same adulterants that led to their recall, but some contained different adulterants and others contained multiple adulterants. Some of the adulterants were prescription drugs such as antidepressants, erectile dysfunction treatments and anabolic steroids. On average the researchers found the banned supplements available for sale 34 months after they were banned.
Despite the bans and recalls of these supplements, the FDA faces obstacles in enforcing its own rulings on these substances. As a result of the Dietary Supplement Health and Education Act of 1994, dietary supplements do not fall under the same regulations as drugs. This means the FDA must prove that supplements are unsafe in order to take action against a supplement and manufacturers do not need to seek FDA approval before selling their products. The FDA does provide consumer alerts and press releases about recalled supplements.
Even after recall and enforcement action against one major distributor, the product may continue to be widely sold,” said Jennifer Dooren spokeswoman for the FDA.
Read More – Presence of Banned Drugs in Dietary Supplements Following FDA Recall (Pieter Cohen, Gregory Mallar, Renan DeSouza, James Neal-Kababick)
Recalled Supplements Linger on US Store Shelves (WebMD, Steven Reinberg)