The study found that intentional adulteration in herbal supplements leads to adverse events including some that are life-threatening. Unfortunately, sexual enhancement supplements and herbal weight loss products are often adulterated and create a health risk for consumers because of the synthetic analogues.
Researchers found that drugs like tadalafil, sildenafil, and vardenafil, all popular prescription drugs used for the treatment of erectile dysfunction, were often found in herbal supplements. An anti-obesity drug, sibutramine hydrochloride monohydrate, was one of the most commonly used adulterants found in herbal slimming supplements.
Other adulterants found in these types of supplements included thyroid hormones, diuretics, laxatives, stimulants, and anorexigens.
The FDA Is Cracking Down on Tainted Supplement Groups
The FDA is aware of the problem of over-the-counter supplements containing hidden ingredients, controlled substances, and untested active ingredients that have not been studied for safety and efficacy in humans. In fact, the FDA has posted Public Notifications for more than 300 tainted and adulterated herbal supplements, including sexual enhancement, weight loss, and bodybuilding supplements.
In response, the government agency sent a stern warning letter to supplement manufacturers addressing adulterated and tainted supplements, adverse event reports, and consumer injuries. The agency detailed the responsibilities of all entities in the herbal supplement supply chain and warned of criminal consequences for makers, distributors and suppliers who violate federal laws and endanger public health. Under the Federal Food, Drug, and Cosmetic Act, responsible parties, even those who did not have personal knowledge of violations, can be criminally prosecuted under 21 U.S.C. § 331. See United States v. Park, 421 U.S. 658 (1975)