The practice of dietary supplement manufacturers selling products with hidden active pharmaceuticals (APIs) “defies logic,” and is a practice not often undertaken by companies registered with the Food and Drug Administration (FDA), “like responsible companies are,” said Capt. Jason Humbert, R.N., national health fraud coordinator in the FDA’s Office of Regulatory Affairs. He made the remarks during a webinar sponsored by the FDA’s Division of Drug Information.
The FDA regulates both finished dietary supplements and dietary ingredients. But inspectors typically do not find adulteration – or the inclusion of hidden ingredients – during good manufacturing practice inspections.
That’s because tainted products often originate from overseas and have confusing labels that are not in compliance with U.S. regulation. Yet, they are often sold in retail stores, gyms, fitness centers, convenience stores, bridal and resort magazines, and hair and nail salons.
The safety labels of these products don’t always list all ingredients contained in the product, feature drug-like recommendations for usage, and claim that they are made in the USA or are compliant with good manufacturing practices. “But they are not,” Humbert cautions.
The FDA typically learns of illicit dietary supplement products from consumer complaints or when an adverse event has been reported to its database. The types of supplements most often found to be contaminated are those used for bodybuilding or performance enhancement, sexual enhancement, and weight loss. Contaminants include steroids, prescription drugs, and banned or illicit drugs. These ingredients pose serious and potentially life-threatening risks to consumers.
When the FDA confirms a tainted product on the market, it adds the supplement to its publicly available list of tainted products. There are currently more than 800 products on that list, with more than 40 adulterants.
The FDA says it is intent on protecting consumers from these potentially dangerous products but that it faces challenges in doing so, such as lack of cooperation during investigations and bad actors who use technology to stay just outside the agency’s reach. Thus, consumers should use caution when choosing dietary supplements, and report any adverse events to the agency’s database at www.FDA.gov/MedWatch/Report.htm.
Source: Natural Products Insider