Study Reveals Hidden (Potentially Dangerous) Pharmaceuticals May Be Found in OTC Supplements
A new study published Friday in JAMA reports that many dietary supplements consumed by people in the United States contain unapproved pharmaceutical ingredients in the over-the-counter products that pose a health risk for unsuspecting consumers.
The analysis conducted by the California Department of Public Health showed that the unapproved pharmaceutical ingredients were identified in 776 dietary supplements that were sold between 2007 and 2016. The supplements were typically marketed as boosts for sexual enhancements, weight loss or muscle building, according to the JAMA article. The most common pharmaceutical ingredients identified in these products include sildenafil for sexual enhancement supplements, which is sold commercially as Viagra. Additional discoveries include sibutramine, a weight loss drug that had been marketed by Abbott Laboratories before being removed from the market in 2010 due to cardiovascular risks, as well as synthetic steroids or steroid-like ingredients for muscle building supplement.
In the report, the analysis showed that 20 percent of the supplements contained two or more undeclared drugs. As an example, the report said weight loss supplements contained both an anorectic and a laxative. The supplements have been linked to an estimated 23 000 emergency department visits attributed to dietary supplements each year in the United States, the researchers said.
The report is also critical of the U.S. Food and Drug Administration (FDA) for not taking a more stringent oversight role in the supplement market. Peter Cohen, one of the authors of the study who also published a commentary, noted that the U.S. Food and Drug Administration “does not assess the safety of supplements prior to market,” but noted that the “agency is tasked with identifying and removing adulterated and hazardous supplements from the marketplace.” The latest research, Cohen said, is similar to previous concerns about lack of FDA oversight raised in a 2013 report.
Cohen said he and his colleagues raised concerns over the supplement issue in 2017 with the FDA. At that time, they had identified two experimental stimulants, 1.4-dimethylamylamine and octodrine, in dietary supplements. One had never been approved by the FDA and the other had been removed from the U.S. market, Cohen said. As of September, Cohen said the “FDA has not taken any regulatory action to remove these synthetic stimulants from commerce or warn consumers about the novel adulterants.”
According to Kaiser Health News, dietary supplements are not classified as drugs by the FDA They fall under the food category. Because they are not intended as disease treatment or prevention, the supplements are not subject to premarket safety and efficacy testing like pharmaceuticals, KHN said. The supplements for weight loss, sexual performance and the like fall under the same umbrella as those that regulate vitamin supplements, such as vitamin C or E.
The new study said more than 50 percent of adults in the United States consume some kind of dietary supplement, which has led to the establishment of a $35 billion industry.
In his column, Cohen said that “more than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market.” He said Congress should require companies to register supplements with the FDA ahead of marketing a product. He also noted that Congress could provide the FDA with more enforcement tools that would allow the agency to product’s registration if a supplement is found to be “adulterated with pharmaceutical drugs.