Potentially harmful pharmaceuticals not listed on product labels were found in more than 700 over-the-counter OTC) dietary supplements, researchers report. Reuters Health reports that the pharmaceuticals, which were found in so-called natural products, were most likely to appear in supplements marketed as weight loss aids, muscle builders and male libido enhancers, according to the study.
Data for the study came from the US Food and Drug Administration’s Tainted Products Marketed as Dietary Supplements, Centre for Drug Evaluation and Research database. The researchers, led by Madhur Kumar of the California Department of Public Health in Sacramento, identified 776 tainted supplements in the database, from 2007 to 2016.
The report says to put the problem in perspective, the authors point to a study in 2015 that study found dietary supplement use was associated with 23,000 emergency department visits and 2,000 hospitalisations each year.
Of the tainted products in the current study, 45.5% were marketed as aids for sexual enhancement, 40.9% for weight loss, and 11.9% for muscle building. They contained pharmaceuticals such as sildenafil, which is the active ingredient in Viagra; sibutramine, which is the active ingredient in Meridia, a weight loss drug removed from the market because of links to stroke and other cardiovascular events; and anabolic steroids or steroid-like substances.
Dr Louis Aronne wasn’t at all surprised by the study’s findings. “This is something we’ve seen again and again and again,” said Aronne, a professor of metabolic research and director of the Comprehensive Weight Control Centre at Weill Cornell Medicine in New York City. “There’s no evidence that over-the-counter products work for weight loss and the ones that do work seem to have a high risk of being what the FDA calls ‘adulterated,’” Aronne said. “They have prescription medications in them and that is why they work.”
Another danger in these “adulterated” supplements is “they can have a combination of many different agents that do similar things that add up to a pharmacologic effect,” Aronne said. Unfortunately, he added, “people want to believe these things work and have no side effects.”
Tainted supplements are very hard to regulate, Aronne said, because they are often sold and marketed on the internet. What the California researchers reported “is just the tip of the iceberg,” Aronne said. A big part of the problem, he said, is that US laws allow a company “to say anything it wants and it’s up to the FDA and the Federal Trade Commission to stop it from saying it. In Canada the rules are different. Health Canada has to approve the claims that are on the label.”
When it comes to supplements that promise to aid in weight loss, muscle gain or libido enhancement, “it’s the Wild West,” said Dr Lawrence Appel, director of the Welch Centre for Prevention, Epidemiology and Clinical Research at the Johns Hopkins Medical Institutions in Baltimore. “There’s a huge amount of really, almost unregulated supplements.”
Daniel Fabricant, CEO/president of the Natural Products Association, argues that most supplements are at least as safe as medications approved by the FDA. The products reported in the new study “aren’t dietary supplements,” Fabricant said. “They are drugs masquerading as supplements. We support prosecution of criminal activity whether it’s illegal drugs coming into our country or illegal drugs in supplements.”
Supplement safety is monitored by the same kind of adverse event reporting system that keeps track of medications after they are approved by the FDA, said Fabricant, who is a former director of the division of dietary supplement programs at the FDA.
Fabricant offered some advice on how to avoid tainted supplements. “There are some red flags,” he said. “If it sounds too good to be true, it is too good to be true. If it’s promising great weight loss gains, or great strength gains or it says it’s comparable to Viagra, that’s a red flag. And look out for products that have labels in dual languages.”
The report says the California Department of Public Health would not make the authors available for comment.
Importance: Over half of adults in the United States report consuming dietary supplements. The US Food and Drug Administration (FDA) has warned of numerous dietary supplements containing undeclared, unapproved pharmaceutical ingredients. These FDA warnings have not been comprehensively analyzed for recent years.
Objective: To summarize trends across adulterated (containing unapproved ingredients) dietary supplements associated with a warning released by the FDA from 2007 through 2016.
Design, Setting, and Participants: In this quality improvement study, data were extracted from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a 6-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning. Data analysis was conducted from February 2017 to June 2017.
Results: From 2007 through 2016, 776 adulterated dietary supplements were identified by the FDA and 146 different dietary supplement companies were implicated. Most of these products were marketed for sexual enhancement (353 [45.5%]), weight loss (317 [40.9%]), or muscle building (92 [11.9%]), with 157 adulterated products (20.2%) containing more than 1 unapproved ingredient. The most common adulterants were sildenafil for sexual enhancement supplements (166 of 353 [47.0%]), sibutramine for weight loss supplements (269 of 317 [84.9%]), and synthetic steroids or steroid-like ingredients for muscle building supplements (82 of 92 [89.1%]). There were 28 products named in 2 or 3 warnings more than 6 months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once. In recent years (2014-2016), 117 of 303 adulterated samples (38.6%) were identified through online sampling and 104 of 303 (34.3%) were identified through the examination of international mail shipments.
Conclusions and Relevance: Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.
Jenna Tucker; Tessa Fischer; Laurence Upjohn; David Mazzera; Madhur Kumar