Posted 15 October 2018
So it’s not the ‘herbs’ doing the work…
PETER DOCKRILL 15 OCT 2018
The labels promise miracles: Fast Weight Loss! Eliminates Hunger! Burns Calories!
Now new research highlights how hundreds of brands of dietary supplements deliver so much kick from a modest blend of vitamins and herbs. The answer is many labels leave out one important ingredient: a hidden payload of pharmaceutical drugs and experimental chemicals.
A new analysis of 10 years of FDA records reveals that from 2007 to 2016, almost 750 dietary supplements were found to be contaminated with secret doses of totally unregulated drugs, including prescription medicines, banned and unapproved chemicals, and designer steroids.
Over 20 percent of these offending products contained more than one unapproved drug ingredient, and numerous contained a cocktail of clandestine chemicals – in two cases, as many as six unlisted ingredients.
For a US$35 billion industry patronised by about half of American adults, it’s possible this data could be just the tip of the iceberg, too.
“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,” researchers from the California Department of Food and Agriculture, Sacramento, explain in their paper.
Given that supplement use is associated with some 23, 000 ER visits and 2,000 hospitalisations in the US each year, it’s clear we’re looking at a big problem here, but what’s even more shocking than the brazen selling of these illicit additives is how tame and toothless the FDA’s official actions were.
Of 746 products identified as adulterated by the FDA, just 360 (48 percent) were subsequently recalled, leaving more than half of the contaminated supplements available for sale.
“The agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk,” writes general internist Pieter Cohen from Harvard Medical School in a commentary on the new research.
Many of the tainted supplements analysed in the study contained sildenafil (the active ingredient of Viagra) to boost their powers of sexual enhancement. Another erectile dysfunction drug, tadalafil, was also common.
Other chemicals included hidden antidepressants, a withdrawn weight loss drug called sibutramine, and undeclared anabolic steroids or steroid-like substances.
It’s been argued however that since almost 75 percent of the offending supplements were sold online or through international mail order, they don’t represent the ‘mainstream’ of the supplements industry.
“These come from dark corners of the internet,” president of the Natural Products Association, Daniel Fabricant, told the San Francisco Chronicle.
“They’re not what you get at your health food store.”
Still, given that none of these products are actually subjected to the same stringent tests reserved for pharmaceutical drugs, it’s possible any supplement could contain anything – which is why Cohen advises choosing products that only contain a single ingredient and avoiding products that purport to offer spurious, medical-sounding benefits.
Why? Because as this research shows, many supplements turn out to be medicine after all – only it’s an unknown drug, potentially a banned one, and there’s no way of measuring your dose.
“If the company is saying it works like Viagra or you’re going to gain muscle like you’re on steroids – that’s not a supplement. That’s a drug,” Fabricant says.
“Dietary supplements are meant to maintain health, not to take 30 minutes before sex.”
The findings are reported in JAMA Network Open.
Original Investigation Public Health
October 12, 2018
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings Jenna Tucker, MPH1,2,3; Tessa Fischer, DVM, MPH2,3; Laurence Upjohn, PharmD3; et al David Mazzera, PhD3; Madhur Kumar, MS, PhD3 Author Affiliations Article Information JAMA Network Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337
Question What are the trends across adulterated dietary supplements associated with a warning released by the US Food and Drug Administration from 2007 through 2016?
Findings In this quality improvement study, analysis of the US Food and Drug Administration warnings from 2007 through 2016 showed that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements, with 157 products (20.2%) containing more than 1 unapproved ingredient.
Meaning Potentially harmful active pharmaceuticals continue to be identified in over-the-counter dietary supplements.
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.