10.12.18
A newly released study published in JAMA, “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings,” set out to analyze trends across adulterated dietary supplements that contained unapproved ingredients, and came away with troubling conclusions, particularly for the sexual enhancement, weight management, and muscle building categories.
In this quality improvement study, data were extracted from FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database during the determined time period of 2007-2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a six-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning.
Between 2007-2016, 776 adulterated dietary supplements were identified by FDA and 146 different dietary supplement companies were implicated. The supplements most commonly impacted were 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 one unapproved ingredient.
The most commonly identified adulterants included sildenafil—the active pharmaceutical ingredient in Viagra—for sexual enhancement supplements (166 of 353 [47.0%]). The most common adulterant in weight loss supplements was sibutramine (269 of 317 [84.9%]), a weight loss drug that was removed from the U.S. market in 2010 because of cardiovascular risks. Synthetic steroids or steroid-like ingredients were most commonly found in muscle building supplements (82 of 92 [89.1%]).
There were 28 products named in two or three warnings more than six months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, indicating that FDA products that were adulterated more than once.
Researchers concluded that dietary supplements, particularly those for sexual enhancement and weight loss, continue to have unapproved pharmaceutical ingredients present, even after FDA warnings. The study’s authors stated that “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.”
Industry Reaction
In response to the article, the Council for Responsible Nutrition (CRN), offered three reminders for consumers:
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), said the organization is “committed to working with the FDA to prevent supplements masquerading as drugs from reaching consumers and ensuring people who break the law are punished. The safety record of the dietary supplement and natural products industry is far superior to prescription drugs or even conventional foods because of a strong federal regulatory regime, significant investment in product safety and quality, consumer demand and self-regulatory programs developed by the men and women of our industry, who want to help people lead healthier lifestyles.” He added that NPA strongly supports the prosecution of criminal activity and has robust internal measures and quality assurance programs to report bad actors to authorities.
In this quality improvement study, data were extracted from FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database during the determined time period of 2007-2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a six-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning.
Between 2007-2016, 776 adulterated dietary supplements were identified by FDA and 146 different dietary supplement companies were implicated. The supplements most commonly impacted were 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 one unapproved ingredient.
The most commonly identified adulterants included sildenafil—the active pharmaceutical ingredient in Viagra—for sexual enhancement supplements (166 of 353 [47.0%]). The most common adulterant in weight loss supplements was sibutramine (269 of 317 [84.9%]), a weight loss drug that was removed from the U.S. market in 2010 because of cardiovascular risks. Synthetic steroids or steroid-like ingredients were most commonly found in muscle building supplements (82 of 92 [89.1%]).
There were 28 products named in two or three warnings more than six months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, indicating that FDA products that were adulterated more than once.
Researchers concluded that dietary supplements, particularly those for sexual enhancement and weight loss, continue to have unapproved pharmaceutical ingredients present, even after FDA warnings. The study’s authors stated that “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.”
Industry Reaction
In response to the article, the Council for Responsible Nutrition (CRN), offered three reminders for consumers:
- These are illegal and unsafe tainted products that should be avoided. Do not purchase products with outrageous names sold by unknown or unfamiliar brands and companies. Purchase products from nationally recognized brands or store brands, and through reputable retailers, distributors, or websites.
- Be wary of products marketed as dietary supplements that have drug-like claims or promise unrealistic results, especially in the categories of sexual enhancement, weight loss, or muscle building. These tainted, illegal products are not dietary supplements.
- Always talk to your doctor or healthcare practitioner about all of the dietary supplements and other self-care products you use, especially if you’re thinking about starting something new.
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), said the organization is “committed to working with the FDA to prevent supplements masquerading as drugs from reaching consumers and ensuring people who break the law are punished. The safety record of the dietary supplement and natural products industry is far superior to prescription drugs or even conventional foods because of a strong federal regulatory regime, significant investment in product safety and quality, consumer demand and self-regulatory programs developed by the men and women of our industry, who want to help people lead healthier lifestyles.” He added that NPA strongly supports the prosecution of criminal activity and has robust internal measures and quality assurance programs to report bad actors to authorities.
