Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own.
...the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.
first are new ways to communicate more quickly when we have concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements.
Second, we also need to ensure that our regulatory framework is flexible enough to adequately evaluate product safety while promoting innovation. The key to this effort will be important steps to foster the submission of new dietary ingredient (NDI) notifications.
Third, as with other commodities that the agency regulates, it’s critical that the FDA continue to work closely with our partners in industry to achieve our primary goal of protecting public health and safety. As the dietary supplement industry develops new products and ingredients, advances new delivery systems and innovates in other ways, the FDA must do more to leverage its existing resources and authorities to evaluate these products.
Fourth, we’ll continue to take actions to protect public health – like those we took today for illegal Alzheimer’s disease products – and develop new enforcement strategies, as a key element of our approach to protecting consumers as the risks evolve.
Last April numerous companies were contacted about selling supplements that contained drugs regulated by the FDA. A study published in October found that nearly 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, based on an analysis of FDA data. More than one unapproved pharmaceutical ingredient was found in 20% of those supplements.
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.
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.
Most adulterated products (619 [79.8%]) were found to contain 1 unapproved drug ingredient. Still, 157 of 776 products (20.2%) were found to contain more than 1 pharmaceutical, including 33 products that tested positive for 3 or more adulterants. (Prozac was one of the drugs found in supplements)
Sixteen of 317 adulterated weight loss supplements (5.0%) were found to contain other drug ingredients, including bumetanide, cetilistat, diclofenac, dimethylamylamine, fenfluramine, fenproporex, furosemide, lorcaserin, orlistat, phenytoin, propranolol, rimonabant, and an unspecified diuretic. In total, 80 of 317 adulterated weight loss supplements (25.2%) were found to contain more than 1 hidden drug ingredient.