The FDA promised to update its dietary supplements, promising "one of the most significant modernizations of dietary supplementation and oversight over 25 years," according to a statement by FDA Commissioner Dr. Scott Gottlieb.
The FDA does not consider dietary supplements before they turn on the market, but it may intervene when products are considered unsafe or carry false, misleading or untested claims about health benefits. The agency said these claims can cause real harm when people refuse approved treatments that have proven safe and effective.
About three-quarters of US consumers regularly take supplements – including four out of five older adults, Gottlieb said. The industry has swelled with 10s of thousands of products totaling more than $ 40 billion, he added.
On Monday, FDA sent 12 notification letters and five online advisory letters to companies that marketed their products illegally as Alzheimer's treatments. In recent months, the agency has also pursued a number of other products, including male enhancements, and those claiming to treat opioid dependence.
The Alzheimer's Association says there is a "growing number" of alternative treatments, including supplements, which are "promoted as memory enhancers" or treatments to delay or prevent Alzheimer's disease and other dementia. " The organization says there are "legitimate concerns" when patients use these products instead of or alongside doctoral treatments, citing unknown purity, questionable safety and efficacy, and potential drug interactions.
A study published in October showed that nearly 800 diets of dietary supplements sold over the counter from 2007 to 2016 contained unauthorized drug ingredients, based on an analysis of FDA data. Merlie than an unauthorized pharmaceutical ingredient was found in 20% of these supplements.
In his statement on Monday, Gottlieb said plans were on the way to improving the agency's dietary guidelines – including "new enforcement strategies" and "a new speed-up tool to alert the public" of unsafe products. He said more details would be available "in the coming months."
"As the popularity of supplements has grown, so many entities have marketed potentially dangerous products or made untested or misleading claims about the health benefits they can deliver," Gottlieb said.