The FDA promised to update its dietary supplements, promising "one of the most significant modernization of dietary supplements and oversight over 25 years," according to a statement from the FDA Commissioner, Dr. Scott Gottlieb.
The FDA does not undergo dietary supplements before they hit the market, but it can intervene when products are considered unsafe or carry false, misleading or unproven claims about their health benefits. The Agency said that these claims can cause real harm when people refrain from approved treatments that have been proven safe and effective.
About three-quarters of American consumers regularly take supplements – including four out of five older adults, Gottlieb said. The industry has swelled with 10s of thousands of products worth more than $ 40 billion, he added.
On Monday, FDA sent 12 warning letters and five online advisory letters to companies that marketed their products illegally as Alzheimer's. In recent months, the agency has also pursued a number of other products, including male enhancement supplements and those claiming to treat opioid dependence.
The Alzheimer's Association says there is a "growing number" of alternative treatments, including dietary supplements, "promoted as memory enhancers or treatments to delay or prevent Alzheimer's disease and other dementia." The organization says "legitimate concerns" when patients use these products instead of or with medical prescriptions – citing unknown purity, questionable safety and efficacy, and possible drug interactions.
A study published in October showed that nearly 800 supplements sold over the counter from 2007 to 2016 contained unauthorized drug ingredients based on an FDA data analysis. More than one 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 policies on dietary supplements – including "new enforcement strategies" and "a new rapid reaction tool to alert the public" of unsafe products. He said more details would be available "in the coming months."
"As the popularity of dietary supplements has grown, the number of devices that market potentially hazardous products or make unproven or misleading claims about the health benefits they can deliver," said Gottlieb.