The FDA promised to update its policies on food supplements, promising "one of the most significant modernizations of regulation and supervision of food supplements over 25 years," according to a statement by FDA Commissioner Dr. Scott Gottlieb.
The FDA does not review food supplements before they reach the market, but may intervene when the 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 give up approved treatments that have been proven safe and effective.
About three-quarters of US consumers regularly take dietary supplements – including four out of five older adults, Gottlieb said. The industry has grown with 10s of thousands of products totaling over $ 40 billion, he added.
On Monday, the FDA sent 12 warning letters and five letters of online advice to companies that market their products illegally as Alzheimer's treatments. In recent months, the agency has also followed a number of other products, including male enhancement supplements and those claiming to treat opioid addiction.
The Alzheimer's Association says there is a "growing number" of alternative treatments, including dietary supplements, which are "promoted as memory stimulators or treatments to delay or prevent Alzheimer's disease and other dementias". The organization says there are "legitimate concerns" when patients use these products in place of or next to treatments prescribed by the doctor – citing unknown purity, questionable safety and efficacy, and possible drug interactions.
A study published in October found that nearly 800 dietary supplements sold over the counter from 2007 to 2016 contained unapproved pharmaceutical ingredients, based on an FDA data analysis. More than one unapproved pharmaceutical ingredient was found in 20% of these supplements.
In his statement Monday, Gottlieb said plans were underway to improve agency policies when it comes to food supplements – including "new application strategies" and "a new rapid response tool to alert the public "of unsafe products. He said more details will be available "in the coming months."
"With the increase in popularity of supplements, the number of entities that market potentially dangerous products or make untested or misleading claims about the health benefits they can offer," Gottlieb said.