The US Food and Drug Administration
The US Food and Drug Administration is taking new measures Food supplements, send warning letters to companies that claim, without evidence, that their products can prevent or treat Alzheimer's, diabetes and cancer, the agency reported Monday.
The FDA promised to update its policy on dietary supplements and promised in more than 25 years one of the most important modernization of regulations on dietary supplements and supervision, "said a statement from FDA Commissioner Dr. ir. Scott Gottlieb.
The FDA does not assess dietary supplements before they enter the market, but can intervene when products are deemed unsafe or have false, misleading or unproven claims about their health benefits. The agency said that these claims can actually cause harm if people leave approved treatments that are proven safe and effective.
About three quarters of US consumers regularly take dietary supplements, including 4 out of 5 older adults, Gottlieb said. The industry has grown by tens of thousands of products that are jointly worth more than $ 40 billion, he added.
On Monday, the FDA sent twelve warning letters and five online advisory letters to companies that market their products illegally as treatments for Alzheimer's. 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, that "are being promoted as memory enhancers or treatments to delay or prevent Alzheimer's disease and other dementias." The organization says that there are & # 39; legitimate concerns & # 39; are when patients use these products instead of or in addition to treatments prescribed by a physician – referring to unknown purity, questionable safety and efficacy and possible interactions between drugs.
A study published in October found that nearly 800 dietary supplements sold without prescription between 2007 and 2016 contain non-approved ingredients for medicines based on an analysis of FDA data. More than one unapproved pharmaceutical ingredient was found in 20% of those supplements.
In his statement Monday, Gottlieb said there were plans to improve the agency's policy when it comes to dietary supplements, including new enforcement strategies & # 39; and & # 39; a new quick answering tool to alert the public & # 39; for unsafe products. He said that more details will be available & # 39; in the coming months & # 39 ;.
"As the popularity of supplements has grown, so is the number of entities that potentially sell dangerous products or make unproven or misleading claims about the health benefits they can bring," Gottlieb said.