The FDA is cracking down on those selling dietary supplement and has sent warning letters to companies who claim, without scientific evidence, that their products can cure diseases such as diabetes, cancer and Alzheimer’s, when their safety and efficacy is unknown.
“The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle,” FDA commissioner Scott Gottlieb said in a statement. “That’s why today we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernisations of dietary supplement regulation and oversight in more than 25 years.”
Under the 1994 dietary supplement law, such products were regulated more like food than like drugs. Manufacturers don’t need to provide evidence of a supplement’s safety before selling it to consumers. Instead the onus is on the FDA to demonstrate that it is not safe and should be removed from the market. However, these supplements are not permitted to contain drug ingredients, or to be marketed with claims that they prevent or treat disease.
On Monday of this week, the FDA sent 12 warning letters along with five online advisory letters to companies worldwide who are marketing their products illegally as Alzheimer's treatments. The agency has also contacted those selling proposed cures for opioid addiction and those offering male enhancement supplements. The companies contacted have been asked to respond to the FDA within 15 days detailing how the violations outlined will be corrected.
The FDA’s new policy priorities include communicating better about safety issues related with dietary supplements and establishing a regulatory framework to promote innovation, as well as upholding product safety and creating new strategies of enforcement.
“Our first priority for dietary supplements is ensuring safety,” said Gottlieb. “Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labelled to contain, and nothing else, and that those products are consistently manufactured according to quality standards.”
“Our third priority is informed decision-making,” said Gottlieb. “We want to foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.”