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F.D.A. Warns Supplement Makers to Stop Touting Cures for Diseases Like Alzheimer’s

F.D.A. Warns Supplement Makers to Stop Touting Cures for Diseases Like Alzheimer’s


He also expressed frustration that the F.D.A. has spent years debating policy that would encourage manufacturers to notify the agency of new dietary ingredients, but has not yet released it.

Dr. Gottlieb said the F.D.A. would create an online watchlist of specific ingredients the agency is concerned about.

The F.D.A.’s oversight is based on a 1994 federal law, which imposed minimal reporting and labeling requirements on the makers of vitamins, minerals and herbs — a fledgling industry at the time. To prevent a company from selling a product, the law requires the F.D.A. to prove that it is unsafe. The agency says that it is difficult to track the myriad products, many of which are sold on the internet.

The law also requires businesses to notify the F.D.A. that they are making a dietary supplement, but not to say what’s in it.

“That just makes it impossible for the agency to police the market,” Dr. Lurie said.

The 25-year-old law has drawn increasing criticism as the sector has grown. There are now between 50,000 and 80,000 dietary supplements on the market, according to the F.D.A. The agency also says that three of every four American consumers now take a dietary supplement regularly. For older Americans, the rate is four out of five.

In recent years, the F.D.A. has cracked down on several sectors of the industry, including dietary supplements sold for weight loss, sexual function and energy enhancement. More recently, one of the biggest targets has been kratom, a botanical substance that is marketed as a safe alternative for opioids or to help opioid users’ withdrawal symptoms. The F.D.A. has ordered that kratom imports be seized and told companies not to use it in supplements. The agency has linked several deaths to kratom.

Steve Mister, chief executive of the Council for Responsible Nutrition, which represents the dietary supplement business, said he believed the dietary supplements industry is “a remarkably safe.” He also said the current law strikes the right balance between ensuring safety and giving consumers access to affordable products.

“These products are not drugs and should not be regulated like drugs,” he said. Mr. Mister also said his group supports the F.D.A.’s enforcement actions, and has been working with Congress to increase the program’s budget.



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