FDA warns supplement makers about false claims

The Food and Drug Administration on Monday warned 12 sellers of dietary supplements to stop claiming their products can cure Alzheimer’s disease.

At the same time, Dr. Scott Gottlieb, the agency’s commissioner, suggested Congress strengthen the FDA’s authority over an estimated $40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny.

Those products range from benign substances like vitamin C or fish oil, to more risky mineral, herbal and botanical concoctions that can be fatal.

“People haven’t wanted to touch this framework or address this space in, really, decades, and I think it’s time we do it,” Gottlieb said. He is particularly concerned about supplements that purport to cure diseases for which consumers should seek medical attention.

“We know there are effective therapies that can help patients with Alzheimer’s,” he said. “But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care.”

The companies included TEK Naturals, Pure Nootropics and Sovereign Laboratories. In their letter to TEK Naturals, the FDA and the Federal Trade Commission chastised the company for marketing “Mind Ignite” as a product “clinically shown to help diseases of the brain such as Alzheimer’s and even dementia.”

On TEK Naturals’ website, a statement notes, “We draw the line when it comes to disingenuous marketing. We don’t make stupid claims.”

Gottlieb said the FDA would create an online watch list of specific ingredients the agency is concerned about.

The FDA’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 FDA to prove it is unsafe. The agency says it is difficult to track the myriad products, many of which are sold on the internet.

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

The 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 FDA. The agency also says three of every four American consumers now take a dietary supplement regularly.