FDA sends warning letters to dietary supplement companies
U.S. agency accuses 17 companies of illegally selling products as treatments for diseases
The Food and Drug Administration on Monday accused 17 nutritional-supplement makers of selling more than 58 products with improper claims that they can prevent, treat or cure serious diseases, including Alzheimer’s.
The agency sent 12 warning letters and five online advisory letters to the U.S. and foreign companies, which often sold and marketed their products on websites and social media, according to an agency statement.
The companies—all but two of which are U.S. based—have 15 business days to explain how the violations alleged by the FDA will be corrected, or they could face further enforcement actions.
The agency is updating its oversight of the dietary supplement industry, including by adding a system for alerting the public about unsafe products, FDA Commissioner Scott Gottlieb said in a separate statement Monday.
“Legitimate industry benefits from a framework that inspires the confidence of consumers and providers,” Mr. Gottlieb said. “Patients benefit from products that meet high standards for quality.”
Dietary supplements are a booming industry, with some 80,000 kinds of supplements sold in 2016, according to a recent government report. U.S. supplement sales reached nearly $133 billion in 2016, according to the most recent data from Zion Market Research.
Supplements, however, aren’t regulated like medicines and other products taken to improve health. The FDA doesn’t review whether a supplement works and is safe, as it does with prescription drugs and overthe-counter medicines. Supplement manufacturers and distributors are subsequently responsible for ensuring the safety of their products. In recent years doctors and public-health professionals have raised concerned over the limited oversight, triggering government probes.
Last year, the U.S. Government Accountability Office found that two dietary supplements promoted as improving memory using Ginkgo biloba contained either none of the ingredient or a lower amount than advertised.
The FDA has previously issued warnings to supplement makers that said their products can help patients suffering from cancer, male sexual dysfunction and opioid addiction.
Over the past five years, the agency said it has sent more than 40 warning letters to companies it determined had illegally marketed—on websites and social media as well as in retail stores—more than 80 products with false or misleading claims about treating or preventing Alzheimer’s disease.
Some of the companies that received the latest warnings expressed surprise, while others said they were reviewing the letters.
“We’ve never had any issues,” said Kolleen Sunde, president of Nutrition Coalition Inc., which is based in Moorhead, Minn., and was founded in the early 1980s. “We’ve always been told we were fine and in compliance.” Mr. Sunde declined to comment on the specific allegations.
Dennis Butts, owner of Peak Nootropics in Houston, said it has worked to remove any misleading or exaggerated claims or links from its site since Mr. Butts bought the company about two years ago.
The claims “should be all be gone,” he said. “I think our claims are actually less grand than most vitamin sellers.”
Steven Griffin, CEO of Blue Ridge Silver of Blowing Rock, N.C., said his company’s nutritional supplements don’t violate any laws or FDA guidelines because “we are careful not to make claims that our colloidal silver products treat, prevent or cure diseases” but added that the company would cooperate with the agency.
Pure Nootropics, of Albuquerque, N.M., said it is developing a corrective action plan and will soon update its website. Another company, TEK Naturals, said in a statement that it is reviewing the FDA’s letter, has reached out to the agency and is committed to complying with the law.
Gold Crown Natural Products in Miami didn’t respond to requests for comment.
Steve Mister, CEO for the Council for Responsible Nutrition, a Washington, D.C.,-based trade group for supplement companies, said it supported the recent actions by the FDA to root out “bad actors who put consumers at risk.”
“We welcome additional enforcement actions to bring to justice those who would cynically trade on the halo effect of responsible industry to make a quick buck while ignoring the safety and health of consumers,” Mr. Mister said.
Pieter Cohen, an associate professor at Harvard Medical School who studies the safety of supplements, said one reason supplement companies tend to make assertions about diseases like dementia is because nothing legally prohibits them from making much more general claims—for example, that their products enhance brain function—and consumers may not realize the difference.
“As soon as you have an environment where you can say supplements are good for your brain and you don’t need clinical data to support that, then you’ve got an environment that’s ripe for fraud,” he said.
Alzheimer’s disease affects an estimated 5.5 million people in the U.S., and scientists and the pharmaceutical industry have struggled to develop effective treatments for it. Several experimental drugs have failed.