The US Food and Drug Administration (FDA) has warned sellers of dietary supplements to stop claiming their products can cure diseases ranging from Alzheimer’s to cancer to diabetes, reports The New York Times. At the same time, Dr Scott Gottlieb, the agency’s commissioner, suggested that Congress strengthen the FDA’s authority over an estimated $40bn industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny.
The report says these 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 is quoted in the report as saying. 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 report says the companies included TEK Naturals, Pure Nootropics and Sovereign Laboratories. In a 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.”
The report says in response to a request for comment, TEK Naturals said that it was reviewing the letter and was committed to complying with legal requirements.
Gottlieb said the FDA would create an online watch list of specific ingredients the agency was concerned about.
The report says the FDA’s oversight is based on a 1994 federal law, which imposed minimal reporting and labelling 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 that it is unsafe. The agency says it is difficult to track the myriad products, many of which are sold on the internet.
The report says the law also requires businesses to notify the FDA 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,” Lurie said.
The report says 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 FDA. The agency also says that three of every four US consumers now take a dietary supplement regularly. For older Americans, the rate is four out of five.
In recent years, the report says the FDA 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 FDA 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, CEO of the Council for Responsible Nutrition, which represents the dietary supplement business, said in the report that he believed the dietary supplements industry was “remarkably safe.” He also said the current law struck 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. Mister also said his group supported the FDA’s enforcement actions, and had been working with Congress to increase the programme’s budget.
[link url="https://www.nytimes.com/2019/02/11/health/Alzheimers-drug-fda.html?emc=edit_th_190212&nl=todaysheadlines&nlid=425053800212"]The New York Times report[/link]