The U.S. Food and Drug Administration says it’s finally overhauling its oversight of dietary supplements sold in the United States.
Describing the move as “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” the agency said this week that it’s rolling out a multi-prong plan aimed at protecting the public from potentially “unsafe and unlawful products.”
The FDA also announced a crackdown on more than a dozen supplement makers that had allegedly touted misleading claims about their products’ ability to treat serious diseases including Alzheimer’s and cancer.
Three out of every four American consumers take a dietary supplement on a regular basis, according to the FDA. Yet despite their widespread use, the multibillion-dollar supplement industry has long operated with little federal supervision.
The FDA is not authorized to review dietary supplements for safety and efficacy before they are marketed. The agency only has the authority to stop the sale of a supplement if it can prove the product is dangerous. But with tens of thousands of products on the market today, many of which are sold online, the agency has conceded just how challenging this task can be.
“We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk,” FDA Commissioner Scott Gottlieb said Monday, announcing the agency’s planned efforts to beef up oversight.
“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb added.
In what’s been interpreted as a nudge to lawmakers to boost the FDA’s authority over supplement makers, Gottlieb pointed out just how much the supplement industry has changed and grown since Congress passed the Dietary Supplement Health and Education Act in 1994.
“What was once a $ 4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $ 40 billion, with more than 50,000 ― and possibly as many as 80,000 or even more ― different products available to consumers,” the commissioner wrote.
The FDA’s improved oversight plan includes the development of a new “rapid-response tool” that would warn consumers to avoid purchasing potentially unsafe products, Gottlieb explained. He said the agency also intends to update its compliance policies regarding “new dietary ingredient” notifications, or NDIs. Supplement makers are required to alert the FDA of any ingredients in their products that weren’t sold in the U.S. before 1994.
“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb said.
He added the FDA will be engaging the public in dialogue around the topic of supplements and will announce more details of its oversight plan in the “near future.”
Also on Monday, the FDA announced that it had sent out warning letters to 17 companies that had sold dozens of products allegedly bearing improper claims of preventing, treating or curing serious diseases like Alzheimer’s, dementia, diabetes and cancer.
“These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat,” the agency wrote in a press release. “These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”
The companies, which included TEK Naturals, Pure Nootropics, Gold Crown Natural Products and Sovereign Laboratories, have 15 business days to respond to the FDA’s letters.
Harvard associate professor Pieter Cohen, who studies the safety of supplements, told The Wall Street Journal that supplement companies are legally allowed to make very broad claims about their products, which may encourage some to make assertions about diseases like dementia.
“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,” Cohen said.