On the same day the FDA warned companies against hawking dietary supplements for Alzheimer’s disease, Commissioner Scott Gottlieb announced “one of the most significant modernizations of dietary supplement regulation and oversight in 25 years.” Three out of every four Americans take dietary supplements regularly, contributing to an industry worth more than $40 billion.
The supplement industry has grown ten-fold and it markets up to twenty times the number of products as it did a quarter-century ago when Congress created the current regulatory framework. “To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” said Gottlieb on Monday. Scientific advances can provide opportunities for consumers to improve their health, he said. “At the same time, the growth in the number of adulterated and mis-branded products – including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks – creates new potential dangers.”
The FDA took action against 17 companies selling 58 products, many of them as dietary supplements, that claim to prevent, cure or treat Alzheimer’s and other serious diseases and health conditions. The FDA said the products are unapproved or mis-branded drugs that have not been proven safe or effective. “Alzheimer’s is a challenging disease that, unfortunately, has no cure,” said Gottlieb in warning against scams that waste money and delay proper care.
“It’s encouraging that Commissioner Gottlieb seems open to making changes to the Dietary Supplement Health and Education Act—the deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today,” said president Peter Lurie of the consumer group Center for Science in the Public Interest. Lurie said supplement makers should be required to list their ingredients with the FDA and the FDA should have to the power to order recall of tainted supplements.
Besides the warnings about Alzheimer’s supplements, the FDA has taken action against companies and dietary supplements that claim to treat conditions such as cancer and opioid addiction.
Gottlieb listed a half-dozen steps that FDA will take to improve oversight of dietary supplements. “These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders,” he said.
The agency is developing a new “rapid response tool” to alert the public against buying or using products with suspect ingredients and to notify supplement makers and retailers against them as well.
There also will be “a public dialogue about whether additional steps to modernize” the 1994 Dietary Supplement Health and Education Act that provides the foundation for FDA regulation of the industry.
Under the 1994 law, dietary supplements are regulated as foods and do not go through the reviews or tests that are standard for medicine, said the Washington Post: “While the FDA doesn’t clear the products ahead of time, it is charged with removing unsafe ones from the market.”
To read Gottlieb’s statement on dietary supplements, click here.