FDA to Tighten Oversight of Supplements
MONDAY, Feb. 11, 2019 (Pharmacist's Briefing) -- The U.S. Food and Drug Administration plans to strengthen regulation of dietary supplements, such as vitamins, minerals and herbs, the agency announced Monday.
The changes would be "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
Three out of every four Americans take a dietary supplement on a regular basis, including one in three children. The rate is highest -- four in five -- among older Americans.
"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," Gottlieb said.
"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," he noted.
The Council for Responsible Nutrition, a trade association that represents the nutritional supplement industry, took no issue with the FDA's action.
The group said it supports "Dr. Gottlieb's enthusiasm for rooting out bad actors who put consumers at risk by spiking products with unapproved ingredients or drugs," said Steve Mister, president and CEO of the council. "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."
Gottlieb added that he's concerned that "changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks."
The new measures 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," Gottlieb said.
The agency took a first step toward that end Monday, when it sent 12 warning letters and five online advisory letters to companies illegally selling or marketing unapproved products that claim to prevent, treat or cure Alzheimer's disease, and a number of other serious conditions.
"Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer's," Gottlieb said.
But enforcement actions are just one part of the FDA's efforts to update its policies on dietary supplements.
"I recently directed the establishment of a Dietary Supplement Working Group at the FDA, led out of my office and comprised of representatives from multiple centers and offices across the agency," Gottlieb said.
He said the FDA's priorities for dietary supplements are to ensure they're safe, contain the ingredients listed on the label and are made according to quality standards.
Gottlieb also said the FDA is "developing a new rapid-response tool to alert the public so consumers can avoid buying or using products with [dangerous ingredients], and to notify responsible industry participants to avoid making or selling them."
The FDA is improving the efficiency of enforcement actions when dietary supplements contain illegal ingredients, including drug ingredients.
The agency will also update its compliance policy regarding dietary ingredient notifications, to better evaluate the safety of a new ingredient before it becomes available to consumers. In addition, the agency will hold a public meeting on the responsible development of new products in the dietary supplement industry.
Another measure announced Monday is the creation of the Botanical Safety Consortium, a public-private partnership that will include leading industry, academia and government scientists "to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements," Gottlieb said.
The FDA will also seek public input on whether further measures are needed to modernize the Dietary Supplement Health and Education Act (DSHEA), which gives the FDA the authority to regulate dietary supplements, Gottlieb said.
The U.S. Office of Dietary Supplements has more on dietary supplements.