FDA is Cracking Down on Supplements to Protect Consumers
The agency plans on overhauling its 25-year-old rules.
The Food and Drug Administration said Monday it planned to revamp and strengthen oversight of the sprawling, $50-billion-a-year dietary supplements industry.
In doing so, the agency acknowledged that the explosive growth of the industry has resulted in risks to consumers, like more supplements “spiked” with unlisted drug ingredients, and false and misleading claims about health benefits, The Washington Post reported.
The FDA also announced that it has sent 12 warning letters and five advisory notices int his month alone to companies it said were selling dozens of products that contain unapproved drugs or making illegal claims for treating Alzheimer’s disease and other serious conditions.
The agency is now planning an array of policy changes that could lead to the most important regulatory modernization since enactment of the 1994 Dietary Supplement Health and Education Act, according to the Post.
FDA Commissioner Scott Gottlieb said in a recent interview that while most supplement makers act responsibly, the industry’s exponential growth has allowed “bad actors” to sell dangerous products or ones that carry unproven claims.
“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” he said.
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