FDA to crack down on supplement
The administration warns the dietary supplement industry’s growth has resulted in risks to consumers.
WASHINGTON — The Food and Drug Administration said Monday it plans to beef up oversight of the sprawling, $50 billion-a-year dietary supplements industry, warning that the sector’s explosive growth has resulted in risks to consumers — such as an increase in supplements “spiked” with unlisted drug ingredients and false and misleading claims about health benefits.
The agency underscored the need for greater oversight by announcing it had sent 12 warning letters and five advisory letters earlier this month to companies the FDA said are selling dozens of products that contain unapproved drugs or use illegal claims for treating Alzheimer’s and other serious diseases.
FDA Commissioner Scott Gottlieb said the agency is planning changes that could lead to the most important regulatory modernization since enactment of the 1994 Dietary Supplement Health and Education Act, which considers supplements safe until proved otherwise. “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.
Under the 1994 law, dietary supplements are regulated as food and, therefore, are not subject to premarket approval or the kind of safety and effectiveness testing required for drugs. Since the law was enacted, the industry has grown from 4,000 products and $4 billion a year in sales to as many as 80,000 products and $50 billion in sales, according to the FDA.
Three out of four Americans take a dietary supplement on a regular basis, and for older Americans the proportion is four out of five, the agency said.
Gottlieb said he plans a “balanced approach” to improve safety, reduce inaccurate claims and encourage industry innovation.