Tuesday, February 12, 2019 1:00 am
Dietary supplements draw FDA scrutiny
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 – more supplements “spiked” with unlisted drug ingredients, and false and misleading claims about health benefits.
At the same time, the agency announced it had sent 12 warning letters and five advisory letters earlier this month to companies the FDA said were selling dozens of products that contain unapproved drugs or making illegal claims for treating Alzheimer's disease or other serious conditions.
FDA Commissioner Scott Gottlieb said the agency is planning policy changes that could lead to the most important regulatory modernization since enactment of the 1994 Dietary Supplement Health and Education Act, which set up the regulatory regime.
Under the 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.
While the FDA doesn't clear the products ahead of time, it is charged with removing unsafe ones from the market.
Gottlieb said in an interview that although most supplement makers act responsibly, the huge growth in the industry 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.
The safety of supplements has long been debated. A study published in 2015 in the New England Journal of Medicine estimated 23,000 emergency department visits in the United States every year were attributed to adverse events related to dietary supplements. According to the study, many such visits often involve cardiovascular problems arising from weight-loss or energy products.
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 FDA said. One in 3 children also takes supplements.
Gottlieb said he plans a “balanced approach” to improve safety, reduce inaccurate claims and encourage industry innovation. For example, the agency plans to create a rapid-response tool to quickly alert the public if a supplement contains an illegal and potentially dangerous ingredient. It intends to streamline the handling of supplements containing prescription drugs such as the generic version of Viagra and to increase enforcement actions.
The potential policy changes were greeted with cheers and skepticism by consumer advocates and industry officials. Pieter Cohen, an associate professor of medicine at Harvard University's medical school, said: “The FDA seems to be restating things they have been doing for years. Not making any changes. There is nothing short of here except for a big PR push.”