The U.S. Food and Drug Administration (FDA) plans to step up its oversight of the dietary supplements industry to curtail consumer exposure to unlisted drug ingredients and misleading claims about health benefits. FDA Commissioner Scott Gottlieb, MD, said the agency is planning policy changes that could lead to the most substantial modernization since setting up the regulatory regime in 1994, according to The Washington Post.
A 2015 study published in the New England Journal of Medicine estimated that 23,000 emergency department visits were attributed to dietary supplements, particularly weight-loss or energy products.
Under the Dietary Supplement Health and Education Act, supplements are regulated as food, so they are not subjected to premarket approval or the same rigorous safety and effectiveness tests as medications. The FDA is responsible for removing unsafe drugs from the market, which has grown from 4,000 to 80,000 products since the law was enacted.
A policy update is long overdue, Dr. Gottlieb told The Washington Post. “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 proposed changes include the following:
- a rapid-response tool to quickly alert the public if a supplement contains an illegal and potentially dangerous ingredient
- quicker handling of supplements containing prescription drugs such as the generic version of Viagra
Dr. Gottlieb also appeared to endorse a proposal that companies list their products and ingredients with the FDA, but such a substantial change would likely require legislation.
Source: The Washington Post, February 11, 2019.