FDA Commissioner Scott Gottlieb in a statement on Monday announced the agency plans to strengthen its oversight of the dietary supplement industry, the Washington Post reports.
How FDA currently regulates dietary supplements
Under the 1994 Dietary Supplement Health and Education Act (DSHEA), FDA regulates dietary supplements as food, which means they are not subject to premarket approval or the same effectiveness and safety testing required for drugs, the Post reports. However, FDA is responsible for removing unsafe dietary supplements from the market, according to the Post.
Currently, federal law permits dietary supplement makers to make so-called "structure/function claims" to describe how a dietary ingredient or a nutrient affects the body. For example, a supplement maker can claim that "'calcium builds strong bones,'" the Post reports. Federal law does not permit supplement makers to claim a product treats or cures a disease or health condition.
Since the DSHEA's enactment, the dietary supplement industry has grown from a $4 billion industry with about 4,000 products to a more than $40 billion industry with more than 50,000 different products, according to the Post. In an interview with the Post, Gottlieb said, "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." While most dietary supplement makers follow FDA regulations and accurately market safe products, Gottlieb said the market's growth has allowed "bad actors" to market and sell dietary supplements with safety risks and unproven medical claims, the Post reports.
A study published in the New England Journal of Medicine in 2015 attributed an estimated 23,000 emergency department (ED) visits in the United States annually to adverse reactions related to dietary supplements. Many of the ED visits involved cardiovascular issues related to supplements for weight loss or energy. Meanwhile, a study by California Department of Public Health published in October 2018 found 746 dietary supplements contained unapproved or recalled pharmaceuticals that have "the potential to cause serious adverse health effects," the New York Times reports.
Gottlieb says FDA plans to bolster oversight
Gottlieb said FDA plans to modernize federal policies regulating dietary supplements, which he said could represent the most important regulatory change to oversight of the dietary supplement industry since DSHEA was enacted.
Gottlieb said FDA intends to take a "balanced approach" to improve the safety of dietary supplements, reduce the number of supplements marketed with inaccurate claims, and promote industry innovation, the Post reports. For instance, Gottlieb said FDA is developing a rapid-response tool to alert the public and notify industry stakeholders when a supplement contains an illegal or potentially dangerous substance. In addition, Gottlieb said FDA plans to streamline its management of supplements that contain prescription drugs, such as the generic version of Viagra, and increase the number of enforcement actions the agency takes against supplement makers, the Post reports.
In accordance with that effort, Gottlieb said FDA has sent 12 warning letters and five online advisory letters to companies marketing products—many of which are dietary supplements—with unapproved and unproven claims to cure, prevent, or treat Alzheimer's disease, cancer, diabetes, and other diseases and health conditions. He said, "Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions."
Gottlieb said FDA also plans to "develop new enforcement strategies" and review how the agency regulates new dietary ingredients to ensure its regulations are flexible enough to permit product improvements, according to the Post.
Further, Gottlieb said FDA will engage in public dialogue to determine whether additional steps are needed to modernize DSHEA, noting that some stakeholders have called on federal lawmakers to amend DSHEA to require companies to list their products and ingredients with FDA. Supplement manufacturers currently are required to register with FDA, but they are not obligated to list what products or ingredients they produce.
Gottlieb said mandatory listing "could provide significant benefits by improving transparency in the marketplace" and permitting FDA to focus on enforcement actions, the Post reports.
Several observers applauded FDA's proposed policy changes, the Post reports.
Sandra Eskin, head of the food safety project at The Pew Charitable Trusts, said Gottlieb's "statement is the first time in 25 years that FDA's leadership has publicly committed to taking meaningful steps to improve dietary supplement oversight." Eskin added, "FDA needs to know what supplement products each company makes, as well as the ingredients and copies of the product labels. This information is the cornerstone of an effective oversight and enforcement system, and Congress should require that supplement companies provide it to the agency."
The Consumer Healthcare Products Association indicated its support for FDA's "efforts to identify bad actors selling adulterated or misbranded dietary supplement products."
Steve Mister—president and CEO of the Council for Responsible Nutrition, which represents supplement makers—said FDA "shares our vision to further develop the thriving, innovative, and safe marketplace for dietary supplements."
But others expressed disappointment, saying Gottlieb did not announce any substantial policy changes.
Pieter Cohen, an associate professor of medicine at Harvard Medical School, said, "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 [public relations] push."
Peter Lurie, a former FDA official who currently serves as president of the Center for Science in the Public Interest, applauded FDA's commitment to increasing enforcement action, but said he wants the agency to do more. "FDA is hampered by a terrible law and drastically limited resources within that there's only so much [it] can do," Lurie said (Kaplan, New York Times, 2/11; Jagadeesh Babu, Reuters, 2/11; Sullivan, The Hill, 2/11; Meyer, USA Today, 2/11; McGinley, Washington Post, 2/11; Gottlieb statement, 2/11).
Just updated: Your cheat sheets for understanding health care's legal landscape
To help you keep up with the ever-changing regulatory environment, we recently updated our cheat sheets on some of the most important—and complicated—legal landmarks to include a brand new one-pager on the new tax law.
Check out the cheat sheets now for everything you need to know about MACRA, the Affordable Care Act, antitrust laws, fraud and abuse prevention measures, HIPAA, and the two-midnight rule.