Less than 30 years ago, there was a $4 billion dietary supplement industry and there were about 4,000 products on the market. Today, it’s a $40 billion industry with more than 80,000 products on the market that the Food and Drug Administration (FDA) does not have authority to regulate the products until after they are already on the market.
The AMA and FDA joined forces to provide physicians with a CME module help them learn more about dietary supplements and get strategies for counseling patients about their benefits and risks. The CME module, “Dietary Supplements: What Physicians Should Know,” helps doctors and other learners understand how these products are defined, regulated and labeled—and provides information on how to identify adverse events and report them. The module also includes information and resources tailored to patients.
“With the dietary supplement market in the U.S. continuing to grow and use of these products increasing among the population, it’s important for physicians and other health care professionals to have the information they need to help their patients weigh the benefits and risks of taking dietary supplements,” said Gerald E. Harmon, MD, the AMA’s immediate past president. “While some supplements can help people meet daily requirements of essential nutrients or help improve or maintain overall health, patients must be aware that dietary supplements can come with health risks.”
More knowledge, better decisions
The resources in the module “are aimed at helping health care professionals and patients make informed decisions about dietary supplements,” Dr. Harmon said.
The AMA Ed Hub™ module includes three, 10-minute videos. Two are aimed at physicians and a third is created in a way that physicians can share it with patients to increase their knowledge about dietary supplements.
The first video explores how dietary supplements are defined, regulated and labeled. For example, manufactures are responsible for ensuring that their products are safe and labeled appropriately, which includes a fact label and only making statements about how the supplement impacts the structure or function of the human body.
The second video reviews the risks tied to taking dietary supplements, including how supplements can interact with medications, interfere with laboratory tests and how to look for common hidden drug ingredients that can be found in some supplements. The video also discusses how to report adverse events associated with supplement use and contains an example of how physicians can productively talk to patients about supplements they may be taking.
The third video is a general overview of dietary supplement regulation, labeling, claims, benefits and risks. It has practical guidance for physicians and can be shared directly with patients.
The module also contains resources in PDF for both English and Spanish speakers that address, among other things:
- Adverse events.
- How to report adverse events to the FDA.
- Understanding dietary supplements.
“We know that health care professionals are among the most trusted when it comes to providing information to their patients, so this collaboration is especially valuable in our efforts to better inform healthcare professionals and their patients about the potential risks as well as benefits of dietary supplements,” said Douglas Stearn, deputy director for regulatory affairs in the FDA Center for Food Safety and Applied Nutrition.
The “Dietary Supplements: What Physicians Should Know” module was developed, in part, after the AMA House of Delegates adopted a policy urging physicians to ask patients’ about their dietary supplements, calling for the AMA to work with the FDA to educate physicians and the public about FDA's Safety Reporting Portal and strongly encouraging physicians and the public to report potential adverse events associated with dietary supplements.
The May 2022 issue of AMA Journal of Ethics® further explores underregulated supplements, and includes an article that tackles the question of whether clinicians should ever recommend supplements to patients trying to lose weight.
Find out what doctors wish patients knew about vitamins and supplements.