Key takeaways:

• Clinicians should routinely ask patients about dietary supplement use and educate them on potential risks.
• ACP is pushing for reforms that would require supplements to undergo premarket review and be registered.

ACP has released a position paper on dietary supplements’ controversial regulations, offering FDA suggestions for a more proactive approach.

In the United States, dietary supplements are considered a subcategory of food, so they are not required to undergo FDA review and approval, according to the position paper. That “inadequate regulatory framework,” according to the paper, “has allowed adulterated and mislabeled products to repeatedly enter the market and poses a health threat to the public.”

As Healio previously reported, some companies have used these regulations as loopholes to offer products like colloidal silver, which is unsafe and can lead to serious health effects, such as argyria. Plus, with the rise of GLP-1s, some patients also sought out dupe products that celebrities claim produce similar results, unaware of the serious dangers taking unprescribed supplements can pose.

The ACP paper offers recommendations that would “bolster the FDA’s pre- and postmarket regulatory authority for dietary supplements, standardize dietary supplement terminology and data sharing, and implement changes within the health care system to improve care for patients using dietary supplements,” according to the authors.

Healio spoke with Katelan Cline, one of the authors of the paper and an analyst in health policy at ACP, to learn about the organization’s position paper, dubious dietary supplement regulations and more.

Healio: Why did ACP publish this position paper? Why is this important for primary care physicians to know about?

Cline: As dietary supplements have become increasingly widely used, ACP felt this was an important topic to address, both for advocacy and education. Additionally, with the proliferation of health information from a wide range of individuals and sources, particularly on social media platforms, ACP is concerned that non-evidence-based supplement advertisements and misinformation spread online pose a risk to patients. Patients may be taking dietary supplements without consulting a clinician and, therefore, may be unaware of potential interactions with prescription medications or impacts related to certain health conditions. ACP wanted to raise physician awareness of this issue as it may be impacting their patients.

Healio: What are the consequences of inadequate regulations for dietary supplements? Can this be a public health threat?

Cline: While manufacturers are legally required to substantiate labeling and marketing claims, they are not required to submit safety information prior to marketing a product. This reliance on postmarket surveillance has allowed products adulterated with restricted pharmaceutical ingredients and illicit substances to repeatedly enter the market, posing a health threat to patients. Further, the public perception that dietary supplements are more heavily regulated than they are in practice may lead many consumers to assume they are safe without considering potential risks, such as adulteration and interactions with prescription medications. Additionally, the volume of supplement-related misinformation on social media is concerning in the context of ACP’s attempts to combat health-related mis- and dis-information.

Healio: Why is the current regulatory framework inadequate, and what are ACP’s recommendations for what regulations should look like?

Cline: The FDA has authority to take action against supplements once they are already on the market, but they have no mechanism to detect adulterated or mislabeled supplements prior to their availability to consumers. The recall process can also be lengthy, allowing supplements that have already been identified as potentially harmful to remain on the market during the investigation and recall process. ACP recommends extending FDA authority through modifying the Dietary Supplement Health and Education Act (DSHEA) framework to require evidence-based review, premarket approval, and registration of supplements that would allow the FDA to monitor available supplements, identify nonregistered products, and take swift action against noncompliant manufacturers. Registration would also allow distributors and retailers to verify products before selling them to the public. Further, ensuring the Federal Trade Commission is well resourced to act against advertising violations is essential to help prevent the spread of claims not backed by evidence.

Healio: How can PCPs get involved in advocacy to make their voices heard on this issue?

Cline: Physicians are well positioned to help raise awareness about the potential risks of dietary supplements with their patients. Public education and awareness of how dietary supplements are currently regulated is one of the most important steps to take at present because of the widespread misconception that supplements are more strongly regulated than they are in practice. Further, sharing stories about adverse events can help raise awareness of the inadequacy of the current regulatory framework and enforcement of DSHEA.

Healio: How should PCPs be talking to their patients about dietary supplements? Do you have any advice for navigating those conversations?

Cline: Research has shown that patients prefer their physician to initiate conversations on dietary supplement use. Physicians can play an important role in helping patients understand the benefits and potential risks of dietary supplement consumption, particularly when patients may be taking prescription medications. Research shows that supplements for weight loss, muscle building and sexual enhancement carry a higher risk for adulteration and severe adverse events, so this may be a targeted area of discussion to focus on with patients. As the current regulatory framework relies on postmarket surveillance, ACP also encourages physicians to familiarize themselves with the FDA’s Safety Reporting Portal so that adverse events suspected to be related to dietary supplements can be swiftly reported. ACP also recommends that practices implement procedures to collect information on patient dietary supplement usage for inclusion in patient electronic health records.

Healio: What is the take-home message here? If nothing else, what would you want readers to get out of this Q&A?

Cline: Ultimately, dietary supplements can aid in the consumption of essential vitamins and minerals, especially for certain populations such as older adults and pregnant persons. But physicians and patients should be aware that dietary supplements do not go through premarket approval, which presents some risks that are more acute for certain categories of supplements. Further, awareness and utilization of evidence-based sources for supplement information is essential. Both physicians and patients should be prepared to discuss supplement use in regular visits, and use should be documented in patient records.

For more information:

Katelan Cline can be reached at kcline@acponline.org.