ACP urges stronger US supplement regulation to protect public health
Key takeaways
- The ACP is calling on US policymakers to modernize dietary supplement regulation, such as adding FDA premarket registration and approval.
- In a position paper, the organization says the DSHEA regulatory framework is outdated and inadequate to prevent adulterated and mislabeled products from entering the market.
- ACP also wants stronger FTC oversight of social media influencer claims and calls for a public, searchable supplement database.
The American College of Physicians (ACP) has recommended policy adoptions to modernize the regulation of dietary supplements in the US, saying that these products must be “more regulated to protect public health.” The organization’s position paper urges policymakers to strengthen the manufacturing and marketing of dietary supplements.
US supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), defining these as products for ingestion that contain a dietary ingredient intended to supplement the diet, such as vitamins, minerals, amino acids, and botanicals.
ACP underscores that since the enactment of DSHEA, the quantity of supplements on the US market has increased exponentially. Online commerce and complex global supply chains have also contributed to a very different commercial environment than 30 years ago.
Moreover, it says that the “skewed public perception” of product safety and efficacy, combined with low rates of supplement use reported to health care professionals, puts consumers at risk for adverse outcomes.
“ACP strongly recommends the adoption of policies to bolster the regulation of dietary supplements, including amending the current framework to require dietary supplement products to be registered with the FDA,” states the organization’s position paper in Annals of Internal Medicine.
“A robust approach to premarket registration and postmarket surveillance of dietary supplements is needed to prevent the marketing of harmful products and protect the health of the public.”
ACP notes that over half of US adults take supplements, but that only a quarter consume products recommended by a health care professional. Recent research revealed that US dietary supplement use rose from 51% in 1999 to 60% in 2023.
ACP urges a modernization of DSHEA to require that supplements undergo an evidence-based review, registration, and premarket approval.The organization calls on dietary supplement manufacturers to ensure their products are safe and effective with a secure supply chain, robust clinical research, accurately labeled products, and adherence to current Good Manufacturing Practices.
Modernizing DSHEA
As a subcategory of food, US dietary supplements are not required to undergo review and approval by the FDA. ACP says this “inadequate regulatory framework” has allowed adulterated and mislabeled products to enter the market.
Its position paper notes that some products, mainly vitamins and minerals, are tested for safety and efficacy and may aid in ensuring the consumption of essential nutrients. However, it says that “many others” are not backed by strong scientific evidence.
The organization calls on Congress to modernize DSHEA to require supplements to undergo an evidence-based review, registration, and premarket approval with the FDA, and to require them to meet quality standards as established by the US Pharmacopeia.
Moreover, ACP says the FDA should receive adequate funding and resources for the oversight and regulation of supplement manufacturing, quality, safety, and labeling. It also recommends bolstering the FDA’s postmarket surveillance authority for dietary supplements.
“Amending DSHEA to give the FDA the authority to bypass voluntary recall when notified of adverse events or mislabeled products would allow the FDA to more quickly remove adulterated or mislabeled supplements from the market and shift the burden of proof to manufacturers to demonstrate that their product is safe and accurately labeled before returning to market,” states the paper.
Product marketing and safety
The Federal Trade Commission (FTC) has the authority to regulate the advertising of dietary supplements. ACP supports efforts to ensure the FTC has the necessary resources to adequately monitor the product marketing and advertising, specifically on social media.
ACP recommends that the FDA create a national, public, searchable database of supplements with information on products, ingredients, and research.According to the ACP, social media influencer marketing has contributed to the uptake in supplement use and proliferation of health claims not backed by scientific evidence.
A national survey earlier this year revealed that nearly half of US consumers act on guidance from social media influencers or AI tools, often without fact-checking or professional input.
To support consumer access to data on supplements, ACP urges the FDA to create a national, public, searchable database of supplements with information on products, ingredients, and scientific research on health impacts and drug interactions.
Earlier this year, representatives of the US supplement industry debated the creation of such a database and registration after senators reintroduced the Dietary Supplement Listing Act.
ACP also encourages a standardization of language and data sharing to ensure the consistency and safety of products manufactured in a global supply chain. Additionally, it calls on Congress to continue funding the National Institutes of Health Office of Dietary Supplements to ensure the study of the safety of supplements on the market and promote public awareness.
The organization urges electronic health record vendors to integrate supplement knowledge databases into their platforms to alert health care professionals about interactions with medications and facilitate monitoring of patients’ supplement use. It also supports the education of health care professionals on the safe use of dietary supplements.
