Introduction to Dietary Supplement Warning Labels
The Food and Drug Administration is considering a rule change that would cut back on how often dietary supplement warnings must appear on packaging, a move experts say could make them easier to miss.
Unlike prescription drugs, the FDA doesn’t review dietary supplements for safety and effectiveness before they hit the market.
Current Regulations
A 1994 federal law requires supplement companies to include a disclaimer when they make health claims like “supports immune health” or “promotes heart health” or better memory. According to the law, next to promises about benefits, the packaging must display in boldface type: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Proposed Rule Change
In a letter to supplement makers dated Thursday, Kyle Diamantas, the head of the FDA’s food division, said the possible proposal would still require companies to include the disclaimer on their products at least once, but it would no longer require it to be repeated every time a health claim appears.
Diamantas said that the agency has rarely enforced the existing rule and that the change would cut down on label clutter and costs.
Impact of the Rule Change
He didn’t say when the rule change could take effect, but said the FDA wouldn’t enforce the existing requirement while it reviews the policy.
“If FDA does not identify significant concerns as we continue our review of the available data and information regarding this request, we are likely to propose a rule to amend this requirement,” Diamantas wrote in the letter.
More than three-quarters of Americans take at least one supplement, botanical, mineral or vitamin, according to the FDA. As many as 100,000 supplement products are sold in stores or online in the U.S.
Expert Opinions
Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said the FDA’s move could be the first step toward making already weak supplement warnings even weaker.
“Then you start saying things like, ‘We only need it on the actual bottle,’” Cohen said. “Then you say, ‘It only needs to be on the back.’ Then you let the print get smaller.”
In a statement, Andrew Nixon, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said the change wouldn’t make it harder for consumers to notice the warning, adding that “a growing number of Americans are paying closer to attention to product labels.”
Controversy and Criticism
Dietary supplements are popular among figures tied to the Make America Healthy Again movement. Dr. Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, was criticized during his confirmation hearing in March for previously promoting supplements he described as a “magic weight loss cure” or a “miracle in a bottle.”
Health Secretary Robert F. Kennedy Jr., who has stated he takes a wide range of supplements himself, said the Trump administration would move to free Americans from what he called the FDA’s “aggressive suppression” of vitamins and dietary supplements.
Scott Gottlieb, a former FDA commissioner, said he wasn’t sure what it meant for consumers but a rule change means supplement makers wouldn’t have to make the disclaimers as prominent, possibly making them easier to miss.
Safety Concerns
Cohen countered that because dietary supplements aren’t reviewed before they’re sold, the products can contain different amounts of ingredients than what’s listed on the label — or ingredients not listed at all.
A 2023 paper by Cohen published in the Journal of the American Medical Association found that nearly 9 out of 10 melatonin gummy brands were inaccurately labeled.
“This further undermines the ability of consumers to understand the true health effects,” Cohen said.
Industry Response
Steve Mister, the president and CEO of the Council for Responsible Nutrition, a trade group for the supplement industry, said in a statement the group “welcomed” the FDA’s clarification on warning labels.
The group previously told the FDA that a single disclaimer on a supplement’s label — linked to health claims with an asterisk or similar symbol — is enough to inform people and meet the federal law’s intent.
Conclusion
The proposed rule change by the FDA has sparked controversy and debate among experts and industry leaders. While some argue that the change would simplify labels and reduce costs, others believe it could make it easier for consumers to miss important warnings and potentially harm their health. As the FDA continues to review the policy, it is essential for consumers to remain vigilant and informed about the supplements they take.
FAQs
Q: What is the current regulation for dietary supplement warning labels?
A: The current regulation requires supplement companies to include a disclaimer on their products when they make health claims, which must be displayed in boldface type.
Q: What is the proposed rule change?
A: The proposed rule change would allow companies to include the disclaimer only once on the product label, rather than repeating it every time a health claim is made.
Q: What are the potential consequences of the rule change?
A: The rule change could make it easier for consumers to miss important warnings, potentially harming their health.
Q: What do experts say about the rule change?
A: Experts are divided, with some arguing that the change would simplify labels and reduce costs, while others believe it could harm consumer health.
Q: How many Americans take dietary supplements?
A: More than three-quarters of Americans take at least one supplement, botanical, mineral, or vitamin.
