In an open letter to dietary supplement manufacturers, distributors, and retailers, the Food and Drug Administration (FDA) announced its intent to loosen the disclaimer requirements for dietary supplements.

The Dietary Supplement Health and Education Act (DSHEA) currently requires that, if a product package features structure-function claims, a label must prominently feature the statement: “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.”

While the present regulation requires this disclaimer to appear on every panel of a product, FDA intends to amend the rule, so that it only has to appear once, to reduce label clutter and unnecessary costs. “FDA recognizes that we have rarely, if ever, enforced this requirement,” the agency said, and it will exercise enforcement discretion at this time until the rule is amended.

Advocates from the dietary supplements industry have been pushing for reform for several years, calling the requirement for a disclaimer to appear on every single panel of a product excessive.  Further, FDA has allowed manufacturers over the past several decades to simply use asterisks directing consumers to a full disclaimer elsewhere, without any enforcement. However, there has been an uptick in class action lawsuits targeting companies for not following the regulation.

“This news is a major win for the dietary supplement industry,” said Graham Rigby, president and CEO of the American Herbal Products Association. “AHPA has long led the charge for this sensible regulatory reform, and we thank FDA for taking action on an unenforced provision that has fueled opportunistic litigation. This is a strong, positive signal of the agency’s commitment to modernizing regulations, and AHPA looks forward to continued engagement in shaping a rational and modern regulatory environment for this vital category of products.”

“We welcome FDA’s attention to this matter and appreciate the opportunity to support the agency in recognizing the practical, commonsense approach that consumers and companies have relied on for nearly three decades. Consistency in labeling standards strengthens consumer confidence and supports a stable regulatory environment,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“This clarification is in alignment with the statute and eliminates ambiguity that has fueled opportunistic litigation,” said Megan Olsen, senior vice president and general counsel at CRN. “Clear guidance helps ensure that companies can meet their obligations without unnecessary litigation risk, while still providing consumers with accurate, meaningful information.”

Over the past several months, the Natural Products Association (NPA) had requested these changes, and submitted a regulatory filing and letters to FDA, icnluding a co-authored letter with AHPA, and met in-person with the agency, noted Daniel Fabricant, president and CEO of NPA. “NPA appreciates that FDA carefully considered the concerns of industry over the requirement for the DSHEA disclaimer to appear on each panel of a dietary supplement product label where an applicable claim is made. Our association will continue to advocate for dietary supplement rules that ease undue burdens on our members, reduce frivolous litigation, and protect the integrity of DSHEA.”