DSHEA label change welcomed by industry
A proposed rule change regarding the placement of DSHEA disclaimers on dietary supplement labels has been seen as a welcome clarification by industry sources. FDA has rarely if ever enforced the existing rule, but the issue has given rise to class action lawsuits.
The Dietary Supplement Health and Education Act (DSHEA) specifically requires that the standard disclaimer relating to claims be printed on every panel of a product label on which a health claim appears.
The standard verbiage is: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Over the years the practice in the industry has become to refer to a lone disclaimer, often but not always located on the back panel of the product label, via asterisks appended to each appearance of a claim. While that does not fulfill the letter of the law, in a statement announcing the proposed rulemaking procedure, FDA said it “recognizes that we have rarely, if ever, enforced this requirement.”
FDA’s proposed rule change would allow the currently accepted industry practice to be formally codified in the law. At least one appearance of the disclaimer would still be required, however.
That de facto enforcement discretion on FDA’s part hasn’t stopped the plaintiff’s bar from seeking to capitalize on this perceived lapse on the part of dietary supplement companies. As the Council for Responsible Nutrition (CRN) noted in a recent press statement, “[A] recent uptick in class-action lawsuits has relied on an alternative interpretation, arguing that the full disclaimer must be placed on every panel where a structure/function claim is used on a product label. These legal challenges have created confusion, prompted unnecessary litigation, and imposed costly and disproportionate burdens on responsible manufacturers — without improving consumer understanding.”
Ivan Wasserman, partner in the law firm Amin Talati Guarani, was effusive in his praise of the move.
“This development is certainly welcome news to all of us in the industry. It is public acknowledgement of the enforcement discretion that we all know FDA has been unofficially exercising for decades, and we hope FDA will ultimately revise the regulation. It provides peace of mind to everyone trying to label supplements correctly, and will hopefully help put an end to at least this one labor of whack-a-mole class actions. Our firm was thrilled to be part of the catalyst for this by assisting CRN in drafting its submission to FDA advocating for this change,” he told SupplySide Supplement Journal.
Wasserman noted that the change was announced via a “letter to industry” rather than a guidance document. He speculated that this is in response to the first Trump administration’s executive order against using guidance documents rather than rulemaking procedures as standard regulatory tools.
The practice has grown in recent years because of the many months to years required to conclude a formal rulemaking procedure. The argument in favor of rulemaking is that the rule can be challenged in court, giving some potential redress if stakeholders believe the process has gone awry.
The Natural Products Association (NPA) and the American Herbal Products Association (AHPA) had collaborated on a similar submission to FDA, and NPA’s president and chief executive officer Daniel Fabricant, Ph.D., said the change will ease burdens for industry.
“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,” he said.
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