The letter, signed by Kyle Diamantas, JD, added that FDA intends to exercise enforcement discretion on this topic while potential regulatory changes advance.
According to the Dietary Supplement Health and Education Act (DSHEA), all dietary supplements making structure/function claims must include a disclaimer stating: “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 DSHEA did not specify where that disclaimer must appear as long as it is “prominently displayed,” subsequent regulations (21 C.F.R. § 101.93(d)) implementing this requirement added a sentence requiring the separate posting of this disclaimer on every panel of a label where structure/function claims are displayed.
The push for deregulation
Efforts to amend labeling regulation and the positioning of the DSHEA disclaimer began in the summer. Dr. Daniel Fabricant, president and CEO of the Natural Products Association (NPA), and Graham Rigby, CEO of the American Herbal Products Association (AHPA), penned a joint letter to Dr. Cara Welch, director of the Office of Dietary Supplement Programs, on July 14 urging the agency to alter the regulations so that the disclaimer only needs to appear only once per label, versus being repeated on every panel or page where a structure/function claim appears, provided that a symbol (e.g., an asterisk) connects each claim to the disclaimer.
AHPA and NPA also requested that FDA clarify publicly that this revision satisfies the plain language and intent of the law, while reducing label clutter, unnecessary costs and litigation risk. In addition, the associations asked for interim enforcement discretion guidance on this issue by the agency.
An Aug. 18 letter from AHPA, the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) also included a call to amend 21 C.F.R. §101.93(d) to “reflect the reality of current industry practice.”
“This simple deregulatory fix will reduce attacks on law-abiding industry by the plaintiffs’ bar looking for quick settlements over an administrative violation,” the letter stated. “As long as the disclaimer is prominently displayed on the product label or labeling and linked to the statement by an asterisk or other connecting symbol, consumers are not misled. The requirement that the disclaimer be displayed on every panel of a label where these statements occur exceeds the demands of the statute.
“Rescinding the rule will demonstrate a more commonsense approach to dietary supplement product labeling while preserving the goals and intentions of DSHEA.”
Efforts continued into the Fall, with a Nov. 24 letter from Dr. Fabricant to Diamantas and Dr. Welch stating that “Enforcement discretion guidance or an FDA statement […] would provide important guidance to the federal district courts, amid litigation and demand letters over placement of the disclaimer. A public statement from FDA that it is reviewing potential changes to 21 CFR § 101.93(d) would signal to the judiciary that these cases are best left stayed, pending FDA determinations, based on the primary jurisdiction doctrine. In 2020, in lawsuits related to CBD, courts applied this same doctrine, ordering stays.”
‘A major win’
In the new letter to industry, Diamantas stated that removing the requirement for the DSHEA disclaimer to appear on each panel of a product label where there is a structure-function claim (403(r)(6)) would be consistent with the Food, Drug, and Cosmetic Act while reducing label clutter and unnecessary costs.
“Further, FDA recognizes that we have rarely, if ever, enforced this requirement,” Diamantas stated. “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.”
“Given that the rulemaking process can take some time, we intend to exercise enforcement discretion regarding the requirement for the DSHEA disclaimer to appear on each panel of a product label where a 403(r)(6) claim appears.”
NPA’s Fabricant told NutraIngredients that he appreciated the speed at which Diamantas and Dr. Welch have addressed this issue. He added that rulemaking can take a minimum of 180 days but added that his association would love to see this expedited.
AHPA’s Rigby called the news “a major win for the dietary supplement industry.”
“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,” he added.
“AHPA is pleased that its longstanding advocacy for enforcement discretion on this straightforward issue has borne fruit,” said Robert Marriott, AHPA’s VP of government & regulatory affairs. “AHPA has continuously and consistently advocated for both rulemaking and an interim enforcement discretion policy. Today’s letter almost fully comports with the elements AHPA has requested. We will continue our work to ensure this commonsense reform proceeds through the rulemaking process.”
Megan Olsen, senior vice president and general counsel at CRN, said the clarification is in alignment with the statute and eliminates ambiguity that has fueled opportunistic litigation.
“For years, FDA’s implementation has allowed companies to use an asterisk to direct consumers to the disclaimer, and that approach is fully consistent with DSHEA,” she said.
“Clear guidance helps ensure that companies can meet their obligations without unnecessary litigation risk, while still providing consumers with accurate, meaningful information. We appreciate FDA’s willingness to revisit this issue and apply a clear, legally sound interpretation moving forward.”
