October marked the 25th anniversary of the Dietary Supplement Health and Education Act (DSHEA)—on October 23, the Council for Responsible Nutrition (CRN), American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA) and United Natural Products Alliance (UNPA), along with the Congressional Dietary Supplement Caucus, were set to celebrate the milestone in a special luncheon briefing.
Since the passage of DSHEA, the dietary supplement industry has changed—a lot. In 1994, roughly 40% of Americans used supplements, according to the CDC, and the industry brought in around $4 billion. Today it is a $46 billion industry with products used by more than 77% of Americans. In 2019, the industry got a boost from the popularity of hemp, and in particular cannabidiol (CBD). And as the year went on, it became clear that any discussion of the future of DSHEA would involve CBD.
At the 7th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements by the American Conference Institute (ACI) in June, Steve Mister, President & CEO of CRN, noted that CBD’s impact on the future of the industry can’t be overstated. “This is the ingredient that either proves that DSHEA works,” Mister said, “or it could be the downfall of DSHEA.”
In considering whether DSHEA has met its match with CBD, Mister posed several key questions, including: Will FDA use its discretionary authority in section 321? What is an “article” for clinical investigation—full spectrum hemp, CBD isolate? Will CBD expose weaknesses in the self GRAS affirmation? And notably, he asked: What if Congress loses its patience and gets involved? Will that set precedent for other ingredients to be legislated ingredient by ingredient? “All of these questions,” Mister said, “have the potential to undo the last 25 years. We have one ingredient that could really shake down the law.”
At press time, CRN, AHPA, CHPA and UNPA got together and asked Congress to get involved. The associations sent a joint letter to Congress, asking them to take legislative action to clarify the legal status of hemp-derived CBD dietary supplements. The letter states that action is urgent, citing the strong consumer interest in CBD, growth in product and sales, and need for clarity among consumers, retailers, and manufacturers regarding the legal status of these products—additional details and a link to the letter can be found here.
Talking to WholeFoods’ Julia Peterman about the letter, Mister said going to Congress is “part of a multi-pronged approach” aimed at creating a legal pathway to market for CBD. “We are continuing the dialogue with FDA—we’ve sent them written comments, we’ve appeared in public meetings, we’ve had private meetings—but we’re concerned. The Farm Bill passed in December. Ten months have gone by and we are no closer to getting a legal pathway to market.”
The letter brought up the comment made by Scott Gottlieb, M.D., then-Commissioner of FDA, in which he suggested that even an expedited rulemaking process would take three to five years. “That’s simply unacceptable,” Mister said. “There is a several hundred million dollar marketplace for ingestible products that contain CBD, but the agency gets up to the podium and says it’s illegal, but isn’t doing much to enforce that? If we have to go to Congress, well, maybe they’ll put pressure on the agency, or simply legislate it.”
Given all that has—and hasn’t—happened since June, does Mister now think CBD will be the proof of DSHEA’s worth, or could it spell doom for DSHEA? “I sure hope it’ll be the former,” he said. “I’m still very optimistic that it’ll demonstrate that DSHEA does work.”
As we send our November issue to press, industry groups were heading to the Hill to get a sense of Congress’ response to the letter. We’ll keep you posted.