New York, NY—Day one of the 7th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements by the American Conference Institute (ACI) together with the Council for Responsible Nutrition (CRN) covered a lot of ground. The keynote was given by Cara Welch, Ph.D., Acting Special Assistant to the Deputy Commissioner for Policy, Legislation, and International Affairs, Office of the Commissioner U.S. Food and Drug Administration. Welch stressed that FDA has no intention to “wipe out the last 25 years and start over” with the Dietary Supplement Health and Education Act of 1994 (DSHEA). The goal, she said, is to improve, strengthen and modernize. “Modernization can be hard for federal agencies. But the importance of modernization can not be overstated.”
FDA’s Public Meeting to Discuss Responsible Innovation in Dietary Supplements, held on May 16, 2019, started the discussion on how to modernize, Welch said, but now comments from Industry are needed. “This was an interesting public meeting because it was the beginning of a conversation,” Welch noted. “The information we hope to receive in the comments will help us determine how we want to move forward on modernization.” She encouraged those in the Industry to provide insight as to the priorities of industry, which, she said, will be helpful as FDA moves forward. Find more information on submitting comments here. The deadline is July 15, 2019.
In a talk titled “The Dietary Supplement Industry’s State of the Union: How Regulations and Regulators are Addressing the Industry 25 Years After DSHEA,” Steve Mister, President & CEO of CRN, said, “In this year when there are so many other things that we have to deal with, everyone wants to talk about CBD. It is the issue that is dominating the conversion.” And 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? 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.”
In a session titled “Debating the Risks and Benefits of a Mandatory Product Registry,” Scott Bass, Partner & Head, Global Life Sciences, Sidley Austin LLP, and Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP, discussed the FDA’s position on a mandatory product registry. Bass noted that when talking about DHSEA 2.0, the discussion must consider mandatory dietary supplement product listing. Since DSHEA was implemented, he said, the dietary supplement industry has gone from $4 billion to $40 billion, and needs to adjust accordingly. “We want that law to work,” Bass said, “We want to assure the public that someone is looking at the products.” He pointed out that a registry would force companies to do the safety work that they are supposed to do—and right now, he noted, some companies aren’t doing everything they should be doing. “If a company is willing to put a product on the internet or in a store, why would they not tell the government they are selling it? This is a $40 billion healthcare industry. Act like one.”
That said, Woodlee pointed out, “Marketers of drug-spiked products don’t comply with FDA requirements. If we think the bad actors are going to rush to comply, we’re being a little optimistic.” He added that we’ve seen voluntary systems work quite well, like CRN’s Supplement OWL. “Oftentimes,” Woodlee maintained, “those systems are preferable.”
Bass however, stressed that there is a need for even greater accountability. “For 23 years I’ve thought we shouldn’t touch DSHEA—it’s fine. I no longer hold that view.” This system of accountability, he said, will be “relatively risk free and relatively burden free.” Bass stressed the point again in his opening remarks on Day 2, calling mandatory listing “the critical foundation block” for the success and safety of the industry going forward.
WholeFoods will continue to report on the issues being addressed at the Forum as we move on to Day 2.