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Legal Panel (from left to right): Steve Shapiro, Megan Olsen, Eric Unis, Rend Al-Mondhiry, Robert Durkin and Rick Collins.
From CBD to kratom to notification letters and more, a panel of legal experts held a discussion on what they deemed as the most pressing topics in today’s complex regulatory environment in the natural products industry.
The seminar, titled “A Comprehensive Look into Health and Nutrition Legal and Regulatory Landscape” was held on Oct. 24 during SupplySide West at the Mandalay Bay Convention Center in Las Vegas, NV.
The featured speakers were a panel of lawyers and legal experts:
Steve Shapiro (Of Counsel, Rivkin Radler LLP)
Megan Olsen (Senior Vice President and General Counsel, Council for Responsible Nutrition)
Eric Unis (Senior Attorney, National Advertising Division, BBB National Programs, Inc.)
Rend Al-Mondhiry (Partner, Amin Talati Wasserman LLP)
Robert Durkin (Partner and Co-Chair, Arnall Golden Gregory LLP)
Rick Collins (Founding Partner, Collins Gann McCloskey & Barry PLLC)
The three-hour seminar focused on a variety of issues overseen by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), including CBD and hemp regulations, kratom, intellectual property, counterfeiting and other hot-button topics in the dietary supplement and natural product industry.
The panel addressed the recent congressional hearing regarding the newly appointed James “Jim” Jones, who oversees the food division of FDA. Al-Mondhiry said she was “struck by his seeming unfamiliarity” regarding dietary supplement regulations, questioning whether an expert in pesticides and environmental science was the best commissioner.
They panel emphasized the proposed reorganization of FDA, which would require the Office of Dietary Supplements Programs (ODSP) to report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI).
The panel also discussed how supplements need to be treated differently than prescription drugs. Collins said relying on a traditional “pharmaceutical model” is harmful to the industry. Shapiro noted an evolution in what supplement manufacturers can say on product labels.
“It was amazing, during the 1990s, you couldn’t talk about [the] immune system because the FDA said anything talking about the immune system implied AIDS,” Shapiro said.
Shapiro also referenced the 1992 Oakmont black currant oil case where FDA testified that black currant oil constituted a “chemical” food additive. Everyone on the panel agreed dietary supplements are not considered “chemicals.”
“If we follow the FDA position to its logical conclusion, taking a food and adding water makes [the water] a food additive… and that’s Alice in Wonderland,” Shapiro noted.
Unis added that BBB National Programs, an independent agency formerly part of the Council of Better Business Bureau, provides guidance to manufacturers and distributors on how to communicate and substantiate their claims.
“We will also harmonize or seek to harmonize our guidance with [federal] guidelines,” Unis said. “We don’t want to force federal regulations.”
Is it Legal?
The panel also discussed the legalities of kratom and CBD products.
Kratom is used in dietary supplements but is a controversial ingredient due to concerns of its legality, safety and abuse. According to Durkin, federal regulations require FDA to “make a determination” for every product before deciding if it’s truly adulterated.
“One of the things that you’ll notice is that FDA has a webpage on kratom, and they say kratom is not allowed in dietary supplements,” Durkin said. “Any product that contains kratom was adulterated, they’re really, I don’t think, allowed to do that.”
The panel agreed that FDA doesn’t regulate CBD products as well as it should.
“In August 2022, [FDA] sampled 400 CBD products and said they’re filthy and they don’t know what’s in the bottles or what’s on the label … and they did nothing, yet they had ‘serious safety concerns’ for years,” Durkin noted.
The panelists also discussed the recent civil penalty notices from the FTC. In April, the agency sent “notices of penalty offenses” to almost 700 marketing companies, challenging the bases that the companies use for making “product claims,” particularly “health claims.”
“Long story short, they didn’t choose [just] anybody for those letters of wrongdoing … they have some big hitters on that list,” Collins said. “I don’t know the criteria they used, but it seems like it’s based on sales revenues and they’re going after the bid dogs that have money.”
Olsen added that according to the notices, no one did anything wrong. She said the FTC can be looked at from “two lenses.” It wants to protect consumers while also setting precedents and procedural processes.
“I think a lot of what they’re doing is trying to find ways to give the agency [the ability] to resolve these issues whether or not they can actually enforce it,” Olsen said.
Al-Mondhiry said it will be interesting to see whether any of the affected companies receive subsequent assessments since the notices don’t specify exactly what laws are being violated.
“I just can’t see how any of these will go to court,” Al-Mondhiry said. “I think you need to know what you did wrong.”
