Virtual—ACI/CRN’s 9th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements took place earlier this June. It featured sessions on politics under the Biden Administration, navigating the line between structure/function claims and health claims, California-specific reforms and litigation, and more, all of which is available for purchase and on-demand viewing here. A few sessions are highlighted below:
Retailer Compliance Standards
The event featured a panel titled In Search of a Uniform Standard: Understanding the Legal and Regulatory Implications of Inconsistent Retailer Third Party Testing Programs and Quality Standards. Panelists Carlos Lopez, VP, General Counsel, The Vitamin Shoppe; Josue Molina, VP of Quality & Regulatory Affairs, Ancient Nutrition; and Claudia Lewis, Partner, Venable LLP, discussed the driving forces behind retailer compliance standards, and whether or not they should be universal.
A major driving force behind the creation of these quality standards, according to Lopez: “Consumers can read an op-ed in the New York Times saying that the industry isn’t regulated, so they don’t feel safe. And retailers can’t really write an op-ed ourselves, explaining why that’s not true, but we can appeal to customer emotions—we can say, hey, we vetted these products, we have proof that what’s on the label is in the bottle.” He noted that while he can believe a longstanding brand regarding the safety of its products, the same doesn’t go for a new business—“I’m not sure I can just do a traditional purchase agreement.”
So: Retailer standards are necessary, not just for safety purposes, but to safeguard the business. And Lopez argues that that can and should be taken to the logical next step, in which the standards are held up as a point of differentiation in the market. “At the end of the day, I don’t think it’s desirable for this entire thing to be standardized,” he said. “At the end of the day it’s competitive. And brands do that—they compete about quality, about sourcing, and so on, and retailers can do the same, but for us it’s about curation rather than production. Whole Foods Market does that—they have certain ingredients that are just not allowed, and then they have tiers for good/better/best, and that drives customers to them. It’s one thing to say, this product is FDA compliant, and another to say, if you shop here, you get the best products.”
On the manufacturer side, Lewis noted that this isn’t a bad idea, if only because of the difficulty of creating a single standard: “Not all ingredients can be tested the same way,” she pointed out, “so it would be difficult to have a universal standard.”
That said, Molina notes that the variation in standards makes things difficult for brands. “Amazon wants documentation; CVS wants testing. We’re trying to achieve the same goal, but from multiple different points; it’s difficult for us.”
Molina’s suggestion: Retailers need to work with brands in order to establish their requirements. “We’re the ones who need to fulfill those requirements, and we’re the ones who are experts in it,” he pointed out. “Even with the FDA, FDA has to talk to the industry, talk to the people who are affected. Retailers should also collaborate.”
Lopez agreed, and added: “We definitely need a more hands-on approach, someone who will help brands through this and help you figure out what you need, so you aren’t sending in what you think are the right documents, only to get rejected, and then to have no recourse for fixing that rejection.”
Moving Forward with CBD
The panel The Path Forward for CBD: Exploring the Journey to Legalize Hemp-Derived CBD featured Shawn Hauser, Partner, Vicente Sederberg LLP, and Douglas MacKay, N.D., SVP Scientific & Regulatory Affairs, CV Sciences. The two discussed FDA’s technical comments submitted to Congress in October 2020, in which they mentioned only natural CBD—no synthetics, and excluded all other cannabinoids—suggested setting a per-serving limit, and suggesting requiring New Dietary Ingredient Notifications (NDIN) for all CBD products.
As noted in a previous session, the original intention behind DSHEA was always to have all products submit an NDIN. However, MacKay pointed out that NDIN draft guidance is still not final—and hasn’t been for years, now—meaning that every NDIN submitted is a headache for industry members.
Moreover, MacKay said, those October 2020 comments went beyond hemp and CBD. FDA requested new enforcement tools to help it control the market, including changes in import and seizure provisions and a mandatory product listing. And regardless of whether or not anyone agrees, he said, “many in the industry feel that CBD is being held hostage.”
In the meantime, state laws are shaping the market. “In Indiana, products are required to have a QR code linking to third party test results—no other herb is required to do that,” MacKay told attendees. “In Utah, the gummies have to be square. In Louisiana, companies can’t use the term ‘dietary’ in the product’s statement of identity.” These laws, stricter than anything other products face, are becoming country-wide regulation, because companies aren’t going to create different products for different states.
And as things stand, FDA’s current path is slow: The agency has described a framework for the development of research projects that lay the methodological groundwork for real-world data science on the safety of CBD products… which, MacKay pointed out, suggests an extremely slow process, rather than the creation of a regulatory pathway. And that in turn suggests that state law will remain the law of the land.
The Legality of Sustainability
Raqiyyah Pippins, Partner, Arnold & Porter Kaye Scholer LLP, and Jeff Brams, General Counsel & VP, R&D and Regulatory, Garden of Life, LLC, spoke during a presentation titled Sustainability and Ethical Business Practices: Lessons for Industry to Ensure the Integrity of the Supply Chain and Winning Consumer Confidence through Transparency in which they walked through a detailed scenario in which a company is trying to make claims regarding sustainability. Pippins pointed to the holy grail of sustainability claims—the FTC Green Guides, which provides guidance for environmental marketing claims with regards to general principles, specific claims, information on consumer interpretation, and how marketers can qualify claims to avoid deception. While the guides don’t have the force of law, some states—such as California—have incorporated the guides into their laws.
Pippins noted that broad claims are not, in fact, better—“Overly broad claims are seen as unsubstantiated, because consumers can’t tell what they mean. We can say it’s ‘sustainably made,’ but we have to be able to say how, or else it’s deceptive marketing.” She also pointed to claims that are both true and specific, but still deceptive: For instance, a product that now has 3% recycled content rather than 2% can technically make the claim “product contains 50% more recycled content than before,” but that can mislead consumers into thinking that the product is made with a larger amount of recycled content than it is, and can therefore be ruled deceptive.
And another thing, perhaps more frustrating for companies: “Laws are being passed requiring companies to make green changes,” Pippins said, “but those can’t be counted towards any claims about sustainability.”
A tip: “On a product label is the highest-risk place to put a claim,” Pippins told attendees. “That’s permanent and seen by everyone, unlike a one-off social media post.”
Pippins’ suggestion: Get a lawyer, right from the start, to review claims before they go anywhere at all.
The full conference can be purchased for on-demand viewing here.