Virtual—ACI-CRN’s 9th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements was a three-day information extravaganza. It opened with comments from event Co-Chairs Scott Bass, Partner & Head, Global Life Sciences, Sidley Austin LLP, and Steve Mister, President & CEO of Council for Responsible Nutrition (CRN), focused largely on DSHEA 2.0; as Mister commented, “Scott is one of the only people who can actually say he was there when DSHEA was hashed out, so I can always turn to him for clarification on the law’s intentions.” Bass and Mister had three major ideas for 2.0:
1. Mandatory Listing. Bass expressed his support for this idea, with the understanding that it isn’t the same thing as premarket approval. “FDA can’t possibly oversee this market with no idea what’s on it,” Bass said. “I’m happy to see that FDA and industry have seen that. The key is that there should be no prior approval from FDA—but the rest of it is an obligation for the industry to step up.”
Mister’s take: Mandatory listing is a birth certificate, not a driver’s license. “No one can deny it to you,” he said. “There are no conditions for it. It is something you do on the way to market, not something that can delay you.”
Bass’s final word: “This is the basis upon which almost all new, effective provisions rest.”
2. NDIN Requirements. “People have forgotten what Section 413 was about,” Bass said. Section 413 states that all new ingredients must have a new dietary ingredient notification submitted to the FDA—and Bass specified that that includes second- and third-comers to an ingredient. Just because a company has already put CoQ10 in a product, for instance, doesn’t mean that a different company can put CoQ10 in its product without submitting an NDIN. “Different manufacturers have varying quality standards,” Bass noted. “This isn’t prior approval, but FDA has to see the safety evidence before a product goes to market. Industry has to come up to the mark and file so that FDA can protect the public. The exemptions are people doing legitimate self-GRAS reviews on ingredients found in food, not new ingredients. Gaming the system has to stop. The ‘self-GRAS exemption’ has to go.”
Half the problem here, Bass said, is that FDA isn’t enforcing Section 413 as it was meant to: The agency says that it doesn’t have the funds. Congress needs to be made aware of this, Bass asserted, so that it can allocate funds for this. The other half of the problem is that industry itself isn’t adhering to these standards, in large part because if one company does the work and research and submits an NDIN, FDA won’t necessarily protect that work or that intellectual property, and other companies can ride the coattails of responsible industry members; to fix this, Bass feels that FDA needs to protect and incentivize that work.
3. Regulatory Clarity. Mister raised a number of issues that needed clarification. For instance:
- Will drug preclusion find and remove ingredients from the market? This particular question came about thanks in large part to confusion over N-acetyl-L-cysteine, which FDA has retroactively stated falls under the drug preclusion clause of the FD&C Act.
- What purpose is raised by the proprietary blend exemption? Generally speaking, Mister explained, supplements facts labels are required to list ingredients and amounts—but that doesn’t hold for proprietary blends. In order to protect that intellectual property, brands are not required to list amounts of ingredients in a proprietary blend. “But what purpose does this serve,” Mister asked attendees, “when companies can buy another brand’s product and reverse engineer it to get the amounts? And in the meantime, you could say you have a popular ingredient in your blend, but just sprinkle it in, and consumers would never know. Alternatively, one ingredient could overpower the rest: a 500mg proprietary blend could contain 499mg of caffeine, and consumers would have no way of knowing how much they’d taken. And if a brand claims that their proprietary blend is based off a clinical trial, consumers can’t check that the amounts included match the amounts tested. It only makes industry more opaque.”
- How to handle overages? By law, Mister explained, a supplement facts label must display the quantity of each ingredient, and what’s in the bottle must match 100% of the labeled amount through shelf life. However, with ingredient deterioration, brands have taken to using overages to comply, but this creates litigation opportunities for plaintiffs who claim they were harmed by the amount, or that the company didn’t disclose. “The solution here is to hold supplements to a similar standard as drugs,” Mister suggested, “and absolve overages that stay below upper safe levels.”
Mister’s final word: “DSHEA demands transparency. We must adhere to the idea that transparency does not mean premarket review. We must maintain the balance between safety and access. And there must be accountability.”
Keep an eye out for more event coverage, including thoughts on CBD, a retailer’s point of view on harmonized safety and quality standards, and free speech versus consumer safety.