Washington, D.C., and Virtual—The 2021 Dietary Supplements Regulatory Summit covered a range of topics from FTC priorities to manufacturer inspections. Three major takeaways:
1. The Case for Mandatory Listing
Cara Welch, Ph.D., Acting Director, Office of Dietary Supplement Programs (ODSP), FDA, made the opening remarks. Amidst a discussion on work-life balance, prioritizing, and myriad other topics, she also made the case for mandatory product listing. She pointed to both safety and FDA’s use of resources as major points in favor of this listing. “I think we can all imagine a scenario in which FDA isn’t aware of an unsafe product until we receive an adverse event report,” she said. “Luckily, this doesn’t happen often, but if we see these products as they’re listed, we can mobilize our resources. People can mis-list a product, but that would result in an automatic violation.
“It also gives us visibility,” Welch continued. “If there’s an ingredient that is barely in the market, it’s not a good use of our resources. FDA has visibility on the market, of course we do, we have as much as consumers have. But if we don’t know something exists, either we have to go searching for it, or it has to get brought to our attention through an adverse event report, which no one wants.”
Welch further noted that, if done right, this would be tied to importing requirements—an ingredient coming into the United States to be used in supplements would also have to have a listing, providing better transparency starting with the raw materials.
2. The Case for Retailer Quality Standards
A panel titled “Product Quality from FDA and Industry” featured speakers from FDA, Walmart, GNC, and Vitamin Shoppe, and included the inventors of the SSCI—the Supplement Safety Compliance Initiative, a retailer-led initiative to provide a harmonized benchmark standard to recognize supplement safety, authenticity, and compliance standards, globally, throughout the entire supply chain. Supplements must meet or exceed the SSCI benchmark to be accepted by major retailers, so as to boost customer confidence and provide quality products.
Guru Ramanathan, Ph.D., Chair of the Board of SSCI, opened by noting that inspections aren’t always reliable: “We were concerned, because an inspector could give a score, and then come back six months later and come up with a different score, when nothing had changed. Different certifying bodies were coming up with different scores. And we were concerned with education, about how educated inspectors were.”
Dadrion Gaston, Senior Director, Corporate Ethics & Compliance, Walmart and Co-chair of the Board of SSCI, noted a major point that SSCI is trying to address by benchmarking: “Quality standards are a ticket into the industry, not a competitive advantage.”
That said, Sudipta Veeramachaneni, Ph.D., VP of Global Research, Development & Innovation, GNC, and At Large Director for SSCI, noted that it is a competitive advantage—in terms of making it clear that a store is worthy to compete: “We saw it as a way to differentiate between the companies who cared and looked to follow through on quality, and the companies who didn’t.”
Dr. Ramanathan held up SSCI as yet another example of ways in which industry and FDA could work together. “Can existing industry standards would for FDA? Can the Council for Responsible Nutrition’s Supplement Owl work as the basis for a mandatory product listing? Can SSCI work as an FDA-approved measurement of quality, thus allowing FDA to focus more on high-risk inspections?”
And, finally, Dr. Ramanathan noted that the SSCI isn’t done yet, and that help is welcome. “The probiotics working group is done, the American Herbal Products Association is mostly done with the botanical section, but we still need help. We don’t want to leave the little guys behind, we are inclusive, so it’s not a surprise that we’ve had over 100 industry partners, including farmers, to help us figure out what good GMPs and good testing looks like. At the end of the day, this is very much still a retailer-led initiative, but it includes all members of the industry.”
3. The Case for NDINs
New Dietary Ingredient Notifications (NDINs) shouldn’t really need a case, according to Robert Durkin, R.Ph., J.D., Arnall Golden Gregory LLP. “NDINs are not optional,” he told attendees. “FDA’s review of NDINs are a premarket mechanism to ensure that the consumer is not exposed to unnecessary health risks in the form of unknown safety profiles.” And yet, he noted, industry isn’t necessarily stepping up—while the requirement has been in place for 25+ years, he pointed out that FDA has only received around 1,200 NDINs, and only a few unique NDINs. “And submission is trending downwards,” Durkin noted. Not, he added, entirely because of industry members—the requirements are unclear, and FDA isn’t enforcing the practice.
Greg Noonan, Ph.D., Division Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA, discussed ways that companies can make it through the NDIN process. “Pre-NDIN meetings can make a big difference,” he said. “We can address broad questions, and these meetings are valuable in identifying potential gaps. They’re also helpful in allowing a quick start when the notification arrives—even if it’s been a while, the product is already in our minds. But we won’t pre-review a notification.” Once a notification is submitted, Dr. Noonan noted, changes can still be made—safety evidence can be submitted, or changes can be made to intended use states. That can be done through the CFSAN Online Submission Module, which is also where, if necessary, FDA will request more information if necessary. “We try to get all identity and safety information in one request,” he added, “we don’t want to be sending out constant requests for you to fill.” And, of course, the notifier can request a meeting to discuss the information FDA is requesting. “We don’t use this as a way to reset the filing date,” Dr. Noonan said. “We’re not going, ‘well, we need more time,’ and then requesting more information to give ourselves more time—we do everything we can to get you a response letter on time. But if the amendment is substantive, we may reset the filing date.”
In terms of response letters, Dr. Noonan said, there are four types: Acknowledgment, Incomplete, Not a dietary ingredient, or Inadequate. An Acknowledgment letter is what brands are looking for—it means that FDA has no issues with the safety data. An Inadequate response letter is a rejection—the safety data isn’t strong enough, or it doesn’t fit the usage state. A ‘Not a dietary ingredient’ letter is just what it sounds like: FDA has determined that the ingredient submitted isn’t eligible for dietary supplement status regardless. An Incomplete letter, though, isn’t a final decision—it’s a statement that something is missing.
Dr. Noonan’s advice: “Tell your story. Tell the story of safety, of use, of why it fits into DSHEA. Feel free to insult our intelligence a little big—make connections again and again to make sure we understand. If you’re looking for a meeting during a submission, please don’t make it to check up on your submission’s status—we are busy. But if you have new information, you’re welcome to add it. And if you feel a meeting or phone call would be beneficial before, during, or after a submission, please make a request. We find those meetings to be incredibly valuable.”