FDA is not doing enough to target unlawful activity in the dietary supplement industry, according to some executives who spoke Nov. 30 at The Big Natural, a virtual two-day event hosted by the Natural Products Association (NPA).
“Keeping FDA accountable is like nailing Jell-O to the wall,” said Mark LeDoux, chairman of NPA’s board of directors, who founded and leads Natural Alternatives International Inc. (NAI), a manufacturer of nutritional supplements. “It’s problematic in that it doesn’t want to stay in one place at any given time.
“When you overlay that with the simple reality that … all things COVID have really absorbed the attention of the agency for the past nine months, if not a little longer, it’s somewhat understandable,” LeDoux added during a legislative and regulatory session.
But he described “a sense of frustration among many in the industry who are trying to do a good job, who are putting out high-quality product and find themselves competing with basically economic fraudulent product that’s available on famous websites on a direct-to-consumer basis.”
During the event, lobbyist Stephen Northrup of Rampy Northrup LLC described FDA as a “chronically underfunded” agency that has “been less than accountable with the funds” it receives.
FDA, he said, doesn’t "do a very good job of spending [money] on what the priorities ought to be, and certainly as a result of the coronavirus pandemic…that’s actually increased the lack of accountability in all the other areas that don’t directly deal with the pandemic.”
Aaron Secrist is executive vice president of quality, R&D and operations for NOW Health Group, a manufacturer of natural products that celebrated its 50-year anniversary in 2018. He cited a “lack of enforcement for a very long time” at FDA.
“We’ve tried to kind of reason and ask them (FDA officials), ‘Hey, how can we help you? … What can we do to tee up the bad actors? We see them. We know who they are.’ And we’ve gotten a lot of, as some have mentioned … ‘Hey, thank you for coming to meet with us and we’ll think about it,’” Secrist said during the legislative and regulatory session.
LeDoux said the agency seems to be hesitant to tackle “big issues,” such as enforcement of the new dietary ingredient (NDI) notification requirement in the Dietary Supplement Health and Education Act of 1994 (DSHEA), which Congress incorporated to ensure novel ingredients in supplements are reasonably expected to be safe.
One proposed solution: Tying funds appropriated to FDA to the agency meeting certain deliverables.
“We need to figure out a way to tie what we get from the agency to what they’re given, and the only way to do that really is … to put some pressure on our congressional representatives to say, ‘Hey, we’ll give you more money or we’ll fund your budget this year, but these are the deliverables that you have to come back and report on,’” Secrist said.
If FDA doesn’t meet such deliverables, its budget would face a risk of being reduced, he suggested.
New funding boost
Kevin Bell, outside counsel to NPA, pointed out trade associations like NPA lobby for Congress to allocate sufficient funds to FDA. In fact, several industry groups successfully lobbied for more funds for FDA’s Office of Dietary Supplement Programs (ODSP).
The supplement office received a substantial boost in fiscal year 2020 funding through an omnibus appropriations bill signed by President Donald Trump. Report language in the bill allocated an additional $3 million to ODSP.
ODSP received a total of $10.7 million in FY20, according to an FDA spokesman, and the agency is currently being funded at the same levels as last fiscal year under a continuing resolution passed by Congress.
The funding boost has fueled a hiring spree at ODSP, which was created in December 2015. FDA previously regulated supplements through its Division of Dietary Supplement Programs.
“A lot of us in the industry have advocated for more money for the agency,” Secrist said. “We advocated to change from a division to elevate the status to an office and were hopeful that we would see something from that, but I think all we did was maybe pad the salaries of some of the folks leading the office.”
Costs of FDA enforcement?
Bell has represented NAI, which has been critical of FDA for not enforcing against generic forms of beta-alanine manufactured in China that compete with CarnoSyn beta-alanine, an NDI whose identity and safety was reviewed by FDA.
Bell, a partner with the law firm Arnall Golden Gregory LLP (AGG), has also questioned the purported benefits of a NDI master file system. According to FDA and a number of industry trade associations, an NDI master file could allow for the submission of abbreviated NDI filings, making it easier to comply with the law. On the other hand, others—including Bell and NPA’s CEO, Daniel Fabricant, Ph.D., a former FDA official who oversaw the Division of Dietary Supplement Programs—have argued the industry has little incentive to notify FDA about their NDIs if the agency won’t enforce against entities that defy the law and have a competitive advantage over responsible firms that invest hundreds of thousands of dollars or millions into regulatory compliance.
Bell and others have been in favor of FDA using import alerts as a tool to prevent copycat NDIs from entering the U.S. market.
Commenting on the hemp-based CBD market, Bell asked what FDA is going to do when firms start filing NDI notifications for products containing CBD and "people start knocking it off importing hemp the very next day." Among the proposed changes to federal legislation introduced in 2020 that would legalize CBD in dietary supplements, FDA recently recommended firms be required to file NDI notifications.
"I mean how much wood does a woodchuck have to chuck here before the FDA starts issuing some import alerts on things?” Bell asked.
The attorney also expressed interest in the costs of FDA enforcement but he raised doubt that ODSP’s director, Steven Tave, would disclose, for example, the costs to enforce the NDI provision in DSHEA.
FDA has “had 26 years to think about it,” he said during The Big Natural.
“This is more than a lack of resources. We’re now coming up with new Trivial Pursuit phrases like ‘regulatory gap,’” the lawyer added, quoting a phrase used in recent months by Tave to describe the space between requirements in the law and what can be “realistically” achieved through enforcement.
‘Not a plea for resources'
In discussing the regulatory gap in an October phone interview, Tave made clear that resources alone won’t solve the challenges facing the agency.
“Number 1, it’s important to point out that this is not a plea for resources,” he told Natural Products Insider. “Even if you increase our resources, this is still going to be a challenge.”
He added, “We’re going to do everything that we can, and we’re going to use every resource that’s available to us, but there are some … structural and legal and practical impediments to enforcement that I think arise from the divergence between how the law was written in 1994 and how the world has changed since then.”
Tave, an attorney whose experience at FDA includes working in the Office of Chief Counsel, described some of ODSP’s challenges by referencing three buckets of products: those clearly compliant or noncompliant with the law, as well “one bucket where whether or not the product is compliant is kind of ambiguous.”
“When you have a large regulatory gap, the first and the second buckets are pretty small,” he explained, referencing products clearly compliant or noncompliant with the law, “and then you’ve got a big category where you really can’t say.”
He continued, “You might think some of them are not compliant. You might have a pretty strong suspicion, but you don’t know and you can’t do anything about it. And that presents a challenge.”
In trying to narrow the gap, FDA wants to “sort the landscape so that you have more firms and products that are clearly in the first and second buckets that are clearly compliant or clearly noncompliant,” he said.
Sorting the marketplace, Tave said, would make it easier to target noncompliant businesses, as well as more manageable to investigate cases in which there may be ambiguity around the regulatory status of a product.
FDA is in favor of a mandatory dietary supplement product listing to help narrow the regulatory gap. Many people who support FDA’s proposal envision a requirement incorporated in law that firms share their product labels with FDA.
A mandatory listing “would give us a picture of what’s on the market,” Tave said in the interview. “It would tell us what the universe looks like, what products are out there, [and] what ingredients are in them.”
FDA’s supplements chief also described a listing requirement as a “very big first step because instead of kind of getting redirected left or right depending on what industry or the media advocates decide to point out to us, it would give us a systematic way" to identify products on the market and consider "proactively" and "strategically" how to address them.
Targeting ‘sacrificial lambs’
Secrist, however, rejected the idea that FDA can’t identify and take action today against firms running afoul of the law.
“I’m a little dumbfounded sometimes at this whole notion of, ‘We can’t find them. We don’t know who they are,’” he said at The Big Natural. “I mean, can you find all of them? Do you have the resources to go after everybody? No, but a couple of sacrificial lambs—I think—would go a long way.”
LeDoux concurred and suggested FDA enforcement against “two or three sacrificial lambs” through seizure of their products and bank accounts generally “gets people’s attention.”