OR WAIT 15 SECS
Is there a way to strengthen FDA’s regulatory enforcement of dietary supplements? FDA’s Steven Tave discussed the obstacles at CRN’s virtual “NOW, NEW, NEXT” conference on October 14—and industry responded.
FDA may indeed regulate the dietary supplement market, but bad actors who run afoul of lawful compliance still exist. On October 14, during day one of the Council for Responsible Nutrition’s (CRN; Washington, DC) virtual “NOW, NEW, NEXT” conference, Steven Tave, director of FDA’s Office of Dietary Supplement Programs, discussed why a “regulatory gap” still persists that enables non-compliant products to infiltrate the supplements space. Tave also spoke of what’s preventing FDA from catching these bad actors under the current regulatory framework.
Regulated, but Not Well-Regulated?
During the CRN conference, Tave repeated a phrase he introduced back in September at another industry event, the Dietary Supplements Regulatory Summit 2020 hosted by the supplement industry’s leading trade associations. At the summit, Tave said that a “regulatory gap” exists that hinders dietary supplement regulations from being fully and effectively enforced.
Tave revisited this phrase at the CRN conference, stating, “The regulatory gap represents the space between what the law requires on one hand and what can be realistically reached through enforcement on the other.”
He continued: “The regulatory gap is my attempt to explain why there continues to be a significant amount of non-compliance in the dietary supplement marketplace, even though we have a clear segment of responsible industry participants who we believe are generally committed to manufacturing and distributing compliant products.”
Dietary supplements are regulated under FDA’s purview thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA), but the agency still struggles with enforcing against bad actors who do not comply with the law. These bad actors include companies selling products masquerading as dietary supplements that are spiked with drugs and other illegal ingredients, as well as companies not meeting current Good Manufacturing Practices (cGMP) requirements or making illegal drug claims for supplements.
Tave attributed the agency’s enforcement struggles to several problems. One of the challenges, he said, is figuring out how FDA would enforce against a product if the product is deemed not to be a dietary supplement at all—such as if a product marketed as a dietary supplement in fact contained ingredients not approved for supplements or contained ingredients that are drugs or that have been studied as drugs, which would therefore render the product to reside outside the legal definition of a dietary supplement. In that case, said Tave, “[I]f a product turns out not to be a dietary supplement, that means we can’t bring dietary supplement charges, such as dietary supplement cGMP violations, against it.”
Determining whether or not a supplement does or does not meet regulatory requirements is not always straightforward for FDA either, he said. For instance, a supplement company may choose not to submit a New Dietary Ingredient (NDI) notification required for an ingredient that wasn’t marketed in dietary supplements prior to October 25, 1994, but instead opt for the “alternate pathway” (Tave’s words) to legal compliance such as in the form of an independent Generally Recognized as Safe (GRAS) conclusion to demonstrate the safety of an ingredient introduced to the food supply, thereby allowing the company to bypass submitting an NDI notification.
Said Tave: “We know that many dietary supplement firms choose to first introduce new ingredients into the food supply using the self-GRAS process, which does not require notification to FDA. As a result, we can’t just look at a product and assume it is out of compliance simply because there is no NDI notification, and that is a problem because Section 402(f) [of the Federal Food, Drug, and Cosmetic Act], which is the applicable adulteration provision, requires us to bear the burden of proof on each element of an evaluation.”
Finally, said Tave, FDA does not have good-enough tools to identify all of the dietary supplements that are on the market. “To put it simply, we cannot enforce against what we cannot see or do not know is there. This is why dietary supplements continue to be spiked [with adulterated ingredients and] continue to appear on the market, even after we’ve taken action against those…because we cannot investigate every store in every state, and we do not have a constantly updating window into every retail corner of the entry market. We are left trying to play catch-up.”
Also, he stated that import alerts, which FDA can issue to help prevent illegal supplements from entering the U.S., are not sufficient to catch bad actors because “while import alerts might lower the burden and allow us to detain products based on an appearance of a violation, we still have to show evidence of a violation.”
Tave did not attribute FDA’s current enforcement obstacles to a lack of resources or a lack of a will on the agency’s part to render enforcement.
“I want to be clear that this isn’t a complaint about resources,” he said. “Yes, FDA can always do more with more resources, but my office was very fortunate to receive a boost in funding during the last appropriations cycle…We’re working hard to put all those funds to efficient use.”
Also, he said: “I also want to be clear that this isn’t a matter of FDA not wanting to enforce the law. I can’t understand why people insist on repeating that fallacy. We have an active enforcement program. I’m standing before you saying that we want to enforce the law more.”
Rather, Tave said, as a result of the challenges outlined earlier, “[A] regulator might not in practice be able to act against every violation…” These challenges, he said, will continue to plague FDA and the industry unless improvements can be made.
Said Tave: “[T]he regulatory gap is not just a function of inadequate resources. And it isn’t the result of some bizarre, self-defeating conspiracy not to enforce the law. Rather, the regulatory gap results from structural, legal, and practical forces [that create] a divergence between how the law was written in 1994 and how the world has changed since then—and now combine to impede the effective, full regulation of the dietary supplement marketplace. And this regulatory gap will persist no matter how many resources are made available and no matter how vigorously the agency seeks to enforce.”
Working within DSHEA
Tave emphasized his desire not to dismantle DSHEA. The question of whether DSHEA should be revised is increasingly discussed among industry these days.
Said Tave: “The good news is that the problems at the heart of the regulatory gap can, with an open mind and some creativity, be addressed without disrupting the broader framework of DSHEA.” Tave pointed to FDA’s previous comments about its desire to “modernize” dietary supplement regulations while still preserving the consumer access to these products that DSHEA ensures. In this vein, FDA also held a public meeting in May 2019 to foster dialogue about how to strengthen the regulation of dietary supplements moving forward.
One of the proposals favored by FDA and some members of industry is the creation of a mandatory product listing that would require all supplement firms to enter the products they sell in a federal listing database that would then give FDA eyes on products on the market. This resource would assist FDA in identifying products that have skirted the listing requirement, helping them to flag the bad actors behind those products. Said Tave: “Now, a [mandatory product listing] is not a cure-all, but a well-constructed listing requirement will represent a dramatic step forward in narrowing the regulatory gap.”
During a live panel following Tave’s address, attorneys who represent dietary supplement firms also expressed the same desire not to significantly change the DSHEA statute. Changing the statute could open the door to further changes industry might not agree with, they said.
Panelist Miriam Guggenheim, a partner at Covington & Burling LLP, said, “Overall, I don’t favor opening DSHEA at all. I think we may get there. But we just heard from Steve Tave about how difficult it is for [FDA] to even enforce the statute that they have…I just cannot conceive that adding more tools into the toolbox that are still going to need to run through the same channels is going to get us something more efficient. Perhaps a mandatory product listing could be designed as an efficient way to do that, but right now, I do not think the statute is the problem.”
Panelist moderator Steve Mister, CRN’s president and CEO, said: “I think most of us agree that we don’t want to narrow that gap by expanding what the law requires, so it looks like the way we’re going to narrow the gap is expanding what can be reached through enforcement.”
Sending Stronger Signals
To improve enforcement, the panelists said, there needs to be more decisive demonstration of FDA punishing bad actors who don’t obey the law. That level of strong, quick action by FDA is not happening currently, they said.
Panelist Stuart Pape, chair of FDA Practice at Polsinelli, said, “[T]he level of compliance requires the perception, if not the reality, that the risk of enforcement is there and the consequences of getting caught up in an enforcement action are serious enough to reinforce your natural inclination to behave.”
Instead, panelists and attendees pointed to slowness on FDA’s part in issuing warning letters or making clear what happens to firms after the warning letter is volleyed.
“I don’t see very much in what FDA does in enforcement in the supplements space as supporting the inclination of people to comply,” said Pape. “The enforcement is too infrequent…[and] even if someone gets a warning letter, it’s next to impossible to know what the resolution of that matter was—and even if there’s a closeout letter posted, those closeout letters are often devoid of detail, so you can’t tell whether the position the agency took in the warning letter at the end of the day was sustained or whether the recipient of the warning letter was able to convince FDA otherwise.”
He continued: “At the end of the day, the problem becomes that well-meaning companies look around and see that the competition is doing things that lawyers have told them they can’t do, and that builds and builds and builds, and then the compliance level winds up being lower than it otherwise would be.”
Court cases that FDA would fight and win, clearly laying down the law for all to see, don’t happen enough either, said panelist Ricardo Carvajal, director at Hyman, Phelps & McNamara P.C. While acknowledging that legal fights of this sort are extremely time consuming and resource intensive, he said, “There aren’t going to be any shortcuts to establishing the definitive meaning of some of these provisions that we’ve been arguing about now for over two decades.”
The takeaway from the panel, and from FDA’s Tave, is that change is needed in how FDA is able to carry out enforcement under existing law.
Guggenheim said: “I still think there are ways in which the Office of Dietary Supplement Programs right now is inadvertently incentivizing the bad players and disincentivizing the good players by erratic enforcement and lack of clear guidance, so you don’t have the folks who would do things right even getting into the fray. They’re sitting on the sidelines while the less-scrupulous players are jumping in and not necessarily crossing every T and dotting every I.”
As an example of how FDA’s lack of regulatory clarity is incentivizing bad players, Guggenheim pointed to the hemp cannabidiol (CBD) market, for which FDA hasn’t created a legal pathway even as products continue to populate the market.
“I think it would behoove the entire industry, as well as the agency, if the agency were to go forward and clarify and clean this up, because I think the CBD context is exactly where you see the folks who would be the responsible players who would apply the most rigorous cGMPs and identity evaluations for the material are the ones who are sitting back and waiting for clarity. And you have folks who are taking a little more risk…[Y]ou have a really wide range of players in this space, and this is reflected in the claims that are made as well. But FDA’s lack of action is meaning that only those who are willing to take the risk are entering this space, and that shouldn’t be the way the agency incentivizes the industry.”
She continued: “I think if FDA could go ahead and clear a pathway for CBD, it would solve a lot of other problems. It would show that the agency can handle science….that it can make decisions, and that it can make decisions in a difficult environment. And that would set a tone that would say, ‘Okay, FDA is drawing lines, and here’s what’s in and here’s what’s not,’ and it will be a strong signal beyond even just the substance of CBD itself.”
Working Together to Find Solutions
All three attorneys noted that a spirit of collaboration between the dietary supplement industry and FDA’s Office of Dietary Supplement Programs may help move the needle in the right direction when it comes to creating an environment of more effective enforcement. “I think that developed relationship and respect is heading us in the right direction,” said Guggenheim.
Said Carvajal, “To me, that is perhaps the most encouraging signal that we maybe have turned a corner and are heading toward an era where we have more consistency in terms of leadership, personnel, funding, and programmatic objectives for that office, and I think that will make a world of difference both to FDA’s program and to industry as well.”
Guggenheim added: “The key difference is the relationship now between industry and FDA leadership. I think there is a renewed respect, despite the regulatory gap that Steve Tave discussed. I think there’s more of a respect for industry and a starting position that industry really is out to do the right thing. They are not looking to cut corners, and that with appropriate guidance and clear and consistent guidance from FDA, industry players really are desirous of doing the right thing. I think having that dynamic, off on what I would call the right foot, makes a big difference.”
Change is needed, and the hope is that solutions can be found on the enforcement end that will help FDA clean up the market. And if changes to the statute are actually made? Said Pape, “Are there things you could introduce that are more self-executing, self-enforcing, than not, because the agency’s resources in this space are not likely to be materially different now, five years from now, 10 years from now. If collectively we can’t find ways to make enforcement happen, but happen without expenditure of large resources, then I think we’re going to be having the same conversation a decade later.”