Is the new Mandatory Product Listing bill actually premarket approval for dietary supplements?

Nutritional OutlookNutritional Outlook Vol. 25 No. 4
Volume 25
Issue 4

The newly proposed “Dietary Supplement Listing Act of 2022” lights a fire under the debate over mandatory product listing.

Photo © Evlakhov

Photo © Evlakhov

Legislation is officially here proposing that all dietary supplements sold in the U.S. be listed in a federal database. This bill concretely shows industry what a mandatory product listing (MPL) proposal looks like in reality—and has unleashed fierce arguments between MPL opponents and supporters. And there’s no indication how it will end.

On April 26, 2022, U.S. Senate Majority Whip Dick Durbin (D-IL) and Senator Mike Braun (R-IN) brought to the floor Senate Bill S. 4090, the “Dietary Supplement Listing Act of 2022.” Following the bill’s introduction, years of simmering debate over MPL boiled over as industry trade associations immediately released statements supporting or opposing the bill. (You can read some of those responses here.)

Those opposing S. 4090 say their number-one objection is that the bill infers that FDA would need to “confirm” a company’s product listing submission before the product can go to market. Upon receiving a company’s listing submission, the bill says FDA will “confirm” a “complete listing” and issue an identification number.

The questions opponents are asking are: What could cause FDA not to confirm a listing? Can products automatically go to market after submitting a listing, regardless of FDA’s response? Could FDA, in fact, use MPL as a premarket-approval lever to keep certain ingredients off the market?

Is S. 4090 Premarket Approval?

Is S. 4090 requiring premarket approval? It depends on who you ask. Some interviewed for this story say they don’t believe the bill is requiring premarket approval. Pointing to select passages of the bill, others state that it is. So, who is right?

“This is purely premarket approval, and anyone who tells you different is lying,” says Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC). He points to parts of the bill’s text he says imply that rather than establishing a simple notification process allowing a company to notify FDA and immediately go to market, S. 4090 instead creates the one requirement most industry leaders don’t want: premarket approval.

Under the bill’s section on “New Dietary Supplements,” the text reads: “In the case of a dietary supplement that is not being offered in interstate commerce on the date that is 18 months after the date of enactment of the Dietary Supplement Listing Act of 2022, a listing for each such dietary supplement formulation introduced or delivered for introduction into interstate commerce by the responsible person for commercial distribution which has not been included in any listing previously submitted by the responsible person to the Secretary under this section shall be submitted to the Secretary prior to introducing the dietary supplement into interstate commerce.”

It's the words “prior to introducing the dietary supplement into interstate commerce” that has Fabricant and some others believing the bill calls for premarket approval. And while another, already existing regulation—for new dietary ingredient (NDI) notification—requires that supplement companies notify FDA 75 days prior to putting an NDI on the market, the NDI process is still not a premarket approval requirement because companies can automatically proceed to market once they wait 75 days after submitting their notification to FDA. They can go to market after submitting their notification regardless of whether FDA has issued a response in the form of an acknowledgement letter or a disagreement letter.

In that respect, Fabricant says, “The difference with the NDIs is that it’s truly a notification process.” Once a company has submitted its NDI notification and waited the 75 days, he says, “the burden is on FDA to show the product is adulterated.” The burden is not on companies to do more; they can go to market. “So, it’s a notification”—and not premarket approval, he says.

By contrast, he says, S. 4090 does not explicitly state that FDA is automatically required to issue a listing identification number to every company once it receives the company’s listing submission. The bill does state that “The Secretary shall promptly confirm, electronically, receipt of a complete listing submission under this section”—but, Fabricant says, the bill does not outrightly state that FDA must issue an identification number to every company, no matter what, nor does it specify what would render FDA to deem a listing incomplete.

Couple this with the fact that the bill says that, “If it is a dietary supplement for which a responsible person is required to file a listing under section 403D and such responsible person has not made a listing with respect to such dietary supplement,” that the supplement would be considered to be “misbranded”—meaning FDA could then take action against that supplement. Opponents say this essentially means that if FDA doesn’t confirm a listing submission because it feels it is incomplete (for whatever reason) and doesn’t issue an identification number, a company’s product can’t legally go to market because it’s considered misbranded.

It’s the notion that FDA could call a listing submission incomplete and not confirm a listing that has opponents up in arms. The concern primarily involves ingredients that FDA currently excludes from the definition of a legal dietary ingredient even though the industry believes the ingredients are legal dietary ingredients. Those ingredients include hemp cannabidiol (CBD) and N-acetyl-L-cysteine (NAC), both of which today are stuck in legal and regulatory quagmire.

Could FDA prevent a product from coming to market via MPL? “There’s nothing in the bill that says you will automatically get listed,” says Fabricant. “It doesn’t say that once you notify, you will receive a number. That’s what it would have to say…It should say, ‘Hey, if it’s an ingredient, no matter what the ingredient, we’ll take it.’ It says nothing like that.” He adds, “This detail can be written into the legislation. The fact that it is not should tell you it’s only here to be misused.”

His takeaway? “Yes, 100%, let’s be realistic. If the agency disagrees with claims or ingredients, do we really think they’ll list the product?”

Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), says he also believes S. 4090 is akin to premarket approval.

Pointing to the bill’s language over new dietary supplements, he says, “You would be required to submit to the Secretary the required information prior to introducing a dietary supplement into interstate commerce. That ‘prior’ is a direct and perfect synonym for premarket, isn’t it? So, there would be a premarket requirement.”

Others believe that S. 4090 as written does obligate FDA to automatically issue an identification number. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), says CRN participated in discussions with Senator Durbin’s team when the team crafted the bill. (CRN issued a statement supporting S. 4090.) Mister says that when CRN was present in those discussions, Senator Durbin did not seem to be advocating for premarket approval.

“Our vision of this is that FDA does not have the ability to say no [to accepting a listing],” Mister says. “If you give them a label and you have filled in all the blanks, they don’t have the ability to say no. And once you have given them that information, you can go to market…So as soon as you’ve given them the information, you’re free to market your product.”

He adds: “You do not have to wait for FDA. Once you have submitted that information, completed your listing, you are free to go to market. We do not envision this to be a situation where you submit your information and then you sit and wait for FDA to get back to you. We would never support that, because that then gives FDA the discretion to hold up your launch.”

He continues: “Our mantra on this is: It’s a birth certificate, not a driver’s license. The local health officials cannot reject your birth certificate because they don’t like the name that you gave your child. If a child is born, it gets a birth certificate—unlike a driver’s license where there is premarket approval, if you will, over the driver. You hit the cones, and you don’t get your license…This is not that. And if people think that the language is not clear enough on that regard—because that is what Durbin is intending, that it’s a birth certificate—if they think that’s not clear enough, they should come to the table and work with us.”

On the bill’s current wording, he says, “I think it’s clear—but, like I said, if others feel it’s not clear enough, they should come to the table and help us improve the bill. But I can tell you that is the intent, that you do not have to wait.”

Likewise, says Duffy MacKay, ND, senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA; Washington, DC), “There’s no authority in this law to block ingredients or products. This doesn’t give FDA the ability to say no. I don’t know which sentence people are pointing to that says FDA gets a chance to say yes or no.”

Other product listing systems have worked in the past, he adds. One example is FDA’s regulatory process for over-the-counter products in the U.S., including homeopathic products. “On the over-the-counter medicine side, homeopathic products go through a listing. You get on the computer, you put the information in, and away you go. There’s no authority for the agency to block an ingredient or a product from proceeding,” he says.

For instance, he says, “You can register your homeopathic product, as wild and as crazy as that homeopathic product might be. And FDA cannot stop or block it. And you see lots of homeopathic products out there where you look at them and you’re like, ‘Wow, this is an interesting take on homeopathy.’ But they all have numbers. There is no authority to block.”

In fact, he says, the fact that S. 4090 proposes issuing identification numbers in batches to companies ahead of time (“to reserve multiple dietary supplement identifier numbers in advance of listing,” the bill says) indicates the bill’s desire to “benefit the industry so they can get right to market.”

“That’s intentionally put there to not delay the process,” MacKay says, “You’ve got your number, you’ve got your groups of numbers, you can start assigning those numbers.”

Mister adds that “part of the reason why the [MPL] identifier [number] is not required to be on the product label is because we said to Senator Durbin’s staff that it you have to wait to get an answer back from FDA, they could hold up your product launch. And we won’t agree to that.”

Still, opponents say the bill’s failure to specify the boundaries of FDA’s ability to reject a submission is reason enough to oppose the bill.

“Can FDA refuse to accept a notification? Will FDA accept the notification if it contains an ingredient that the agency has said isn’t allowed? I don’t know!” says McGuffin. “And if I don’t know, I’m really uncomfortable with saying, ‘Well, why don’t we pass this bill?’” He continues, “If I list CBD, does FDA have the authority to not confirm the listing? The law doesn’t say that they do, and it doesn’t say that they do not. I’d like to know that.”

Moreover, McGuffin says, by raising this very question over automatic approval and immediately going to market, the bill even creates a dilemma for industry, because while industry wouldn’t want FDA to use MPL to keep a supplement containing, say, CBD off the market, it would want the agency to keep a product containing illegal drugs like sildenafil off the market. If FDA were obligated to accept listings for all products that pass through MPL, including ones containing illegal drugs, “then what did the listing mechanism achieve in terms of transparency or clarifying compliant products?” McGuffin asks.

Some say FDA could use MPL precisely to identify these illegal products. MacKay states that with homeopathic listings, “Now, FDA can use that information that’s found in the listing to prioritize the limited resources for enforcement.” S. 4090, he says, “gives FDA a new tool to proceed after the criminals who are going to ignore this…Well now? Their products are misbranded.”

Others say those companies wouldn’t bother listing their products in the first place. “The people selling drugs masquerading as supplements are no more likely to register their products with the government than illegal drug cartels are going to call the DEA with information regarding when and where they’re going to make shipments,” Fabricant says.

Changes Needed?

It should be noted that those supporting or at least unopposed to S. 4090—such as CRN and CHPA—still say there are things they’d like to change in the bill.

Says Mister, “We had a lot of input into the bill with Senator Durbin when negotiating this over the course of months. That’s not to say that we love, 100%, everything that’s there, and we do think there are still some minor technical things that can be addressed.”

He adds, “Here’s the other thing I think is really important: As I said, we know the bill isn’t perfect as is. But few bills are when they’re introduced. So, this is a chance—and we were really pressuring Durbin’s folks to get the bill introduced, to get it out so there so there was no argument that the bill was being negotiated in secret or anything like that. Now’s the chance to work on this, clean things up that if people think there’s something that’s not clear enough or that needs to be expressed a little bit better, now’s the time to do it. And I’m really surprised about the level of opposition that basically has just said, ‘This is a nonstarter. We won’t even talk about it.’ That’s not the way to deal with it. The way to deal with these, what I consider minor issues, is come to the table, bring your suggestions, let’s amend it early in the process and make it work—rather than just stand on the sidelines and say, ‘This is premarket approval,’ when it’s not.”

CHPA would like to see changes regarding what information in the database is public facing and whether new listings should be required in the case of a minor difference between product SKUs, such as a difference in flavor. He adds, “As long as we don’t make it overly burdensome from what we’re already doing, this will be no problem.” Even information the bill would require, such as the requirement for supplier information recordkeeping which companies would be obligated to provide to the Secretary within 72 hours if requested, are already elements companies should have in place due to Good Manufacturing Practices laws, he says. “As long as you’re keeping that [record] and [regulators] can get it, [it’s] no different than GMPs.”

Some firmly balk at these kinds of duplicitous requirements, however. “We’re concerned about the redundancies,” says McGuffin. For instance, he says, “This says that you submit the label and also the ingredients. Well, that’s on the label. The amount of each ingredient per serving? That’s on the label. The number of servings per container? That’s on the label. I could go on. There are half a dozen of these.”

McGuffin emphasizes that this is not a kneejerk response and that AHPA is not against changes to the law if the association thinks the changes makes sense. “AHPA has, in the past, been willing to support changes to the law, including changes that appear to create burdens for industry when we think those changes are necessary to serve the interest of consumers, of supplements, and when we think that can be done in a manner that is efficient in terms of compliance,” he says. For instance, he notes, AHPA played an active role in helping to get the serious-adverse-event reporting law for dietary supplements passed in 2006.

NPA also objects to MPL requiring companies to submit redundant information that they’ve already submitted under other existing regulations for dietary supplements. Says Fabricant, “Of course, we pointed this out on several different occasions to Senator Braun and Senator Durbin. The FDA already has access to information regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events. These requirements fall under facility registration, the Bioterrorism Act, structure/function claims, new dietary ingredient notifications, and adverse-event reporting.” In May, NPA sent a letter to U.S. Attorney General Merrick Garland, Secretary of the Department of Homeland Security Alejandro Mayorkas, and Secretary of the Department of Health and Human Services Xavier Becerra expressing concern that consolidating information in a single database poses a security risk inviting bioterrorism.

Does FDA need the information an MPL database would provide? Mister, for instance, says FDA doesn’t haven’t this information in a centralized location but needs it. He adds, “When you look at this whole issue, we have a perception problem when consumers learn that FDA does not know how many products are on the market…There’s some great survey data that the Pew Charitable Trusts did about a year ago that, I think it’s something like 85% or 90% of Americans already assume that FDA has this data, and they’re surprised when they find out that it doesn’t.”

“And that’s the basic argument,” he continues. “FDA cannot regulate what it cannot see. I know NPA will tell you, ‘Oh, FDA already has this information.’ They don’t. The Supplement OWL [the product listing database CRN created in 2016], as good as it is, does not have the entire industry in it.”

Even the Office of Dietary Supplements’ Dietary Supplement Label Database (DSLD) doesn’t serve the same purpose as a MPL database because while the DSLD collects supplement label information, “the company that makes the product has no accountability for those labels,” Mister says. “They may not even know their label is in the ODS database.” Furthermore, outdated labels aren’t expeditiously removed, while MPL would require companies to keep their own product listings in the database up to date for accuracy.

“So, this notion that, ‘Oh, we already have something like this?’” Mister says. “Well, no, we don’t, because what we have is not mandatory.”

Some still support modernizing supplement regulations even if they don’t think that introducing MPL is the answer. For instance, says MacKay of CHPA, “We are not in favor of this bill because we would like to see more additional DSHEA modernization.” At the same time, he says, CHPA “is not against or scared of what’s in [MPL].” Still, the association would prefer to see supplement regulatory reforms focus on improving things like GMP inspection requirements and inspections of foreign facilities.

AHPA, meanwhile, believes it’s other regulatory elements that need rethinking, such as 1) How the Federal Food, Drug, and Cosmetic Act’s drug preclusion clause creates inequities for supplements versus drugs, 2) how supplement companies are restricted from providing truthful information about studies they’ve done on the ingredients in their products if those studies address disease endpoints, and 3) FDA’s definition of what constitutes “chemical alteration” and would render an ingredient a new dietary ingredient. Those are all more important questions to be answered—not MPL, says McGuffin.

The Court of Public Opinion

Now that S. 4090 is here, it enters the political process and the court of public opinion. Industry trade associations will no doubt be taking their objections to Capitol Hill.

Burdens on the supplements industry aside, consumers and lawmakers will be faced to reckon with questions like: Does MPL provide FDA with additional information to better enforce the market? Will MPL actually help rid the dietary supplement market of bad actors and illegal products? Will MPL restrict consumer access to dietary supplements?

Whether S. 4090 gives FDA better tools to regulate the market—tools it didn’t have before or that were insufficient—remains to be seen. Although S. 4090 does call for millions in funding to get an MPL database off the ground and to maintain it, FDA has said itself that it is underfunded and understaffed, so whether the agency can use the information MPL would provide to further pursue bad actors remains to be seen.

Likely the biggest impact MPL will have is outside of FDA’s scope: with retailers. If there is a national listing database in which the supplement industry’s law-abiding companies are listing their products, then it stands to reason that in an abundance of caution, retailers selling supplements would automatically want to only sell products that are listed in the database.

The very fact that this could leave some companies out in the cold—companies that make gray-area ingredients like CBD or NAC—is what opponents fear. “This is where FDA can, by not listing a product, effectively take away its ability to be sold on the market,” says Fabricant. “Large retailers will use this list to decide whether they sell a product or not. So, not appearing on the list for a technical disagreement with FDA—not a dispute over safety or disease claims—could take away your whole business by the stroke of a keyboard.”

“That gives FDA a lot of power if they don’t put things on the list. I mean, this is the problem. This is the fundamental problem,” he says. Also, he points out, there’s no telling what dietary ingredients FDA might object to in the future which might then run into problems getting listed in an MPL database. As he points out, “We never saw [FDA’s] objections to NAC coming, and look what that did—that took two years and a lawsuit just to get us back to where we were two years ago—and we’re not even all the way back…I’m not going to trivialize NAC and CBD. I think everyone should be very cautious. I can see them doing this on probiotics; I can see them doing this on some botanical ingredients. This is potentially very difficult.”

Will a proposal for mandatory product listing find support in the general public? It depends. Those who oppose the bill say consumers should be made aware that MPL could end up restricting their access to products like CBD or NAC.

Others believe the additional transparency they say MPL would provide is sensible and appealing to many consumers. “Again, nobody is claiming that this is 100% going to solve all of the industry’s problems,” Mister says. “Nothing is going to solve every problem, and every industry is going to have bad actors that lurk around the fringes of the industry. But what this does is, first of all, is it gives FDA a clear catalogue of what’s in the industry…Secondly, most retailers will probably not market a product if it’s not in the listing, so that helps to start weeding out these bottom feeders that lie in the corners of the industry and then depend on a retailer who doesn’t know any better than to put their product on the shelf. If it’s not in the listing, I would suspect most retailers won’t sell it…Thirdly, FDA will be able to see violative labels. Right now, we have a lot of labels that, on their face, do list illegal ingredients. They do list DMAA on the label, or the label says, ‘Helps to cure cancer.’ So, by having a label database like this, it lets FDA see the easy ones and get rid of them….So I would be the first to concede that we’re not going to solve 100% of the industry’s problems with this, but I do think we solve a lot of them.”

“You know, it’s easy to stir the pot and claim ‘premarket approval,’” MacKay says. “But at the end of the day, all they’re asking for is the information from our label to be put into a public database that FDA has access to. And for anybody who’s opposing it, it’s really hard not to ask, ‘What are you hiding? What are you worried about?’” He points to “the side of the market that’s really standing up, fighting for the lack of transparency, which looks terrible. You know, ‘We don’t want to put our products in a public database. We don’t want the agency to know what’s going on.’ It’s a really untenable argument from an industry where people put things in their mouth to be healthy,” he says.

To some consumers, transparency could go a long way, Mister says. “If you put yourself in the consumer’s place—and so many of us are consumers of supplements as well as being in the industry—you put yourself in the place of the consumer and you go, ‘Why wouldn’t you want FDA to have this information?’ And, in fact, when you talk to some of these consumer groups, they want a lot more than just mandatory listing. But we’ve been able to get an agreement that this will only be about mandatory listing.”

Then again, not all consumers support such a bill. Says McGuffin, “I hope that consumers are more sophisticated. If I get a t-shirt and it says Transparency and Sustainability, are you going to be my friend? I hope not. I hope they don’t just get influenced by a few words thrown around. And the evidence is they don’t.” He says consumer groups such as the Alliance for Natural Health, as well as Citizens for Health, “publicly stated their opposition. They don’t like it. They believe it will restrict access.”

“If we look at actual consumers, these are activist consumers,” he continues. “These are people who use dietary supplements and want dietary supplements and are rather insistent on continuing to have access. To some degree, the public has spoken, and they are not sold by this message of, ‘Oh, this will increase transparency.’ They’re more sophisticated than that. They’ve asked tougher questions.”

“The public doesn’t support this bill,” Fabricant says. “There are tens of thousands of emails to Congress in opposition. That trumps any half-baked survey.” He adds: “Transparency is nothing short of a dog whistle as it has been used here. Who wouldn’t be in favor of transparency? However, what is currently in this bill does nothing for consumers in the name of ‘transparency.’”

How open will S. 4090’s authors—Senators Durbin and Braun—be to altering the bill? CRN says it was privy to meetings with Durbin during the bill’s drafting. Conversely, says McGuffin, “We have reached out to Senator Durbin’s office several times in the last few months, and they’ve been nonresponsive. That’s, of course, disappointing.” And Fabricant says that as NPA anticipated the bill’s release, “During our conversation with Senator Braun’s team, while they refused to share the legislative text until the 11th hour, they still indicated there would be several areas of concern for our members.”

Interestingly, McGuffin points out, this is not the first bill Senator Durbin has introduced proposing some kind of listing for dietary supplement products. Back in 2011, Durbin introduced the Dietary Supplement Labeling Act which, among other requirements, would have had dietary supplement products register their products with FDA, including a description of each supplement, a list of ingredients, and a copy of the label. For new dietary ingredients, companies would have been required to submit the information 30 days after going to market.

Of S. 4090, Durbin’s new bill, “how [the listing requirement] went from within 30 days to in advance, I don’t know,” McGuffin says. “We’ve worked with Senator Durbin’s office for quite some time. They’re sophisticated. They’re professional. They almost certainly have an institutional memory, which makes me think that their decision to go from 30 days to zero days was intentional and conscious, and whether it happened in that office or whether it was the influence of the Food and Drug Administration, I don’t know. But it’s just an interesting historical glance to see that the last time Senator Durbin proposed mandatory product listing, it was a less burdensome requirement than is being proposed currently.”

So, what happens now with S. 4090? Quite honestly, although industry associations will be fighting hard to get their views heard, at the end of the day, no one really knows whether S. 4090 will have legs to stand and get to the finish line.

Will the opposing views in industry cancel each other out or render their advocacy ineffective? “I would say that because industry is not aligned, we’re not speaking with one voice, and we risk getting something we really don’t like because we’re not influencing it,” says MacKay. “I really think that we need to move forward. We have a 27-year-old regulation, and we have an industry that’s grown immensely in that our products have changed, our scope has changed, and our role in healthcare has changed. I think it’s time.”

McGuffin, on the other hand says, “I guess there’s a little bit of, ‘What’s the hurry?’…What happens when we create laws in a hurry is we get laws that aren’t very well thought out. Maybe we’re just supposed to take the time and look to the next Congress. I know that infuriates a lot of people. There are colleagues who really want to get this done now. We’ve got a Democratic majority still. We’re more likely to see something happen now. That’s not an unrealistic consideration. But I would rather take our time, get something done thoroughly and well—and we’ll continue to be engaged in that conversation with all parties.”

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