Mandatory product listing debate over U.S. dietary supplements raises key questions

Nutritional OutlookNutritional Outlook Vol. 25 No. 5
Volume 25
Issue 5

Newly proposed legislation is driving the urgency to build support for or against mandatory product listing. What are the topline arguments?

Photo © Fokussiert

Photo © Fokussiert

It’s easy to get caught up in the divisiveness of mandatory product listing (MPL) these days.

News headlines, from Nutritional Outlook included, on the latest arguments for why the U.S. should or should not create a federal database for dietary supplements are head turning. Editor Sebastian Krawiec and I recently interviewed industry association leaders on The Nutritional Outlook Podcast about their groups’ reasoning on MPL. You can listen to Part I of those interviews here. (Part II will be posted later this week.) It’s handy listening for anyone trying to decide whether to oppose or support MPL.

As we know, newly proposed legislation is driving urgency for these industry groups to quickly build support for their positions. Now there is a deadline looming—not only potentially for April’s proposed S. 4090 bipartisan bill from Senators Dick Durbin (D-IL) and Mike Braun (R-IN) but even more imminently for the FDA Safety and Landmark Advancements Act (FDASLA) officially introduced in May by the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP). Led by Senators Patty Murray (D-WA) and Richard Burr (R-NC), the FDASLA—aside from its main goal of reauthorizing FDA user fees for drugs and medical devices—proposes creating a MPL database for dietary supplements. Because this user fee authorization bill is considered “must pass” legislation, this is the bill industry leaders believe stands the greatest chance of moving MPL forward.

Nutritional Outlook began covering MPL anew when the standalone S. 4090 bill was introduced in April. In that story, we stuck closely to the text of S. 4090, interviewing industry association heads about why some believe that S. 4090—and also the newer FDASLA—could give FDA a premarket approval leverage over dietary supplements such that the agency could use a mandatory listing process to prevent certain dietary supplement ingredients from coming to market.

In our conversations with industry leaders since, key discussion points continue to emerge. Putting aside the specific bills and whether their wording does or does not infer premarket approval, let’s take a look at some of the leading discussions to consider about MPL.

Would MPL Really Boost Supplement Safety and Credibility? Or Would It Give FDA Premarket Approval Power?

Advocates argue that MPL, by serving as a public repository of information on U.S. dietary supplements, would provide not just regulators but also consumers with a one-stop hub where they can educate themselves about the thousands of supplement products on the U.S. market. A mandatory database would be more complete than something like the already existing—but not mandatory—National Institutes of Health (NIH) Dietary Supplement Label Database (DSLS), which captures the labels of some, but not all, supplement products on the market. With a MPL database, advocates say, information such as ingredients or dosage would be inputted into searchable fields, rather than just being provided graphically via a photo of the label, making it easier for FDA and consumers to search for information.

A centralized, mandatory database would give FDA a tool to better regulate the market, say advocates. As Duffy MacKay, senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), told Nutritional Outlook on the podcast, “I know a lot of people say, ‘Well, Google, and you can go online [to get information about individual supplements on the market].' But a real tool is a systematic and complete tool.”

Opponents, meanwhile, argue that FDA can already gather such information from other existing sources, such as facility registrations—not to mention the company, ingredient, and dosing information that’s already on product labels the public can see online or in stores. They argue against what they say would be the redundancy in burdening supplement companies to enter the very same information into a brand-new database. As Michael McGuffin, president of the American Herbal Products Association (AHPA), told Nutritional Outlook, “We keep looking at both of these bills and wonder why the reporting requirement is so redundant. It requires submission of not just the label but also a whole bunch of information that’s already on the label.”

In official comments AHPA sent the Senate HELP Committee on FDASLA, AHPA suggested that the bill’s requirements at least be stripped down to require companies to submit only product label images and contact information. This would reduce the cost burden of data entry on the industry, the association said. Regardless, McGuffin also said that the NIH Dietary Supplement Label Database already contains some supplement label information and that creating a second database is unnecessary. He said, “You gotta ask this question: Should American taxpayers pay for two databases?” (Editor’s note: One also wonders whether these databases might somehow be integrated into one in order to reduce any redundancy or burden on industry.)

MPL opponents say that because creating a MPL database is unnecessary and burdensome, it is especially not worth the risking of passing new legislation they believe could become a FDA premarket approval tool to keep products off the market.

Daniel Fabricant, president and CEO of the Natural Products Association (NPA), said, “The thing is, if the safeguards were there”—meaning language built into the bill to clearly state that the law doesn’t let FDA reject any database submissions—“they would be specifically spelled out. They would say, ‘Hey, nothing in this act would allow the Secretary to remove an ingredient that isn’t the subject of final agency action.’…That would give you a safe harbor, but we haven’t seen any language here that would present that [in the current bills].And, again, if the goal is…to get FDA labels? Okay, those would meet that goal.Now, if the goal is something else, well then people need to be honest about what that goal is. If that goal is to get FDA an administrative tool that’s in effect premarket approval? Yeah, that’s not going to work at all. Everyone is opposed to that.”

McGuffin also explained, “Again, we don’t see any words in there that say, ‘This is premarket approval.’ We don’t see any words in there that say, ‘This could never become premarket approval.’ And that’s why we’ve continued to push back on that detail.If the language is cleaned up, then we’d be back to, ‘Could somebody please clarify with a great deal of certainty why this is needed, because we’re still at that point of we don’t really see the need. We think it’s redundant to FDA’s existing authority to get as many labels as it wants. We think it’s unlikely to work because…the companies that we really want pushed out of the market are those creepy-creeps that sell products that say ‘dietary supplements’ and contain undeclared drugs. But we don’t think that this will fix that, because they’ll just register. And then, apparently, they’re compliant. And then we’re also concerned about potential regulatory drift. Where does FDA go with this over the next 10 or 15 years? It’s not crazy to think, or I would be naïve to think, that based on decades and decades of history, we should assume that FDA will treat this exactly as we think it should be treated. I think anybody with experience in the trade would have to agree that we need to be aware of FDA’s history, which is to seek narrowing of availability of natural products and dietary supplements, and that we’ve always operated in exactly the opposite manner. We always seek a broadening of access to a wide range of natural products.”

Others don’t believe the bills grant FDA premarket approval power. Loren Israelsen, president of the United Natural Products Alliance (UNPA), described MPL as a “bolt-on” to the regulatory framework created by the Dietary Supplement Health and Education Act (DSHEA). This bolt-on would simply help modernize supplement requirements in order to keep up with the vastly expanding market, much in the way that related supplement requirements have been added through the years, such as foreign supplier verification requirements instituted through the Food Safety Modernization Act (FSMA).

“There have been a number of changes,” Israelsen pointed out. “They were not amendments to DSHEA, but they were bolt-ons to DSHEA. This is a bolt-on. And it’s designed to help reinforce the infrastructure of the principle of DSHEA, which is: first, consumer health freedom, broad freedom of choice of a wide range of supplements. The proposed legislation, I believe, does not interfere with that and provide [premarket approval power to] the regulator—who, prior to DSHEA is…well documented to have exceeded its authority into taking steps that were detrimental and also unlawful and impeded consumer health choices.”

“This bill does not do that,” he continued, referring to FDASLA specifically. “I believe that it is a reasonable and an appropriate step. I’ve asked myself the question: If we were actively opposing this as an industry, how would members of Congress and the public respond, thinking, ‘Is there something to hide? What is such a great concern that you won’t share with us what’s on your label, which you freely share with the public anyway?’”

MPL, Israelsen said, does not create a “new and different authority” for FDA. “And so it is with other requirements,” he said. “The bolt-on requirements from the Food Safety Modernization Act with respect to PCQI, foreign supplier verification, are other good examples. They’re not part of DSHEA, but they’re part of the framework that is the modern regulatory structure for dietary supplements. I always tend to think of DSHEA as the Eiffel Tower, but you’ve got all these other support structures and other operating systems that work in tandem with DSHEA. So, this would be the same. This provision would not amend DSHEA. It would be a bolt-on to DSHEA, with a very specific and narrow objective.”

He and other advocates say that if there are concerns over specific wording in legislation, the language in either bill could possibly be amended to assure opponents that FDA can’t use MPL for premarket approval.

“I’m very familiar with the concerns and the arguments. I honestly have not found them persuasive in terms of this really is premarket approval,” said Israelsen. “That said, and taking those concerns into account, we will make all efforts working with Congress to assure that the bill is explicit, that it is not a preapproval mechanism, nor can be. So, I do believe that if that is explicit in bill language, that the number of people that are concerned—that should relieve their concerns. Others may still feel that somehow FDA will try and find its way around it. The intention is to make it explicit enough that FDA would not have any discretion to do other than what is directly in the bill.”

If concerns about MPL being premarket approval could be eliminated, questions still remain: 1) Is a MPL database really necessary to improve FDA regulatory processes, or would it be redundant to existing information, and 2) Would establishing a MPL foster more credibility and trust between the industry and consumers?

Advocates like MacKay say that not only would MPL help “remove the question mark” consumers have about product integrity and safety regarding supplements; it could also increase credibility of dietary supplements with healthcare practitioners, who he said “are increasingly seeing [supplements] as legitimate parts of the healthcare conversation” but who are still not sure which supplements are safe and sound for patients. These practitioners might view a federal MPL as a credible way to identify legitimate brands.

Meanwhile, opponents argue that because bad actors will not bother listing their products in a MPL database at all, a database will never in reality truly represent the full scope of the supplements market, and that illegitimate products will still lurk around the fringes. It’s also possible that companies could list their products in a MPL but fail to disclose certain problematic ingredients in their products, even if required to by law. Said Fabricant: “So the notion that this tool is somehow going to get the bad guys? It’s a joke. I wish people would put that to rest. And, you know, if there were a way to hit a reset button on this, that would be great, but I think it’s a little too far down the road right now.”

Moreover, MPL opponents like McGuffin argue that consumers will not, in reality, take the time to search through thousands of MPL entries in order to make purchasing decisions. “It’s not going to be a resource for consumers,” he said.

But an argument in support of a MPL database is that retailers and practitioners would at least have a starting tool to judge which companies might be more reputable (based on their participation in the federal database), and recommend only those companies’ products in the MPL database to customers and patients. The database could give those products more legitimacy and help responsible companies stand out. (Whether the information in a MPL database is accurate—for instance, whether companies fail to disclose illegal ingredients—is another matter that needs to be tackled for a database to work well.)

Does Mandatory Listing Work Elsewhere in the World?

Advocates of MPL point out that some non-U.S. countries already require some form of mandatory listing or mandatory registry for supplement products sold in their countries.

“Very simply, product listing is not new, and it’s not scary,” said MacKay. “Companies are doing it right now to be in international marketplaces. We have very successful dietary supplement companies that are listing their products in Canada and Australia—very successful marketplaces.” MacKay also described an incident he recalled from a past trade association conference where “a very influential Canadian CEO grabbed the microphone during a Q&A, and he said, ‘I’m in Canada. We have a much more rigorous regulatory structure that requires the regulator to know what products and ingredients are on the market, and it’s wonderful. It’s great. It fosters success. It keeps the bad actors out. I don’t know what all you guys are so scared of.’”

Israelsen said similarly, “We also know that our members and many other companies in the industry do business internationally, and this kind of requirement is very, very common. Moreover, we live in 2022 as opposed to 1994. Virtually every company has a website where they very openly display their products, making information widely available. That is a requirement of many of the major retailers, particularly online. And if FDA believes that [a MPL database] would make their work more efficient, to have a better overview of what’s in the market, we think that’s an appropriate request at this time.”

He added: “From a company standpoint, it will be easier to register our products in overseas countries if you have a unique FDA-generated identifier number [which a MPL would provide, according to current proposals]. In a number of Asian markets in particular, that will be very helpful and has caused some difficulties quite recently…China has required, has built a new system similar to FSMA, and they ask for exactly that—an identifier number or other mechanism by which the government can identify your product. And the FDA has had to say, ‘We don’t have that system,’ and had to build a workaround for that.”

But there is also, among MPL opponents and others, a strong belief that history has shown that in this country, the FDA has decades of repeatedly trying to create restrictions around supplements. On The Nutritional Outlook Podcast, McGuffin reviewed some of that history, then said, “So, that’s 1970s, 1980s. You can go all through the 1990s, the mischief that FDA was engaged in in trying out new food-additive theories to come after botanicals, and that led directly to DSHEA. And it goes on—N-acetyl cysteine (NAC) and cannabidiol (CBD), more recently.”

He continued: “So, I think there’s a policy mindset at FDA. It’s not the individuals at FDA [who are biased against supplements]. It’s a policy mindset, and there’s also a tendency—and I think this comes out of the general counsel’s office—to reinterpret [supplement laws] all the time.”

McGuffin also discussed supplement regulations in Canada. While supplement laws in Canada aren’t perfect, he emphasized, the difference between FDA and the Canadian regulatory body overseeing dietary supplements—the Natural and Non-Prescription Health Products Directorate (NNHPD)—is that NNHPD was created as a separate federal agency to oversee supplements—“one,” he says, “that did not have decades of complicated relationships, one that started with a position of supporting that industry and those Canadian citizens who want access to these natural products.”

By contrast, he said, “I don’t believe the Food and Drug Administration starts with the position that [supplements] are valuable.”

Keeping Products Off the Market?

Another discussion focuses on what types of products a MPL could feasibly keep off the market. For opponents of MPL, the concern isn’t so much around some of the more common ingredients in the market like vitamins and minerals—although Fabricant pointed out that NPA in the past has observed FDA turning a negative eye on common ingredients like probiotics. But largely, the greatest concern of opponents regards ingredients FDA does not believe are legal but that industry does believe are legal—ingredients like CBD or NAC.

Those who think FDA has and could again try to restrict some ingredients say industry should not trust FDA not to misuse MPL. “That’s back to, ‘What is the problem?’” McGuffin said. “The problem is an absence of transparency at FDA. They don’t like transparency…[I]t’s very difficult to operate a bureaucracy—and I don’t mean that as anything other than a description—in full transparency. It slows things down. But FDA’s not a transparent agency in any full sense. They have tried at times. They are occasionally, but I don’t think we should consider that a highlight value, internal value, of FDA. I just don’t see it.” This skepticism of FDA is the basis of opposition for MPL detractors based on premarket approval concerns.

MPL supporters also say, however, that they, too, would fight back if FDA tried to overexert the powers of MPL to keep products like CBD or NAC off the market. Said Israelsen, “To the extent that it would affect products like NAC or CBD, that, of course, we would strenuously argue with FDA.”

But also, Israelsen, pointed out, FDA has already tried to ban those ingredients from the market—with or without a MPL database. “As we have seen,” he said, “they’ve done that already, without a mandatory product authority. So, they’ve done it.”

He continued: “We are working very hard to assure that the bill itself would not further aggravate that question of lawful status of important ingredients that are safe, that are clearly dietary ingredients, that have a history of food use or a long history of human use. That will be one of the key issues that we’ll be laser-focused on. But MPL itself, as we can see, would not be the trigger for that, because that trigger has already been pulled.”

Rather, he and other advocates say they support MPL because it could, once implemented in addition to other agency tools, help the agency more efficiently identify and remove illegitimate supplement products from the market.

While some argue that MPL would not filter out bad actors who could illegally lie about product contents when entering product information in the database, advocates still believe MPL could help FDA better oversee the market.

“As I understand it, MPL would create a quicker way to have a look-down for ingredients of interest,” said Israelsen. “[FDA is] not interested in multivitamins. They’re not interested in the majority of products that are sold. But they continue—as we do, as I do—to have a concern about spiked drug ingredients found in supplements and other ingredients that are potentially dangerous, harmful. If MPL allows FDA to speed up enforcement action…I think that’s in fact part of the hope here, is that how do we find a way to sweep out of the market products that are harder to find? So, if they don’t have a unique FDA identifier, the product would be misbranded and mislabeled. That would be a tool for FDA to be able to move more quickly against products.”

“So, once again,” he said, “I do agree that if there were new authorities granted in the bill that we haven’t seen before, I too have a real reluctance to grant that.” But, he said, “Those that are fearing the worst case is that they would use this as a tool to wholesale wipe out categories of products or ingredients? I hear them. I don’t see that as the real intent here.”

Would consumers who don’t use ingredients like NAC or CBD, but who do use mainstream supplements like vitamin D or omega-3s, care that a MPL law could potentially restrict their access to these niche ingredients? Perhaps not. But it’s just as unlikely to think that FDA and the industry will never again lock heads over certain ingredients, given what’s happened in the past and what’s happening currently with CBD and NAC. And, McGuffin pointed out, FDA has in the past tried to change requirements even for standard ingredients like vitamin C.

For those who are worried about the fate of an NAC or a CBD ingredient in the face of MPL, Steve Mister, president and CEO at the Council for Responsible Nutrition (CRN), offered another thought: “I would say that if you are putting a product in the marketplace, you should be prepared to defend the legality of the product already. And you should be proud to have it in a registry. And if FDA does come after you, you should be prepared to defend it.”

He continued: “You know, the interesting thing here is, for many of these products, now FDA could eventually find you if they wanted to, because they could do a Google search, or they could go onto Amazon and look there, or they could go to the [NIH] database, which is voluntary, not mandatory, but you know….So, it’s not like you can hide forever. But what the listing says is, as an industry, we are proud to stand up and put our labels in here. We’re not hiding from the agency. And we’re willing to defend why we’re putting this product out there for consumers to use.”

It remains to be seen whether fears of FDA misuse of a MPL can be resolved and whether that would change opponents’ minds about MPL and overcome their other objections.

Financial Cost

Arguments about the cost industry would incur to comply with a MPL requirement have abounded for years. Now, with the introduction of S. 4090 and the FDASLA, those arguments are ramping up again. Recently, AHPA estimated that initial compliance with MPL as suggested in the current legislative bills could cost industry $20 million.

On The Nutritional Outlook Podcast, we asked McGuffin to discuss more thoroughly how the association came up with this preliminary figure. In its efforts to “pull some numbers together promptly,” he said, AHPA asked a few industry members to time how long it took them to insert data about their company and products. They then multiplied the number of minutes and the number of products a company had by a pay rate ($250/hour) that FDA estimates it costs for the agency to do reinspection of firms, which includes overhead costs and insurance costs.

“This is a very limited study to date,” McGuffin said. The association is now working to bring more companies in to provide cost and time estimates. (McGuffin also emphasized again that AHPA’s primary objection to MPL isn’t the cost to industry; it’s that the association doesn’t see the need for MPL in the first place.)

We also got into an interesting discussion with McGuffin about who should bear the burden of inputting data into a MPL database —that is, any data AHPA feels would be duplicative with what’s already on a product label. One of AHPA’s concerns is that if industry were solely responsible for inputting data into a MPL database that is public facing, private plaintiffs will look for opportunities to point out to companies if they’ve entered information the plaintiffs believe is wrong—and could then sue those companies.

NPA has a similar concern, with Fabricant pointing out that state attorneys general could also bring lawsuits against supplement companies on the basis of MPL info. And cases could be brought even for minor technical errors—such as, for instance, if a listing takes too long to get posted (depending on how efficiently a database actually ends up operating).

“For example, let’s say you sent it into FDA, right?” said Fabricant. “Sometimes FDA is much like the DMV in that they take a little too long to do things. So, you send in your materials for a listing. Now, let’s say it’s just a new flavor, a new flavor is already appearing on the shelves, but FDA hasn’t uploaded [the MPL info] into the system. Well, then, some plaintiffs bars go, ‘Oh my god. You’re got this product out there that’s not on the list,’ and all it is a new flavor. And now you’re getting sued because you ‘defrauded’ consumers in whatever state because you didn’t follow federal law, when in actuality you did but there was literally just an administrative entanglement, which happens frequently with the government…[T]he government’s not infallible, so you have to have protections, and the fact that we don’t…yeah, it could really be misused.” He added: “Really, the architecture of a database—that should be an internal function just like it was for food facility registration.”

McGuffin wondered: If FDA were the one to input some of that information, would those private plaintiffs be less apt to go after industry alone on the basis of the MPL, because FDA would also have had a hand in handling database information? Putting the onus on FDA to input data would also reduce the cost burden of database entry for industry if companies were only required to submit label images but not enter other information into the database.

If FDA were to shoulder the burden of inputting most of the information, would AHPA reconsider its argument against the potential cost of MPL compliance, we asked McGuffin?

He said, “I don’t mind having that burden on the Food and Drug Administration, because I think that again relieves the potential plaintiffs burden on us if the plaintiff’s not able to take the position that all of the information in here was submitted by you; therefore if I think it’s false, I’m going to come after you.”

In truth, it’s difficult to estimate what it would actually cost to comply with a MPL database because the database does not exist. No one knows yet if it would be an easy or a difficult database to use. Even when McGuffin pointed out, to support his earlier argument, that FDA probably has advanced tools at its disposal, such as machine learning, that could help it more easily input information into a database itself, one might ask that if that were true, could machine learning also conceivably make it easier to get information into a database full stop—and less burdensome on anyone in that regard?

No one even knows whether a MPL database would be easier or more difficult to use compared to the existing NIH Dietary Supplement Label Database. And no one knows, should a MPL bill actually pass, what the finalized requirements will be in terms of data to be entered.

Those who support MPL say they don’t believe entering the information will be overly burdensome to the industry. Mister pointed to CRN’s feedback on costs when the association created its own Supplement OWL product listing database three years ago, which is mandatory for its members.

“We’re also seeing things about, ‘Oh, it’s so burdensome to the industry,’ and ‘It’s going to cost people a gazillion dollars.’ You know, we’ve been doing the Supplement OWL for three and a half years. We require more information in the Supplement OWL than either the Durbin bill or the HELP Committee bill,” said Mister. “And we have companies of all sizes that are participating in the OWL. Many of them are not even our members. We have a lot of non-members who wanted to be in the OWL, and we let them in. You know, there’s no charge to be in there.So, we’re very confident that companies of all sizes can comply without this breaking the bank. And I just think that argument—it’s an easy straw man to put up: ‘Oh, it’s too burdensome. It’s too expensive.’ We know from our experience—that’s one of the reasons that we did the Supplement OWL—it does work.”

When asked whether CHPA has heard opposition to MPL from its members based on the potential cost of compliance, MacKay said, “Well, most CHPA members are already engaged in some form of listing of their products, whether it be through the NIH Dietary Supplement Label Database…They’ve become very accustomed to working with the Therapeutic Research Center, providing labels through manufacturers direct, and that’s just become operational at this point. Again, many CHPA members are both in the over-the-counter medicine as well as dietary supplement arena, so they’re registering their products in those cases, [and] many CHPA members have international footprints and so they have people who are accustomed to doing international listings—and in some countries, it’s even more rigorous….And so, I’m seeing a little bit of playing with words when the people are trying to drum up a bunch of fear: ‘Let’s stop this thing. It’s the end of the world.’”

MPL Is Part, Not All, of the Solution

If there’s something all parties can agree on is that MPL is not a solution in and of itself for ensuring product safety in the supplements industry. Many associations agree that there are other modernizations that need to take effect to bring supplement regulations in line with the state of the current supplement—and drug—markets.

For instance, many say the drug-preclusion clause that prohibits ingredients to be marketed as supplements if they were ever, at one time, publicly studied as drugs, needs to be reexamined.

Another point is that a mandatory product listing would do no good if FDA does not then have the tools to follow up with enforcement. In that vein, a MPL database alone does not in and of itself represent improved market regulation.

Said MacKay, “That is our colleague and strong critic of the industry, Dr. Pieter Cohen’s, opinion. He says, ‘Well, wait a minute. If you do a database without these other things, you’re not improving the industry, but you’re giving this false sense that there’s a rubber stamp, that FDA has seen these products.’” One can’t argue with that.

To that end, MacKay and others (both those who advocate for and against MPL) would like to see additional FDA enforcement of bad actors. Some believe this can be done if FDA were to use its existing enforcement tools more actively.

Inspections also play a key role given that FDA only inspects a fraction of supplement facilities each year. If accredited, third-party inspectors could help FDA increase those inspection rates, that would help clean up the market (with or without MPL in place). CHPA is one association advocating for this. Said MacKay, “Without additional inspections, without something that can assure us of higher levels of product integrity and safety, there’s the possibility that [MPL] becomes a false sense of, ‘These products are awesome.’”

He said MPL “doesn’t address the issues of product integrity and product safety. So, it’s on equal footing, and what we’re looking for is a more comprehensive modernization of dietary supplement regulations—changes that would do things, important things, like fill inspection gaps. As we know, FDA is not currently inspecting enough facilities every year, and that would do so much if we knew that qualified people were in these facilities ensuring that processes and trainings were aligned with high product integrity, high product safety.”

Even if some see these enforcement tools as going hand in hand with MPL, the reality is that modernizing supplement regulations in the way the industry would like to see—or even FDA would like to see—will not happen all at once. So, for those who support MPL, is it just the first step on the road to regulatory improvement, even if MPL can’t operate alone in policing the market once passed? Is it a matter of taking change one step at a time?

Here’s what MacKay said. “Unfortunately, we have a lot of voices in the industry, and they’re not all marching to the same drum right now. And a little bit of that is this disagreement of, ‘Should we work on this incrementally? Should we get mandatory product listing now and something after and something after? Or, do we wait for a comprehensive package and push that through?’ And so, there’s some disagreement about what is the most efficient way to get to where we want to go.”

He continued: “There are those people who say, ‘No, we don’t want anything. We just want status quo. This industry’s great as it is. We don’t have any problems.’ And, I think that’s ignoring the fact that retailers have to put in programs to assure [consumers] that they’re buying legitimate and high-quality, pure products. That doesn’t happen in other industries. Retailers don’t feel like there’s a gap where they have to add a layer to it for over-the-counter medicines. And so, status quo is status quo. I think we will—let me flip it over. A lot of people feel like as science evolves, as we get more legitimate, as we have ingredients like omega-3s and vitamin D and probiotics, that we have the potential to play a larger role in the healthcare conversations. We have a potential to have our products be a more mainstream part of prevention and wellness, accepted broadly by physicians. We won’t get there with the status quo. We need better assurances of transparency, product integrity, and product safety if we want to be accepted by the healthcare systems of America, to be part of the healthcare solution.”

Discussions Continue

Writing this article simply drove home one fact: It’s clear that there are so many unknowns about what a final MPL database could look like, what final legislation could look like, how a database would work in actuality, and whether FDA could follow up with the proper enforcement tools. It’s also important to remember that developments around the current legislation change constantly, so at this point, even industry leaders say there’s no real way to predict whether or not one of these bills might actually pass, or how their language could change. No one really knows how this will end up, and despite the public juxtaposition of association positions on MPL, the discussions continue, with some parties doing their best to maintain an open mindset.

For instance, said McGuffin, “I can’t really speculate where, at what point, if ever, AHPA would move from ‘oppose’ to either ‘passive’ or ‘support’. But certainly, our view is, ‘Let’s do it a step at a time. What’s the next step?’ Again, if what we saw was a redraft of one of these bills to trim it back to label only, and the proprietary blends [information is] not demanded, and the public-facing database is gone, then we’re going to have a meeting of the board. We’re going to decide what our current position is, because our position is that we oppose these bills. Conceptually, MPL, we don’t support. We would really like somebody to give us a more meaningful expression of support…You know, maybe we would come to be convinced that there’s a meaningful increase in FDA’s ability to make risk-based enforcement priority decisions [with a MPL database]. But, we would prefer more clear communication of how that would actually manifest, because to date we just hear words that are intended to sound meaningful, but we haven’t been able to grasp the meaning yet.”

Industry leaders will continue working lines of communication within the industry as well as on Capitol Hill. Israelsen perhaps put it best when he framed today’s MPL debate within the history of supplement regulations. “Knowing our industry as I do, I love the fact that everyone has a passion,” he said. “Everyone has an opinion. And there’s a wide range of opinions, and there’s a lot of passion behind those—and there was, during DSHEA, far more than people remember or realized. So, the active debate going on now is very much in the spirit of wanting to reach an objective that serves and protects consumers. But there are different paths and different ideas of how we do that. So, I respect the fact that there are lots of different views on this. That creates for a more robust discussion, and that usually produces better legislation in the end. We’ll continue the discussion as the summer proceeds…[T]he fact that it has this much energy in the industry and people are emotional about it, it tells you something important is going on here. It’s been a while since we’ve had a bill that’s generated this kind of response.”

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