OR WAIT 15 SECS
Jennifer Grebow is editor-in-chief of Nutritional Outlook.
A mandatory federal registry might give FDA a better idea of which dietary supplement products are on the market, but will the agency have the resources to pursue bad actors?
Should FDA create a mandatory product-listing database in which dietary supplement companies can list the products they sell at retail, giving FDA a better idea of which dietary supplement products are on the market? It’s a question being discussed now among some members and leaders of the dietary supplements industry. I’ve also written about the discussion more often in recent months. (Here, here, and here.) At the Council for Responsible Nutrition’s (CRN; Washington, DC) annual The Conference in California in October, a panel debated the topic.
Two panelists-attorneys Scott Bass, partner at Sidley Austin LLP, and Anthony Young, partner at Kleinfeld, Kaplan & Becker-argued the pros and cons of such a hypothetical mandatory listing database. They also debated the pros and cons of an alternative: the industry-led, self-regulatory product-listing database in the form of the Supplement OWL registry that has been operational since CRN created it last April. As discussed below, both of these options have potential strengths and weaknesses.
In Favor of a Federal Listing
First and foremost, a mandatory federal listing would, as mentioned above, give FDA eyes on what’s on the market. All dietary supplement products that are on the market would theoretically be required to be listed in this FDA database. If the agency finds a product that isn’t listed in the database, it would know that a company is out of compliance with the listing requirement.
Such a system makes outliers more visible to the agency, Bass argued, and helps the agency better funnel its enforcement efforts so that it can pursue bad actors accordingly. “The beauty of this mandatory listing…is that it just makes it easy within FDA, taking very few resources, to cite a company for not listing,” Bass said at The Conference. “It gives the opportunity to FDA to investigate much more selectively…and then they can focus their resources. It’s a no-brainer.”
In Favor of a Voluntary Listing
Rather than favoring a mandatory listing, Young said that a voluntary listing like the Supplement OWL is preferable-and that it can work as other voluntary programs in other industries have worked.
“There’s a rich history of self-regulation” in many industries, Young said. He pointed to various industry-led self-regulatory initiatives that have been in operation for decades. One is the Cosmetic Ingredient Review, which was created by the industry trade association the Personal Care Products Council (PCPC) in 1976, but that operates separately from the association and that has the support of FDA. The Cosmetic Ingredient Review enables companies to share information on their product ingredients, and allows expert panels to review information on the safety of ingredients used in the cosmetic and personal care market. Another example Young cited is the industry-led National Animal Supplement Council, which helps oversee the safety of dietary supplements for animals, a product category not officially recognized by FDA’s Center for Veterinary Medicine, where animal products are only classified as food or drugs. Both of these self-regulatory initiatives came from industry and are voluntary, Young pointed out, and they have effectively worked to capture majority participation by their respective industries.
Young then pointed to existing listing resources the dietary supplements industry already has at its fingertips. One is the aforementioned industry-led Supplement OWL. The other is the National Institutes of Health’s Dietary Supplement Label Database, which lists a number of dietary ingredients and specific products on the market. The database captures “the labels of about 17,000 dietary supplements,” NIH says. Like the Supplement OWL, the NIH’s Dietary Supplement Label Database is a repository for label information only and does not reflect the legal standing of any products or ingredients therein. Indeed, NIH states, “All information contained in the Dietary Supplement Label Database (DSLD) comes from product labels. Label information has not been verified or checked for conformity with existing U.S. Food and Drug Administration (FDA) regulations.”
Young also mentioned the fear many have that FDA would use the information in a federal listing to police the dietary supplement industry in other ways detrimental to industry. “I just don’t think FDA can put blinders on to the information received,” he said. “They will look at this information. They will use it down the road. There will be a creep. That’s what happens with all of these systems. There’s a creep.”
Where Are the Bad Actors?
Whether voluntary or mandatory, no product listing system will solve all regulatory problems due to a likely reason: non-law-abiding entities will not surface to participate in a listing system of any kind. Even with a federal registry in hand, FDA will still need to search, somehow, to find these bad actors.
During the panel debate, Young was adamant on this. These “bad boys and girls-these are criminals,” he said, who “will not register their products. And so, this system is not going to create, even by omission, a help to FDA in finding those companies.” (He also said he believes a listing system would "inhibit" small businesses. He added: “I think it will cause companies to think more about the ingredients they put into their supplements because they’re going to have the added concern that they’re sending [the information] to the government.”)
Bass maintains that a mandatory listing would help FDA. “If you have a system like this…[FDA] can merely say, ‘It’s not on the list,' and therefore we go after the source and expend our enforcement resources” accordingly, he said.
The existence of a federal listing system could help quiet some critics who claim that the dietary supplements industry is not operating transparently or regulated effectively. Bass said, “The only way we’re going to combat [the continual onslaught of negative press circulating around the dietary supplements industry for many years] is to say, ‘We’re now giving FDA the ability to see what’s there, to know what the bad products are, and to go after them…We’re giving you everything you need; go get them.’ And then the story shifts to the people who aren’t getting them.”
Young said he doesn’t believe a mandatory listing would cease detractors from criticizing the industry. “I just don’t think it’s going to stop anything.” He added, “We have a situation where our FDA has a limited, very limited, scope in terms of how it can enforce. So if there’s a registration system, and we go through all the trouble of registration, I don’t have any belief that that’s going to help FDA in its law-enforcement mechanism. I also don’t believe it will stop The New York Times and other of our detractors…”
But Bass argued that the onslaught of negative press will continue “unless we do something and do something now and let people know we’re taking charge of our future. In my opinion, there isn’t a choice…I think the only way we’re going to take ourselves out of the negative spotlight, out of the increasing efforts to put us into a premarket approval system, is to take charge and give the government the means to find the really bad players.”
The Enforcement Question
Does a mandatory registry give FDA the means to find-and, more importantly, to catch-bad players? Alone, a federal registry will not be effective in policing the market if FDA does not have the resources to search for and enforce against companies who fail to list their products. FDA itself has noted that it has limited resources. Would there be other ways to get FDA the additional funding it would need to pursue registry offenders?
One option, Bass said, would be for Congress to provide the agency with additional funding. “My view would be that Congress would be more than willing to publicly fund given the pressure that’s been brought by not only the press but by a lot of constituencies, like [U.S. Senator Dick Durbin; D-IL], who are constantly pressing for this kind of thing,” he said.
Another proposal circulating among industry is the notion of user fees: a fee companies would pay when listing their products in the federal database. Users would pay the fee and, perhaps, receive a number from FDA indicating that their product has been listed. In a previous interview with me, CRN’s president and CEO, Steve Mister, likened this kind of system to the system of getting a birth certificate: companies would automatically get a listing number upon adding themselves to the database, with no product scrutiny, judgment, or withholding of a listing number from FDA of any kind.
Other industries pay administrative fees of a similar nature, so it is not unthinkable that it could work in the dietary supplements industry. I spoke to Mister on phone after The Conference. He pointed out that such fees could be “earmarked” to guarantee that they would only be used by the government for enforcement of the dietary supplements industry. “So whatever money that gets raised in fees is used to give FDA additional enforcement. And that would be your revenue stream to ensure that FDA does have people that can go out and enforce the registry requirement.”
Mister pointed out some other industries where FDA imposes fees. For instance, he said, when drug companies submit a new drug for review by FDA, they are required to pay a fee. He said that, in return, companies “are guaranteed a timeline in which the drug will be reviewed…[So] there is something in return.”
“Those fees come with a guarantee that the money will be used in that industry,” he said.
I asked Mister whether he thinks a mandatory listing requirement (which, for the record, CRN has not endorsed or taken a position on to date), backed by the enforcement resources from user fees, could actually work. Could this scheme actually give FDA the power it would need to go after bad actors on a registry basis? He said that he does think it could work.
Waiting for Self-Regulation to Work
Some, like Young, still opt for the voluntary, industry-led option. At The Conference, both Young and Bass complimented the Supplement OWL. (Bass called it “a terrific first step,” noting that “it could be a model for how we turn [toward] a mandatory system.”)
Young argued for sticking with a voluntary system like the Supplement OWL. “I think our best argument would be the voluntary system, the OWL. It’s working, and we can make that voluntary system stronger within the industry.” He added: “A voluntary dietary supplement program registration has a strong foundation in the OWL and in the NIH Dietary Supplement Label Database.”
But how long would it take for the majority of industry to get on board and to list their products in a voluntary industry registry? The Supplement OWL was born last April. Already, the number of labels in the OWL is approaching 12,000-but there are still many companies who have not yet joined the OWL. CRN is working hard to increase participation, the latest news being that the association has initiated a pilot program to encourage more companies to participate in the Commercial Data Exchange arm of the Supplement OWL.
In order for a voluntary listing system to convey to FDA and the public that the whole industry is being transparent, everyone, ideally, will need to participate and list their products in the voluntary registry. If not, a listing system will not be able to make the argument that it is giving FDA a substantial look at what is on the market.
“The primary difference that I see between a mandatory registry that’s run by FDA versus what we’re doing with the Supplement OWL is the ability to compel companies to put their products in,” Mister told me. “As an industry initiative, we don’t have a stick at the end of the day that we can use to force somebody to do this. So we try to create lots of carrots that encourage people and incentivize them to get into the Supplement OWL. But there is nothing hanging over their head if they choose not to. A mandatory registry, run by FDA, would presumably have the ability to compel companies to get in and have some kind of regulatory consequence if [companies] did not [participate].”
He added, “There would have to be some provisions in this that would have some consequences for companies who don’t bother to register. I think there are a lot of options out there that we have to talk about. But there would have to be a consequence for companies that didn’t register; otherwise, it’s no different than the Supplement OWL.”
Voluntary or mandatory: those are the choices industry is discussing now. As the debate goes on, one question that comes to mind is how long the industry is willing to wait for a voluntary listing process like the Supplement OWL to reach critical mass and to reach a level of industry participation to make the registry truly effective. As the voices of industry critics get louder, should the industry wait for a voluntary, industry-led option to scale up-or should it opt for a mandatory listing instead?
It’s also worth noting that even as the Supplement OWL builds industry participation in real time, a mandatory federal listing is still hypothetical. There’s no telling how long it would take for a mandatory listing to pass through channels-not to mention to be authorized and created. The Supplement OWL is operational now and is setting an example of how a dietary supplement listing process can work. (There are also discussions of how the Supplement OWL could, having figured out how to make an industry listing successful, serve as a model framework for any federal listing system down the road. Mister said: “I’m not saying we will, but we could hand off the Supplement OWL to FDA and say, ‘It’s now yours. We’ve done the hard work. We’ve created it. We’ve figured out what works and what doesn’t, and we will give it to you if you will enforce it and keep it up.’”)
Again, Mister pointed out, CRN does not have an official position on a mandatory registry. He said, however, that the decision on whether or not to embrace a mandatory federal listing should not be based on how long, by comparison, an industry-led initiative like the Supplement OWL will take to grow.
“That decision should not be based on how long we think it would take for the Supplement OWL to scale up to represent the whole industry,” he said. “Either we think a mandatory listing is a good thing intrinsically, or it’s not.”
As for CRN and its work on the Supplement OWL, he said, “We’re going to move ahead with this because, whether FDA ends up doing [a mandatory registry] or not, we think that it is very important that there be a product registry.”