Is it time for FDA to change dietary supplement regulations?

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When FDA Commissioner Scott Gottlieb, MD, announced in February that the agency intends to “strengthen” dietary supplement regulations, those I interviewed for this article reacted with a sense of calm and-dare I say it-optimism.

This is not necessarily the reaction one might expect when the FDA commissioner starts talking about “taking a close look at our organizational structures, processes, procedures, and practices in order to modernize our oversight of dietary supplements.” After all, the dietary supplement industry has been extremely protective of the Dietary Supplement Health and Education Act (DSHEA), which Congress passed in 1994. This primary law governing supplements ensures that supplements are not regulated like pharmaceuticals; they do not, for instance, require premarket approval from FDA before going to market. DSHEA has allowed dietary supplement companies to ably bring products to market and ensures that, for the most part, consumers can readily access and purchase supplements. In the dietary supplement industry, any talk about making changes to DSHEA is not made lightly.

In his February speech, the commissioner pointed out how vast the dietary supplement industry has become since DSHEA took effect in 1994. In the 25 years since, the U.S. supplements market has grown from a $4 billion entity comprising 4,000 products to a $40 billion industry comprising anywhere from 50,000 to 80,000 or more products, Gottlieb said. “I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” he said. In his speech, Gottlieb announced a few key actions FDA has taken so far as the agency starts down the path of strengthening supplement regulations. Read more about those actions here.

Gottlieb pointed to the growing number of adulterated and misbranded products on the market, which, he said, “creates new potential dangers,” necessitating FDA to take a fresh look at its abilities to regulate the market. And while that all sounds very dark, those I interviewed for this article sounded guardedly optimistic, for reasons discussed below. I spoke to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), as well as attorney Scott Bass of Sidley Austin LLP, who helped draft DSHEA in the 1990s.

Both pointed out that the commissioner opened his speech by calling dietary supplements “a routine part of the American lifestyle.” Not only that, Gottlieb, who is also a physician, affirmed-as he has in the past-that he is a supplement user himself: “I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as part of a comprehensive care plan. It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy,” he said.

To CRN’s Mister, “The thing that struck me most about this statement was the amount of effort that was put into actually recognizing the value of supplements. I’m not sure I can remember an FDA commissioner being so positive about this marketplace….I can’t remember an FDA commissioner who has validated dietary supplements as being part of the healthcare system the way this statement does. For me, that was a pleasant surprise.”

Bass pointed to other positive takeaways from the commissioner’s statements, including his expressed intent that FDA will, as part of the entire process of reevaluation and modernization, be looking into updated technologies that exist today for evaluating the safety of supplements.

Most strikingly, however, both Mister and Bass agreed with the commissioner about the need to determine whether or not DSHEA should be amended for today’s modern market.

According to Mister, “It’s not unusual for FDA to come back and revisit something after 25 years. Certainly there are changes. When DSHEA was passed, there was no Internet, and there was no e-commerce, and now that is a prominent part of the industry. We need to be sure that FDA has both the resources and the tools to deal with online claims with e-marketing, which makes it very easy for companies to come into our space. It used to be that there was always the gatekeeper-the retailer-to get on the shelf, and retailers would often say, ‘We’re not going to carry certain things.’ Now, you come up with a product and you create a website, and you’re on the market.”

Discussions about changing DSHEA-or, what some call “DSHEA 2.0”-have been circulating within the industry for years. For the most part, however, in public statements most industry leaders have focused on stating the need for FDA to enforce existing supplement regulations more fully. Gottlieb’s statement, however, has put the topic of modernizing DSHEA front and center.

Bass said that he and others who helped craft DSHEA have generally taken the position in the past “that DSHEA shouldn’t be touched because of concerns that it is a very well-written law. The house is sturdy, and you don’t need to change it to effect certain upgrades.” However, he says, “I think what you’re seeing is that nobody’s saying that right now. I think everyone agrees with FDA that things have changed, and they’re now willing to take a responsible position…”

For now, it’s unknown what kinds of changes FDA will end up enacting down the road. As such, the consensus in industry is to withhold judgment…and to stay calm.

“I am not suggesting that we’re going to just accept everything that comes out, but until we see the proposals, I think it’s a mistake to express all sorts of alarm and concern,” said Mister. “We might find that we agree with the agency.” The devil, he said, is always in the details. Mister added, “There are some things that I’m sure industry will want to bring to the table that we’d like to see changed. So, is there a willingness to have a discussion about the things we think need to be changed?”

Bass indicated the industry’s willingness to listen-“with safeguards.” He said: “You still want the same safeguards that there is no premarket approval.”

But ultimately, he said, “I think there’s a feeling that it’s time and that so many of us now believe that DSHEA 2.0 is a viable objective if it can be passed in a way that doesn’t take away the freedoms that were won in DSHEA.”

While there are some industry members who remain fearful of an antagonistic relationship between industry and FDA, such as during the pre-DSHEA era, there are others who believe “FDA’s not coming in as an oppositional party” this time and that “with the proper safeguards and the proper attention to Capitol Hill,” change could be positive, said Bass.

Such optimism may not be ill-placed. In his speech, Gottlieb made statements that indicate, for now, his willingness to include the dietary supplement industry in efforts to bolster the regulatory framework and balance consumer access with safety-and to see the dietary supplement industry thrive for decades to come. “We’re interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years," he said.

For now, industry and FDA are tentatively on the same page. Said Bass: “I think we are all joined in a common purpose of finding an improved regulatory scheme.” The most optimistic end scenario could be a safer, better marketplace for dietary supplements, which benefits all of us who consume dietary supplements-industry members, regulators, and everyone in between.

Jennifer Grebow
Editor-in-Chief