CRN Seeks Industry Alignment on Drug Preclusion Reform to Safeguard Supplement Innovation

Speaking at SupplySide Connect New Jersey, Megan Olsen, the SVP and general counsel for the Council for Responsible Nutrition (CRN), discusses the organization’s priorities as the dietary supplement industry navigates an increasingly complex regulatory landscape.

She highlights the interpretation of the drug preclusion provision within the Dietary Supplement Health and Education Act (DSHEA), for example. Olsen describes this provision as effectively a “race to market,” determining whether an ingredient can be sold as a dietary supplement or must be regulated as a drug based on which category establishes precedence.

To address this, CRN is working with industry stakeholders to build alignment around potential legislative solutions, while also considering the perspectives of pharmaceutical interests.

Olsen emphasizes that innovation remains a central focus for CRN, but one that must be supported by clearer regulatory pathways and consistent enforcement. She underscores the organization’s long-standing position that the FDA should take stronger action against bad actors, while allowing responsible firms room to innovate.

A transcript of his conversation can be found below.

Nico Saraceno: Beyond the New York case, obviously CRN has been very active across various scientific initiatives and policies, including federal regulatory advocacy, and new scientific communications efforts. That was a, that was a doozy. But that kind of, I think that kind of puts it in a nutshell. Where do you see, in your opinion, the greatest need for industry alignments or any sort of regulatory clarity right now?

Megan Olsen: So a couple areas and I think, as we'll talk about throughout our conversation this morning, innovation is a clear area that CRN has been focused on for a number of years, ensuring that there are clear paths for innovation, that there's flexibility, but reasonable requests for what we're asking for out of whether it's FDA, Congress, state legislators, you know, it kind of ties in with enforcement as well, because we've always advocated for strong enforcement from FDA against the bad actors. We are not representing those unscrupulous companies that are, you know, putting out products out there masquerading as dietary supplements. So we have a, we have a couple of initiatives. Of course, we, we're among many, many things we're working on.

But we're, you know, I think one thing we're looking for currently right now is alignment around how we, I think, balance the drug preclusion section of DSHEA with drug interests. And so this is actually an interesting one because it's alignment within the dietary supplement industry. But I think it's also ensuring that we don't have strong pushback and potentially buy in from the pharmaceutical industry. We know that there are companies that sell both dietary supplements and drugs.

We've always been very clear when it comes to this provision, which is, what it really is, is a race to market provision for, did the dietary supplement get to market first? They can stay on even if something is also being investigated or used as a drug. But if the drug gets to market first or is investigated first, the dietary supplement has to take a back seat and in fact, try to get FDA to create a rule, that will allow them to sell it. So we, you know, we're working with other trade associations.

We think that the time is ripe. We've tried to get FDA to really hone their interpretation of this rule, to see if there was any way we could create a more balanced interpretation. FDA has been very clear that they think their hands are tied with the way that the the law is written. So we think the time is ripe to introduce legislation in Congress.

However, whenever you're going to Congress, it's very important to have a united front from the industry, but also understand where we could get pushback from those that could oppose this. So, so I think right now, that's a very important area to ensure that industry is aligned with our asks and to understand how we can do this in a way that is balanced. We're not trying to encroach on drug interests. We're not trying to take away from their ability to, you know, have incentives to do research, to innovate.

But we do want to make sure that we are not going to introduce legislation that would run up against some of the same obstacles that we're seeing now, which is really, unfortunately, stifling innovation in the dietary supplement space, because there's a lot unknown about how FDA will say, well, an ingredient out there is being studied. You may not have known it was being studied because it's part of the FDA's IND approval database and until it goes public, FDA's interpretation is saying that once it goes public, they can essentially backdate the time that the dietary supplement had to make and market to that secret end date. So that's really concerning because it gives it doesn't give companies a way to say for sure, if I bring an ingredient to the market, there's no drug interest that's going to remove it.

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