Discussing HSAs/FSAs, CBD, NMN, and drug preclusion with The Council for Responsible Nutrition: SupplySide East 2023

Steve Mister, president and CEO of CRN sits down with Nutritional Outlook at SupplySide East 2023 to discuss the recent Ipsos survey the group commissioned with CHPA, as well as what industry might expect from lawmakers and regulators on CBD and NMN.

Interview transcript:

Nutritional Outlook: Can you tell us about the recent IPSOS survey and what CRN learned?

Steve Mister, president and CEO of The Council for Responsible Nutrition: So, we've been doing some some research looking into how consumers use their flex spending accounts (FSAs) and healthcare savings accounts (HSAs) to make those decisions about what kinds of medica lexpenses that they're using that pre-tax money for. We've just released a survey this morning that looked at consumers and the outcome is that consumers overwhelmingly want to be able to use those FSA's and HSA's for dietary supplements. Right now, as a general rule, consumers are not allowed to use their FSA's to purchase their vitamins and other kinds of supplements, but it's very clear that consumers want to be able to do that.

But the other side of that equation is well if the law were to change and consumers were suddenly allowed to use their accounts for vitamins and minerals and supplements and things like that, would that grossly affect how much money they're putting into the account? And the answer there is isno actually. Consumers want more flexibility, but that doesn't necessarily mean that they're going to put a lot more money into the account.

Which is a good thing for Uncle Sam because one of the concerns that some members of Congress have is that if all of this money were going into FSA's and HSAs, pre-tax, would the federal government lose money because of that and the bottom line is that yes, consumers want that flexibility, but they're not going to put a lot more money into the accounts.

NO: What is the future of cannabidiol (CBD) legislation given FDA’s conclusion that it requires a separate regulatory framework from DSHEA?

SM: You know, actually, I think the FDA's announcement back in January increases the likelihood that one of these bills will pass because there were a number of members of Congress that we talked to over the last year about CBD, and they kept saying we need to let FDA have a chance to do something, we needto let this play out,let the agency try to resolve the problem.With the decision in January, it'svery clear that FDA is not going to solve this problem.

They have kicked the can to Congress. So, I think in many ways it helps us with Congress because now they realize that if somebody's going to solve the problem and create a regulated marketplace around these products, Congress is going to have to be the one that sets that direction.

NO: Does CRN prefer “The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2023” over the “CBD Product Safety and Standardization Act of 2023”? If so, why?

SM: So our feeling about CBD is that it should be treated like any other constituent of a botanical [because] it clearly falls within the definition of a dietary ingredient.And so, what we're looking for is legislation that is the least disruptive to the existing marketplace and the existing regulatory framework.

There are people who want to include CBD and food products as well, and we don't object to that, but we think that maybe taking on a bigger burden than we need to.Let's try to establish a regulatory pathway that brings CBD into the dietary supplement marketplace and give that a chance to work before we take on too much.

So, our mantra is let's look at a regulatory structure that preserves DSHEA, preserves all ofthe regulatory safeguards that are in place for dietary supplements and simply applies that.

NO: What are some lessons from FDA’s NAC decision that will inform how industry deals with FDA’s decision that NMN is not a dietary ingredient?

SM: I think the one lesson that the industry needs to take away from this is that we cannot deal with this problem on a piece meal basis.The drug preclusion issue is also at the heart of the CBD conversation as to whether or not CBD was precluded because of the drug companies work on Epidiolex.

Now we're seeing that we saw it with NAC.We're seeing it with NMN. We cannot thinkthat we're going to solve this by getting enforcement discretion one ingredient at a time, because any time FDA gives us enforcement discretion on one ingredient, then there's going to be the next one and the one after that.

So,we're really looking at how do you solve drug preclusion on a more global basis.That may mean, again, legislation, and maybe having Congress revise the statute to make it very clear what the balance is between pharmaceutical interest and supplement interest.

But for us, the NMN situation is just another indication of a much bigger problem, and we need to solve how FDA has weaponized this provision to protect drug interests at the exclusion of dietary supplements.

NO: What does FDA get wrong about drug preclusion? What needs to change?

SM: Well, I think we would agree with the intent that Congress had back in 1994. There need to be some guardrails that do protect the considerable investment that drug companies make when they bring a new drug to market.

So, it's not that we want to completely undo drug preclusion. I think what we want to do is we want to right the balance.So, you know if a drug company looks at a molecule, they do some work and then it sits for 15 years and that molecule is never commercialized, it should come back into the supplement industry. If the drug company does a phase one clinical trial and then never does anything beyond that, that should not satisfy the requirement that there is substantial clinical investigations.

So again, we just need to kind of right the balance between the two interests. FDA is also saying that if an ingredient is marketed as a supplement, it has to be marketed in the US and it has to be marketed legally, meaning that if you didn't get an NDI when you started selling the ingredient, well, that wasn't legal marketing.

So the drug companies can take that article away from you. These are things that need to be rebalanced so that the supplement interest in protecting innovation is given some consideration in the deal and right now, it's out of whack. All the interest is on protecting the drugs.