NutraIngredients-USA had a front-row seat to the fireside chat from the Council for Responsible Nutrition’s 50th anniversary conference that featured Steve Mister, President & CEO of CRN and Robert Califf, MD, Commissioner of Food and Drugs.
What do structure function claims mean?
While Dr Robert Califf admitted he doesn’t take dietary supplements, he did say that walking down the supplement aisle can be confusing.
“When I walk down the aisle, I see a lot of these structure function claims. And I have no idea what they mean. Maybe you understand it, maybe you can explain it to me one day. In my view, if you ingest something, it makes your health better, it makes it worse, or it has no effect. And we know how to measure whether health is getting better–it's not a secret. And structure function claims, that's the law. And so, we play by the rule book, that's one reason I went out of the way to make that point. So that is the law. But I don't know, the one I love to talk about is it makes your prostate health better. I don't know anything about that, I'm 72 years old, you tell me what that really means. And when you start to tell me what it means, then you have some health benefits that are measurable.”
Califf would love if the industry spent more time on research
The FDA commissioner would appreciate it if the dietary supplement industry used its resources to conduct more research.
“I would love it if the industry spent more time actually measuring what the health benefits are in reliable ways. We're getting so much better with the data now, before it was impossible, before you’d say it would take thousands of people. And you know, you can't handle the data now that it's going to be less and less expensive.”
He supports MPLs
Califf often likened the FDA to referees and made several analogies to sports teams throughout his chat, including this one about mandatory product listings.
“So I think there's agreement across FDA [of things] that we would like to see–there are no surprises to you. And very high on the list is basically registering what's in the stuff that's being sold. I don't know, I'm just a country doctor from South Carolina, but I sort of feel like you if you go to buy something, it ought to be properly displayed just what the heck it is that you're buying. What's in this stuff? And there ought to be a registration process that enables access to regulators. I mean, imagine you were playing a football game. You said, well, we're going to have some kind of a jersey. We're not going to give them a number, but he's going to appear somewhere on the field at some point in time. And that's not a way to have something that people can understand and where it's a fair game by the rules. So a registration, say what's in your product.”
Califf added that the FDA would like to do a lot more with regard to the bad players when it's found that what’s advertised doesn’t match what’s in the product.
Califf supports innovation, can’t talk specifics
Mister brought up the idea of revisiting DHSEA’s “drug preclusion provision” that gives drug developers a monopoly over an article if they bring it to market first or conduct substantial clinical investigations on it prior to the ingredient’s arrival in the supplement market.
Mister asked if Califf sensed any interest within the Agency to look at pharmaceuticals and supplements to determine if it's the right balance.
“Well, as you well know, there is a citizen's petition right now in the House, so I can't talk specifics. Let me just make a few general points. But let me just say that FDA at its best promotes innovation. It's actually on our mission statement, but you'll see it there. So in general, we are in favor of innovation. And this American society right now, needs innovation.”
Califf then referred the audience to a Washington Post article about life expectancy that he said “may be the most important article this year in the press.”
CBD will require different framework
The commissioner said the FDA does believe that the uncertainty surrounding CBD is not good for the industry, the Agency or the public and said it does need to be resolved. But getting to that point will not include regulating CBD as a food or supplement.
“I can't say exactly what it should look like. That's going to be a matter of negotiation with the many players. But let's consider the factors that can go into these considerations. The first is that we’re really trying to see if we could regulate these substances as supplements or food. And unfortunately, in our deep dive, we've been doing research with funding from Congress and we find that there are issues with liver function tests, in animal models, [and] with male fertility. And other safety issues that just make it so they can't be regulated as dietary supplements or food. And so that leaves us in a situation where we need to get a different pathway because the sort of risk-benefit equation doesn't come into play with a lot of these things like it does with drugs. Where many drug benefits are very palpable, but they're also very clear of risks when you balance those two.”
Califf signs off by reminding industry to research, read
When asked for any final thoughts, Califf referred back the need for better research and his favorite article.
“I hope that in the case of our supplements that have a health benefit that we'll see better and better evidence that makes the criteria for definitive evidence so that we can reinforce it to the public. And again, we've got to do something about what's happening to the health of America. Please read the Washington Post articles. Then carefully evaluate it. I'm a sports guy. I’m used to being number one in the league. We won the to state championship when I played basketball. How can we be in last place among high-income countries in the United States in the status of our health? And that's where we are.
“So I hope that you all would do your part, not just to sell stuff, but to let people know what's in what you're selling, and do as much research as you can to get truly balanced scientific answers about the benefits and potential risks.”