DELIVERED THURSDAY, OCTOBER 9, AT THE RITZ-CARLTON, ST. LOUIS
Good morning. Thank you all for being here.
“Why can’t you just meet me in the middle?” Seems like a fair question, doesn’t it?
When we chose this as the theme for CONVERGENCE ‘25 months ago, we intended it largely to connote the physical location of St. Louis. Central…Middle Ground… Easy to get to. But in the months since then, our theme for the conference, “Meet in the Middle,” has taken on a more significant meaning.
Couldn’t we solve a lot more problems if we would just meet in the middle?
Last year, when we gathered in Salt Lake City, we were on the eve of a presidential election. Many of us in this industry thought (regardless of our politics) that we were on the verge of a new era for dietary supplements and functional food. If you shared that view, you had good reason to feel that way. Last October 25th, just one week before the election, RFK Jr. tweeted that “FDA’s war on public health is about to end.” He promised to stop the “aggressive suppression” of among other things “vitamins,… nutraceuticals,… and anything else that advances human health and can’t be patented by Pharma.” To be sure, there was reason to agree with Secretary Kennedy’s assessment about the suppression of dietary supplements. Looking back over FDA’s interactions with the industry since the passage of DSHEA, it could be characterized as…well…a rocky relationship. One that has swung between indifference and benign neglect to aggressive efforts to limit the industry.
It took FDA 13 years from the passage of DSHEA to issue a final rule implementing Good Manufacturing Practices. It’s been 14 years since the agency issued the first Draft Guidance on New Dietary Ingredients — and we still don’t have clarify on the most significant issues.
Despite explicit provisions in the law that make it illegal to market adulterated or misbranded supplements, FDA’s enforcement against unsafe and patently illegal products containing anabolic steroids, SARMS, prescription drugs and counterfeits has been tepid and sporadic at best.
When CRN conducted a content analysis of FDA’s public facing website a couple years ago, we found content that prioritized risk and fearmongering over discussion of the benefits that supplements can provide.
You may even remember a former FDA Commissioner spoke at this conference in 2023 and unabashedly questioned the value of supplements altogether.
So we were ready for a change at FDA.
But we weren’t the only ones to anticipate a change in direction. Critics of the industry, investigative journalists, and watchdog groups were paying attention too. They took notice of the comments made before and shortly after the election about dietary supplements.
They also noticed that several potential senior cabinet officials previously had ties to supplements either through endorsement deals, company ownership or just strong belief in their value. And they predicted changes too, but maybe not the ones we wanted.
So here we are, nearly one year later, and there is understandable impatience, perhaps even disappointment, that the predicted Golden Age of dietary supplements has not materialized….Yet.
So what happened? Did we misread the tea leaves? Have we missed our opportunity?
What can this industry do to gain its rightful place in Making American Healthy Again?
Many of you have asked these questions of me privately, and if I’m being honest, I have asked them too.
Industry journalist Erik Goldman recently authored a provocative article in Nutraceuticals World, “How Do Supplements Fit into the MAHA strategy?” So Erik, I hope you’re able to hear this, because I might have some answers.
How is CRN working to create a healthier America?
Well, I stirred a little controversy back in July when I was interviewed for a Politico article and was quoted saying “The jury is still out as to whether [the MAHA report] will be positive for the supplement industry or not.” …And also said “We have not seen many things out of FDA or HHS that really give dietary supplements their proper place in health care.”
Calley Means, who spoke at the NBJ Summit just after that article published, even referred to it in his remarks. He said the dietary supplement industry was behaving like Pharma and Big Food—looking for special treatment. Calley suggested we were misreading the MAHA movement by merely asking what was in it for us.
With all due respect to Calley—and he and I have spoken since he made those remarks—I think he misunderstood our concerns what our industry has been doing for the past 50 years by suggesting publicly that we are just in it for ourselves. This industry—the dietary supplement industry—has always placed our consumer first. It has always asked how it can improve the health and nutrition of our customers. It’s one of the things that attracted me to CRN 20 years ago.
And since then, I have seen our members advocate for mandatory adverse event reporting and mandatory listing—issues that are more about protecting our consumers than ourselves.
I’ve watched your commitment to self-regulation, imposing requirements on yourselves beyond what’s mandated by the law so consumers can have assurance of safe products and appropriate labeling.
I have seen you defend your customers’ right to access safe products; I have watched you champion nutrition for everyone; and observed your investments in consumer education.
We’ve been about Making America Healthy all along. And if I can borrow a line from the country music song, (with apologies to Barbara Mandrell): we were MAHA even when MAHA wasn’t cool.
And when you think about our recent requests of the Administration and Congress, it’s still about protecting our consumers:
- Getting supplements recognized as qualified medical expense for FSAs and HSAs—so that more consumers can stretch their dollars and make their health regimens more affordable.
- Improving FDA’s inspection efficiency, creating a supplement registry, directing investigation priorities towards facilities with the most risk, and cracking down on unlawful products—all to assure our consumers of safe products.
- Preventing states from imposing misguided age restrictions on our products so that consumers have access to safe and beneficial supplements.
So I would suggest we are much more aligned with the mission of Making America Healthy than we have been given credit for.
Which leads to me the matter of why some folks have perceived a disconnect between the MAHA movement and this industry’s desires.
It’s not a matter of disagreement so much as a matter of priorities.
The early attention of the Administration has been focused on reductionist thinking…Removing ingredients, getting rid of ultra processed foods, addressing the abuses of self-GRAS review that have allowed questionable ingredients into the market. These things are not in opposition to our goals, but we need to refocus the conversation now on what consumers are missing from their diets. What people can proactively do to improve and maintain their health—not just what they should take away.
So I want to spend the rest of my remarks exploring what we have done and what we still need to do to actualize this opportunity to transform the health of America.
To be clear, we have found common ground with the MAHA movement and the Administration.
For example, CRN joined with HHS in calling on medical schools to add more nutrition education. You know, I recently gave a guest lecture at the John’s Hopkins School of Public Health to mostly future MDs and PhDs. For many of them, it was the first time they had a class that addressed how supplements fill nutrient gaps and the consequences of those deficiencies. And the first time, they learned that supplements are regulated by FDA and are held to manufacturing standards. That needs to change.
On the topic of the Dietary Guidelines for Americans, we have urged USDA and HHS that, “To serve public health, the Dietary Guidelines should meet people where they are, which, for many, is a shortfall state, and help them achieve nutrient adequacies using available means.” The nation’s official Dietary Guidelines should recognize that. Shouldn’t the Guidelines acknowledge that “Dietary supplements may be useful in providing one or more nutrients that otherwise may be consumed in less than recommended amounts.” And shouldn’t the Guidelines also acknowledge that “Most healthcare providers recommend women who are pregnant or planning to become pregnant take a daily prenatal vitamin and mineral supplement in addition to consuming a healthy dietary pattern.” Now that's a pyramid I could support. And I think our MAHA friends would agree.
Another area where we seemingly have common ground is to recognize dietary supplements as a “qualified medical expense” in the tax code so that Americans can use the FSA and HSA funds to reimburse themselves for their supplement purchases. I want to recognize our govt relations team, because while a number of organizations have given this initiative lip service, we’ve been doing the hard work.
When the staff of the Joint Committee on Taxation developed a completely preposterous cost assessment of the FSA/HSA proposal, essentially out of thin air, we refuted it. Working with outside economists, CRN has conducted our own economic analysis that came back at about a quarter of the pricetag that JCT fabricated. CRN developed a Congressional briefing for the new Dietary Supplement Caucus to socialize the proposal among Members of Congress. We even made it our #1 request during CRN’s Day on the Hill. We continue to work with Congress on a legislative solution, but we also turning our efforts to the IRS. You see, this change could be done administratively with a Revenue Ruling that recognizes dietary supplements as “qualified medical expenses” without amending the statute. The problem has been, in previous Administrations, we never had the political support at the Cabinet level to persuade the IRS to make the change on its own.
Previously the IRS has even espoused that qualified medical expenses “don't include expenses that are merely beneficial to general health, such as vitamins or a vacation.” What?... Vitamins are like vacations??? Perhaps in this Administration we’ll have more success.
Tariffs is one area where we have our differences with the Administration. CRN has made multiple submissions to the Administration, and conducted numerous meetings with the Dept of Commerce, the U.S. Trade Representative, the White House Office of Public Liaison, the National Economic Council, and anyone else who will listen…
We’ve educated them that many of the raw materials in our products cannot be grown here in the U.S. or manufactured at scale here in the quantities to meet demand. We’ve demonstrated in our meetings that tariffs create the risk of driving manufacturing of finished goods offshore where companies would simply pay the tariff on the finished goods taking advantage of lower labor costs abroad. If we are serious about giving consumers the tools and ability to get and stay healthy, we should not hamstring that effort with higher costs in the form of tariffs.
Then there is the matter of self-GRAS. The Administration’s original message was that they wanted to eliminate self-GRAS altogether. We dug deeper to understand what the real concerns are with self GRAS. We are proposing more transparency and accountability in the self GRAS process, including a public database of self-GRAS ingredients, and information about the expert panels, and the thoroughness of the scientific review, to create a more transparent self-GRAS process instead of throwing the baby out with the bath water.
On another issue, CRN has communicated with FDA and the Department of Justice about revising the 1997 Disclaimer Rule to clarify that the FDA disclaimer does not need to appear on every panel. We are preparing to submit a Citizens Petition asking FDA to make clear that the asterisk next to our claims is sufficient to satisfy the statutory requirement that the disclaimer be prominent. And we hope this clarity will end, or at least forestall, the class action litigation some of our companies are facing.
We have had to play defense too, particularly at the state level. As you may know, we secured an exemption for dietary supplements from the legislation in Texas that requires additional labeling of many food products; and removed titanium dioxide from several bills that sought to restrict certain ingredients. In California, we were able to get clarifying language into law that dietary supplements intended for children are NOT subject to the testing and labeling requirements for baby food that was enacted last year.
And speaking of California, it’s worth spending a moment on a particularly problematic situation there where we have been working to restore balance. Modeled on the baby food law, legislation was introduced this year to require QR codes on prenatal vitamins and monthly testing for heavy metals with the results posted on a website for consumers to see.
We can all agree that women should try to avoid unnecessary exposure to heavy metals especially during pregnancy. But as it was introduced, this legislation would have placed unreasonable testing requirements on products, alarmed women to the potential presence of detectible—not harmful—levels of heavy metals, and it did not provide any context or recognition that these amounts are far less than the levels women would ingest by eating healthy foods like spinach, melon or fish. That would have discouraged women away from prenatal supplements that are critical toward getting the right amounts of essential nutrients, and created incentives for companies to remove or lower the amounts of critical minerals like calcium, iron and magnesium in order to achieve lower test results for heavy metals. CRN could have dug in simply opposed the bill, and ultimately would have lost. Instead, we leveraged our relationships, leaned into the science, and made the case that federal GMPs already mandate specifications and testing for potential contaminants, We worked to get changes. The bill sitting on Governor Newsom’s desk has removed the QR code from the label, changed monthly testing to lot testing (which we are doing anyway), and now provides mandatory language for the testing websites that will educate consumers about the unavoidable presence of minute levels of heavy metals and give context for the presence of these contaminants in many foods… so consumers can understand their options.
Compare this with our efforts to fight age restrictions on products for weight management and sports nutrition. Here there is no scientific basis for the restrictions, and we have relentlessly and successfully opposed these bills. Although the New York law did pass in 2023, as a result of our litigation, there has been no enforcement actions brought by the State. I am hoping before next year’s meeting to have some good news about our ongoing lawsuit.
The common thread in all these examples, is that the focus has always been, and continues to be, on Making America Healthy, and I’m proud to be part of an industry that advances this mission.
But you know, a lot of work has been inward looking too. It’s not about what others can do for our industry, but what we can do to create a healthier world.
So it’s no accident that just as the new Administration was taking shape, CRN was activating a campaign to celebrate and promote responsible behavior among our
members. Hopefully you saw this logo—Responsible. It's Our Middle Name.—and our messages as we touted our range of self-regulatory programs to remind stakeholders and detractors that our industry takes responsibility seriously.
It’s also a call to action. So it’s a good time to check your company’s participation in the Supplement OWL. When was the last time your company updated its entries to account for new products, old one that have been discontinued, and label changes?
Several of our newer Voluntary Guidelines have also become effective this year. CRN guidelines for melatonin now call for certain advisories on the label and child deterrent closures for melatonin-containing products in a flavored format that would be attractive to kids.
Separately, our new voluntary guideline for online sales now directs that online sales sites should contain all same material that is on the label, giving online shoppers the same information they would get if they were standing in the aisle about to make a purchase.
And in response to increasing negative media articles about turmeric, we are beginning new work towards a voluntary program for turmeric. If your company markets a product that contains turmeric, you should be on this task force.
So you can see, we are living up to our middle name.
And of course, there’s our Access Initiative being coordinated by the CRN Foundation, that CRN Board Chairman Bruce Brown spoke so passionately about before the break. It’s all about giving every American the opportunity for better nutrition.
All of these programs are why we “Meet in the Middle.” It’s why we gather each year to celebrate that we are stronger together, to examine the wider climate in which we operate, and to look ahead to new opportunities. We come together to share a vision to Make America Healthy, and that didn’t start with last year’s elections.
If we are going to accomplish our aspirations for the industry, we have to find common ground. Meet in the middle…with our opponents and our detractors, with policy makers and regulators, with our MAHA allies and our fellow trade organizations, with our members and even companies that haven’t joined CRN…yet.
We are stronger when we meet in the middle. If you will indulge me one more song reference, Diamond Rio got it right in their song from 1991, “We gain a lot of ground when we both give a little. Ain’t no road too long when we meet in the middle.”