PHOENIX, Oct. 13, 2022 – CRN President and CEO Steve Mister addressed the attendees of CRN’s Now, New, Next annual conference at the Arizona Biltmore Hotel and Conference Center with his State of the Industry Address. The following is the complete text of his speech.
Good morning, thank you all for being here. It’s great to have so many of you in person this year.
Isn’t the Biltmore a great venue for our event? Organic architecture, the school that was developed by Frank Lloyd Wright, seeks to create structures made out of mostly organic materials, in harmony with the landscape around them.
Isn’t that our approach to healthcare?...Made mostly of organic materials…and trying to create harmony with the world around us. So the Biltmore is a special place for this conference, to be sure.
What a year it has been! And I want to start by extending a huge thank you to our current Board Chair Barry Ritz. He has navigated CRN through the past two years fraught with endless challenges and crossroads. As you heard in his remarks, it’s been a prolific time for CRN as well.
And Barry has made sure every voice gets heard, every option gets considered and that a consensus gets reached every time. They say consensus doesn’t necessarily mean everyone loves every decision, but it means that everyone feels like they were heard and they can live with the decision. And Barry has accomplished just that.
Barry, you have been a great leader and I am honored to have worked with you during the past two years.
I also want to introduce you to Tara Martin of You Theory—newly purchased by Jamieson Wellness—who will become our next CRN Board Chair in January. Tara, would you stand up?
It’s fitting that we recognized WIN—Women in Nutraceuticals—last night, but just for the record, Tara is not our first woman Chair. We broke that glass ceiling in 2007.
Tara, I’m looking forward to working with you next year and can’t wait to see what we can accomplish.
And now I want to acknowledge the real power and brains behind CRN—the CRN staff. All CRN staff, would you please stand up? Please look around at these people…This is the hardest working, most dedicated group of people anywhere.
I feel so blessed and privileged to work with this team and I want you to know they work on your behalf every day. We could not accomplish all we do without these individuals and their commitment, expertise, and tenacity. They are the brains, the muscle, and the soul of this organization. Thank you!
Now let’s get down to business… We have some real threats facing this industry today.
Perception of the Unregulated Industry and Risk without Benefit
In previous years, I have discussed in these remarks the myth of the unregulated industry. Almost daily, our clipping service picks up headlines that repeat this false narrative—“not regulated,” “unregulated,” “barely regulated,” “under regulated,”—you’ve seen these headlines yourselves.
From the New England Journal of Medicine (who, incidentally, should know better) to the New York Times; from the Atlanta Journal Constitution to Forbes. And as recently as yesterday, the Wall Street Journal.
At CRN, we have a triage program to connect with reporters or their editors whenever we see this misinformation and to correct the record and educate them on the myriad ways this industry is regulated. In many cases, we actually get a correction or a retraction; sometimes we get rebuffed, but we keep trying.
Unfortunately, the problem is not limited to the media.
Recently we have seen examples where even FDA seems to perpetuate this perception as well. This past summer, FDA launched a collection of tools purporting to educate the public on dietary supplements. We took a critical look at these programs and here’s a sampling of what we found:
When to comes to cosmetics, FDA’s website says, “they do not need FDA approval to go on the market,” but when it comes to supplements, “FDA is not authorized to approve them for safety and effectiveness” without mentioning all the other ways FDA does regulate them. You might say that is a subtle distinction, but what does a consumer take away from the difference between these two statements?
Then there is the curriculum for high school students that FDA released. Our review of the teacher materials revealed no less than 65 references to risk, harm or potential dangers from using supplements, compared to only 15 acknowledgements in the materials that there are any benefits from the products…more than a 4 to 1 ratio.
FDA also released at the same time a new continuing education program for doctors, developed in conjunction with the AMA. It consists of a series of videos about supposed patient interactions related to supplement usage. It’s quite disappointing. Suffice it to say that if you wanted a training program of what NOT to do if you want to have a constructive dialogue with your patients, this is it. If you want to scare your patients by raising unrelated potential harms, discourage them from being honest about their supplement usage, and dismiss their attempts to improve their nutrition, then this is your video series.
We have submitted our findings in writing to FDA last month and CRN has a meeting scheduled with the agency later this month to discuss our concerns. So stay tuned.
Not to be outdone, the Department of Defense has its own program—this month is “Let’s talk Dietary Supplements” month in the military.
While in general, the materials are objective and balanced, one aspect particularly caught our attention. It’s a seven-question checklist of yes or no questions and encourages the user to compare the labels of their supplements against the list. A passing score is at least four questions answered yes.
The problem is that one question asks if there are less than six ingredients in the product? And others are subjective—like “can you easily pronounce all the ingredient names?” Another asks if there are any “questionable” claims on the label—without describing what constitutes “questionable.” To the uninformed user, even a claim to reduce the risk of osteoporosis, or improved cardiovascular health, or delay cognitive decline might sound “questionable”—even if it’s true.
Another question creates a “no” response if the label uses a proprietary blend (which is entirely legal), and another gets a strike if the product includes a Percent Daily Value greater than 200% of DV. Duh, what about vitamin C with a DV of only 90 milligrams?
How many of your product labels would pass? Well, we ran a number of your products through the quiz and found that many of them would not get enough “yeses.” And these include some multivitamins, some of your pre-workouts and recovery products, even some of your prenatals might not get a passing score. And that’s disturbing that DoD could be alarming service members and their families away from using a wide range of supplements.
So why I am raising these issues?
Because, collectively, these situations illustrate an ongoing perception problem for the industry. And our response has to be calculated, measured and powerful.
Now, to further alarm you, I’m going to turn to some recent coverage of the research:
I’m going to single out Vitamin D because it’s been in the news a lot lately, but it could be melatonin, or any of your ingredients.
There are now more than 100 studies and 13 meta-analyses examining the relationship between vitamin D levels and the incidence or severity of COVID-19. The vast majority of the evidence finds an inverse relationship: higher levels of vitamin D means less danger from COVID.
But of course not all the results have been positive, and it’s the ones that don’t show a benefit that seem to be getting headlines. But a careful examination of the research reveals some curious aspects:
Several of the studies that showed no benefit waited until after the patient presented at the hospital with Covid to start a very high dosage vitamin D regimen. More like a treatment rather than a preventative. Maybe it’s not surprising these didn’t work well.
Another study claimed to find no benefit, but it was an open label study and 49 percent of participants in the control arm were using vitamin D on their own.
Still another trial failed to control for the fact that the vaccine was being rolled out in the middle of the study. Or to get baseline measurements of vitamin D among the two groups.
Speaking of Vitamin D, you may have also seen headlines recently related to the VITAL Trial that proclaimed no benefit from Vitamin D for bone health. Problem is the vitamin D in the study was administered in isolation. Calcium is what builds strong bones; vitamin D is the vehicle that helps you absorb the calcium. In the VITAL trial, but there was no calcium in the study and baseline calcium levels were not measured or even considered.
This facet of the public perception is important because if consumers don’t perceive there are value and benefit from the products, it’s easy to amplify the supposed risks.
Which leads me to one additional trend that’s particularly worrisome.
The Precautionary Principle
Precautionary principle is making a resurgence.
Basically it’s the proposition that governments should err on the side of not accepting any risk for consumers. Precaution dictates that if there is any uncertainty, the authorities must prohibit any use of the substance.
We are already seeing this concept play out with TiO2. The EU has recently banned it. Not because there is any evidence that it is dangerous, but because there is not sufficient evidence that it is safe. The mantra is “When in doubt, just say no.”
In Italy, where there has been a series of adverse events associated with turmeric, the precautionary principle has led to a withdrawal not just of the implicated products, but of health claims for all turmeric products.
And some European countries are starting to lower their upper safe levels of essential vitamins in supplements, not because there is evidence of harm, but because there might be some uncertainty, so precaution dictates a much lower level.
Think that doesn’t affect us here in the US? Well, consumer watchdogs are now pressing to have TiO2 outlawed in the US for the same reasons as Europe—not citing any evidence of risk, but rather the absence of evidence of complete safety. And some plaintiffs’ attorneys aren’t even waiting for the government to act. There are several class actions here in the US against companies who use TiO2 for their failure to warn based on those European actions. The precautionary principle is poised to invade.
Make no mistake, the precautionary principle is not limited to TiO2; not limited to Europe; not limited to government bodies. It’s a mindset that is selectively applied whenever there is uncertainty. It removes all risk from society by starting with the premise that any risk is too much.
It is even impacting our efforts to defend weight management products at the state level. When there is little or no perceived benefit, it’s easy to find supposed risks that justify restriction.
So, we have negative portrayals of the industry as unregulated and potentially risky, one-sided coverage of the science without critical review, and a precautionary principle that argues any risk is too much (especially if there is no little or no benefit).
This constellation of factors is a recipe for concern.
And it raises the question—how should a responsible industry respond?
Last year, I asked this question. Some of you may even remember this slide from those remarks:
How do you exercise responsibility in an era of regulatory uncertainty?
And I offered these four suggestions:
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Advocate for new tools and resources—while preserving the principles that have served the industry well.
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Prepare for would be enforcers who would fill the void.
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Strengthen self-regulation to fill the void ourselves.
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Communicate proactively to demonstrate the value of our products.
It turns out many of the predictions were rather prescient, so I thought this year, I would give you a report card of how we are doing against these principles.
1. Advocate for new tools and resources
We can’t rely on the old ways of defending ourselves in this new environment. The solution goes beyond just demonstrating how we are already regulated to considering what new tools we can give our regulators that assure them our products don’t create unreasonable risk.
And of course, Mandatory Product Listing is at the top of that list—it just makes common sense to give the agency the ability to know what’s being sold in the marketplace.
Cara Welch from FDA recently spoke at an industry event and said, “If you combine this [rate of industry] growth with the statutory construct established for dietary supplements that relies heavily on post-market surveillance, we often face an information gap about the market. In these situations where there's not a lot of information, or bad information about the industry, the resulting decisions are made that much more difficult.”
In an era where the narrative is working against us, it troubles me that opponents of mandatory listing will assert that FDA can adequately regulate an industry that it really can’t see. It just goes against any credibility we have accumulated.
And there have been some rather ridiculous arguments against it.
Some have said that mandatory listing is premarket approval. It’s not. There is nothing in the legislation that gives FDA the ability to preapprove the label. But nevertheless, we went back to the sponsors and they were willing to insert express language in the bill to assure that FDA could not interpret the legislation to give it premarket review.
The opposition claimed the legislation would undermine the bioterrorism law. So the sponsors added provisions just to be sure FDA couldn’t disclose the locations of manufacturing facilities.
Then we heard arguments that, with mandatory listing, FDA would be able to come after ingredients like CBD and NAC that are subject to drug preclusion. Truth is that current law already gives FDA that authority, and the agency has already used it. It’s already a prohibited act to introduce a food that contains an article that is already a drug. So again, there’s no there there.
Even more disturbing, although perhaps a little amusing, are the arguments against mandatory listing that actually contradict themselves.
Opponents says we don’t need mandatory listing because FDA can use the Office of Dietary Supplements database, the DSLD to find whatever they want – despite the fact that it’s not mandatory. But then they say if we have a comprehensive roster of dietary supplements, we would be handing plaintiffs attorneys a road map for lawsuits. Well if the DSLD is actually functioning as comprehensive registry, can’t the attorneys already find your products there?
And then they argue that MPL won’t have any effect on the bad actors but they acknowledge that retailers--including one certain very large online retailer—will become the foot soldiers in the war with tainted products because they simply won‘t stock items that are not registered with FDA. So which is it? If major retailers keep unregistered products off their shelves (virtual or real), then we’ve made a dent in the illegal market, and if the product is listed in the registry, it’s a lot easier for FDA to find them.
Lastly, opponents put forward the dichotomy that we shouldn’t have MPL, because FDA isn’t doing enough now to enforce the law. Maybe part of that is—like Cara says—because it’s so difficult for FDA to get a clear snapshot of the industry. This is not an either/or. Why not do both? Enact MPL and hold FDA accountable for increased enforcement at the same time?
But let’s be clear: This is NOT a fundamental change in the balance of DSHEA—it’s a tool for enforcement. DSHEA is a law that was created when there were 4,000 products in the market, mostly sold in independent retailers versus a market today where there are more than 80,000 products today, sold online, direct to consumer, in retail, mass market, through medical professionals. The agency needs new tools just to keep up.
2. I suggested the industry should prepare for other would-be enforcers.
Now, I’m not saying I have a crystal ball but last year, I predicted an increase in state legislative activity directed toward supplements; further escalation of the private class action litigation; and more international regulatory activity. All of these have come to fruition.
Thinking of the states, the California age restriction bill is worth further examination.
As you know, there were bills in several states that were defeated rather easily, but not in California. And as an industry we had to make some tough choices. Look at the odds—the sponsor is powerful Democratic woman in California politics who happens to chair the committee that would hear the bill; the chair of the Senate committee also favored the bill. You have a supermajority of Democrats in the legislature and a Democratic governor. On top of that, there is an emotional (if factually incorrect) premise with a lot of pathos on its side.
And let’s not forget there is this legitimate problem of illegal ingredients in certain fringe weight loss products that are associated with real harm, as well as advertising by celebrity spokespeople to peddle claims too good to be true, and the perception that FDA is not doing enough to crack down. It was not good odds.
So, in consultation with our members, and working with AHPA, we decided to negotiate. As a result of our efforts, we narrowed the bill by:
- narrowing the list of products affected;
- eliminating liability for retail clerks;
- getting rid of caging requirements;
- getting rid of the behind-the-counter restrictions;
- limiting the bill to express weight loss claims and we removed the ingredients that were nonsensically included in the original bill.
We also created a framework where the California Dept. of Public Health would have to evaluate each product based on express claims of weight loss on the label and whether the ingredients contribute to one of eight negative health conditions.
And despite our good faith discussions, that turned out to be the poison pill because Governor Newsom’s veto message acknowledges that the measure that arrived on his desk would “require [the Dept. of Public Health] to evaluate every individual weight loss and dietary supplement product for safety.” In vetoing the bill he wrote that his administration will “work with the legislature next year to create legislation that does not require the state to undertake lengthy and costly pharmacological studies on the many supplements on the market today.” We dodged a bullet this year, but the issue will return next year.
We could have played the odds and just opposed the original version of the bill, but I suspect if we had, the original legislation would have passed over our objection, and Governor Newsom would not have been so concerned about a law that just restricted an entire category of products.
For our efforts, CRN and AHPA looked like a reasonable, responsible industry that wants to do the right thing for its consumer.
And, on this topic of would-be enforcers, retailers—despite being our customers—are more than willing to fill the void too. Major retail chains have taken matters into their own hands, leaving FDA behind. They are implementing their own programs using private third-party auditors to get assurance that GMPs are being observed. So CRN’s efforts to harmonize and streamline these various certification program with uniform requirements is more important than ever.
3. Third, I suggested we needed to strengthen self-regulation to fill the void ourselves.
In addition to our considerable voluntary guidelines this year, we have added new voluntary best practices for proprietary blends and a Considerations document for dosage forms to address concerns about swallowing and potential choking hazards associated with supplements.
A task group currently evaluating how to appropriate identity and label the quantity of ingredients inextricably bound up in their carriers.
And as I indicated earlier, we are continuing our support and work with the Global Retailers and Manufacturers Alliance to develop harmonized standards that go beyond the legal requirements. We are actively encouraging retailers to adopt these uniform standards as they create hurdles to get better quality products to the store or virtual shelf.
4. Lastly, I said we would communicate proactively to demonstrate the value of our products.
Rather than allow our critics to control the narrative, CRN has been promoting the critical role nutrition plays for better health and advocating for the role of supplements in that pursuit. You’ve already heard about our new Supplements to Savings study and our Vitamin D & Me initiative. We have also been promoting to positive results from the COSMOS study that found a positive relationship between multivitamins and preserving cognitive function.
We are also committed to getting coverage of all supplements as medical expenses in Flexible Spending Accounts and Medical Savings Accounts. We believe our Supplement to Savings research, along with some new consumer data we are hoping to assemble, will help justify these changes. But in the short-term, we are also exploring how to encourage doctors to use letters of medical necessity to allow reimbursement for particular ingredients – that’s something that is already allowed by the existing law.
We are also starting a dialogue with health insurance companies—using our cost savings data—to introduce coverage for dietary supplements. Our early discussions have already revealed some insurers are already providing these benefits in small ways and we want to expand those initiatives.
The recently convened White House Conference on Hunger, Nutrition, & Health has received both praise for raising important questions and criticism for not producing more immediate results. We believe it presents new opportunities to talk about the role of nutrition in better health outcomes and the ability of supplements to address those nutrition gaps. We have called on the Administration and Congress to expand access to nutrition, but also to use this opportunity to revisit the Dietary Reference Intakes based on the nutrition science of the last 20 years.
And we are already starting to plan for the Dietary Guidelines for Americans for 2025. We do this every five years—and are the only supplement trade association at the table. In each cycle, we make incremental progress and expect to do it again.
Lastly, our Act 4 Access initiative not only is bringing tangible benefits to the people that are served by these acts of generosity, but it also gives us a way to communicate how supplements can improve nutrition, and to educate on the role nutrition plays for better health. Which is why raising visibility for access and inclusivity are so important.
This is a new industry, not the one of 1994. We need to accept that we are no longer a few former natural products enthusiasts who will forgive the occasional manufacturing error, or overlook illegal ingredients or misleading claims.
Today we are soccer moms, retirees, millennials, weekend warriors, professional athletes, pregnant mothers, but one of the fastest growing categories right now is children’s supplements. We are a $56 billion industry and that calls for being responsible in ways that weren’t required 28 years ago.
It calls for not just exercising responsibility in times of uncertainty, or in spite of times of uncertainty, but BECAUSE of times of uncertainty.
We have to be the industry that answers that call and responds with responsibility even if times are uncertain and even when no one is watching.
Lastly, I would be remiss if I did not mention that CRN is going into its 50th year. That’s right, we were established in 1973, so next year will be CRN’s golden anniversary. We will be planning special events throughout the year. Culminating with our 50th anniversary celebration at next year’s conference October 3–6 at the Ritz Carlton Laguna-Nigel. You won’t want to miss the special event.
So to close, I have one more thank you….to all of you. Our members. You are the strength and the lifeblood of this organization. We are your stewards, here to do the good work that advances this industry. We love your input, your suggestions and even your criticisms because it helps us get stronger. It keeps us responsible. And as we are apt to say at CRN, “responsible” is still our middle name. Thank you very much.