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Leaders in the Natural Products Industry Point the Way Forward
The Panel:
Corinna Bellizzi, Head of Sales & Marketing- U.S. Nutraceuticals Division, Örlö Nutrition & VAXA Technologies, Wilmington, DE, https://orlonutrition.com
Ramona Billingslea, Marketing Manager, Betsy’s Health Foods, Spring, TX, https://betsyhealth.com
Blake Ebersole, President & Founder, NaturPro Scientific, Carmel, IN, http://naturproscientific.com
Jim Emme, CEO, NOW Health Group, Bloomingdale, IL, www.nowfoods.com
Jonathan Emord, President & Principal, Emord & Associates, Clifton, VA, https://emord.com
Karen Howard, CEO, Executive Director, Organic & Natural Health Association, Washington, D.C., https://organicandnatural.org
Mark LeDoux, Chairman & CEO, Natural Alternatives International, Carlsbad, CA, www.nai-online.com
Catherine Kwik-Uribe, PhD, Vice President of Scientific & Regulatory Affairs, Nutrition21, Saddle Brook, NJ, https://nutrition21.com
Betsy Lehrfeld, Board Chair, Citizens for Health, Washington, D.C., https://citizens.org
Len Monheit, CEO, Industry Transparency Center and Executive Director of the Global Prebiotic Association, Chicago, IL, https://itcstrategy.com
Steve Mister, President & CEO, CRN, Washington, D.C., https://crnusa.org
Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com
Kyle Turk, Director of Government Affairs, Natural Products Association (NPA), Washington, D.C., www.npanational.org
Rob Verkerk, PhD, Executive and Scientific Director, Alliance for Natural Health USA and International, Edinburg, VA, https://anh-usa.org
From the FTC’s (Federal Trade Commission) expansion of the Section 13(b) provision, to the FDA’s retroactive application of DSHEA’s (Dietary Supplement Health and Education Act of 1994) drug exclusion provision, to the FDA’s (U.S. Food and Drug Administration) assault on homeopathy, to restrictive state bills, there are many challenges with which the natural products industry must currently contend.
Fortunately, there is also good news—companies and organizations that are doing the right things and advancing both optimal health and the natural products industry.
In order to dive into all of these issues, and more, we assembled a panel of respected dietary supplement industry experts.
VR: Over the past four decades, the FTC has relied on Section 13(b) of the Federal Trade Commission Act to go after fraud and scams. The FTC has been expanding its use of this provision in what an outgoing FTC commissioner stated was overly broad and was targeting “legitimate companies.” Given this, and the recent “Notice of Penalty Offenses Concerning Substantiation of Product Claims” that was sent out to nearly 700 companies—many of them industry leading and compliant firms—what do you make of the FTC’s posture and recent broad-brush and arguably aggressive tactics?
Mister: FTC’s recent campaign targeting dietary supplements is misplaced on two grounds. First, although the industry appreciates that FTC recently updated the Health Products Substantiation Guidance, it seems to have omitted some of the legal decisions that have denied their efforts to remove flexibility from the “competent and reliable scientific evidence” standard and fails to recognize differences between substantiating permitted structure function claims for dietary supplements and illegal disease claims.
The new guidance does not accurately represent the state of the law. And secondly, the mass mailing of 670 notices that was sent to industry this spring, which created quite a bit of unnecessary heartburn in corner offices may be for naught. FTC is trying to retain its ability to collect civil fines from wrongdoers despite a recent court decision limiting that authority.
It remains to be seen whether blanketing an industry with courtesy letters, without identifying specific violations, satisfies the requirement to give violators a warning of their conduct in order to collect fines.
LeDoux: I think the FTC through this release is signaling a concern that companies need to contemplate when preparing their remarks. It is interesting to note that while no actual “infractions” were being cited, that the agency appeared to be notifying marketers that they are watching activities in our space with heightened concerns. It remains to be seen however what recent Supreme Court rulings dealing with the administrative agencies overstepping their Congressionally mandated objectives will mean for potential enforcement.
Emord: When government lacks probable cause in a specific case to proceed against a party for fraud and, instead, blankets the universe of speakers with a threat of prosecution in the absence of probable cause, it violates the First Amendment. It causes a chilling effect on speech. FTC argues the chilling effect doctrine only applies to political speech, but there is no sound rationale to support that limitation because whether commercial or not protected speech is chilled when government uses coercive threats to intimidate prospective speakers from opening their mouths.
The Supreme Court’s recent Axon decision, in which it authorized constitutional challenges to be brought in federal court at the start of administrative agency actions (specifically involving the FTC and the SEC), reveals that the High Court is united in its opposition to agency abuses of power that trench on constitutional liberties and intends for federal courts to hear these challenges.
Kwik-Uribe: As the FTA has indicated, these letters are not an indication of wrongdoing but do put the company on notice regarding the need for appropriate substantiation for claims made by brands/products. What these actions should foremost signal is the importance of reviewing claims—in all places where claims are made—and ensuring that substantiation is in place and up to date and claims appropriately reflect the evidence they are drawn from. At Nutrition21, we have made this an absolute priority over the years with dossiers ready and up to date to support all the claims we make. For all of us in the industry, we will have to continue to watch and see how this topic of claims and substantiation evolves.
Monheit: Previously, there were times of solid and robust dialogue with FTC, despite times when that agency has appeared to overreach, especially with regard to claim substantiation. Many of those with whom industry are familiar have left the agency underscoring the need to develop new relationships. Going directly to the latest broad-brush communication—responsible industry members should take it as a warning, and at minimum, use it to challenge newer FTC staff.
Ebersole: The recent letter to 670 mostly dietary supplement firms confuses me. On one hand, I appreciate that industry is being put on notice—more attention on claims substantiation is certainly needed. But the message and mode of delivery could have been more clear and robust. In the accompanying letter regarding “product claims,” there’s no reference to specific products or claims, much less categories or areas of priority. So, we have to question whether this was just the result of an ad hoc silo at FTC putting forth minimal effort for maximum effect, and not the well-planned outcome of an institutional process with rational follow-up.
Emme: The FTC has issued similar statements in the past, and this one appears to be an advisement to all the companies listed that although the FTC has not yet found problems with them, they are letting us know they are watching. The FTC is also clearly stating that any violators will be subject to fines for such violations. We received a letter containing similar language to the press release, and there was not new information or specifics. We at NOW are very conservative with our claims and will follow the rules as set forth by the FTC.
Sudberg: While I don’t agree with product claim laws, I do appreciate the laws and why they exist. This is complicated—the FTC has a tricky job and I don’t envy the choices they have to make. In this case, on behalf of the compliant firms, I think the FTC screwed up with too broad of a stroke. I can’t help but think that sometimes disruptive ingredients or products are a target for removal by the disrupted.
Verkerk: The FTC and the FDA, and the laws they enforce, attempt to sideline low cost, natural therapies, while creating safe havens for medications that have done little to avert any of the major diseases, are vastly more expensive, and are recognized, when prescribed correctly, as being the third leading killers in society.
Howard: This represents a highly flawed attempt by the government to ‘chill’ advertising. Companies who make “health claims” inappropriately should be on alert. If the FTC had the resources to actually manage such a program, it might help eradicate the fly-by-night advertisers who violate the law. I’m not holding my breath.
Billingslea: On the one hand, I find the whole situation bleak. If “they” can’t get rid of us through the FDA, they’ll just shut us down using the FTC, which, I think, has more legal flexibility to target us.
On the other hand, I realize that the growth in interest in the natural industry means many more rotten apples are out there trying to sell inferior products and making outrageous claims. Since the internet is such a powerful tool, consumers are more targeted than ever for scammers and counterfeit products. The more the FTC or FDA can do to get rid of these bad players, the better off our industry will be.
But it’s a fine line between efforts against illegitimate operations and just using a blanketed approach, even against above-board companies. Since the latter seems to be the FTC approach, I think Big Pharma is using its clout to push for fewer nutritional products on the market.
Lehrfeld: Protected speech can be chilled by overly broad warnings regarding all speech. By essentially implying that all motorcyclists, for example, are potential outlaws, the agency is insulting the law-abiding motorcyclists and diluting whatever warning was meant to strike fear in the hearts of the outlaws.
The fact that the FTC’s own commissioner was concerned about misuse of Section 13(b) is telling.
This intimidating notice may make law-abiding supplement companies more hesitant to communicate, market and advertise the benefits of their products, harming them and depriving consumers of information they need to make informed purchasing decisions.
VR: In the case of the FDA, the agency has been increasingly making use of the race-to-market drug exclusion provision of DSHEA to block or retroactively remove safe and legitimate dietary ingredients from commerce. What are your thoughts on this?
Mister: The Council for Responsible Nutrition (CRN) is concerned that the FDA’s current approach goes against the intention of the law, which was meant to give consumers the freedom to choose safe dietary supplements in support of their health. CRN believes that revoking the status of certain ingredients as dietary supplements creates uncertainty for manufacturers, retailers and consumers.
This uncertainty could also discourage innovation and prevent retailers from selling these products. Furthermore, the FDA’s interpretation of drug preclusion could allow pharmaceutical companies to take away ingredients from consumers who have been using supplements containing those ingredients for years.
The FDA’s current position on drug preclusion upends the intended balance the law attempts to achieve in the marketplace and unilaterally harms supplement manufacturers, creating an appearance that the FDA is protecting the financial interests of pharmaceutical companies over those of supplement manufacturers. CRN is engaging with the FDA to address these issues.
LeDoux: This is a major concern in that the agency is apparently willing to remove AKL authorization for NDI’s (new dietary ingredients) issued under their administrative processes once they ‘connect the dots’ (per recent comments made by Dr. [Cara] Welch at Supply Side East) between products that are recognized as being the subject matter of investigational new drug applications and substances such as NMN.
What is of particular interest is that in light of recent actions by the agency, it appears that NMN is not permitted in a dietary supplement due to this exclusion application but is allowed in food preparations under self-affirmed GRAS (generally recognized as safe) documentation. I think Congressional activity will be required to “clarify” the situation.
Lehrfeld: We can look at Cholestin, CBD, NAC, NMN, which are all examples of this provision being invoked, or misused, with the latter three ingredients in various levels of regulatory limbo today. It is pernicious for the FDA to dust off abandoned drug application archives and to then retroactively apply the exclusion provision to beneficial nutritional ingredients that have been safely consumed for decades.
Billingslea: Retailers must be active in ways they’ve never been before. The more they can use whatever platforms that are available to them, the better.
Could it be that the success of encroaching on personal health rights that began during COVID has given the government leeway to broaden their scope in that area? It certainly seems so.
When I first met my husband and was introduced to the health food industry, the battle for DSHEA had just been won. I listened to stories about stores that draped their shelves in black to show consumers just how close they were to having no supplement access at all. In Houston, there was a large supplement store that opened one day to find the feds taking all their product with no idea if they would get the products back. So, I know that, yes, things can get that bad.
Knowing how vital the grassroots efforts were to the passing of DSHEA, I use my emails, website and other marketing tools to inform our customers about these challenges to their supplements every chance I get. I am thankful to the Alliance for Natural Health and Natural Products Association websites, whose Action Alert pages I rely on for the latest communications my customers need to know.
Turk: As Dr. Fabricant pointed out at the beginning of the year, we started 2022 under the fog of drug exclusion interpretation regarding NAC. Following NPA’s citizen petition, we filed a lawsuit against the agency, and this proved to be the turning point in securing enforcement discretion, forcing FDA to come to the table. As we look at the bigger picture, we have been working with Congress to craft a legislative framework that protects the integrity of DSHEA.
Kwik-Uribe: It certainly has been a dynamic and challenging 24 months or so for the dietary supplement industry, as all of us have watched these issues play out. It is frustrating to see companies following the laws, making strong investments in R&D to substantiate the safety and efficacy of their ingredients, and then having these efforts fall flat because of a reversal of FDA’s position, particularly in the absence of evidence of issues of safety.
Monheit: This is an extremely disconcerting trend and is occurring with increasing frequency, especially as Center for Drug Evaluation and Research (CDER) becomes more involved in issues regarding dietary supplements. Ultimately, for phytoactives, there should be a path to both markets, but it seems as if increasingly, the drug path is being aggressively carved out with the agency quite complicit. This violates so many aspects of traditional and holistic use—again vigilance is needed—we as industry are going to need to push back, leverage Capitol Hill allies so that there is a viable path for these phytoactives.
Emme: There has been a pattern of this activity from the agency, from NAC to more recently NMN. NAC had a long history of no adverse events after billions of doses have been consumed over 33 years of use. NMN vendors had received multiple acknowledgement letters, and then the FDA withdrew these approvals after sales had been underway. A reasonable person can see that this pattern and practice of single ingredient enforcement is not going away any time soon. We as an industry need to push back on unreasonable actions that can unreasonably reduce safe choices for consumers.
Ebersole: I can understand the need and law for a drug exclusion clause. But the criteria being applied to that exclusion is misguided and needs to change. I think FDA could realize its mistake if the NMN case ever turns into a major judicial case. My question to FDA is, why would you pick a compound that is naturally occurring, that’s a constituent of food, and that’s innate to all life on Earth to prohibit in foods? We can add the fact that it has established safety, is a well-studied pro-vitamin, and was on the supplement market well before it was researched as a drug.
Sudberg: Smells like a scandal to me . . . Our industry has and continues to lose valuable ingredients from our tool chest. The only reason to remove something after it was deemed safe was because new data has emerged proving otherwise. I have yet to see evidence of such when ingredients are removed which leads me to “conspiratorial land” where said ingredients may be taking too much market share of the grand puppeteers of the FDA (big pharma).
Emord: FDA has chosen to construe the statutory provision expansively, sweeping within its proscriptive grasp products that have been used safely and beneficially for years. Congress should revoke this provision. If a product meets the definition of a dietary supplement, it should be able to enter the market regardless of whether a drug was previously investigated or approved containing the same substance. Drug exclusivity should not be used to rid the market of demonstrably safe and useful nutrients.
Verkerk: I’m concerned about consumers losing access to a growing list of safe, inexpensive and effective dietary supplement ingredients. Congress did not intend for the drug preclusion provision to be used as a method for drug companies to permanently eliminate competition from dietary supplements. The application of this loophole is a massive problem because it creates a stacked deck in favor of Big Pharma monopolies, prioritizing profits over public health.
VR: Whether it’s New York, New Jersey, California or, more recently, Colorado, there are concerted state efforts to, what some might say, demonize and excessively restrict the sales of dietary supplements under the guise of consumer protection. What’s behind these state efforts and how can the industry best tackle these challenges?
LeDoux: There seems to be something of a concerted effort in progressive state legislatures to restricting access to various categories of supplements for minors (those under the age of 18 or 21 in various jurisdictions) under some misunderstandings of adverse events.
In the case of “muscle-building,” “energy supporting” or “weight loss” preparations, legislators are relying more on hearsay than actual science to attempt to restrict access for segments of the population. In point of fact, there are no significant findings in the AER system associated with many of these properly manufactured and labeled products linking them to unintended or injurious outcomes, so the impetus to secure these legislative restrictions seems to be somewhat misguided at best.
Lehrfeld: Ignorance and arrogance are fueling these state efforts—ignorance of the science and safety behind most products and arrogance evidenced by state legislators deciding they know what’s best for us when they don’t.
Turk: I’ve negotiated with lawmakers and staffers across the country on this issue. Unfortunately, the recent inaccurate Washington Post column repeated the same lies the industry’s critics have spewed for years. It also signaled that Harvard’s STRIPED (Strategic Training Initiative for the Prevention of Eating Disorders) group has doubled down on its narrative that healthy habits like exercising and using recovery supplements like creatine and protein cause body dysmorphia along with eating disorders.
The industry has stepped up to this challenge by engaging our grassroots campaigns, resulting in more than 30,000 letters to state capitals supporting the dietary supplement industry. Despite this, our work in the state legislatures is still dominated by blocking dangerous and costly proposals that would restrict, reduce or eliminate access to supplements or impose dramatically higher costs for consumers, manufacturers, distributors and retailers.
I cannot stress enough how essential it is to be engaged with your local leaders. People have no problem spending on new advertising, promotions, trade shows, etc., but as far as being involved in the policy process, our industry lags. When you look at industries that are comparable in size, you’ll notice there is a major discrepancy, and we need to make a correction before it’s too late in the game.
Mister: The efforts to place age restrictions on weight management and sports nutrition supplements are driven by an eating disorders group from Harvard that mistakenly believes these products cause eating disorders among young people.
CRN has commissioned a review of the scientific research that demonstrates the fallacy of this narrative and a separate study that corroborates the safety of these ingredients. Unfortunately, having the facts on our side is not enough—state hearings on body dysmorphia among young people are charged with emotion and require lots of on-the-ground lobbying to diffuse.
That’s why CRN has also retained local counsel in many of these states, built coalitions with local retail organizations and has expended a great deal of “shoe leather” lobbying in these state capitols.
Kwik-Uribe: Most often, what seems to be behind these efforts is misinformation and ignorance. The evidence does not support that supplements cause harm or contribute to eating disorders. Like other examples of push back we have seen directed toward the supplement industry, these efforts are presented as acts for consumer protection when, in fact, these efforts prevent consumers from having easy access to safe products that can help them support their health and nutritional goals. Ignoring these issues won’t make them go away, so it is the responsibility of those in the supplement industry—from suppliers to brand leaders—to work together to shine a spotlight on the facts and bury the lies and misinformation.
Sudberg: I mean, come on . . . We know these excessive restrictions are not implemented to keep the people safe, since ours is an industry with an impeccable safety record. To me this seems like a “take out the competition” tactic puppeteered by the grand puppeteer, Big Pharma.
Emme: These are serious challenges that not only come up every year, but the efforts are also propagating to many new states. The bills are typically sent to committee by the same representative every year in their state, and the effort is being supported by those who believe eating disorders are caused by the consumption of sport supplement products. All retailers need to respond to a call to action whenever one of these bills enters a committee in their statehouse. Sign up with an industry trade association to stay informed of these attempts to restrict sales of supplements. NPA is a great resource for staying on top of these attempts.
Emord: Parties desirous of market protection perennially seek to restrict dietary supplement marketing and availability to the advantage of drug companies and special interest groups anathema to individual freedom of choice and personal autonomy.
Howard: This issue has been around since 2011 when FDA dinged Lazy Larry for lacing brownies with melatonin. Bad actors will always be a problem, and O&N Health itself has worked to educate consumers on staying away from “gas station supplements.” Since retailers generally can’t discern good from bad, it’s no surprise state legislators take such stands. I would suggest more education at the big box store level on quality consumer health products as a great place to start.
Verkerk: These bills communicate to the public that supplements are a public health hazard, but the simple truth is that supplements have a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. Efforts like these are the exact opposite of what we should be doing. While we see bills affecting dietary supplements and other natural health products that have other stated goals, many are Trojan horses that, one way or another, end up trying to limit access to, or communication about, healthful products that have been used safely, on a daily basis, by millions of Americans with benefits for the nation’s health.
Bellizzi: Given that I’m from California, this is by no means the first time I’ve seen an overreach from a regulatory perspective. California’s Proposition 65 offered a crash course in how regulations could become a profit center for law firms all over a given state.
One bill sets precedent for another, after all, and each regulatory “win” by our legislative body erodes the foundations of DSHEA. This is exactly what Big Pharma wants to see. Generally speaking, if Big Pharma wins, the natural health industry loses.
So, if you happen to market general supplements that seem “safe,” understand that while this may be true today, it may not remain so. If we simply stand by and let DSHEA be whittled to nothing, it may fall victim to a slow death by a thousand cuts.
VR: Despite the fact that the Homeopathic Pharmacopoeia of the United States pre-dates the FDA by nine years, homeopathy has certainly taken a beating over the last year. What do you forecast for this category in the U.S.?
Sudberg: Being raised with homeopathic medicine and continuing that path with my own two children, I find the current resurgence of doubt and challenge beyond frustrating. Since the 1700s humans have been effectively relying on homeopathy as an alternative to allopathy and now, 300 years later, we are being told by the NIH (National Institutes of Health) and the FDA that they cannot ensure their safety and effectiveness? Really? A little late to the worry game, don’t you think? You know what else seemed to miss the mark on safety? The FDA approved drug Vioxx. After almost 40,000 people died from it, they finally “called it.” I am glad it was much sooner than 300 years.
Lehrfeld: Homeopathy is a 227-year-old system of medicine designed to treat the whole person without toxic side effects. It has an unparalleled safety record and growing consumer demand. Unfortunately, our access to homeopathic products is now challenged by a final guidance from the FDA, published in December 2022, stating that the agency considers homeopathic medicines to be “unapproved new drugs.” That’s why Citizens for Health is allied with Americans for Homeopathy Choice (AFHC) in the fight to preserve access to the full range of safe and genuine homeopathic products.
Emord: FDA will be sued again for this violation of the FDCA, as amended, despite prior unsuccessful challenges. If litigation fails to confirm the plain and intended meaning of the Act, which recognizes homeopathy as a separate category of drugs not to be regulated as new drugs, then Congress will have to act to pass legislation protecting homeopathy. As it now stands, every homeopathic drug is unlawful to sell, albeit FDA is selectively taking action against those products that, in its fancy, it cares to force out of the market. This arbitrary and capricious system of selective removal under a misconstruction of the Act must be checked either by the courts or by Congress, or both.
Verkerk: Properly manufactured and labeled homeopathic products are inherently safe and present little or no health risk to consumers, with hundreds of millions of people relying on the practice worldwide. The FDA’s now final guidance on homeopathy is a clear attack that aims to eliminate access to this popular and important natural health option that competes with pharmaceutical drugs. That’s why ANH and many other homeopathy supporters are advocating for a legislative change to protect homeopathy in the U.S.
Emme: We have heard many retailers state that there still is a demand for homeopathic products in North America. We do support safe choices for consumers and would encourage these brands to partner with the industry trade groups to establish a more formal recognition of these items.
Billingslea: My understanding is that, as of this moment, the FDA can remove our homeopathic products any time they choose. I can only imagine that no new companies will be investing into a new homeopathy product or line in this unsure situation, which means fewer homeopathy options across the board even if the FDA never decides to take homeopathy products off our shelves. So, the FDA sort of wins either way.
VR: Has there been any substantive (and constructive) dialogue between industry stakeholders and the FDA/FTC over the last year, and what has that been?
Emme: We at NOW have had some great cooperation from the FDA in support of stopping a counterfeiter of NOW products selling on Amazon. The Agency has moved quickly and is fully engaged in stopping this bad actor from selling products that aren’t just counterfeited, but also adulterated with an API (active pharmaceutical ingredient).
Ebersole: I am not sure it would be called a dialogue like as in a conversation, but there seems to have been more communication, if only coming to us one way and getting sent back to an abyss. To me, in general, the more that communications are transparent and shared with the general industry, the better position we are in to continue to self-regulate. Responsible members of industry are fairly good at meeting standards, especially if we know what the standards are, and can gauge to what extent they are ”real” and could be enforced.
Emord: I am not aware of any meaningful change in FDA or FTC enforcement as a result of dialogue with the industry or stakeholders. The Supreme Court, however, has achieved a major reduction in the power of the agencies as a result of the Axon and West Virginia versus EPA decisions.
VR: Very briefly, speak to ways that either a specific company or organization, a leader or a segment of the industry, is positively moving the industry forward, and in what ways?
Billingslea: I am grateful to Citizens for Health, the Alliance of Natural Health, and others, including our Natural Products Association, for their efforts to keep communicating the latest news we need to know.
Emme: The Natural Products Association has been stellar in the past year in addressing the issues of NAC and NMN with staff and legislators in Washington DC.
Howard: I am delighted at the broad support our association (Organic & Natural Health) has garnered for the Williams-Franklin Foundation. In 2021, we committed to raise $50,000 in five years for scholarships for HBCU (historically Black colleges and universities) students pursuing degrees in natural health. To date, we have raised more than $47,000 in a little more than two years for the Organic & Natural Health Scholarship Fund. In addition to providing scholarships to students, we are now supporting students seeking employment in our industry and hoping to identify internship opportunities. It’s a tangible way to diversify our workforce. I’m also honored to be on the board of Women In Nutraceuticals (WIN), which I believe is the fastest way to advance women, as well as women’s research, and investment in women owned companies in order to better represent our customer base.
Mister: CRN is a proud member of the International Alliance of Dietary Supplement Associations (IADSA) that protects the industry at the global level. Composed of many national associations around the globe, and multi-national companies too, IADSA works to address trade barriers, open markets for supplements, and battle drug-like models of regulation that would limit consumer access. It has been leading the opposition to proposals at Codex that would restrict probiotics or limit even use of the word “probiotic” on product labels. It works at the national level too, from Singapore to India, China to Mexico, to foster regulations that make supplements available to more consumers.
Ebersole: I applaud what NOW Foods and Fungi Perfecti are doing to root out counterfeiters of their products. More firms should be testing competition and publicizing the results—including Amazon—of their numerous products.
There has also been immense interest in providing for the people in our supply chain. Fair trade and human labor are increasingly part of ESG initiatives of healthy food and supplement firms. We work in an industry that relies on cheap labor on farms overseas, and many farmers and collectors around the world are suffering. It’s an untenable situation for our supply future.
My group, Ethical Sourcing Review, is supporting natural products firms to evaluate and improve their impacts on people, planet and product. We’re helping firms take the next steps, wherever they are in their sustainability journey.
Verkerk: NOW Foods and CEO Jim Emme are doing incredible work to better the supplement industry. Their initiative to conduct independent testing of supplements is positively influencing industry standards and highlighting the need for the FDA to focus its resources on improving its inspections of dietary supplement manufacturers.
Sudberg: I think we as an industry owe a great deal of gratitude to the brazen legends of our industry who are tirelessly working to correct false narratives. One of those is NOW Foods. We cannot express enough appreciation for what they are doing to expose the biggest perpetuator of poor quality products in our industry, Amazon.com. Without NOW, counterfeit and adulterated products would continue to tarnish our wonderful industry without detection. While Amazon.com has been mostly quiet since their previous team (I miss that team), I know in the background that the needle is moving in the correct direction.
Bellizzi: We’re working to build cause into the brand from the beginning—starting with algae that’s regeneratively grown using only green energy, pristine Icelandic water, and the nutrients our algae need to thrive. We don’t use any pesticides or harsh chemicals like hexane to process our omega-3 oils and spirulina extracts. We package in post-consumer recycled materials, reusable glass bottles, and even print our shipping materials with algae-based inks.
Our eye is on circularity, responsible business practices, and building endless abundance into everything we do. We are aiming high, as we provide algae-based nutrition solutions that use 99 percent less land and water resources than other sources, while harnessing algae’s full potential with the power of technology. While our algae are proudly non-GMO (genetically modified organism), we use a biotech approach to managing our growing conditions, utilizing AI-driven machine learning to optimize growing conditions.
The end result? An algae that is higher in omega-3, that can be minimally processed, and that retains its polar lipid structure for better absorption than other sources—with EPA and DHA. Our Icelandic Ultra Spirulina even has a protein profile comparable to that of beef and contains vitamin B12 in the methylcobalamin form, providing a long-term and viable nutrition solution for vegans and vegetarians.
VR: What is the biggest industry problem that needs to be addressed? How can retailers help?
Verkerk: In one word? Apathy! We only have to look back to the DSHEA campaigns leading up to 1994 to remind ourselves that it was the concerted effort by a few companies that mobilized millions of consumers that prevented catastrophe, including the medicalization of supplements.
The threats may not have been as obvious since then, but when you look how the FDA is increasingly harmonizing its approach with that of the highly restrictive regulatory regime of the E.U., it’s time to wake up. The now internationally coordinated efforts of the FDA and FTC, together with social media companies, “fact checkers,” and self-appointed arbiters of so-called “scientific misinformation,” are all working toward a full-frontal assault on all natural products that have therapeutic benefits that compete with drugs or vaccines.
Sudberg: I identify as a marketing guy with a chemistry degree and so while I love phytochemistry, I find myself spending more time pondering the marketing of our industry.
One thing as an industry we must do to correct the narrative that we are an unsafe, unregulated, and ineffective industry is to share proof of our quality. We all know there is science behind our ingredients. The marketing teams behind our favorite brands do a fine job there, but we don’t talk enough about proof of quality. Many millions of dollars are spent each year to make sure the ingredients in our products are correct, safe, and effective (as judged by measurements of “things”). Let’s talk about. Let’s lead with it. Let’s show the world that we are safe, regulated, and effective.
Emme: The root cause of many of these problems is that consumers are constantly being told that our industry in unregulated and out of control. Retailers can help address this by educating their consumers about the regulations that all supplement companies must follow. Howard: Consumer education, consumer education, consumer education. Let’s not forget state and federal legislators (and regulators) are also consumers. Let’s see if there is a way to ensure that major retailers and big box stores, and Amazon, are as educated as our independent retailers.
Emord: The greatest threat to the survival and success of the supplement industry remains government censorship of health information and costly regulation and enforcement in the absence of proof of public harm.
Monheit: I would say it’s an agency that does not have the will to enforce current regulations. It’s been obvious for some time that the agency has taken a rather passive position—sure, eventually they may send a letter or seize product. But not soon enough and not nearly enough in frequency. And there are other actions such as initiating criminal proceedings that they have the power to take. As to what the retailers can do here, I’d say be aware of the regulations, stay away from products that violate, and continue to notify if you see egregious violations—and work at local levels to communicate to your representatives that this is an issue of will to enforce as much if not more than power to enforce.
Kwik-Uribe: The continued pushback on the supplement industry, e.g., by federal agencies, state legislators, etc. puts strain on a lawful industry. Rather than using their power and regulatory authority to address the bad players in the industry (bad players that are not unique to the supplement industry but exist in all areas of business), these groups look to impose unnecessary restrictions on the industry as a whole, an industry that offers safe, effective products that help support the health and well-being of millions of consumers every day. These issues won’t be solved overnight, but a unified approach by the industry—including everyone from suppliers to retailers, in joint efforts with trade associations—using data, facts and persistence can help these groups see the facts and in doing so, adjust their stance from restrictions directed towards “the good,” toward efforts directed towards “the bad.”
Mister: Despite all the positive news about the role dietary supplements play in better health, it doesn’t take much to rattle consumer trust; one incident that jeopardizes consumer safety could reverse years of industry growth. One way to build that trust is through more transparency and assurance that these products are well made. FDA has called for a dietary supplement listing and the idea makes sense—FDA can’t properly regulate a marketplace when it doesn’t even know which products and ingredients are out there.
Retailers can curate the products they sell by asking their supplement vendors about their ingredient supply chains, their adherence to GMPs (good manufacturing practices), their use of third parties to audit their facilities and spot test their products. They can demand their vendors submit their labels to the Supplement OWL (the industry’s voluntary label registry) and substantiate their label claims. Retailers are the last gatekeepers before consumers take our supplements home to use; they can be proud stewards by insisting product vendors deliver only safe, high-quality products.
VR: Is there anything else you would like to add especially regarding retailer considerations?
Monheit: We run an annual survey with supplement consumers and the value they place on trust, and transparency continues to increase. In 2022, 72 percent of our 3,600-plus survey respondents said that transparency information from manufacturers “somewhat increases” or “greatly increases” the chances they will purchase the product. The strongest indicators of transparency include detailed information on packaging/website and quality seals. When it comes to trust, consumers ranked a health care professional recommending the brand on top followed by consistent product quality and quality certifications and seals—retailers should pay attention to these factors when selecting which products to carry (source: 2022 ITC Insights Consumer Supplement User Survey).
Howard: We must never forget that the independent retailers are our own frontline. They are the backbone of the industry, and central to any successful advocacy initiative—especially in today’s highly dysfunctional and divisive political atmosphere.
Verkerk: As the stakes rise, we’re hoping to be able to collaborate with retailers so that our campaign messages can get out there, far and wide, expanding grassroots reach and impact. This kind of collaboration is essential if we’re going to be serious about protecting our rights and freedoms for future generations.
Emme: We at NOW are grateful for the support of retailers, not just for our brand, but also our industry. They continue to be a frontline resource of valid information to educate consumers.
Billingslea: Politics is not my favorite thing. I find it difficult to keep up with the headlines and rarely have time to read all the articles sent to me to inform me of what is going on. On top of that, most of us small guys are using up a lot of our energy on just keeping customers coming through the doors and not being undercut by cheaper, online prices. Even as popular as the health industry has become, we are truly in some of the most challenging years I’ve seen yet, with no promise of relief in sight. VR
Leaders in the Natural Products Industry Point the Way Forward
The Panel:
From the FTC’s (Federal Trade Commission) expansion of the Section 13(b) provision, to the FDA’s retroactive application of DSHEA’s (Dietary Supplement Health and Education Act of 1994) drug exclusion provision, to the FDA’s (U.S. Food and Drug Administration) assault on homeopathy, to restrictive state bills, there are many challenges with which the natural products industry must currently contend.
Fortunately, there is also good news—companies and organizations that are doing the right things and advancing both optimal health and the natural products industry.
In order to dive into all of these issues, and more, we assembled a panel of respected dietary supplement industry experts.
VR: Over the past four decades, the FTC has relied on Section 13(b) of the Federal Trade Commission Act to go after fraud and scams. The FTC has been expanding its use of this provision in what an outgoing FTC commissioner stated was overly broad and was targeting “legitimate companies.” Given this, and the recent “Notice of Penalty Offenses Concerning Substantiation of Product Claims” that was sent out to nearly 700 companies—many of them industry leading and compliant firms—what do you make of the FTC’s posture and recent broad-brush and arguably aggressive tactics?
Mister: FTC’s recent campaign targeting dietary supplements is misplaced on two grounds. First, although the industry appreciates that FTC recently updated the Health Products Substantiation Guidance, it seems to have omitted some of the legal decisions that have denied their efforts to remove flexibility from the “competent and reliable scientific evidence” standard and fails to recognize differences between substantiating permitted structure function claims for dietary supplements and illegal disease claims.
The new guidance does not accurately represent the state of the law. And secondly, the mass mailing of 670 notices that was sent to industry this spring, which created quite a bit of unnecessary heartburn in corner offices may be for naught. FTC is trying to retain its ability to collect civil fines from wrongdoers despite a recent court decision limiting that authority.
It remains to be seen whether blanketing an industry with courtesy letters, without identifying specific violations, satisfies the requirement to give violators a warning of their conduct in order to collect fines.
LeDoux: I think the FTC through this release is signaling a concern that companies need to contemplate when preparing their remarks. It is interesting to note that while no actual “infractions” were being cited, that the agency appeared to be notifying marketers that they are watching activities in our space with heightened concerns. It remains to be seen however what recent Supreme Court rulings dealing with the administrative agencies overstepping their Congressionally mandated objectives will mean for potential enforcement.
Emord: When government lacks probable cause in a specific case to proceed against a party for fraud and, instead, blankets the universe of speakers with a threat of prosecution in the absence of probable cause, it violates the First Amendment. It causes a chilling effect on speech. FTC argues the chilling effect doctrine only applies to political speech, but there is no sound rationale to support that limitation because whether commercial or not protected speech is chilled when government uses coercive threats to intimidate prospective speakers from opening their mouths.
The Supreme Court’s recent Axon decision, in which it authorized constitutional challenges to be brought in federal court at the start of administrative agency actions (specifically involving the FTC and the SEC), reveals that the High Court is united in its opposition to agency abuses of power that trench on constitutional liberties and intends for federal courts to hear these challenges.
Kwik-Uribe: As the FTA has indicated, these letters are not an indication of wrongdoing but do put the company on notice regarding the need for appropriate substantiation for claims made by brands/products. What these actions should foremost signal is the importance of reviewing claims—in all places where claims are made—and ensuring that substantiation is in place and up to date and claims appropriately reflect the evidence they are drawn from. At Nutrition21, we have made this an absolute priority over the years with dossiers ready and up to date to support all the claims we make. For all of us in the industry, we will have to continue to watch and see how this topic of claims and substantiation evolves.
Monheit: Previously, there were times of solid and robust dialogue with FTC, despite times when that agency has appeared to overreach, especially with regard to claim substantiation. Many of those with whom industry are familiar have left the agency underscoring the need to develop new relationships. Going directly to the latest broad-brush communication—responsible industry members should take it as a warning, and at minimum, use it to challenge newer FTC staff.
Ebersole: The recent letter to 670 mostly dietary supplement firms confuses me. On one hand, I appreciate that industry is being put on notice—more attention on claims substantiation is certainly needed. But the message and mode of delivery could have been more clear and robust. In the accompanying letter regarding “product claims,” there’s no reference to specific products or claims, much less categories or areas of priority. So, we have to question whether this was just the result of an ad hoc silo at FTC putting forth minimal effort for maximum effect, and not the well-planned outcome of an institutional process with rational follow-up.
Emme: The FTC has issued similar statements in the past, and this one appears to be an advisement to all the companies listed that although the FTC has not yet found problems with them, they are letting us know they are watching. The FTC is also clearly stating that any violators will be subject to fines for such violations. We received a letter containing similar language to the press release, and there was not new information or specifics. We at NOW are very conservative with our claims and will follow the rules as set forth by the FTC.
Sudberg: While I don’t agree with product claim laws, I do appreciate the laws and why they exist. This is complicated—the FTC has a tricky job and I don’t envy the choices they have to make. In this case, on behalf of the compliant firms, I think the FTC screwed up with too broad of a stroke. I can’t help but think that sometimes disruptive ingredients or products are a target for removal by the disrupted.
Verkerk: The FTC and the FDA, and the laws they enforce, attempt to sideline low cost, natural therapies, while creating safe havens for medications that have done little to avert any of the major diseases, are vastly more expensive, and are recognized, when prescribed correctly, as being the third leading killers in society.
Howard: This represents a highly flawed attempt by the government to ‘chill’ advertising. Companies who make “health claims” inappropriately should be on alert. If the FTC had the resources to actually manage such a program, it might help eradicate the fly-by-night advertisers who violate the law. I’m not holding my breath.
Billingslea: On the one hand, I find the whole situation bleak. If “they” can’t get rid of us through the FDA, they’ll just shut us down using the FTC, which, I think, has more legal flexibility to target us.
On the other hand, I realize that the growth in interest in the natural industry means many more rotten apples are out there trying to sell inferior products and making outrageous claims. Since the internet is such a powerful tool, consumers are more targeted than ever for scammers and counterfeit products. The more the FTC or FDA can do to get rid of these bad players, the better off our industry will be.
But it’s a fine line between efforts against illegitimate operations and just using a blanketed approach, even against above-board companies. Since the latter seems to be the FTC approach, I think Big Pharma is using its clout to push for fewer nutritional products on the market.
Lehrfeld: Protected speech can be chilled by overly broad warnings regarding all speech. By essentially implying that all motorcyclists, for example, are potential outlaws, the agency is insulting the law-abiding motorcyclists and diluting whatever warning was meant to strike fear in the hearts of the outlaws.
The fact that the FTC’s own commissioner was concerned about misuse of Section 13(b) is telling.
This intimidating notice may make law-abiding supplement companies more hesitant to communicate, market and advertise the benefits of their products, harming them and depriving consumers of information they need to make informed purchasing decisions.
VR: In the case of the FDA, the agency has been increasingly making use of the race-to-market drug exclusion provision of DSHEA to block or retroactively remove safe and legitimate dietary ingredients from commerce. What are your thoughts on this?
Mister: The Council for Responsible Nutrition (CRN) is concerned that the FDA’s current approach goes against the intention of the law, which was meant to give consumers the freedom to choose safe dietary supplements in support of their health. CRN believes that revoking the status of certain ingredients as dietary supplements creates uncertainty for manufacturers, retailers and consumers.
This uncertainty could also discourage innovation and prevent retailers from selling these products. Furthermore, the FDA’s interpretation of drug preclusion could allow pharmaceutical companies to take away ingredients from consumers who have been using supplements containing those ingredients for years.
The FDA’s current position on drug preclusion upends the intended balance the law attempts to achieve in the marketplace and unilaterally harms supplement manufacturers, creating an appearance that the FDA is protecting the financial interests of pharmaceutical companies over those of supplement manufacturers. CRN is engaging with the FDA to address these issues.
LeDoux: This is a major concern in that the agency is apparently willing to remove AKL authorization for NDI’s (new dietary ingredients) issued under their administrative processes once they ‘connect the dots’ (per recent comments made by Dr. [Cara] Welch at Supply Side East) between products that are recognized as being the subject matter of investigational new drug applications and substances such as NMN.
What is of particular interest is that in light of recent actions by the agency, it appears that NMN is not permitted in a dietary supplement due to this exclusion application but is allowed in food preparations under self-affirmed GRAS (generally recognized as safe) documentation. I think Congressional activity will be required to “clarify” the situation.
Lehrfeld: We can look at Cholestin, CBD, NAC, NMN, which are all examples of this provision being invoked, or misused, with the latter three ingredients in various levels of regulatory limbo today. It is pernicious for the FDA to dust off abandoned drug application archives and to then retroactively apply the exclusion provision to beneficial nutritional ingredients that have been safely consumed for decades.
Billingslea: Retailers must be active in ways they’ve never been before. The more they can use whatever platforms that are available to them, the better.
Could it be that the success of encroaching on personal health rights that began during COVID has given the government leeway to broaden their scope in that area? It certainly seems so.
When I first met my husband and was introduced to the health food industry, the battle for DSHEA had just been won. I listened to stories about stores that draped their shelves in black to show consumers just how close they were to having no supplement access at all. In Houston, there was a large supplement store that opened one day to find the feds taking all their product with no idea if they would get the products back. So, I know that, yes, things can get that bad.
Knowing how vital the grassroots efforts were to the passing of DSHEA, I use my emails, website and other marketing tools to inform our customers about these challenges to their supplements every chance I get. I am thankful to the Alliance for Natural Health and Natural Products Association websites, whose Action Alert pages I rely on for the latest communications my customers need to know.
Turk: As Dr. Fabricant pointed out at the beginning of the year, we started 2022 under the fog of drug exclusion interpretation regarding NAC. Following NPA’s citizen petition, we filed a lawsuit against the agency, and this proved to be the turning point in securing enforcement discretion, forcing FDA to come to the table. As we look at the bigger picture, we have been working with Congress to craft a legislative framework that protects the integrity of DSHEA.
Kwik-Uribe: It certainly has been a dynamic and challenging 24 months or so for the dietary supplement industry, as all of us have watched these issues play out. It is frustrating to see companies following the laws, making strong investments in R&D to substantiate the safety and efficacy of their ingredients, and then having these efforts fall flat because of a reversal of FDA’s position, particularly in the absence of evidence of issues of safety.
Monheit: This is an extremely disconcerting trend and is occurring with increasing frequency, especially as Center for Drug Evaluation and Research (CDER) becomes more involved in issues regarding dietary supplements. Ultimately, for phytoactives, there should be a path to both markets, but it seems as if increasingly, the drug path is being aggressively carved out with the agency quite complicit. This violates so many aspects of traditional and holistic use—again vigilance is needed—we as industry are going to need to push back, leverage Capitol Hill allies so that there is a viable path for these phytoactives.
Emme: There has been a pattern of this activity from the agency, from NAC to more recently NMN. NAC had a long history of no adverse events after billions of doses have been consumed over 33 years of use. NMN vendors had received multiple acknowledgement letters, and then the FDA withdrew these approvals after sales had been underway. A reasonable person can see that this pattern and practice of single ingredient enforcement is not going away any time soon. We as an industry need to push back on unreasonable actions that can unreasonably reduce safe choices for consumers.
Ebersole: I can understand the need and law for a drug exclusion clause. But the criteria being applied to that exclusion is misguided and needs to change. I think FDA could realize its mistake if the NMN case ever turns into a major judicial case. My question to FDA is, why would you pick a compound that is naturally occurring, that’s a constituent of food, and that’s innate to all life on Earth to prohibit in foods? We can add the fact that it has established safety, is a well-studied pro-vitamin, and was on the supplement market well before it was researched as a drug.
Sudberg: Smells like a scandal to me . . . Our industry has and continues to lose valuable ingredients from our tool chest. The only reason to remove something after it was deemed safe was because new data has emerged proving otherwise. I have yet to see evidence of such when ingredients are removed which leads me to “conspiratorial land” where said ingredients may be taking too much market share of the grand puppeteers of the FDA (big pharma).
Emord: FDA has chosen to construe the statutory provision expansively, sweeping within its proscriptive grasp products that have been used safely and beneficially for years. Congress should revoke this provision. If a product meets the definition of a dietary supplement, it should be able to enter the market regardless of whether a drug was previously investigated or approved containing the same substance. Drug exclusivity should not be used to rid the market of demonstrably safe and useful nutrients.
Verkerk: I’m concerned about consumers losing access to a growing list of safe, inexpensive and effective dietary supplement ingredients. Congress did not intend for the drug preclusion provision to be used as a method for drug companies to permanently eliminate competition from dietary supplements. The application of this loophole is a massive problem because it creates a stacked deck in favor of Big Pharma monopolies, prioritizing profits over public health.
VR: Whether it’s New York, New Jersey, California or, more recently, Colorado, there are concerted state efforts to, what some might say, demonize and excessively restrict the sales of dietary supplements under the guise of consumer protection. What’s behind these state efforts and how can the industry best tackle these challenges?
LeDoux: There seems to be something of a concerted effort in progressive state legislatures to restricting access to various categories of supplements for minors (those under the age of 18 or 21 in various jurisdictions) under some misunderstandings of adverse events.
In the case of “muscle-building,” “energy supporting” or “weight loss” preparations, legislators are relying more on hearsay than actual science to attempt to restrict access for segments of the population. In point of fact, there are no significant findings in the AER system associated with many of these properly manufactured and labeled products linking them to unintended or injurious outcomes, so the impetus to secure these legislative restrictions seems to be somewhat misguided at best.
Lehrfeld: Ignorance and arrogance are fueling these state efforts—ignorance of the science and safety behind most products and arrogance evidenced by state legislators deciding they know what’s best for us when they don’t.
Turk: I’ve negotiated with lawmakers and staffers across the country on this issue. Unfortunately, the recent inaccurate Washington Post column repeated the same lies the industry’s critics have spewed for years. It also signaled that Harvard’s STRIPED (Strategic Training Initiative for the Prevention of Eating Disorders) group has doubled down on its narrative that healthy habits like exercising and using recovery supplements like creatine and protein cause body dysmorphia along with eating disorders.
The industry has stepped up to this challenge by engaging our grassroots campaigns, resulting in more than 30,000 letters to state capitals supporting the dietary supplement industry. Despite this, our work in the state legislatures is still dominated by blocking dangerous and costly proposals that would restrict, reduce or eliminate access to supplements or impose dramatically higher costs for consumers, manufacturers, distributors and retailers.
I cannot stress enough how essential it is to be engaged with your local leaders. People have no problem spending on new advertising, promotions, trade shows, etc., but as far as being involved in the policy process, our industry lags. When you look at industries that are comparable in size, you’ll notice there is a major discrepancy, and we need to make a correction before it’s too late in the game.
Mister: The efforts to place age restrictions on weight management and sports nutrition supplements are driven by an eating disorders group from Harvard that mistakenly believes these products cause eating disorders among young people.
CRN has commissioned a review of the scientific research that demonstrates the fallacy of this narrative and a separate study that corroborates the safety of these ingredients. Unfortunately, having the facts on our side is not enough—state hearings on body dysmorphia among young people are charged with emotion and require lots of on-the-ground lobbying to diffuse.
That’s why CRN has also retained local counsel in many of these states, built coalitions with local retail organizations and has expended a great deal of “shoe leather” lobbying in these state capitols.
Kwik-Uribe: Most often, what seems to be behind these efforts is misinformation and ignorance. The evidence does not support that supplements cause harm or contribute to eating disorders. Like other examples of push back we have seen directed toward the supplement industry, these efforts are presented as acts for consumer protection when, in fact, these efforts prevent consumers from having easy access to safe products that can help them support their health and nutritional goals. Ignoring these issues won’t make them go away, so it is the responsibility of those in the supplement industry—from suppliers to brand leaders—to work together to shine a spotlight on the facts and bury the lies and misinformation.
Sudberg: I mean, come on . . . We know these excessive restrictions are not implemented to keep the people safe, since ours is an industry with an impeccable safety record. To me this seems like a “take out the competition” tactic puppeteered by the grand puppeteer, Big Pharma.
Emme: These are serious challenges that not only come up every year, but the efforts are also propagating to many new states. The bills are typically sent to committee by the same representative every year in their state, and the effort is being supported by those who believe eating disorders are caused by the consumption of sport supplement products. All retailers need to respond to a call to action whenever one of these bills enters a committee in their statehouse. Sign up with an industry trade association to stay informed of these attempts to restrict sales of supplements. NPA is a great resource for staying on top of these attempts.
Emord: Parties desirous of market protection perennially seek to restrict dietary supplement marketing and availability to the advantage of drug companies and special interest groups anathema to individual freedom of choice and personal autonomy.
Howard: This issue has been around since 2011 when FDA dinged Lazy Larry for lacing brownies with melatonin. Bad actors will always be a problem, and O&N Health itself has worked to educate consumers on staying away from “gas station supplements.” Since retailers generally can’t discern good from bad, it’s no surprise state legislators take such stands. I would suggest more education at the big box store level on quality consumer health products as a great place to start.
Verkerk: These bills communicate to the public that supplements are a public health hazard, but the simple truth is that supplements have a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. Efforts like these are the exact opposite of what we should be doing. While we see bills affecting dietary supplements and other natural health products that have other stated goals, many are Trojan horses that, one way or another, end up trying to limit access to, or communication about, healthful products that have been used safely, on a daily basis, by millions of Americans with benefits for the nation’s health.
Bellizzi: Given that I’m from California, this is by no means the first time I’ve seen an overreach from a regulatory perspective. California’s Proposition 65 offered a crash course in how regulations could become a profit center for law firms all over a given state.
One bill sets precedent for another, after all, and each regulatory “win” by our legislative body erodes the foundations of DSHEA. This is exactly what Big Pharma wants to see. Generally speaking, if Big Pharma wins, the natural health industry loses.
So, if you happen to market general supplements that seem “safe,” understand that while this may be true today, it may not remain so. If we simply stand by and let DSHEA be whittled to nothing, it may fall victim to a slow death by a thousand cuts.
VR: Despite the fact that the Homeopathic Pharmacopoeia of the United States pre-dates the FDA by nine years, homeopathy has certainly taken a beating over the last year. What do you forecast for this category in the U.S.?
Sudberg: Being raised with homeopathic medicine and continuing that path with my own two children, I find the current resurgence of doubt and challenge beyond frustrating. Since the 1700s humans have been effectively relying on homeopathy as an alternative to allopathy and now, 300 years later, we are being told by the NIH (National Institutes of Health) and the FDA that they cannot ensure their safety and effectiveness? Really? A little late to the worry game, don’t you think? You know what else seemed to miss the mark on safety? The FDA approved drug Vioxx. After almost 40,000 people died from it, they finally “called it.” I am glad it was much sooner than 300 years.
Lehrfeld: Homeopathy is a 227-year-old system of medicine designed to treat the whole person without toxic side effects. It has an unparalleled safety record and growing consumer demand. Unfortunately, our access to homeopathic products is now challenged by a final guidance from the FDA, published in December 2022, stating that the agency considers homeopathic medicines to be “unapproved new drugs.” That’s why Citizens for Health is allied with Americans for Homeopathy Choice (AFHC) in the fight to preserve access to the full range of safe and genuine homeopathic products.
Emord: FDA will be sued again for this violation of the FDCA, as amended, despite prior unsuccessful challenges. If litigation fails to confirm the plain and intended meaning of the Act, which recognizes homeopathy as a separate category of drugs not to be regulated as new drugs, then Congress will have to act to pass legislation protecting homeopathy. As it now stands, every homeopathic drug is unlawful to sell, albeit FDA is selectively taking action against those products that, in its fancy, it cares to force out of the market. This arbitrary and capricious system of selective removal under a misconstruction of the Act must be checked either by the courts or by Congress, or both.
Verkerk: Properly manufactured and labeled homeopathic products are inherently safe and present little or no health risk to consumers, with hundreds of millions of people relying on the practice worldwide. The FDA’s now final guidance on homeopathy is a clear attack that aims to eliminate access to this popular and important natural health option that competes with pharmaceutical drugs. That’s why ANH and many other homeopathy supporters are advocating for a legislative change to protect homeopathy in the U.S.
Emme: We have heard many retailers state that there still is a demand for homeopathic products in North America. We do support safe choices for consumers and would encourage these brands to partner with the industry trade groups to establish a more formal recognition of these items.
Billingslea: My understanding is that, as of this moment, the FDA can remove our homeopathic products any time they choose. I can only imagine that no new companies will be investing into a new homeopathy product or line in this unsure situation, which means fewer homeopathy options across the board even if the FDA never decides to take homeopathy products off our shelves. So, the FDA sort of wins either way.
VR: Has there been any substantive (and constructive) dialogue between industry stakeholders and the FDA/FTC over the last year, and what has that been?
Emme: We at NOW have had some great cooperation from the FDA in support of stopping a counterfeiter of NOW products selling on Amazon. The Agency has moved quickly and is fully engaged in stopping this bad actor from selling products that aren’t just counterfeited, but also adulterated with an API (active pharmaceutical ingredient).
Ebersole: I am not sure it would be called a dialogue like as in a conversation, but there seems to have been more communication, if only coming to us one way and getting sent back to an abyss. To me, in general, the more that communications are transparent and shared with the general industry, the better position we are in to continue to self-regulate. Responsible members of industry are fairly good at meeting standards, especially if we know what the standards are, and can gauge to what extent they are ”real” and could be enforced.
Emord: I am not aware of any meaningful change in FDA or FTC enforcement as a result of dialogue with the industry or stakeholders. The Supreme Court, however, has achieved a major reduction in the power of the agencies as a result of the Axon and West Virginia versus EPA decisions.
VR: Very briefly, speak to ways that either a specific company or organization, a leader or a segment of the industry, is positively moving the industry forward, and in what ways?
Billingslea: I am grateful to Citizens for Health, the Alliance of Natural Health, and others, including our Natural Products Association, for their efforts to keep communicating the latest news we need to know.
Emme: The Natural Products Association has been stellar in the past year in addressing the issues of NAC and NMN with staff and legislators in Washington DC.
Howard: I am delighted at the broad support our association (Organic & Natural Health) has garnered for the Williams-Franklin Foundation. In 2021, we committed to raise $50,000 in five years for scholarships for HBCU (historically Black colleges and universities) students pursuing degrees in natural health. To date, we have raised more than $47,000 in a little more than two years for the Organic & Natural Health Scholarship Fund. In addition to providing scholarships to students, we are now supporting students seeking employment in our industry and hoping to identify internship opportunities. It’s a tangible way to diversify our workforce. I’m also honored to be on the board of Women In Nutraceuticals (WIN), which I believe is the fastest way to advance women, as well as women’s research, and investment in women owned companies in order to better represent our customer base.
Mister: CRN is a proud member of the International Alliance of Dietary Supplement Associations (IADSA) that protects the industry at the global level. Composed of many national associations around the globe, and multi-national companies too, IADSA works to address trade barriers, open markets for supplements, and battle drug-like models of regulation that would limit consumer access. It has been leading the opposition to proposals at Codex that would restrict probiotics or limit even use of the word “probiotic” on product labels. It works at the national level too, from Singapore to India, China to Mexico, to foster regulations that make supplements available to more consumers.
Ebersole: I applaud what NOW Foods and Fungi Perfecti are doing to root out counterfeiters of their products. More firms should be testing competition and publicizing the results—including Amazon—of their numerous products.
There has also been immense interest in providing for the people in our supply chain. Fair trade and human labor are increasingly part of ESG initiatives of healthy food and supplement firms. We work in an industry that relies on cheap labor on farms overseas, and many farmers and collectors around the world are suffering. It’s an untenable situation for our supply future.
My group, Ethical Sourcing Review, is supporting natural products firms to evaluate and improve their impacts on people, planet and product. We’re helping firms take the next steps, wherever they are in their sustainability journey.
Verkerk: NOW Foods and CEO Jim Emme are doing incredible work to better the supplement industry. Their initiative to conduct independent testing of supplements is positively influencing industry standards and highlighting the need for the FDA to focus its resources on improving its inspections of dietary supplement manufacturers.
Sudberg: I think we as an industry owe a great deal of gratitude to the brazen legends of our industry who are tirelessly working to correct false narratives. One of those is NOW Foods. We cannot express enough appreciation for what they are doing to expose the biggest perpetuator of poor quality products in our industry, Amazon.com. Without NOW, counterfeit and adulterated products would continue to tarnish our wonderful industry without detection. While Amazon.com has been mostly quiet since their previous team (I miss that team), I know in the background that the needle is moving in the correct direction.
Bellizzi: We’re working to build cause into the brand from the beginning—starting with algae that’s regeneratively grown using only green energy, pristine Icelandic water, and the nutrients our algae need to thrive. We don’t use any pesticides or harsh chemicals like hexane to process our omega-3 oils and spirulina extracts. We package in post-consumer recycled materials, reusable glass bottles, and even print our shipping materials with algae-based inks.
Our eye is on circularity, responsible business practices, and building endless abundance into everything we do. We are aiming high, as we provide algae-based nutrition solutions that use 99 percent less land and water resources than other sources, while harnessing algae’s full potential with the power of technology. While our algae are proudly non-GMO (genetically modified organism), we use a biotech approach to managing our growing conditions, utilizing AI-driven machine learning to optimize growing conditions.
The end result? An algae that is higher in omega-3, that can be minimally processed, and that retains its polar lipid structure for better absorption than other sources—with EPA and DHA. Our Icelandic Ultra Spirulina even has a protein profile comparable to that of beef and contains vitamin B12 in the methylcobalamin form, providing a long-term and viable nutrition solution for vegans and vegetarians.
VR: What is the biggest industry problem that needs to be addressed? How can retailers help?
Verkerk: In one word? Apathy! We only have to look back to the DSHEA campaigns leading up to 1994 to remind ourselves that it was the concerted effort by a few companies that mobilized millions of consumers that prevented catastrophe, including the medicalization of supplements.
The threats may not have been as obvious since then, but when you look how the FDA is increasingly harmonizing its approach with that of the highly restrictive regulatory regime of the E.U., it’s time to wake up. The now internationally coordinated efforts of the FDA and FTC, together with social media companies, “fact checkers,” and self-appointed arbiters of so-called “scientific misinformation,” are all working toward a full-frontal assault on all natural products that have therapeutic benefits that compete with drugs or vaccines.
Sudberg: I identify as a marketing guy with a chemistry degree and so while I love phytochemistry, I find myself spending more time pondering the marketing of our industry.
One thing as an industry we must do to correct the narrative that we are an unsafe, unregulated, and ineffective industry is to share proof of our quality. We all know there is science behind our ingredients. The marketing teams behind our favorite brands do a fine job there, but we don’t talk enough about proof of quality. Many millions of dollars are spent each year to make sure the ingredients in our products are correct, safe, and effective (as judged by measurements of “things”). Let’s talk about. Let’s lead with it. Let’s show the world that we are safe, regulated, and effective.
Emme: The root cause of many of these problems is that consumers are constantly being told that our industry in unregulated and out of control. Retailers can help address this by educating their consumers about the regulations that all supplement companies must follow. Howard: Consumer education, consumer education, consumer education. Let’s not forget state and federal legislators (and regulators) are also consumers. Let’s see if there is a way to ensure that major retailers and big box stores, and Amazon, are as educated as our independent retailers.
Emord: The greatest threat to the survival and success of the supplement industry remains government censorship of health information and costly regulation and enforcement in the absence of proof of public harm.
Monheit: I would say it’s an agency that does not have the will to enforce current regulations. It’s been obvious for some time that the agency has taken a rather passive position—sure, eventually they may send a letter or seize product. But not soon enough and not nearly enough in frequency. And there are other actions such as initiating criminal proceedings that they have the power to take. As to what the retailers can do here, I’d say be aware of the regulations, stay away from products that violate, and continue to notify if you see egregious violations—and work at local levels to communicate to your representatives that this is an issue of will to enforce as much if not more than power to enforce.
Kwik-Uribe: The continued pushback on the supplement industry, e.g., by federal agencies, state legislators, etc. puts strain on a lawful industry. Rather than using their power and regulatory authority to address the bad players in the industry (bad players that are not unique to the supplement industry but exist in all areas of business), these groups look to impose unnecessary restrictions on the industry as a whole, an industry that offers safe, effective products that help support the health and well-being of millions of consumers every day. These issues won’t be solved overnight, but a unified approach by the industry—including everyone from suppliers to retailers, in joint efforts with trade associations—using data, facts and persistence can help these groups see the facts and in doing so, adjust their stance from restrictions directed towards “the good,” toward efforts directed towards “the bad.”
Mister: Despite all the positive news about the role dietary supplements play in better health, it doesn’t take much to rattle consumer trust; one incident that jeopardizes consumer safety could reverse years of industry growth. One way to build that trust is through more transparency and assurance that these products are well made. FDA has called for a dietary supplement listing and the idea makes sense—FDA can’t properly regulate a marketplace when it doesn’t even know which products and ingredients are out there.
Retailers can curate the products they sell by asking their supplement vendors about their ingredient supply chains, their adherence to GMPs (good manufacturing practices), their use of third parties to audit their facilities and spot test their products. They can demand their vendors submit their labels to the Supplement OWL (the industry’s voluntary label registry) and substantiate their label claims. Retailers are the last gatekeepers before consumers take our supplements home to use; they can be proud stewards by insisting product vendors deliver only safe, high-quality products.
VR: Is there anything else you would like to add especially regarding retailer considerations?
Monheit: We run an annual survey with supplement consumers and the value they place on trust, and transparency continues to increase. In 2022, 72 percent of our 3,600-plus survey respondents said that transparency information from manufacturers “somewhat increases” or “greatly increases” the chances they will purchase the product. The strongest indicators of transparency include detailed information on packaging/website and quality seals. When it comes to trust, consumers ranked a health care professional recommending the brand on top followed by consistent product quality and quality certifications and seals—retailers should pay attention to these factors when selecting which products to carry (source: 2022 ITC Insights Consumer Supplement User Survey).
Howard: We must never forget that the independent retailers are our own frontline. They are the backbone of the industry, and central to any successful advocacy initiative—especially in today’s highly dysfunctional and divisive political atmosphere.
Verkerk: As the stakes rise, we’re hoping to be able to collaborate with retailers so that our campaign messages can get out there, far and wide, expanding grassroots reach and impact. This kind of collaboration is essential if we’re going to be serious about protecting our rights and freedoms for future generations.
Emme: We at NOW are grateful for the support of retailers, not just for our brand, but also our industry. They continue to be a frontline resource of valid information to educate consumers.
Billingslea: Politics is not my favorite thing. I find it difficult to keep up with the headlines and rarely have time to read all the articles sent to me to inform me of what is going on. On top of that, most of us small guys are using up a lot of our energy on just keeping customers coming through the doors and not being undercut by cheaper, online prices. Even as popular as the health industry has become, we are truly in some of the most challenging years I’ve seen yet, with no promise of relief in sight. VR
