Upcoming Issue Highlights
Home Subscribe Advertise Sourcebook Free Product Info Home

Leadership Forum

Albion Minerals®
 
CapsCanada
Leadership Forum Leadership Forum

Natural products leaders help the industry forge ahead.

The panel:

Corinna Bellizzi, Head of Sales & Marketing – U.S. Nutraceuticals Division, Örlö Nutrition & VAXA Technologies, Wilmington, DE, https://orlonutrition.com

Blake Ebersole, President & Founder, NaturPro Scientific, Carmel, IN, https://naturproscientific.com

Jonathan Emord, President & Principal, Emord & Associates, Clifton, VA, https://emord.com

Catherine Kwik-Uribe, PhD, Vice President of Scientific & Regulatory Affairs, Nutrition21, Saddle Brook, NJ, https://nutrition21.com

Mark LeDoux, Chairman & CEO, Natural Alternatives International, Carlsbad, CA, www.nai-online.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

Martha Yaney, Chief Marketing Officer, Turmeric Innovations, Darien, CT, https://turmericinnovations.net

Over the last few years, there have been a number of what might be characterized as puzzling governmental decisions and pronouncements regarding dietary supplements and ingredients, including N-acetyl-cysteine (NAC), nicotinamide mononucleotide (NMN), CBD and more.

Some of these decisions have involved retroactively invoking the race-to-market drug exclusion provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA) to decree that certain supplements, which have been safely sold for decades, are now unapproved drugs.

While industry organizations and leading companies band together to responsibly fight these challenges, shady online sellers and TikTok “influencers” continue, unabated it seems, to peddle questionable products from no-name LLCs.

Fortunately, industry leaders are not standing by on the sidelines but are, instead, making their voices heard.

NIE: Video clips on TikTok are creating a buzz about berberine for weight loss similar to the buzz on the Dr. Oz show once created about NetiPot, raspberry ketones, astaxanthin and much more. Any comment on TikTok creating this new Oz Effect-like craze, or about these crazes, in general?

Ebersole: If we thought a TV doctor could spin the needle, just wait until crazy supplement claims go viral on TikTok!

That means that today, on Amazon, a no-name brand of berberine HCl (1,200 mg per serving) is a top-10 bestseller in the Blended Vitamin and Mineral Supplements category.

On the label, the ingredient, berberine hydrochloride, is supposedly made from Berberis aristata, which is also known as Indian barberry or tree turmeric.

But there’s more. If you’ve never heard of this no-name brand, that’s ok because neither did I. They don’t have a website, but their label traces to an anonymous LLC in Delaware.

Yet wait—scroll down to the next row, and there’s Berberine 4,700 mg! With ceylon cinnamon! And from a brand that has a website, but no location. The larger questions are: Where is the berberine (or any of these fad supplements or ingredients) sourced or made? Why are anonymous businesses with untraceable or missing addresses allowed to sell on Amazon and elsewhere? Why are online e-commerce sites selling and promoting mislabeled products with false claims from foreign businesses?

Consumers are apparently trusting the recommendation of TikTok influencers to take 9,000 mg a day of berberine or more, or, you name it, anything else!

Yaney: TikTok, as a China-based platform, should be banned in the U.S., just as American websites are banned in that country. Reciprocity!

LeDoux: No greater time to learn and follow the Latin admonition: “Caveat emptor.”

NIE: The U.S. Food and Drug Administration (FDA) 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. Thoughts?

Kwik-Uribe: It certainly has been a dynamic and challenging time 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.

Sudberg: Our industry has and continues to lose valuable ingredients from our tool chest. The only reason to remove something after it was deemed safe is if new data have 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 from the grand puppeteers of the FDA (Big Pharma). 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.

Turk: 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.

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.

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.

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.

Yaney: This restricts commerce and is not consistent with a free market economy.

Given 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 Federal Trade Commission’s (FTC) posture and recent broad-brush and arguably aggressive tactics?

Ebersole: The 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. Yet 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.

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.

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 past 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.

Kwik-Uribe: As the FTC 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.

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 protected, speech is chilled when government uses coercive threats to intimidate prospective speakers from opening their mouths.

Monheit: 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.

Yaney: It’s time to end the stepchild treatment of natural supplementation and put it on a par with regulated pharma, albeit without the need for phase 1-3 studies that restrict competition but is necessary for serious medication. It is not needed for naturally occurring and plant-based ingredients.

NIE: What’s going on with NMN? What do retailers need to be aware of?

Verkerk: Supplement companies have made significant business investments researching, marketing and selling NMN to consumers. That’s being rewarded by good sales, rave reviews and many happy consumers who are winding back the years, probably taking pressure off groaning health care services.

Yet, the FDA is in the process of allowing a pharmaceutical company to create a monopoly on NMN that will drive up the price of this ingredient and make it harder for consumers to access and benefit from. We recently joined with the Natural Products Association (NPA) to submit a Citizen’s Petition to the FDA urging the agency to reverse its determination that NMN is not a legal dietary supplement.

Turk: Absent any safety concerns retailers should continue to sell NMN. In March, the NPA submitted a citizen’s petition requesting a reevaluation of NMN by the FDA or an exercise of enforcement discretion on the drug exclusion clause for NMN. The agency does not have the statutory authority to reverse course on the NDI (new dietary ingredient) for NMN as a dietary supplement. Just like in the case of NAC, our citizen’s petition gives the industry a platform to work the agency on resolving this issue. Make no mistake, NPA will use every resource available to right this wrong.

Monheit: Despite initial acceptance of an NDIN, FDA later withdrew this acceptance and determined the drug exclusionary principle applied. for retailers, this means that FDA does not consider NMN as a lawful dietary ingredient so products containing it should not be sold.

Emord: FDA has deemed it unlawful for sale under the drug exclusion provision of DSHEA, which is further proof of the draconian abuse that provision is causing. Congress should revoke the provision.

Kwik-Uribe: Despite efforts by consumers, companies, and trade associations over the past few months, the FDA, disappointingly, has not changed their position. This feels like another attack on an industry that works to bring new innovations to market to support affordable, safe products that can maintain and improve their health. It is important for all parts of the supplement industry—from suppliers and distributors to brands and even consumers to work together, now more than ever, to ensure these products remain available and accessible to all the millions of consumers who use them daily to support their health.

Mister: Despite FDA’s warning letters to several companies, there has been no official final agency action on this matter and there is no public indication that FDA has been willing to support its position with any enforcement activity. Purportedly, Amazon has announced it is removing all NMN supplements from its platform, but we believe that action is premature. With citizen petitions pending on this issue leaving this an open matter at FDA, companies should take that into consideration when determining if they will continue to offer NMN to their customers until the citizen petitions are resolved.

NIE: Homeopathy has certainly taken a beating over the last year. What do you forecast for this category in the U.S.?

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.

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.

Emord: FDA will be sued again for this violation of the FDCA (Food, Drug and Cosmetic Act), 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.

NIE: Also regarding the FDA, do you see a way forward for CBD as a dietary supplement ingredient? Please elaborate, and indicate what industry should prepare for.

Sudberg: It’s messy. Clearly the CBD flash in the pan has since expired, leaving a few legacy brands still standing along with the strongest and most science backed newer brands. Having started AHPA’s (American Herbal Products Association) cannabis committee I would never have predicted the path cannabis took but feel confident that eventually it will be considered a dietary supplement.

Monheit: FDA has moved this issue back to Congress so that’s where next steps must occur. At the same time, FDA has continued to message its concerns and belief that the path forward for CBD containing products is solely through the drug route. Cited reasons include cumulative consumption, absence of safety data (especially long-term) and by all appearances, an industry-unacceptable interpretation of DSHEA. In fact, under such interpretations, one could argue that traditional botanicals, such as kava, would not even cross the threshold were it presented today, certainly not the intention of the framers of DSHEA.

Verkerk: The FDA has indicated it would like to heavily regulate CBD and group it with other cannabis-derived products, instead of more appropriately undergoing a rulemaking process to permit CBD in supplements.

In our view, the FDA clearly has an interest in restricting or banning CBD supplements due to the existence of an FDA-approved CBD drug, Epidiolex. Due to the FDA’s lack of action, ANH believes this is an issue where Congress needs to act to legally permit CBD and related, non-psychoactive cannabinoids in dietary supplements.

Mister: FDA made apparent in January it has no intention of moving forward with a pathway for CBD in dietary supplements on its own. So, the action has moved back to Congress to direct the agency how it should establish an orderly over-the-counter marketplace with appropriate guardrails. Fortunately, one already exists: the dietary supplement category. As a botanical extract, CBD unmistakably qualifies as a dietary ingredient, and the safeguards that FDA claims to want for consumers—GMPs (good manufacturing practices), adverse event reporting, oversight of labeling, the ability to limit unsafe levels—have already been established for supplements. CRN is working to build support on Capitol Hill for legislation that will mandate FDA properly treat CBD and other cannabinoids as dietary ingredients.

Ebersole: The way forward is to acknowledge CBD like any other ingredient. Assess the safety and maximum dosage based on the GRAS (generally recognized as safe) and/or NDI standard for the dosages that have already been determined as safe. And acknowledge that a safe supplement dosage is going to be lower than an effective drug dosage.

NIE: Whether it’s New York, New Jersey, California or, more recently, Colorado, what’s behind these state efforts to restrict or ban supplements and how can the industry best tackle these challenges?

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 effort 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 towards 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.

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.

Yaney: Seems motivated by big pharma’s persistent opposition to low-priced natural remedies. Dietary supplements as a category are overwhelmingly safe.

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.

NIE: What is the biggest industry problem that needs to be addressed?

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.

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.

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 toward “the good,” toward efforts directed toward “the bad.” NIE

Extra! Extra!

Albion Minerals®
 
CapsCanada