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Washington and the Natural Products Industry

| July 1, 2022

Washington and the Natural Products Industry

The Panel:

Ramona Billingslea, Marketing Manager, Betsy’s Health Foods, Spring, TX, https://betsyhealth.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

Dan Lifton, CEO, Quality of Life Labs, Port Chester, NY, https://qualityoflife.net

Jeff Lind, National Director of B2B Ingredient Sales, Novozymes One Health, Bagsværd, Denmark, https://novozymesonehealth.com

Robert Marriott, Director of Regulatory Affairs, American Herbal Products Association (AHPA), Silver Spring, MD, www.ahpa.org

Steve Mister, President & CEO, Council for Responsible Nutrition, Washington, D.C., https://crnusa.org

Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com

As the world’s attention shifts from a global health crisis to political, humanitarian and economic crises both abroad and at home, there is a danger that concerns of businesses and industries can get lost in the shuffle. Nevertheless, legislators in Washington, D.C. and officials in D.C. and Maryland continue to advance legislation, interpret existing law and promulgate regulations that affect every single product sold in the natural products industry.

Here to discuss some of the major issues regarding dietary supplements is a panel of dietary supplement industry experts.

VR: What is the single biggest regulatory or enforcement problem the natural products industry faces?

Lind: The biggest single regulatory or enforcement issue that the industry faces is adulteration. With the likelihood of being caught relatively low and the potential financial gain high, this will continue to trouble our industry. The two ways to fight this issue is to adequately fund and staff the FDA (U.S. Food and Drug Administration) so that the regulations in place can be enforced. Additionally, supplement manufacturers need to be concerned with product quality and efficacy as opposed to price alone. Alarm bells should go off when you are offered “the same” product/ingredient at a price well below the current range of offerings. It is up to the manufacturers to actually do the required testing in order to root out adulterated offerings that make it past the FDA.

Lifton: One of the biggest issues is economic adulteration. Adulteration hurts everyone, from consumers to retailers to manufacturers and the industry at large, and it’s rampant in the world of botanicals, with bilberry being one example. One of the top-selling wild-harvested berries in the U.S., bilberry supplies are rife with adulterated product. That’s why our sister company, Maypro, offers Bilberon, which is derived from DNA-authenticated 100 percent naturally grown northern European bilberry.

Sudberg: From the lab perspective, the biggest regulatory/enforcement problem our industry faces is that there is no agreed upon testing methods to comply with cGMPs (current good manufacturing practices). “Scientifically valid” is the guidepost but this allows unfit for purpose methods to sneak in and decrease quality, efficacy and then sales or at worst allow in harmful adulterants.

Mister: The largest regulatory issue facing the industry is the malaise of inaction and tepid enforcement of DSHEA (Dietary Supplement Health and Education Act of 1994) by FDA. After 28 years, FDA still has tools provided by DSHEA that it has not fully utilized, like the new dietary ingredient provision. Despite clear legal authority to address illicit substances in supplements, NDIs (new dietary ingredients) being marketed without notification, and blatant disease claims on some labels, FDA is reluctant to protect consumers and responsible manufacturers against these bad actors. That’s not to say we don’t work with the agency to establish new ways for it to be more effective—mandatory listing is such an opportunity. But at the same time, we need our regulators to regulate, so we need to identify the causes for that inaction and fix them too.

Emme: The NAC issue is problematic, yet avoidable. We provided marketing materials from October 1994, prior to the passage of DSHEA, showing that we had marketed NAC a year earlier. We also informed the agency that we have never had an Adverse Event Report about NAC. We asked the industry’s trade associations to work on a solution with FDA, and NPA has been very effective. They recommended the option of discretionary enforcement, which is what the agency ultimately decided upon.

Howard: We are ill prepared to face a legislative assault by Congress. Our prior champions no longer hold office, and too many members and staff currently hold an ill-informed understanding of DSHEA, can’t differentiate the good from bad actors, and completely devalue supplement efficacy and safety. Add to that the fact that defining a unified position on any of the issues we grapple with continues to be elusive. Any potential success will require a grassroots effort that must far exceed what was required to pass DSHEA in 1994. I’m not sure how much longer we want to (or can) rely on Congress’ dysfunction and government bureaucracy as protection.

Emord: Drug protectionism continues to skew the agency’s treatment of dietary supplements away from permitting public access to and receipt of dietary substances and truthful claims concerning their effects. We see that, for example, in FDA’s failure to give fulsome protection to NAC (n-acetyl-l-cysteine) and its demand for an expansive interpretation of what constitutes a new dietary ingredient and refusal to embrace supplement industry concerns or recommendations.

VR: What is the single-biggest challenge that natural-product retailers now face?

Billingslea: Our biggest challenge continues to be staying competitive and making ourselves unique enough so that customers keep coming back to us instead of turning to big box or Amazon as options for their supplements. That means we have to be cost competitive on the name brands we carry, offer a quality store brand that customers will love, and being as convenient as possible with online orders as well as in-store shopping.

Lifton: Brick-and-mortar retailers continue to face the ongoing challenge associated with people just ordering on Amazon or somewhere else online. However, those stores which offer excellent and knowledgeable customer service—along with other things, like special orders—are retailers who are most likely to succeed, no matter what’s happening online.

Sudberg: This industry has a lot of opportunity to improve its efforts to earn the trust of the next generation of consumers. It’s been a while since we’ve had a scandal about quality. Still, transparency about quality is one of the most important factors in a buyer’s consideration to buy or not to buy a dietary supplement. Ingredient risk is brand risk and those brands willing to differentiate from better sameness by sharing their quality story are the ones who will succeed.

Emme: Competition from online sellers continues to be a challenge for natural product retailers, which was not helped by the lockdown phase of the pandemic. NOW has always supported independent retailers in various ways, including education, because we know consumers rely on guidance that they only get in store aisles.

Mister: On the one hand, retailers want to be responsible gatekeepers who curate their retail shelves with safe and beneficial, high-quality products. But at the same time, they get conflicting messages on how to evaluate products, what standards to impose for their vendors and how to curate their supplement assortment from quality manufacturers. Organizations like the Global Retailers & Manufacturers Alliance (GRMA) are helping to create these industrywide standards.

Lind: These are challenging times for everyone, from increased costs to supply chain-related delays, and natural channel retailers are additionally faced with intense competition from online sellers. One advantage natural retailers have always had is that they have access to education from industry trades, brands and suppliers that they can use to help customers make informed decisions. That keeps people coming back.

VR: The FDA recently refused to reverse its position that NAC is not a dietary supplement but said it does not plan to enforce against otherwise legally marketed NAC supplements. Comment?

Mister: Yes, retailers and many other stakeholders are confused about the effects of the so-called “drug preclusion provision” that creates a race to market among drugs and supplements. FDA conflates a pure economically driven determination that was intended to protect the financial incentives for drug innovation with the issue of safety, which is addressed elsewhere in DSHEA. While the announcement of enforcement discretion is good news for retailers and marketers of NAC, it doesn’t provide a roadmap for other ingredients that may find themselves in a similar predicament.

Emme: There may be some confusion as to the legality of NAC at the retail level, but articles like this one may help. What FDA said was they will exercise “enforcement discretion” and apparently only take action if a product is marketed using drug or disease claims, which of course is illegal for dietary supplement labeling. NOW is continuing to sell NAC.

Howard: It is a step in the right direction. However, it is also a common feint to employ when a regulator does not want to admit it made a mistake. However, only by our unrelenting political pressure can we expect this détente to last.

Emord: FDA’s so-called “exercise of enforcement discretion” is an old means by which the agency avoids grappling with a politically sensitive or legally difficult issue. It effectively punts until the time arrives when it may assert its power without fear of repercussions.

It is a cop out, revealing a lack of courage and adherence to principle. The current law affords the agency considerable discretion in interpreting ambiguous statutory provisions, and ordinarily the agency uses that discretion to increase its own power and promote its own pro-drug regulatory agenda.

In this instance, it wishes to avoid confronting the consequences of its decision in light of the considerable backlash likely to come if it removed NAC from the market. No one should be lulled into a false sense of security, however. Legislation needs to be introduced to eliminate any doubt that NAC may be marketed as a dietary supplement.

Lind: When FDA says one thing (NAC is not a dietary supplement) but does another (not enforcing this) they are sending mixed messages to both industry and consumers. If industry feels FDA may or may not enforce their decisions, some players may partake in questionable activities. All this does is to erode consumer confidence in the FDA and, more concerning, in our products.

Billingslea: It feels like the government is instituting the frog in the pot approach to taking over our industry. Rulings like this that say one thing and do another make us feel like we’re sitting in the pot of cool water as it slowly comes to a boil, blissfully unaware of our impending doom.

VR: Talk about California AB-1341, which would ban the sale of weight-loss supplements to consumers who appear to be under 18 years of age.

Sudberg: Oh California, how I wish I didn’t live in you sometimes. This is a classic misguided bill that demonizes a threat to big pharma, natural products, for risks that simply are not being shown in reality. There is no data to support the need for this bill and, if that wasn’t enough to show how unwarranted it is, the fines are higher than selling a natural product known to cause cancer (tobacco) to someone under 18. This hurts brick-and-mortars, hurts trust in the industry and should be filed in the recycling bin.

Emord: The blunderbuss approach taken in AB-1341 is born of ignorant prejudice against the industry, when in truth only a subset of sellers fall into the bad actors category. Whatever happened to the idea of innocence until guilt is proven and of due process. This bill would condemn everyone, the good and the bad alike, in this market.

Mister: So much misinformation around the promotion of this bill. There is no causal relationship between dietary supplements for weight management and eating disorders or body dysmorphia. A just-released literature review commissioned by CRN reaffirms the broad margins of safety of the most popular ingredients in these products. Age restrictions on these products will restrict access to these products for everyone, not just youngsters. And this legislation does not solve any supposed problems, it just pushes teens to buy products online, which ironically, is where the vast majority of products with illegal ingredients can be found. This legislation is misguided and hurts all consumers, but especially teens who lose local retailers as a place to buy safe products.

Marriott: AHPA has been actively engaged on Assembly Bill 1341 since its introduction by Assemblywoman Cristina Garcia in February 2021. AHPA does not oppose placing an age limit of 18 on products that are specifically labeled for weight loss, but we believe it is important that any such restriction should be clear about what products it covers and must give retailers flexibility to use the most appropriate methods when applying that restriction.

We will continue our discussions with Assemblymember Garcia to remove unnecessarily burdensome elements from the bill and improve the focus of any final legislation.

LeDoux: If there existed a causal linkage between adverse events and the materials envisioned by this legislation to require restricted access, that would be one thing worthy of discussion. That said, it appears that this legislation is a remedy in search of a problem given the lack of evidence that nutrients in this category have been linked to widespread adverse events in the target demographic.

VR: What kind of burden would “AB-1341 policing” place on retailers?

LeDoux: Restrictions of sales to consumers in retail settings is a slippery slope. Should this legislation be enacted and become law, how will it be policed particularly when products are widely available via direct purchase online or through third party vendors?

Mister: These bills place a huge burden on retailers to police these restrictions, which means many stores may just not sell the products at all. If the restrictions for behind-the-counter-only access are left in the bill, large sections of the supplement aisle simply become inaccessible for consumers. Some stores will remove the products altogether. And lastly, the penalties fall squarely on the retailer for selling the product, and in some states, directly on the store clerk who accidentally makes a sale to a minor.

Lifton: Making retailers serve as supplement police is never a good solution. It does nothing to help the retailer yet opens them up to liability.

Sudberg: I imagine the big box retailers have the infrastructure necessary to tag items and trigger ID checks. The smaller shops will need to do so manually and could find compliance with this absurd bill more disruptive.

Emme: Retailers will need to restrict access to these products including possibly locking them up. There have been some proposals to create a point-of-sale restriction in which the cashier will be prompted to ask for identification for the sale of these products (much like used for the sale of OTC [over-the-counter] decongestants), but this concept has yet to be accepted and defined in the current bill. Either way the burden of enforcement falls on the individual retailer.

VR: What is the status of HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021?

Sudberg: This legislation would finally ensure a legal pathway for hemp-derived CBD and other ingredients derived from hemp to get to market. The bill also directs the FDA to use its authority and resources to set forward a clear and robust federal regulatory framework for these products, promoting consumer safety while providing an economic boost to struggling farmers and their employees. It is likely to pass, considering the 2018 farm bill and how it showed Congress’s intention to support the production and sale of hemp and hemp derivatives such as CBD.

Emord: The bill is in limbo and is not likely to pass anytime soon because of other, pressing congressional issues and gridlock associated with our highly polarized political parties.

LeDoux: The CBD bill is winding its way through the legislative process, but I frankly think this is something of a “Hail Mary” pass by legislators to address their inaction over the past several years in this burgeoning marketplace. To date, the FDA has indicated that oral ingestion of CBD is illegal, yet almost daily, I receive offers via e-mail from internet sellers of all things in gummy form that contain CBD, apparently without regard to the stated position of the FDA. Ignorance of the law is not an excuse for violating law, but inaction of the agency tasked with protecting the consumer is a whole other matter.

VR: Recently, a Massachusetts district court judge issued a summary judgement in favor of Vitamin Shoppe versus two plaintiffs who challenged three structure-function claims on a product containing glutamine. Comment?

Emord: This decision builds on emerging precedent which supports the proposition that when a company complies with the DSHEA requirements for structure/function claims, federal law pre-empts putative class action suits designed to demand a different, or higher, level of substantiation and claim requirement than federal law. Moves in this direction are needed to limit the number of class action suits, which are crippling the industry and hampering the availability of useful products for consumers.

Emme: Our view is that this was a win for our industry, and we applaud Vitamin Shoppe for taking a stand in challenging this case. It would have set a challenging precedence for other natural products.

Mister: This decision is important because it reaffirms the supremacy of federal law and the preemption of state laws in areas like dietary supplement labeling where FDA’s actions occupy the field. It reaffirms the principle that individual states may not substitute their judgment for the reasoned decision making of Congress and FDA.

LeDoux: Private actions seeking legal redress for apparent violations of FD&C Act provisions as amended seem to be telegraphing a frustration with the lack of agency activity in certain areas. Until the agency has appropriately identified issues, communicated action plans, and actually implemented said plans, I would anticipate that this behavior will continue.

VR: Are you in favor of a Mandatory Product Listing (MPL) for all dietary supplements?

Billingslea: I am very concerned about a mandatory product registry for supplements that is neither warranted nor welcomed by the natural products industry and even supplement users across the country. DSHEA has effectively governed the way supplements are made available to Americans for almost 30 years. The passage of DSHEA was a hard-won battle.

That’s why we’re very concerned about Braun and Durbin’s proposed Dietary Supplement Listing Act of 2022, which would create new regulatory barriers, including what would basically amount to pre-market approval of dietary supplements. This would give the FDA new authority to prevent health and wellness products from reaching millions of consumers. In fact, we have posted an Action Alert on our store’s website linking to the Natural Products Association’s action page on the topic. We have also started handing out flyers in the store and talking about this threat with customers so that they too can take action.

Emme: Absolutely not. Simply making a mandatory list a law doesn’t address the issue of how that list will be used. There are too many unanswered questions as to how the list will be used by the Agency. We support transparency, but not in this form. We believe that the Agency needs to inspect, test and report for label accuracy. Our own experience shows that this can work when we tested and showed that some online brands were not meeting label claims. These brands were bad actors who will never list their products before going to market, so an MPL most likely won’t address that issue. The timing of this push for an MPL is puzzling. One could look at this as a solution looking for a problem, and the presentation of this legislation implies that all companies selling and marketing dietary supplements are dishonest.

The MPL is a poor substitute for more effective solutions to real problems that exist and more productive uses of FDA’s limited resources. It’s a very real concern that it will evolve into pre-market approval, which would place a heavy burden on the industry, creating delays and increasing costs. And it just doesn’t make sense given that supplements are such a safe class of goods as demonstrated by the very low number of adverse event reports.

Emord: I am opposed to any such listing. It is generally unwise to impose new statutory and regulatory requirements where there is an absence of consumer injury. We do not suffer from an epidemic of non-disclosure of material ingredients in products; to the contrary, I believe it the usual circumstance for manufacturers to err on the side of disclosing ingredients which may have a material effect on consumer choice, health or interest.

Lind: I’m steadfastly opposed to a mandatory product listing. A MPL shifts the burden and cost of regulatory enforcement from the FDA to industry. I’m all for appropriate regulation of dietary supplements but an MPL adds cost and an unnecessary and monumental burden on industry without further protecting consumers.

Howard: A federally mandated product listing will likely be used to reduce competition by using it to deem certain products “misbranded.” This gives the largest and most influential lobbyists the power to eliminate products and ingredients that compete with their own. Since a registry cannot be controlled to be fair, transparent and equitable, it is a tool more dangerous that what we are told it is designed for. It does nothing to prevent fly-by-night companies to continue to sell dangerous pharmaceuticals masquerading as dietary supplements. FDA enforcement is the problem, not whether a product is registered.

Sudberg: This is not as simple an issue as some seem to think. On one hand, a mandatory product listing could provide the transparency for the dietary supplement market that FDA needs and consumers deserve. It would be a benefit to all labs in the industry since we’d now have a simple list from which to sell our needed services.

On the other hand, it does smell like a solution looking for a problem given our industry’s products have a far better safety record than many other sectors.

I do have concerns about it being an undue burden on the smaller companies in the industry that have fewer resources to assign to this responsibility. I have heard from some colleagues that it would be quite disruptive.

Marriott: AHPA has interest in potential regulatory modernization, provided that it actually benefits consumers. There remain many unaddressed concerns about MPL proposals—including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets.

Mister: CRN strongly supports mandatory listing. FDA cannot regulate an industry if it can’t see it. And FDA can’t see the breadth and range of the industry now. Mandatory listing provides the transparency that a responsible industry should crave and consumers should expect.

VR: Can you speak to the recent commentary in Military Times calling for a separate AER reporting system for military members?

Emme: The Military Times article was filled with fallacies to address a problem which does not exist. We’ve seen this before, with reporting that claims adverse events are a very real risk with dietary supplements, when actual AER reports don’t support that assertion. When consumers, including members of the military, buy and use products made by established brands that rigorously test their products and strictly follow GMPs (good manufacturing practices), the likelihood of an adverse event is miniscule.

Sudberg: I am not aware of issues around tainted dietary supplements and military unreadiness that would justify this concern, though. While the categories commonly used in this demographic (bodybuilding, energy or pre-workout, and weight loss) are of the highest adulterated categories, making rules based on events that transpired over a decade ago is really idiotic.

Lifton: Our military members need to be in tip-top health, which is why dietary supplements are especially important for them. That being said, there already is an AER reporting system which works, so why would there be the need for a duplicate or redundant system for a subset of the U.S. population?

Mister: If the military developed its own duplicative adverse event reporting system just for service members, it would create redundant systems with the FDA-administered AER system for all Americans. A separate military AER system would lead to both over- and under-reporting as providers won’t know who to file their reports with. It’s an inefficient use of federal funds and potentially denies FDA the information it needs to detect early signals of a potential problem.

Emord: There is no sound empirical evidence to support this position. It is conjecture and, indeed, contrary to the experience in each of the services where dietary substances have been tested and evaluated for use in improving hydration, resistance to fatigue and endurance. Far from hurting the military, certain dietary supplements have been shown to assist the military in fulfillment of specific missions.

VR: Sustainable practices, transparency and clean labels—please discuss.

Lifton: There is a troubling yet common practice in the nutritional supplement industry known as “fairy dusting”—a manufacturer includes a tiny amount of a popular herb or nutrient in a product, then lists the ingredient on the product label, even though the dose is far too small to be effective. That’s why it’s time to change the current industry practices and embrace transparency in order to reassure consumers that they’re getting effective doses of the ingredients they take.

That’s why QOL has been working with several physicians and nutrition experts to develop a new reference standard for dietary supplements: Clinically Validated Daily Intake (CVDI). The CVDI is the minimum daily amount of an ingredient that has been found to produce a positive health effect in human studies. For example, the CVDI for whole turmeric is 1,000 mg, because that’s the lowest dose at which turmeric has been shown to benefit health in human research.

Quality of Life has committed to including at least 100 percent of the CVDI for every single ingredient in every one of our products. We want to inspire the entire supplement industry to adopt the same level of integrity and transparency.

Emme: If our experience at NOW is any indication, more and more people are looking for clean versions of mainstream offerings, from sports nutrition to foods to personal care to supplements. NOW customers are very comfortable reaching out to us if they have concerns about an ingredient, and we’re happy to engage with them, which all companies should be doing today.

Sudberg: I believe the consumer wants a clean, sustainable and trustworthy product, and the sharing of all those important things comes down to transparency. Given that we all know how important this is, brands need to be looking at what areas of their operations they are not being open about and working to share those. I’m a huge advocate of companies making their test results public and am very happy to see more and more companies doing so.

Marriott: Thanks to the choice that consumers now have—in the form of hundreds of thousands of products available to them—gone are the days that companies can operate in a vacuum and expect to win market share and loyalty. Consumers vote with their dollars and have increasingly shown that they are willing to spend more in support of brands whose values they share and whose work they believe in.

Lind: Consumers today have made it clear that when they have questions about companies and products, they expect answers, so the industry’s increased focus on transparency in recent years is working out well for those companies who made it a priority. With severe weather as a consequence of climate change impacting an ever higher portion of the population, sustainability efforts should be clearly delineated, and constantly improving.

Billingslea: Transparency and clean labels have always been super important to our customers and to us as we choose the products we carry. I would say sustainability has a little more feel of being forced on us than being a major concern. Yes, most of us want to make sure the supplements we buy are harvested ethically, but it’s not at the top of the list for what we are looking for in a supplement.

VR: What steps do the FDA and industry need to take for a better working relationship in 2023?

Emme: One of the criticisms of FDA through the years is that they come from a pharma mindset, which is inappropriate to apply to dietary supplements. If they were at least conscious of the difference, that might be helpful in working through some of the issues, such as the long-delayed NDI guidelines.

Sudberg: I think if the FDA sent a team of delegates to each trade association conference and talked through some of their issue with us and us them, and we did this at each trade show, there would be a better working relationship in 2023.

Howard: Let’s remember that the FDA can only act on the authority of Congress. The Senate picks the FDA Commissioner, Congress drives the budget. A better relationship will absolutely require the will to move beyond the status quo. Pharma is never going to be best friends with us. History has shown us we need champions in Congress, state legislatures, regulatory bodies, and among grassroots advocates.

Billingslea: That’s a tough one. How do we get the FDA to listen to us, when they have turned a deaf ear in our direction for a long time? I am especially sad that Orrin Hatch has passed, while Senator Durbin continues to gun for us like we were the No. 1 on America’s Most Wanted. The atmosphere in D.C. has got to feel particularly chilly these days if you are part of the supplement industry.

LeDoux: When industry and the agency work in a collaborative manner to protect the safety of the consumer, while bringing to market life giving substances that have been properly vetted for purity, potency and stability, the outcome can be extraordinary.

This requires dialogue and communication based on trust and respect. Unfortunately, with the agency having been operating on the sidelines given the restrictions associated with the COVID pandemic, this process needs to restart and ultimately it has to in order to adequately safeguard the consumers of these products. VR

Extra! Extra!

The Panel:

Ramona Billingslea, Marketing Manager, Betsy’s Health Foods, Spring, TX, https://betsyhealth.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

Dan Lifton, CEO, Quality of Life Labs, Port Chester, NY, https://qualityoflife.net

Jeff Lind, National Director of B2B Ingredient Sales, Novozymes One Health, Bagsværd, Denmark, https://novozymesonehealth.com

Robert Marriott, Director of Regulatory Affairs, American Herbal Products Association (AHPA), Silver Spring, MD, www.ahpa.org

Steve Mister, President & CEO, Council for Responsible Nutrition, Washington, D.C., https://crnusa.org

Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com

As the world’s attention shifts from a global health crisis to political, humanitarian and economic crises both abroad and at home, there is a danger that concerns of businesses and industries can get lost in the shuffle. Nevertheless, legislators in Washington, D.C. and officials in D.C. and Maryland continue to advance legislation, interpret existing law and promulgate regulations that affect every single product sold in the natural products industry.

Here to discuss some of the major issues regarding dietary supplements is a panel of dietary supplement industry experts.

VR: What is the single biggest regulatory or enforcement problem the natural products industry faces?

Lind: The biggest single regulatory or enforcement issue that the industry faces is adulteration. With the likelihood of being caught relatively low and the potential financial gain high, this will continue to trouble our industry. The two ways to fight this issue is to adequately fund and staff the FDA (U.S. Food and Drug Administration) so that the regulations in place can be enforced. Additionally, supplement manufacturers need to be concerned with product quality and efficacy as opposed to price alone. Alarm bells should go off when you are offered “the same” product/ingredient at a price well below the current range of offerings. It is up to the manufacturers to actually do the required testing in order to root out adulterated offerings that make it past the FDA.

Lifton: One of the biggest issues is economic adulteration. Adulteration hurts everyone, from consumers to retailers to manufacturers and the industry at large, and it’s rampant in the world of botanicals, with bilberry being one example. One of the top-selling wild-harvested berries in the U.S., bilberry supplies are rife with adulterated product. That’s why our sister company, Maypro, offers Bilberon, which is derived from DNA-authenticated 100 percent naturally grown northern European bilberry.

Sudberg: From the lab perspective, the biggest regulatory/enforcement problem our industry faces is that there is no agreed upon testing methods to comply with cGMPs (current good manufacturing practices). “Scientifically valid” is the guidepost but this allows unfit for purpose methods to sneak in and decrease quality, efficacy and then sales or at worst allow in harmful adulterants.

Mister: The largest regulatory issue facing the industry is the malaise of inaction and tepid enforcement of DSHEA (Dietary Supplement Health and Education Act of 1994) by FDA. After 28 years, FDA still has tools provided by DSHEA that it has not fully utilized, like the new dietary ingredient provision. Despite clear legal authority to address illicit substances in supplements, NDIs (new dietary ingredients) being marketed without notification, and blatant disease claims on some labels, FDA is reluctant to protect consumers and responsible manufacturers against these bad actors. That’s not to say we don’t work with the agency to establish new ways for it to be more effective—mandatory listing is such an opportunity. But at the same time, we need our regulators to regulate, so we need to identify the causes for that inaction and fix them too.

Emme: The NAC issue is problematic, yet avoidable. We provided marketing materials from October 1994, prior to the passage of DSHEA, showing that we had marketed NAC a year earlier. We also informed the agency that we have never had an Adverse Event Report about NAC. We asked the industry’s trade associations to work on a solution with FDA, and NPA has been very effective. They recommended the option of discretionary enforcement, which is what the agency ultimately decided upon.

Howard: We are ill prepared to face a legislative assault by Congress. Our prior champions no longer hold office, and too many members and staff currently hold an ill-informed understanding of DSHEA, can’t differentiate the good from bad actors, and completely devalue supplement efficacy and safety. Add to that the fact that defining a unified position on any of the issues we grapple with continues to be elusive. Any potential success will require a grassroots effort that must far exceed what was required to pass DSHEA in 1994. I’m not sure how much longer we want to (or can) rely on Congress’ dysfunction and government bureaucracy as protection.

Emord: Drug protectionism continues to skew the agency’s treatment of dietary supplements away from permitting public access to and receipt of dietary substances and truthful claims concerning their effects. We see that, for example, in FDA’s failure to give fulsome protection to NAC (n-acetyl-l-cysteine) and its demand for an expansive interpretation of what constitutes a new dietary ingredient and refusal to embrace supplement industry concerns or recommendations.

VR: What is the single-biggest challenge that natural-product retailers now face?

Billingslea: Our biggest challenge continues to be staying competitive and making ourselves unique enough so that customers keep coming back to us instead of turning to big box or Amazon as options for their supplements. That means we have to be cost competitive on the name brands we carry, offer a quality store brand that customers will love, and being as convenient as possible with online orders as well as in-store shopping.

Lifton: Brick-and-mortar retailers continue to face the ongoing challenge associated with people just ordering on Amazon or somewhere else online. However, those stores which offer excellent and knowledgeable customer service—along with other things, like special orders—are retailers who are most likely to succeed, no matter what’s happening online.

Sudberg: This industry has a lot of opportunity to improve its efforts to earn the trust of the next generation of consumers. It’s been a while since we’ve had a scandal about quality. Still, transparency about quality is one of the most important factors in a buyer’s consideration to buy or not to buy a dietary supplement. Ingredient risk is brand risk and those brands willing to differentiate from better sameness by sharing their quality story are the ones who will succeed.

Emme: Competition from online sellers continues to be a challenge for natural product retailers, which was not helped by the lockdown phase of the pandemic. NOW has always supported independent retailers in various ways, including education, because we know consumers rely on guidance that they only get in store aisles.

Mister: On the one hand, retailers want to be responsible gatekeepers who curate their retail shelves with safe and beneficial, high-quality products. But at the same time, they get conflicting messages on how to evaluate products, what standards to impose for their vendors and how to curate their supplement assortment from quality manufacturers. Organizations like the Global Retailers & Manufacturers Alliance (GRMA) are helping to create these industrywide standards.

Lind: These are challenging times for everyone, from increased costs to supply chain-related delays, and natural channel retailers are additionally faced with intense competition from online sellers. One advantage natural retailers have always had is that they have access to education from industry trades, brands and suppliers that they can use to help customers make informed decisions. That keeps people coming back.

VR: The FDA recently refused to reverse its position that NAC is not a dietary supplement but said it does not plan to enforce against otherwise legally marketed NAC supplements. Comment?

Mister: Yes, retailers and many other stakeholders are confused about the effects of the so-called “drug preclusion provision” that creates a race to market among drugs and supplements. FDA conflates a pure economically driven determination that was intended to protect the financial incentives for drug innovation with the issue of safety, which is addressed elsewhere in DSHEA. While the announcement of enforcement discretion is good news for retailers and marketers of NAC, it doesn’t provide a roadmap for other ingredients that may find themselves in a similar predicament.

Emme: There may be some confusion as to the legality of NAC at the retail level, but articles like this one may help. What FDA said was they will exercise “enforcement discretion” and apparently only take action if a product is marketed using drug or disease claims, which of course is illegal for dietary supplement labeling. NOW is continuing to sell NAC.

Howard: It is a step in the right direction. However, it is also a common feint to employ when a regulator does not want to admit it made a mistake. However, only by our unrelenting political pressure can we expect this détente to last.

Emord: FDA’s so-called “exercise of enforcement discretion” is an old means by which the agency avoids grappling with a politically sensitive or legally difficult issue. It effectively punts until the time arrives when it may assert its power without fear of repercussions.

It is a cop out, revealing a lack of courage and adherence to principle. The current law affords the agency considerable discretion in interpreting ambiguous statutory provisions, and ordinarily the agency uses that discretion to increase its own power and promote its own pro-drug regulatory agenda.

In this instance, it wishes to avoid confronting the consequences of its decision in light of the considerable backlash likely to come if it removed NAC from the market. No one should be lulled into a false sense of security, however. Legislation needs to be introduced to eliminate any doubt that NAC may be marketed as a dietary supplement.

Lind: When FDA says one thing (NAC is not a dietary supplement) but does another (not enforcing this) they are sending mixed messages to both industry and consumers. If industry feels FDA may or may not enforce their decisions, some players may partake in questionable activities. All this does is to erode consumer confidence in the FDA and, more concerning, in our products.

Billingslea: It feels like the government is instituting the frog in the pot approach to taking over our industry. Rulings like this that say one thing and do another make us feel like we’re sitting in the pot of cool water as it slowly comes to a boil, blissfully unaware of our impending doom.

VR: Talk about California AB-1341, which would ban the sale of weight-loss supplements to consumers who appear to be under 18 years of age.

Sudberg: Oh California, how I wish I didn’t live in you sometimes. This is a classic misguided bill that demonizes a threat to big pharma, natural products, for risks that simply are not being shown in reality. There is no data to support the need for this bill and, if that wasn’t enough to show how unwarranted it is, the fines are higher than selling a natural product known to cause cancer (tobacco) to someone under 18. This hurts brick-and-mortars, hurts trust in the industry and should be filed in the recycling bin.

Emord: The blunderbuss approach taken in AB-1341 is born of ignorant prejudice against the industry, when in truth only a subset of sellers fall into the bad actors category. Whatever happened to the idea of innocence until guilt is proven and of due process. This bill would condemn everyone, the good and the bad alike, in this market.

Mister: So much misinformation around the promotion of this bill. There is no causal relationship between dietary supplements for weight management and eating disorders or body dysmorphia. A just-released literature review commissioned by CRN reaffirms the broad margins of safety of the most popular ingredients in these products. Age restrictions on these products will restrict access to these products for everyone, not just youngsters. And this legislation does not solve any supposed problems, it just pushes teens to buy products online, which ironically, is where the vast majority of products with illegal ingredients can be found. This legislation is misguided and hurts all consumers, but especially teens who lose local retailers as a place to buy safe products.

Marriott: AHPA has been actively engaged on Assembly Bill 1341 since its introduction by Assemblywoman Cristina Garcia in February 2021. AHPA does not oppose placing an age limit of 18 on products that are specifically labeled for weight loss, but we believe it is important that any such restriction should be clear about what products it covers and must give retailers flexibility to use the most appropriate methods when applying that restriction.

We will continue our discussions with Assemblymember Garcia to remove unnecessarily burdensome elements from the bill and improve the focus of any final legislation.

LeDoux: If there existed a causal linkage between adverse events and the materials envisioned by this legislation to require restricted access, that would be one thing worthy of discussion. That said, it appears that this legislation is a remedy in search of a problem given the lack of evidence that nutrients in this category have been linked to widespread adverse events in the target demographic.

VR: What kind of burden would “AB-1341 policing” place on retailers?

LeDoux: Restrictions of sales to consumers in retail settings is a slippery slope. Should this legislation be enacted and become law, how will it be policed particularly when products are widely available via direct purchase online or through third party vendors?

Mister: These bills place a huge burden on retailers to police these restrictions, which means many stores may just not sell the products at all. If the restrictions for behind-the-counter-only access are left in the bill, large sections of the supplement aisle simply become inaccessible for consumers. Some stores will remove the products altogether. And lastly, the penalties fall squarely on the retailer for selling the product, and in some states, directly on the store clerk who accidentally makes a sale to a minor.

Lifton: Making retailers serve as supplement police is never a good solution. It does nothing to help the retailer yet opens them up to liability.

Sudberg: I imagine the big box retailers have the infrastructure necessary to tag items and trigger ID checks. The smaller shops will need to do so manually and could find compliance with this absurd bill more disruptive.

Emme: Retailers will need to restrict access to these products including possibly locking them up. There have been some proposals to create a point-of-sale restriction in which the cashier will be prompted to ask for identification for the sale of these products (much like used for the sale of OTC [over-the-counter] decongestants), but this concept has yet to be accepted and defined in the current bill. Either way the burden of enforcement falls on the individual retailer.

VR: What is the status of HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021?

Sudberg: This legislation would finally ensure a legal pathway for hemp-derived CBD and other ingredients derived from hemp to get to market. The bill also directs the FDA to use its authority and resources to set forward a clear and robust federal regulatory framework for these products, promoting consumer safety while providing an economic boost to struggling farmers and their employees. It is likely to pass, considering the 2018 farm bill and how it showed Congress’s intention to support the production and sale of hemp and hemp derivatives such as CBD.

Emord: The bill is in limbo and is not likely to pass anytime soon because of other, pressing congressional issues and gridlock associated with our highly polarized political parties.

LeDoux: The CBD bill is winding its way through the legislative process, but I frankly think this is something of a “Hail Mary” pass by legislators to address their inaction over the past several years in this burgeoning marketplace. To date, the FDA has indicated that oral ingestion of CBD is illegal, yet almost daily, I receive offers via e-mail from internet sellers of all things in gummy form that contain CBD, apparently without regard to the stated position of the FDA. Ignorance of the law is not an excuse for violating law, but inaction of the agency tasked with protecting the consumer is a whole other matter.

VR: Recently, a Massachusetts district court judge issued a summary judgement in favor of Vitamin Shoppe versus two plaintiffs who challenged three structure-function claims on a product containing glutamine. Comment?

Emord: This decision builds on emerging precedent which supports the proposition that when a company complies with the DSHEA requirements for structure/function claims, federal law pre-empts putative class action suits designed to demand a different, or higher, level of substantiation and claim requirement than federal law. Moves in this direction are needed to limit the number of class action suits, which are crippling the industry and hampering the availability of useful products for consumers.

Emme: Our view is that this was a win for our industry, and we applaud Vitamin Shoppe for taking a stand in challenging this case. It would have set a challenging precedence for other natural products.

Mister: This decision is important because it reaffirms the supremacy of federal law and the preemption of state laws in areas like dietary supplement labeling where FDA’s actions occupy the field. It reaffirms the principle that individual states may not substitute their judgment for the reasoned decision making of Congress and FDA.

LeDoux: Private actions seeking legal redress for apparent violations of FD&C Act provisions as amended seem to be telegraphing a frustration with the lack of agency activity in certain areas. Until the agency has appropriately identified issues, communicated action plans, and actually implemented said plans, I would anticipate that this behavior will continue.

VR: Are you in favor of a Mandatory Product Listing (MPL) for all dietary supplements?

Billingslea: I am very concerned about a mandatory product registry for supplements that is neither warranted nor welcomed by the natural products industry and even supplement users across the country. DSHEA has effectively governed the way supplements are made available to Americans for almost 30 years. The passage of DSHEA was a hard-won battle.

That’s why we’re very concerned about Braun and Durbin’s proposed Dietary Supplement Listing Act of 2022, which would create new regulatory barriers, including what would basically amount to pre-market approval of dietary supplements. This would give the FDA new authority to prevent health and wellness products from reaching millions of consumers. In fact, we have posted an Action Alert on our store’s website linking to the Natural Products Association’s action page on the topic. We have also started handing out flyers in the store and talking about this threat with customers so that they too can take action.

Emme: Absolutely not. Simply making a mandatory list a law doesn’t address the issue of how that list will be used. There are too many unanswered questions as to how the list will be used by the Agency. We support transparency, but not in this form. We believe that the Agency needs to inspect, test and report for label accuracy. Our own experience shows that this can work when we tested and showed that some online brands were not meeting label claims. These brands were bad actors who will never list their products before going to market, so an MPL most likely won’t address that issue. The timing of this push for an MPL is puzzling. One could look at this as a solution looking for a problem, and the presentation of this legislation implies that all companies selling and marketing dietary supplements are dishonest.

The MPL is a poor substitute for more effective solutions to real problems that exist and more productive uses of FDA’s limited resources. It’s a very real concern that it will evolve into pre-market approval, which would place a heavy burden on the industry, creating delays and increasing costs. And it just doesn’t make sense given that supplements are such a safe class of goods as demonstrated by the very low number of adverse event reports.

Emord: I am opposed to any such listing. It is generally unwise to impose new statutory and regulatory requirements where there is an absence of consumer injury. We do not suffer from an epidemic of non-disclosure of material ingredients in products; to the contrary, I believe it the usual circumstance for manufacturers to err on the side of disclosing ingredients which may have a material effect on consumer choice, health or interest.

Lind: I’m steadfastly opposed to a mandatory product listing. A MPL shifts the burden and cost of regulatory enforcement from the FDA to industry. I’m all for appropriate regulation of dietary supplements but an MPL adds cost and an unnecessary and monumental burden on industry without further protecting consumers.

Howard: A federally mandated product listing will likely be used to reduce competition by using it to deem certain products “misbranded.” This gives the largest and most influential lobbyists the power to eliminate products and ingredients that compete with their own. Since a registry cannot be controlled to be fair, transparent and equitable, it is a tool more dangerous that what we are told it is designed for. It does nothing to prevent fly-by-night companies to continue to sell dangerous pharmaceuticals masquerading as dietary supplements. FDA enforcement is the problem, not whether a product is registered.

Sudberg: This is not as simple an issue as some seem to think. On one hand, a mandatory product listing could provide the transparency for the dietary supplement market that FDA needs and consumers deserve. It would be a benefit to all labs in the industry since we’d now have a simple list from which to sell our needed services.

On the other hand, it does smell like a solution looking for a problem given our industry’s products have a far better safety record than many other sectors.

I do have concerns about it being an undue burden on the smaller companies in the industry that have fewer resources to assign to this responsibility. I have heard from some colleagues that it would be quite disruptive.

Marriott: AHPA has interest in potential regulatory modernization, provided that it actually benefits consumers. There remain many unaddressed concerns about MPL proposals—including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more-reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets.

Mister: CRN strongly supports mandatory listing. FDA cannot regulate an industry if it can’t see it. And FDA can’t see the breadth and range of the industry now. Mandatory listing provides the transparency that a responsible industry should crave and consumers should expect.

VR: Can you speak to the recent commentary in Military Times calling for a separate AER reporting system for military members?

Emme: The Military Times article was filled with fallacies to address a problem which does not exist. We’ve seen this before, with reporting that claims adverse events are a very real risk with dietary supplements, when actual AER reports don’t support that assertion. When consumers, including members of the military, buy and use products made by established brands that rigorously test their products and strictly follow GMPs (good manufacturing practices), the likelihood of an adverse event is miniscule.

Sudberg: I am not aware of issues around tainted dietary supplements and military unreadiness that would justify this concern, though. While the categories commonly used in this demographic (bodybuilding, energy or pre-workout, and weight loss) are of the highest adulterated categories, making rules based on events that transpired over a decade ago is really idiotic.

Lifton: Our military members need to be in tip-top health, which is why dietary supplements are especially important for them. That being said, there already is an AER reporting system which works, so why would there be the need for a duplicate or redundant system for a subset of the U.S. population?

Mister: If the military developed its own duplicative adverse event reporting system just for service members, it would create redundant systems with the FDA-administered AER system for all Americans. A separate military AER system would lead to both over- and under-reporting as providers won’t know who to file their reports with. It’s an inefficient use of federal funds and potentially denies FDA the information it needs to detect early signals of a potential problem.

Emord: There is no sound empirical evidence to support this position. It is conjecture and, indeed, contrary to the experience in each of the services where dietary substances have been tested and evaluated for use in improving hydration, resistance to fatigue and endurance. Far from hurting the military, certain dietary supplements have been shown to assist the military in fulfillment of specific missions.

VR: Sustainable practices, transparency and clean labels—please discuss.

Lifton: There is a troubling yet common practice in the nutritional supplement industry known as “fairy dusting”—a manufacturer includes a tiny amount of a popular herb or nutrient in a product, then lists the ingredient on the product label, even though the dose is far too small to be effective. That’s why it’s time to change the current industry practices and embrace transparency in order to reassure consumers that they’re getting effective doses of the ingredients they take.

That’s why QOL has been working with several physicians and nutrition experts to develop a new reference standard for dietary supplements: Clinically Validated Daily Intake (CVDI). The CVDI is the minimum daily amount of an ingredient that has been found to produce a positive health effect in human studies. For example, the CVDI for whole turmeric is 1,000 mg, because that’s the lowest dose at which turmeric has been shown to benefit health in human research.

Quality of Life has committed to including at least 100 percent of the CVDI for every single ingredient in every one of our products. We want to inspire the entire supplement industry to adopt the same level of integrity and transparency.

Emme: If our experience at NOW is any indication, more and more people are looking for clean versions of mainstream offerings, from sports nutrition to foods to personal care to supplements. NOW customers are very comfortable reaching out to us if they have concerns about an ingredient, and we’re happy to engage with them, which all companies should be doing today.

Sudberg: I believe the consumer wants a clean, sustainable and trustworthy product, and the sharing of all those important things comes down to transparency. Given that we all know how important this is, brands need to be looking at what areas of their operations they are not being open about and working to share those. I’m a huge advocate of companies making their test results public and am very happy to see more and more companies doing so.

Marriott: Thanks to the choice that consumers now have—in the form of hundreds of thousands of products available to them—gone are the days that companies can operate in a vacuum and expect to win market share and loyalty. Consumers vote with their dollars and have increasingly shown that they are willing to spend more in support of brands whose values they share and whose work they believe in.

Lind: Consumers today have made it clear that when they have questions about companies and products, they expect answers, so the industry’s increased focus on transparency in recent years is working out well for those companies who made it a priority. With severe weather as a consequence of climate change impacting an ever higher portion of the population, sustainability efforts should be clearly delineated, and constantly improving.

Billingslea: Transparency and clean labels have always been super important to our customers and to us as we choose the products we carry. I would say sustainability has a little more feel of being forced on us than being a major concern. Yes, most of us want to make sure the supplements we buy are harvested ethically, but it’s not at the top of the list for what we are looking for in a supplement.

VR: What steps do the FDA and industry need to take for a better working relationship in 2023?

Emme: One of the criticisms of FDA through the years is that they come from a pharma mindset, which is inappropriate to apply to dietary supplements. If they were at least conscious of the difference, that might be helpful in working through some of the issues, such as the long-delayed NDI guidelines.

Sudberg: I think if the FDA sent a team of delegates to each trade association conference and talked through some of their issue with us and us them, and we did this at each trade show, there would be a better working relationship in 2023.

Howard: Let’s remember that the FDA can only act on the authority of Congress. The Senate picks the FDA Commissioner, Congress drives the budget. A better relationship will absolutely require the will to move beyond the status quo. Pharma is never going to be best friends with us. History has shown us we need champions in Congress, state legislatures, regulatory bodies, and among grassroots advocates.

Billingslea: That’s a tough one. How do we get the FDA to listen to us, when they have turned a deaf ear in our direction for a long time? I am especially sad that Orrin Hatch has passed, while Senator Durbin continues to gun for us like we were the No. 1 on America’s Most Wanted. The atmosphere in D.C. has got to feel particularly chilly these days if you are part of the supplement industry.

LeDoux: When industry and the agency work in a collaborative manner to protect the safety of the consumer, while bringing to market life giving substances that have been properly vetted for purity, potency and stability, the outcome can be extraordinary.

This requires dialogue and communication based on trust and respect. Unfortunately, with the agency having been operating on the sidelines given the restrictions associated with the COVID pandemic, this process needs to restart and ultimately it has to in order to adequately safeguard the consumers of these products. VR

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