The panel:

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, President, Maypro Ventures, Port Chester, NY, www.maypro.com

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 (CRN), Washington, D.C., https://crnusa.org

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

Considering that the U.S. Centers for Disease Control and Prevention (CDC) states that “mandatory folic acid fortification of cereal grain products has helped about 1,300 U.S. babies to be born without [a neural tube defect] each year,” many industry members and experts were amazed by the recently issued vitamin supplementation recommendations from the U.S. Preventative Services Task Force that discourage the use of vitamins A, C or E, beta carotene, antioxidant formulas and multivitamins with folic acid.

In a modern era when preschoolers are now being diagnosed with ADHD (attention-deficit/hyperactivity disorder) and treated with stimulant drugs, suddenly, at least mainstream headlines tell us, there is now an epidemic of melatonin poisoning, a contention which has fortunately been arguably debunked and put in context by industry associations.

Despite the fact that the natural products industry is highly regulated, this hasn’t stopped states, such as New York, Illinois, Rhode Island and California from moving forward with anti-supplement legislation that are said would hurt, not help protect, consumers.

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

NIE: Describe the main problems with S. 4348, FDA Safety and Landmark Advancements Act (FDASLA)—should the dietary supplements portion be removed—what is the way forward on this?

LeDoux: The Senate bill being promulgated is strange for several reasons. First, this is a recurring piece of legislation authorizing the collection of “User Fees” from pharmaceutical industry to the FDA (U.S. Food and Drug Administration) apparently for “oversight.” I’ll avoid the apparent conflict of interest associated with this entire arrangement and focus on the fact that dietary supplements have never paid user fees to the agency, and this proposed legislation does not envision that taking place in the future.

Responsible industry has been sharing test results and other findings through scientifically valid methods with the agency when adulterated, misbranded or sub-potent products are collected and identified in the commercial marketplace. This has been done without compensation and at great cost to many leading members of industry, but to their utter amazement, the sales of “fraudulent” or “adulterated” or “misbranded” products continues unabated.

Might it be possible, prior to initiating another large bureaucratic headache for the industry and the agency, for the agency to actually enforce the laws and regulations that are already on the books courtesy of DSHEA (Dietary Supplement Health and Education Act of 1994), Bio-Terrorism and FSMA (Food Safety Modernization Act)? Is this too much to ask?

Frankly, reading the proposal in the Senate there are really none of these provisions present in any meaningful way. The presence of a “prohibited act” clause is of significant interest and importance, and frankly, is kind of a showstopper.

The potential of the agency to capriciously identify a substance as prohibited means the game is over for that product or the company producing it, no matter how valid the science is supporting its use and safety.

The wording allowing for public access to information is also overbroad and conceivably would be mined by the plaintiff’s bar intent on having a field day extorting money from companies who may have had a product or ingredient deemed prohibited by the agency—without recourse or comment period or any potential means of relief.

Emme: The language of the bill goes way beyond the intent of the conceptual transparency that a master product list was advertised to have delivered by industry proponents of this effort.

The new “Prohibited Act” item is of great concern. This language does not appear to be related in any way to the concept of a master product list and could give the agency a way to avoid a science-based opinion, empowering the agency to say “no” to ingredients like CBD administratively. This could supersede the current NDI/ODI (new dietary ingredient/old dietary ingredient) process as outlined in DSHEA.

Emord: This bill is a “solution” in search of a problem. It causes a number of anti-competitive and market debilitating effects that are wholly unjustified. It establishes new, higher and exorbitant base user fees for new applications in the drug categories, erecting impossible barriers to market entry for all but the largest drug companies.

It also establishes new labeling, adverse event reporting and GMP (good manufacturing practice) compliance requirements, analogous to those now imposed on dietary supplements, for all cosmetics sold in America. Cosmetics, like supplements, are profoundly safe (virtually no evidence of serious adverse events), making such a massive new regulatory regime unwarranted and effectively creating major barriers to market entry that will skew the cosmetic market in favor of large concerns over small ones and reduce variety and options in the marketplace. Now every cosmetic manufacturer will need costly regulatory counsel.

Finally, it brings dietary supplements fully within federal control by compelling the identification and listing for the government of all product ingredients and imposing new penalties for products failing to meet the new requirements.

Again, for a product category that is safer than foods in common form, this imposition of major new regulatory requirements is a “solution” in search of a “problem” and will have anti-competitive effects and impose new, unwarranted costs on the industry and deny consumers freedom of choice.

Over time, it will increase the costs of cosmetics and supplements, as added costs will have to be passed on to consumers. This is a very bad bill that should be opposed by every conscientious legislator and by the regulated community.

NIE: In light of this, does the Mandatory Product Listing (MPL) movement now take on greater urgency for dietary supplements; should this be a self-regulatory activity or legislated?

Emord: Private manufacturers of cosmetics and dietary supplements have done an extraordinary job of making, with rare exceptions, high-quality products with very few serious adverse effects. That is proof positive that the market, left to self-regulation, is working well in this area to protect the public.

The MPL is an authoritarian approach that will unnecessarily burden good manufacturers and sellers. The government should presume them innocent and limit its role to prosecution of those proven guilty of violating existing laws rather than adopt a host of new prior restraints that simply add more shackles to the law-abiding and conscientious.

Emme: The negative impact on retailers, as well as consumers, could be large in scope. We believe that the agency needs to inspect, test, and enforce against violators, actions for which the FDA already has authoritative ability to do against bad actors in our marketplace. These same bad actors will never use the MPL process, so this will continue to be an issue that the MPL doesn’t address.

LeDoux: I was supportive of a mandatory product listing with the agency based on several conditions.

First, this issue had to be federal and the states would be pre-empted from further mischief in this area. Second, the agency would have a time frame in which to censure, seize, warn or fine companies found non-compliant or whose products were found adulterated or misbranded (this would have been further mined by the plaintiff’s bar). Third, reviews of the system would be required by independent auditors every three years reducing the chances that the system would become “gamed” by criminals. Fourth, and this is a big one, if companies were selling on the internet or otherwise and they failed to register, the fines would be significant on the first violation, and upon the second, the business would have products seized and the matter would go to federal court.

Finally, if industry were to collaborate on a product listing and identification number scheme, it should follow in some way what has been established in the E.U., Canada, Australia and other developed nations—and mandate that in exchange for industry compliance, the plethora of accepted health claims for dose dependent nutrients should be adopted by the FDA, which has been glacially slow in recognizing viable health claims.

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 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 than 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.

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 want and consumers should expect.

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.

NIE: 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?

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.

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.

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.

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.

NIE: 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.

Mister: There is 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.

Sudberg: 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.

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.

NIE: Rhode Island has upped the anti-supplement ante with its proposed SB 2613, which would place all supplements behind the counter and force people to show IDs. Comments?

Emme: This is a heavy-handed approach that more recently came into being in California, only the Rhode Island version is more comprehensive. It restricts an entire category of supplements (possibly multiple categories) and puts them behind a counter in the same manner as cigarettes.

Other states like New York and Illinois have attempted to follow the California model, with no success to date. It doesn’t create a more safe environment, and puts the burden onto retailers to enforce where government agencies have been unwilling or unable to do so. This approach is no guarantee of improved safety and reduces consumer choice.

Emord: This bill, like the FDA Safety and Advancements Act, is anti-supplement with no proof that its new draconian restraints will affect any improvement in the safety of supplements over existing safety levels.

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

Mister: The largest regulatory issue facing the industry is the malaise of inaction and tepid enforcement of DSHEA 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 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.

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 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 we offer Bilberon, which is derived from DNA-authenticated 100 percent naturally grown northern European bilberry.

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.

NIE: Any comment on the melatonin poisoning scare that recently caused such a media circus?

Emord: There are many factors which may have contributed to abuse of melatonin supplements by children, causing instances of illness and even two deaths. These were, however, instances of product abuse, not instances of product use in accordance with labeling instructions. It would appear the proper response would be to alert the public of the risk posed to children of ingesting high amounts of melatonin and to encourage parents to keep melatonin products out of the reach of children.

Emme: Although more information is needed to determine the exact cause of these adverse events, some media outlets have stated that the products concerned contained higher levels of melatonin than claimed on the supplement facts panel on the label of each product involved. If this is the case, these mislabeled products are in violation of the GMPs (good manufacturing practices) required by DSHEA, and the FDA needs to be enforcing the label claims found on these products. Every manufacturer is required by DSHEA to make sure that what is listed on the label is what is found in the product. These are very basic rules that need to be enforced by the FDA. NIE

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