30 supplement industry voices suggest changes to DSHEA

This article was originally published in Nutrition Business Journal's Market Overview Issue.

To some, DSHEA is something that should be approached not just with caution but with reverence. To others, it might be more of a good start rather than a for-the-ages institution. But nearly everybody agrees it’s not perfect.

As the 30th anniversary approaches, New Hope Network's Nutrition Business Journal reached out to 30 people in the industry to ask what they would add or what they would change abut the bill. Many talked about enforcement, and there were multiple requests for more leeway on claims. But each contributor brought their perspective and ideas. Here’s what they had to say.

Adel Villalobos, Lief Labs

DSHEA empowered consumers to take a more active role in their health, provided industry with guidelines and FDA jurisdiction to protect consumers. Because of the letter “c” in cGMP, it is inherent and implied that DSHEA is practiced and enforced based on “current” compliance practices required in today’s landscape. DSHEA works. We see examples of that with safety of consumers and the great organizations that have thrived because they use DSHEA and cGMPs as a guide. What doesn’t work is poor enforcement. The FDA needs to do a better job of enforcing, rather than adding more laws without enforcing the “current” part of cGMPs.

Related:The Vitamin Shoppe CEO talks challenges in today’s dietary supplement market

Gena Kadar, Sonoran University of Health Sciences

As an academic and a healthcare professional, I see an evidence-based approach as key to enhancing DSHEA. Any intervention intended to support health should have evidence of safety and efficacy. It is therefore reasonable (and ethical) that before market entry, manufacturers bear this burden of proof, including transparent disclosure of ingredients and adherence to clearly defined quality standards. Optional premarket reviews could be used to validate and categorize products based on degree of compliance. These measures would empower consumers to make better-informed decisions and may also foster improved health outcomes.

Kristina Hall, True Grace Health

We at True Grace would like to see clarification of FDCA Section 201(ff)(3). The provision excludes any article approved as a new drug or authorized for investigation as a new drug from the definition of a dietary supplement. An exception to this exclusion is if the article was marketed as a dietary supplement before the drug was approved. However, there is no official and complete list for supplements that were marketed pre-DHSEA, so the regulatory status of many long-standing supplements can be called into question at any time, as we saw with NAC.

Related:USP’s new dietary supplements policy supports mandatory product listing

Akash Shah, IngredientAI

I think enhancing our approach to claims is critical for DSHEA 2.0. Currently, the structure/function approach can mask product quality and differentiation among competing products. Companies that invest in science and high-quality ingredients should be rewarded with better claims. DSHEA 2.0 could help provide that structure. As a technologist, I believe new innovations like AI can help evaluate the amount and strength of the science that supports claims. The ultimate goal should be getting high-quality products in the hands of consumers who need them. Better claims enable consumers to find these effective products more easily.

Rend Al-Mondhiry, Amin Talati Wasserman

Although it’s been a never-ending source of discussion and client work for us regulatory lawyers, modifying DSHEA’s NDI provisions would be my starting point. We only have scant legislative history to help us understand what substantial terms like “chemical altered” and “marketed” mean, and industry’s stalemate with the FDA seems to have no end in sight. The agency is finally rolling out updated guidance piece by piece that might forge a path forward, but actual clarity in the law itself might have led to better compliance and less acrimony with the FDA.

Lisa Thomas, Nuherbs

When asked, “What would you add to/change about DSHEA?” I thought about it from the four angles through which I have spent time in this incredibly flexible industry: as a regulatory/third-party certification provider, finished product developer, ingredient supplier and end consumer. Same response under all hats: DSHEA 30 years ago was a positive, novel move forward for our industry—but that was 30 years ago. Let’s expand DSHEA to account for new delivery formats, functional foods and technological advancements. It was also built for aisles and shelves, so together, let’s upgrade it for internet sales and that one-button click.

Bill Chioffi, Nammex

Given the $9.3 billion global fungi market, DSHEA should be updated to correct ambiguity in the current FDA regulatory framework at 21 C.F.R. § 101.4(h) to include the fungal kingdom. It should clarify that the requirement to list the “part” of ingredients that are botanicals, along with the common or usual name, expressly applies to fungal ingredients. Industry guidance should make clear that “mycelium” is not a “mushroom” or part of “mushroom” though both “mycelium” and “mushroom” are derived from fungi. Full disclosure of any grain substrate included in the fungal ingredient should be required.

Diana Morgan, Nutrabolt and What’s Up with Supps

I would expand the definition of acceptable dosage forms for dietary supplements. In the 30 years since DSHEA was passed, industry has dramatically improved manufacturing capabilities, and science has evolved. Some nutrients are preferable to be absorbed by the mucous membranes of the mouth by such formats as oral dissolving strips (hello B12!) I would also reword the DSHEA disclaimer. The current language “This statement is not evaluated by the Food and Drug Administration…” plays into the public perception that the industry is not regulated. I would add a mandatory statement that “Dietary supplements are regulated by the Food and Drug Administration. Regulations can be viewed at FDA.gov/dietary-supplements.”

Will Rowe, Nutrasource

The main area missing in the U.S. dietary supplement market and regulations is a way for novel products to get qualified health claims in a streamlined process. A framework should be established for companies that innovate to conduct an established set of requisite safety and efficacy studies to achieve novel health claims for their products in a more streamlined manner, similar in mechanics to the GRAS notification process. That would be a welcome addition and clean up lots of issues around claims in the U.S. market. A letter of no objection would then provide the brand confidence to market the product within its health indication area and spur lots of new innovation, which ultimately benefits the consumer.

Christine Burdick Bell, Pharmavite

I would revise DSHEA’s drug preclusion to achieve two objectives: 1. clearly state the correct interpretation of the provision, and 2. provide a better balance between the interests of the drug industry and the supplement industry. If a drug is approved, the right date for the drug preclusion clause is not the date of the filing of IND but the date substantial clinical investigations (i.e., phase III investigations) are made public. To better balance interests, the filing of an NDIN prior to the time substantial clinical investigations were made public should avoid application of the drug preclusion clause.

Rick Collins, Collins Gann McCloskey & Barry PLLC

FDA warning letters may be fine for marketers making disease claims, but the way the Center for Drug Evaluation and Research currently writes them backfires in cases involving noncompliant ingredients. A company selling kratom, tianeptine or SARMs might get a 4,000-word letter focusing predominantly on improper labels. Nowhere in the letter is it clearly stated that the ingredients are per se illegal. The company may delete the cited claims but continue selling the products. Better warning letters would reduce the noncompliant ingredient market so that the FDA could focus on the most appropriate targets. Rather than an exhaustive citation of all the improper claims, warning letters involving noncompliant ingredients should be short and to the point. Less is more.

Kenn Israel, Beyond Brands

I still believe that DSHEA was the best legislation we could get at that time, but there are some shortcomings. There was not a mechanism or path to market for ingredients that are not (or should not) be in consumer dietary supplements. Such a path would serve us well with ingredients that are potentially beneficial but not safe for all consumers all the time. (Psilocybin, iboga, cannabis, and kratom come to mind). I would have liked to have seen better protections for new ingredients, specifically ingredients that are produced via synthesis or novel extraction methods. All too often, NDIs and new GRAS affirmations are followed with knockoffs that are significantly different and, in some cases, may not be safe.

Michael McGuffin, AHPA

Current regulations that prohibit marketers of herbal dietary supplements from providing truthful and not misleading information, and from making claims backed by scientific evidence, are detriments to both the public and to the industry. The market has evolved, and consumers looking to use botanicals in their personal health regimens should have ready access to truthful information from reliable sources.

Josh Beatty, Merical

With new ingredients and formulations emerging regularly, it’s become increasingly important to ensure that our regulatory framework can effectively evaluate the safety and efficacy of these innovations. The New Dietary Ingredient guidance is clearly not cutting it. I believe it’s time to consider amendments or additions to DSHEA that create a better evaluation process for novel ingredients. By establishing clearer guidelines and perhaps even a separate framework for assessing these new additions, we can better uphold the integrity of our industry while fostering innovation. We need to go bold for the good of the consumer, the industry and regulatory clarity. 

Mustafa Hashimi, Naturex

It would be great if, in helping to strengthen DSHEA, the FDA also included a communications/PR campaign to better educate and inform consumers, assuring the safety and regulation of dietary supplements, as misinformation is rampant. We should reframe the current narrative and focus on recognizing the positives rather than only noting the negatives. 

Petra Erlandson, Alkemist Labs

More clarity and definition are certainly needed regarding DSHEA’s analytical methodology exclusion. Section 9 restricts the (then forthcoming) cGMPs from imposing standards “for which there is no generally available analytical methodology.” Unfortunately, that phrase leaves way too much room for abuse. We have seen companies excuse themselves from making even the most basic attempt at optimizing or modifying existing methods to suit their product. I believe DSHEA intended to allow for flexibility but not let companies off without any accountability.

Spencer Lynn, AN US Holdings

I believe the disclaimer for structure/function claims needs to be eliminated or significantly reworded. “These statements have not been evaluated by the Food and Drug Administration” makes it seem like the entire industry is unregulated, which we all know isn’t true because of DSHEA, but the average consumer only sees that statement on the side of a label and makes that assumption without looking into it further. I think that’s a catalyst for a lot of misinformation.

Kyle Garner, Better Being Co.

If I could go back 30 years and improve DSHEA, I would want to ensure more clarity around disclosure of scientific research. The market is limited by ambiguous or excessive restrictions on dissemination of truthful and non-misleading information about dietary supplements. The scientific research supporting dietary supplements has grown exponentially over the past 30 years, and responsible manufacturers are currently unfairly limited in what scientific findings they can share with consumers, regardless of how much clinical backing the products have. 

Shaheen Majeed, Sabinsa

The specific part of DSHEA I would change is this: “A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” Since this law was written, the amount of clinical research done on dietary supplement ingredients has grown exponentially. Sabinsa alone has hundreds and hundreds of studies. Some products have strong evidence that they can, indeed, prevent, treat or mitigate a disease, but we can’t share that information with the consumers who would benefit.

Karen Todd, Kyowa Hakko

I would provide protection for branded ingredients with science-backed claims. This would address the issue of branded ingredients versus generics, it’s crucial to provide protections for branded ingredients that have science-backed claims. This could be achieved by allowing these brands to have exclusive rights to their clinical study results for a certain period, thereby preventing generic products from making the same health claims without their own supporting evidence. This approach would encourage investment in high-quality, scientifically validated supplements and differentiate them from generic counterparts that may not have the same level of evidence or quality assurance.

Traci Kantowski, Cypress Systems

If I could wave a wand and improve DSHEA, it would be for it to include funding for the Office of Dietary Supplements to fully enforce guidelines. DSHEA’s current scope is good, but without appropriate resources to fully enforce, it doesn’t mean much. There needs to be more rigorous and frequent inspections and greater penalties for violations.

Uday Gosalia, UGo Beyond

In the 30 years since DSHEA, the internet has changed the profile of a supplement consumer. Let’s get DSHEA to add education of nutrition through food and supplements for students in grades K through 12. Empowering the future consumer with knowledge would impede efforts from bad actors’ ineffective products.

Jason Dyer, Green Door Strategic Partners

What DSHEA needs is a better structure for dialogue and consultation between the industry and the FDA. The us-and-them relationship we are trapped in now doesn’t serve either side. If there were language added to DSHEA that makes communication part of the institution, it might allow the industry to have its position heard more clearly than what we get from standard lobbying. It could start with a collective agreement that the adversarial approach is not working, and things could get better. I believe accountability, policy evolution, prioritization and much more can be more effectively managed through greater collaboration between industry and agency. 

Chee Lin, ExcelVite

To improve consumer safety and empower them to make wiser, well-informed choices, I propose an addition mandating comprehensive due diligence by dietary supplement manufacturers in sourcing practices to ensure adherence to safety and ethical standards. It is crucial to implement transparency and traceability mechanisms across the supply chain to foster trust and accountability. This aims to mitigate issues such as adulteration, misrepresentation (including switching out ingredients without consumer knowledge) and unfair trade practices. Ultimately, this will enhance consumer safety and preserve the integrity of the industry.

Gene Bruno, Nutraland

If I were to add something to DSHEA today, it would be an addendum to “Old Dietary Ingredients,” which is defined as those nutraceuticals that were in U.S. commerce prior to August 1994. Specifically, I’d like to see the definition expanded to include nutraceuticals in commerce in other countries. Think about it. Some countries have decades or even hundreds of years of safe and effective use for specific nutraceuticals. Why should we limit the options to just commerce in the U.S.?

Michael Murray, doctormurray.com

For DSHEA to still be in place after 30 years signifies that it has worked well. The major shortcoming has been the lack of execution by the FDA in enforcing Good Manufacturing Practices (GMPs) and what constitutes a dietary supplement. As a result, the industry is still plagued by too many issues with quality control, lack of GMPs and illegitimate products in the markets. That has to end. Reasonable additions to DSHEA are acceptance of the FDA proposed establishment of a mandatory listing of dietary supplement products by manufacturers, repercussions for products not meeting label claims, and a quicker response by the FDA and FTC in issuing warning letters related to products containing ingredients misbranded as dietary supplements.

Holly Bayne, Bayne & Associates

I would remove the following statement from the “dietary supplement” definition at § 201(ff) of the FDC Act: Except for purposes of § 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. The FDA has improperly interpreted and misconstrued this statement to mean dietary supplements do not qualify as “food” under § 201(g)(1)(C), which, since 1938, exempts “food” intended to affect bodily structure or function from the “drug” definition. The result is greater regulatory burdens on dietary supplements compared to conventional foods and a continued narrowing of the scope of permissible structure/function claims. 

Asa Waldstein, Supplement Advisory Group

Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies.

Derek Webber, Beyond Brands

My suggestion would be to add a PSA campaign to DSHEA. Maybe this is too simplistic, but I think there is still a large gap in public understanding of DSHEA and the powers it gives the federal government. If you were to ask the average person on the street if dietary supplements are regulated by the FDA, the answer would be a resounding no. As industry insiders, we know that is not true, that DSHEA was written to give the FDA regulations for dietary supplement manufacturers and sellers to operate apart from drug companies. Can we rally around the idea that DSHEA allows the FDA to oversee dietary supplements in a regulatory space between foods and drugs? As a second point, with the dietary supplement industry now well on its way to being a $100 billion industry, should we rename the Food & Drug Administration to the Food, Supplement and Drug Administration?

Jill Staib, William Hood and Company

DSHEA provides a stable (30 years and counting) regulatory framework for our thriving industry that’s good for business, and I would not risk that by proposing to change it at all. There is significant downside risk to tinkering with regulatory frameworks, and those risks far outweigh the potential benefits to be gained from incremental tweaks. Given one wish surrounding DSHEA, I would ask for better and more consistent enforcement of the current regulations to force out the handful of bad actors that tarnish our industry and to raise the overall standards to foster even greater consumer trust for the category.

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