A self-regulated supplement industry is the path to responsible innovation

It is a privilege to work in an industry devoted to identifying, researching and distributing ingredients and products that improve lives — an industry that has attracted many talented and interesting people. But there are some problems that require attention.

Since the passage of the Dietary Supplement Health and Education Act (DSHEA), the industry has grown from an estimated $4 billion in 1994 in the U.S. to over $61 billion in 2023, according to Nutrition Business Journal (NBJ). However, that substantial growth has not come from innovation, but rather an increase in the number of sellers — many of whom seem to care little about public health or about compliance.

In a Q&A podcast, the Food and Drug Administration estimates that nearly 100,000 dietary supplement products are on the U.S. market today, up from 4,000 in 1994. That’s a 25-fold increase. Yet the agency has received only around 1,300 new dietary ingredient notifications (NDINs) since 1995, with more than a third of those being multiple filings by the same companies for the same ingredient (in some cases more than 20). The industry is simply repackaging and reformulating the same ingredients repeatedly and mischaracterizing that as innovation.

Fifty-one percent of non-supplement users in the U.S. distrust the industry, according to a 2023 consumer survey by the Council for Responsible Nutrition (CRN). Why? Because too many companies selling supplements make false health claims, mislabel their products, place illegal ingredients in the product, fail to adhere to the regulations spelled out in DSHEA, and rarely do the clinical studies necessary to properly validate safety and efficacy.

Related:ChromaDex agrees with FDA on NMN decision

In 2022, ChromaDex tested the top-selling NMN (nicotinamide mononucleotide) products on Amazon. The results revealed the majority contained less than 1% of the active ingredient claimed on the label. Some had no active ingredient at all.

Later that year, FDA declared it illegal to sell NMN in dietary supplements. Yet today we have more sellers of NMN than before that decision. Amazon, Walmart and other reputable retailers have removed NMN, but dozens of companies and manufacturers have not heeded FDA’s declaration. What’s more, Shopify, Facebook, TikTok, Google and other online marketing platforms continue to enable NMN companies to sell their products.

As participants in the industry are well aware, this is only one recent example of many.

We believe there are three primary causes at the root of this dilemma: 

I would like to expound on this third point further and then propose a solution to all three challenges. 

ChromaDex was founded by Frank Jaksch in 1999 as a reference standards company. We later added a consultancy for regulatory approvals, then an ingredient supply business, and ultimately a consumer supplement brand called Tru Niagen.

We consider ourselves the global leader in NAD+ (nicotinamide adenine dinucleotide) research through our ChromaDex External Research Program (CERP^TM). Through CERP, independent investigators have studied our patented nicotinamide riboside (NR) ingredient, Niagen, resulting in 30+ peer-reviewed published human studies and 100+ total published scientific studies for its numerous health benefits.

Today, Niagen has achieved regulatory acceptance in major markets worldwide, and we continue to invest heavily in research and intellectual property (IP) to protect our innovations. I am aware of few supplement companies that invest as much of their resources toward true innovation — research, regulatory approvals, novel ingredients, IP and protection.

The financial disadvantage from adhering to the rules is exacerbated by the well-intended yet restrictive and outdated requirement in DSHEA that limits dissemination of research findings over concerns of implied disease claims. This is the case even if the studies are valid with positive outcomes.

Findings from numerous independent, peer-reviewed, published clinical studies have demonstrated the therapeutic benefits of Niagen NR on a range of conditions. Yet because of the restrictions on disseminating research findings, most of the public is unaware of this life-altering science. 

We know some other responsible companies have faced this challenge and believe this aspect of the law should be updated. To be clear, we do not think supplements should be allowed to make disease claims comparable to approved drugs, but when studies validate efficacy, there should be a more acceptable way of communicating the findings to consumers.

Proposal: The best way to be trusted is to be trustworthy.

As FDA Commissioner Robert Califf, M.D., said last October at the CRN annual conference, “I hope that you all would do your part, not just to sell stuff, but to let people know what’s in what you’re selling, and do as much research as you can to get truly balanced scientific answers about the benefits and potential risks.”

Cara Welch, Ph.D., who directs FDA’s Office of Dietary Supplement Programs (ODSP), said in the Q&A podcast that the marketplace contains more than “100,000 products and we have limited resources to analyze the composition of dietary supplements. Because of this, we focus our resources first on public health emergencies and products that may have caused injury or illness.”

When enforcement resources are limited, the industry must police itself.

I propose the formation of an organization consisting of industry players endeavoring to be righteous in their practices. Such members should include suppliers, manufacturers, distributors, associations, retailers and, importantly, internet companies. The entity’s primary mission would be to assist the regulatory bodies in enforcing existing regulations and to propose regulatory and legislative reform.

The consortium would evaluate challenges that arise against existing quality, safety and efficacy standards, recommend best practices, provide evaluations and make recommendations to regulators and policymakers, and provide industry opinions on topics like patent protection. Evaluation could include post-market analytical testing, facility inspections, literature and scientific study reviews, and timely reviews of marketing and advertising materials.

Perhaps most important to the success of this consortium would be the commitment of retailers and e-commerce marketing platforms to work only with products that meet these standards.

The consortium would be governed by a board of respected industry figures, alongside representatives from FDA, Federal Trade Commission (FTC), consumer groups and perhaps members of Congress.

This effort needs to be appropriately funded. Doing this effectively will require significant investment.

This may not be a new idea. Various companies, trade associations, nongovernmental entities and third-party organizations have endeavored to help solve the problem. NOW Foods, ConsumerLab.com, UL Solutions, the U.S. Pharmacopeia (USP), Alkemist Labs and NSF are advocating for self-regulation by establishing quality standards, conducting facility inspections, testing products and in some cases, publicizing.

CRN has worked to promote a more responsible industry through initiatives such as the partnership with the National Advertising Division (NAD), the establishment of the Supplement OWL (Online Wellness Library), the publication of voluntary guidelines, and overall engagement with FDA. These noble efforts, which we support, are still not sufficient.

I invite anyone reading this to take an additional small step toward the betterment of our industry and the safety and trust of our consumers by calling for a fairer industry — one that values and fosters innovation. Let us remember what brought us here: the desire to do good with our work, improving lives through science and innovation while building successful companies. If you share this sentiment and are open to working collectively toward change, we want to hear from you.

To join the conversation or share your thoughts, please write to us here: [email protected].

Imagine, if you will, a world in which dollars invested in research and innovation yielded significant direct returns to the companies taking the risk. Imagine if conventional consumer thinking was that daily supplement use improved health. Think of how much good we could do and how significant our industry could be if everyone trusted our products. I submit that the best way—indeed the only way—to get there is to be trustworthy.

This mission requires teamwork. But the results will be worthwhile.