A mandatory dietary supplement registry: Transparency as ‘disinfectant’

The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of this new regulatory tool. The author addresses the critical role a mandatory product listing can play in building a safer and stronger dietary supplement marketplace of responsible companies for the benefit of FDA, retailers, and ultimately consumers.
   
Introduction
A century ago, Justice Louis Brandeis advocated for more transparency of financial and government institutions as the best way to combat corruption and stamp out unethical behavior. He rightly recognized that when corporations and government officials know that their actions and decisions will be held up to public scrutiny, they are more likely to act ethically and responsibly.
 
Today, consumers are demanding similar transparency in the products they purchase and the companies they patronize. Twenty-first‒century consumerism demands that product manufacturers reveal not only the contents of their wares, but provide visibility into their employment practices, the ethical and environmental impacts of their supply chains, and the causes their corporate leaders support. It is clichéd to state that holding companies and their products up to scrutiny changes behavior, but it is nevertheless true. For the benefit of consumers, it is time for a bit more sunlight to shine on the dietary supplement industry.
 
The 1994 Dietary Supplement Health and Education Act provided the US Food and Drug Administration (FDA) with a range of enforcement tools at its disposal: warning letters, seizures, recalls, detention at the port, civil fines, and more. However, the agency cannot fully and efficiently regulate the industry when it has no way of knowing what products are in the market, which companies are producing those supplements, and what ingredients they contain ‒ until after safety concerns have arisen, and the agency has to scramble to address the problem. As such, almost 25 years after Congress enacted the law, its greatest weakness is not any single flaw in the balance it struck between protecting public safety and promoting consumer access, but rather, the lack of transparency on the part of companies, and the agency’s inability to “see” into the marketplace. It is too easy for companies that ignore their transparency and accountability obligations ‒ from failing to notice their new dietary ingredients¹ to not reporting their serious adverse events² ‒ to evade FDA scrutiny by staying in the shadows, out of view. A mandatory product listing will turn on the “light” and expose them.
 
This article will examine what dietary supplement stakeholders mean when they refer to a proposed mandatory product listing or registry, what the benefits are to such a regulatory scheme, and finally, it will address the reservations and objections voiced by the opponents. Some argue that a product registry connotes a different concept than a product listing because a registry might imply that the products included therein have been evaluated or certified in some way. The author disagrees with that interpretation, and “product registry” and “product listing” are used interchangeably in this article.
 
What is a mandatory product listing?
FDA, in both its 2020 and 2021 budget justifications to Congress, has called for the creation of a mandatory listing for dietary supplements and described this new regulatory tool as the following: "This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against noncompliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, and improve transparency and promote risk-based regulation."³

Filing a notification
A more detailed concept of mandatory listing comes from the Council for Responsible Nutrition (CRN), a dietary supplement industry trade association that advocates for it. In draft legislation being prepared for introduction, a mandatory product listing calls for the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement offered for sale in the United States to file a notification of that product with the FDA. Each unique formulation of the product, or each separate brand marketer of identically formulated products, would have to file its own notification. A notification, or product listing, with the FDA would entail providing the agency with a full electronic copy of the product labeling that could be accessible in an online database made by the FDA. In addition, the responsible party would be required to complete, along with submitting the label, a questionnaire about the product, the answers to which would all be readily ascertainable from the label itself.
 
Although there will likely be some negotiation of the specific fields to be included, most supporters of mandatory listing agree that it would include: the brand name, a list of ingredients, serving size, the quantity and percentage of daily value (DV) for those ingredients required to be listed on the label, any claims made on the label, the identity and contact information for the responsible party, and similar information. The contents of the questionnaire would be limited to information on the label to prevent FDA from delving into matters and publishing information (such as proprietary formulations) that would not otherwise be available to the public. In 2016, the supplement industry, led by the CRN, established a voluntary registry of dietary supplements called the Supplement Online Wellness Library (The Supplement OWL®).⁴ Many view this registry as a template a mandatory product listing for supplements might emulate.
 
Regular updating
Such a registry would require regular updating to ensure it is an accurate representation of what is available in the US dietary supplement market at any time. As a “snapshot” of the supplement marketplace, it will depend on regular submissions of new products as they enter the marketplace, and removal of products that have been discontinued, thus requiring marketers to update their entries regularly. Proponents suggest regular updates at least every 6 months, if not more often. This contrasts with a similar database, the Dietary Supplement Label Database (DSLD), constructed by the Office of Dietary Supplements within the National Institutes of Health.⁵ Although the DSLD is helpful as a research tool for identifying any dietary supplement that has been marketed since the database’s creation, there have been lags in uploading new products and updating it to indicate which products have been removed from the US market. For a mandatory supplement listing to serve the goal of providing a snapshot of what is currently available, new supplements must be entered in a timely manner, and those that are discontinued should be removed after they are no longer in commerce.
 
More importantly, the registry must not contain obstacles to the entry of any product marketed as a dietary supplement, even if that product is illegitimate or potentially unsafe. The product listing must be truly representative of what is offered to consumers so that FDA can see what is being marketed. This aspect assures that the mandatory product listing does not become a tool for FDA to impose a veiled premarket review on the industry, as has often been expressed. But even more so, this prerequisite prevents the mandatory listing from serving as a collection of only “approved” dietary supplements. That element is critical, even though some will be concerned that the listing might permit marketers of products containing illicit substances, touting unsupportable claims, or produced under questionable conditions to appear in the registry alongside more reputable products. The registry must be reflective of the actual market; so long as suspect supplements continue to be sold to consumers, they must necessarily appear in the registry so FDA can more easily find them. As Justice Brandeis envisioned, this is the daylight that brings noncompliant products into view.
 
A collection of all labels
So, a mandatory product listing is not, and should not become, a premarket review or premarket approval for dietary supplements. FDA must be prohibited in any authorizing legislation from denying, or even delaying, the admission of a product and its labeling from the registry. If labeling does indeed include a Supplement Facts Box, then the submission is complete and it accurately reflects the product’s label. Mandatory product listing would have to be like a birth certificate, not a driver’s license. The FDA could not use this registry to deny marketers of their ability to go to market, to place further conditions on its acceptance of the submission, or to slow down introduction of new products. Rather, the product listing would be just that: a collection of all labels in the US marketplace, compliant and noncompliant. For the registry to serve its intended purpose, it must be representative of the good, bad, and ugly that compose the US supplement marketplace.
 
Another element that proponents insist upon is that the registry be publicly available on the internet. To fulfill the “sunshine as disinfectant” objective, this database must be freely searchable by all. As such, it would serve as a deterrent to marketing unscrupulous products, allowing one’s competitors, regulators and plaintiffs’ attorneys alike to identify illegal ingredients or claims, and permit retailers and consumers to make more informed decisions about the products and companies with which they associate.
 
Lastly, any mandatory listing must be backed by FDA enforcement authority.⁶ The failure to list a dietary supplement and its actual labeling within the prescribed timeframe should make that product misbranded under section 403 of the Federal Food, Drug & Cosmetic Act (FDCA),⁷ with clear authority for FDA to invoke civil penalties, along with seizures and recalls for noncompliant products. And FDA should be incentivized to use that power, not only with new legal authority but also with sufficient resources to send a clear and strong message to the industry that failure to list a supplement carries a heavy price. Otherwise, the listing requirement will become just another obligation of responsible marketers and ignored by those less reputable. That widens the gap and the expense between producing lawful, high-quality supplements and less reputable ones.
 
What are the benefits?
Over the past 2 years, the idea of establishing a mandatory product listing has gained traction. FDA, in both its 2020 and 2021 budget requests, has called on Congress to create it: "In the 25 years since the [DSHEA] of 1994 was enacted, the dietary supplement market in the US has grown from approximately 4,000 products to somewhere between 50,000 and 80,000 products. Under current law, FDA is not clearly authorized to require listing of individual dietary supplement products on the market, and the Agency has no convenient mechanism for compiling basic information about those products."⁸
 
Those statements reveal the crux of the problem: The agency estimates there are somewhere between 50,000 and 80,000 unique dietary supplement labels on the market ‒ and the fact that there is such a discrepancy in estimates of that number, in an industry FDA is charged with overseeing, should be a concern.
 
DSHEA tenets still hold
At the same time, the solution does not disrupt fundamental tenets of DSHEA. In a speech to industry, Lowell Schiller, the principal deputy commissioner for policy at the FDA, explained, “Under this proposal, the statute would be amended to require all products marketed as ‘dietary supplements’ to be listed with FDA, and it would give FDA authority to act against noncompliant products and their manufacturers or distributors … I believe we can achieve these benefits without upending DSHEA’s framework or adding hugely burdensome new requirements. We’re not talking about imposing a new premarket approval requirement. If manufacturers and distributors were just to provide us with certain basic information – information that, in many cases, already appears on product labels – it would be a big win for public health and legitimate industry, while imposing only minimal new costs.”⁹
 
Former FDA commissioner, Scott Gottlieb, also extolled the benefits of a registry, saying, “A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation. It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.”¹⁰
 
At a public meeting convened by FDA in May 2019, advocates for creating a mandatory product listing included CRN; The Consumer Healthcare Products Association; The Pew Charitable Trust; and Scott Bass, a prominent industry attorney who helped author DSHEA.¹¹
 
Not a cure-all
A mandatory product listing for dietary supplements will address several of the major criticisms of supplement regulation in this country, but to be sure, it is not a cure-all. Requiring marketers to notify FDA of the supplements they market and to provide a sample of their labeling would go a long way toward creating a stronger marketplace of responsible companies.¹² If FDA knows when a product comes to market, the agency can more efficiently analyze labels that are likely to reveal illicit ingredients, find suspect products in the event of a recall, and prioritize inspections and other enforcement activity.¹³ Failure to file would create an administrative violation that is easier for FDA to enforce without engaging in product testing, inspecting facilities, or analyzing the legality of claims.

Mr. Schiller lamented that, without this ability to shine a light on the industry, FDA is at a disadvantage:

"Today, without mandatory product listing, we lack basic, fundamental information about the dietary supplement market:

• We don’t know how many dietary supplements are on the market, and we have no systematic way of knowing when a new product is introduced.
• We don’t know how many products contain any given ingredient. And if it turns out that there’s a safety problem with a particular ingredient or a particular ingredient supplier, we don’t have the basic information to identify quickly which products are affected.
• We don’t have a reliable way to capture trends in the market so we can anticipate and adapt to new areas of risk.
• And we don’t have the visibility we need to be able to prioritize our resources effectively.

Mandatory product listing would address these problems and help us to more effectively weed out irresponsible actors in the market who threaten to tarnish the reputations of those who work hard to try to comply with the law.”¹⁴
 
A 'win-win' tool
The Pew Charitable Trust testified at the public meeting in April 2019 that “every manufacturer would be required to provide the agency with basic information such as the product name, the ingredients, and the labels for every product that is sold. This tool is a win-win for almost everyone. It will enable FDA to determine compliance fairly quickly with NDI [new drug indication] notification process and other requirements. Consumers would be able to identify reputable supplement products, and retailers would have assurance with being able to sell only products that are produced by companies that are on FDA’s radar screen and that are compliant with the law.”¹⁵
 
The agency cannot regulate what it cannot see. Even in routine matters, whether a marketer is submitting serious adverse event reports, filing new dietary ingredient notifications, or filing its structure function claims ‒ all requirements for dietary supplements ‒ could be more easily policed if the agency had a comprehensive list of what’s being sold to US consumers.
 
Identifying products in a crisis
A mandatory listing will also make it easier for FDA to identify products in a crisis. If, for instance, FDA began receiving reports of negative health effects from a particular ingredient, having a national database of all the dietary supplements containing that ingredient would allow the agency to take swift action. FDA could alert those companies, assess patterns or commonalities in the reports, and determine what other products containing those ingredients and manufactured at the same facility might be implicated.
 
A product registry will help FDA monitor problematic behavior and prioritize further surveillance. Having access to dietary supplement product labels can help the agency quickly identify companies listing illegal ingredients on their labels and companies marketing products with new dietary ingredients that have not been properly noticed by the agency. The law requires that new dietary ingredients (those introduced to the US market after October 1994) must be noticed to the agency with sufficient evidence to demonstrate the submitter’s reasonable expectation of the ingredients’ safety when provided in that form and dosage to the consumer.¹⁶
 
The FDA has lamented what it believes is low compliance with that requirement, but the agency often may not know that a product contains the ingredients. A product listing brings those products into view. The agency has also considered establishing a master file framework for encouraging innovation in ingredient development. A product registry would aid FDA in monitoring that finished product brands have properly licensed the use of safety evidence for their products to protect companies that have invested in the scientific studies to support the safety of their NDIs.
 
Promoting compliance
The registry would promote good manufacturing practice compliance by identifying firms with deficient labeling, which may be a signal of other processes leading to misbranding or adulteration. Such intelligence would help FDA prioritize its inspections and concentrate resources on those firms posing a risk to public health.
 
Some proponents even argue that a mandatory product listing for supplements sold in the US would assist with product exports too. Having a dietary supplement appear in the registry would reinforce the process of the Certificate of Free Trade by demonstrating to foreign regulatory officials that a product being proposed for export to that country is indeed freely offered for sale in the US.
 
Lastly, proponents offer that creation of a supplement registry would help counter the notion that the industry is “unregulated.” Despite comprehensive regulation of dietary supplements under DSHEA,¹⁷ dietary supplements continue to suffer from the misinformation¹⁸ that the industry is “unregulated.” Establishing a mandatory, visible, national database of dietary supplements would help to counter that misperception.
 
Answering the skeptics
Critics argue a listing requirement would be too burdensome, particularly on small businesses,¹⁹ but the industry’s voluntary experience with the Supplement OWL has demonstrated that firms of all sizes can routinely compile and enter their product information. Informal interviews with several of the Supplement OWL participants have indicated that once initial training is conducted, responsible parties can enter their products and labels quickly and easily. The Supplement OWL even allows for the bulk uploading of products. At least one industry consulting firm offers to outsource the process for a small fee per product.
 
Opponents of the listing who play the “too burdensome” card also overlook the fact that industry rose to a far greater obligation in 2006 when it strongly supported passage of the Nonprescription Drug & Dietary Supplement Consumer Protection Act. The legislation mandated collecting adverse event reports by the industry and submitting the most serious events to the FDA within 2 weeks of a manufacturer becoming aware of them. By comparison, mandatory listing is much less burdensome.

Proponents of that view also ignore that the dietary supplement industry has grown into a $50 billion market in the US. Since the passage of DSHEA in 1994, dietary supplements have transformed from a cottage industry serving up a limited array of vitamins and botanicals to a small, health-conscious segment of the public, into an industry with a variety of products most consumers have come to rely on to support their health and wellness. Today, 77% of Americans report taking dietary supplements.²⁰ Offering that a simple listing process is too burdensome for small businesses threatens undermining the trust relationship industry has built with consumers.
 
Opponents also assert that FDA has yet to exercise its existing regulatory powers,²¹ but that view ignores that one of the reasons FDA does not do more is that it cannot regulate what it cannot see. For example, critics complain that FDA does not aggressively prosecute firms that fail to register their facilities under the Bioterrorism Act. In many cases, the FDA does not know the firm exists: It would be easier to identify those firms for enforcement if their products were visible in a national registry that identifies their manufacturer. Those who say FDA should be pressured to use its existing tools first, overlook the possibility that a registry gives FDA the tools it needs to do both.
 
Skeptics of the registry lament that FDA does not do more to address drug-spiked products. Although that is a valid criticism of the agency, it is not a reason to dismiss mandatory listing. The opposition fails to recognize that a registry would help keep many tainted products off the market. Failure to file a product in the registry would create an administrative violation that FDA could easily enforce without enacting product testing, inspecting facilities, or persuading a US attorney to bring the case. Mandatory listing could be enacted with a self-executing administrative mechanism that allows FDA to bring allegations of failing to file without involving the Justice Department.
 
Some opponents raise the possibility that FDA would misuse the listing, which would undermine the foundations of DSHEA and lead to FDA mischief that will transform the registry into premarket approval. As already discussed, concerns about FDA excess or misuse of the registry can be addressed with careful drafting of the authorizing legislation. With any new regulatory tool, there is the opportunity for abuse, but proponents can rein in and constrain potential misconduct with clear limitations in the law.
 
Opponents also raise the possibility that a centralized database of dietary supplements will provide one more centralized feeding trough for plaintiffs’ attorneys. A recent uptick in class action product liability actions targeting dietary supplements exacerbates that concern. But most product labels can be identified now with Google searches, searches of the Amazon retail platform, and artful search terms on other shopping platforms. At best, a publicly accessible product registry speeds up the trolling of plaintiffs’ attorneys, but without a mandatory registry, they are hardly prevented from identifying the targets for their next lawsuits.
 
Conclusion
So, while it is fair to say that all of industry is not yet convinced of the merits of a mandatory dietary supplement listing, it is difficult to articulate winning reasons to oppose it. Mandatory listing gives FDA transparency to see what is in the supplement market. It signifies the maturity of the industry and willingness to be accountable. And 21st century consumers demand as much. Despite the dark corners of the dietary supplement market ‒ ones that still allow illegal ingredients, fraudulent claims to cure disease, and poorly made products to exist ‒ consumer confidence remains high. In all, 76% of Americans believe the supplement industry to be trustworthy.²² But that confidence could be quickly eroded by those products hiding in the shadows. Justice Brandeis was right: a little daylight might raise trust in the industry even more.
 
Abbreviations
CRN, Council for Responsible Nutrition; DSHEA, Dietary Supplement Health and Education Act; DSLD, Dietary Supplement Label Database; DV, daily value; FDA, Food and Drug Administration; FDCA, Federal Food, Drug & Cosmetic Act.
 
References

1. Federal Food, Drug & Cosmetic Act, 21 USC § 350b.
2. Federal Food, Drug & Cosmetic Act, 21 US Code § 379aa–1.
3. US Food and Drug Administration. Justification of Estimates for Appropriations Committees for Fiscal Year 2020, p. 41. www.fda.gov/media/121408/download. March 2019. Accessed 28 May 2020; US Food and Drug Administration. Justification of Estimates for Appropriations Committees for Fiscal Year 2021, p. 43. https://www.fda.gov/media/135078/download. March 2020. Accessed 28 May 2020.
4. Council for Responsible Nutrition. The Supplement OWL. Accessed May 28, 2020. www.SupplementOWL.org.
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7. 7 FD&C Act, 21 USC § 343.
8. US Food and Drug Administration. Justification of Estimates for Appropriations Committees for Fiscal Year 2020, p. 41. www.fda.gov/media/121408/download. March 2019. Accessed May 28, 2020.
9. Schiller L. Perspectives from FDA. 2019 CRN Annual Conference, 17 November 2019, Carlsbad, California. Conference presentation.
10. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary. Accessed 28 May 2020. Press release 11 February 2019. Accessed 15 June 2020.
11. US Food and Drug Administration. Responsible Innovation in Dietary Supplements. https://www.fda.gov/media/127746/download. 2019 DA/CFSAN public meeting transcript, 16 May 2019. Accessed 15 June 2020.
12. Siroi J. Responsible Innovation in Dietary Supplements. https://www.fda.gov/media/127746/download. 2019 DA/CFSAN public meeting transcript (p. 213), 16 May 2019. Accessed 15 June 2020.
13. Bass S. Responsible Innovation in Dietary Supplements. https://www.fda.gov/media/127746/download. 2019 DA/CFSAN public meeting transcript (p. 40), 16 May 2019. Accessed 15 June 2020.
14. Schiller L. Perspectives from FDA. 2019 CRN Annual Conference, 17 November 2019, Carlsbad, California. Conference presentation.
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16. Federal Food, Drug & Cosmetic Act, 21 USC § 350b(a).
17. Mister S. Dietary Supplements and Public Safety: A Defense of DSHEA’s ‘Three-Legged Stool.’  www.raps.org/news-and-articles/news-articles/2019/6/dietary-supplements-and-public-safety-a-defense-o. RAPS Regulatory Focus, 20 June 2019. Accessed May 28, 2020.
18. Nagata JM, Ganson KT, Gorrell S, Mitchison D, Murray SB. Association Between Legal Performance-Enhancing Substances and Use of Anabolic-Androgenic Steroids in Young Adults. JAMA Pediatrics. Published online 18 May 2020. [Behind paywall]
19. Long J. Experts debate pros, cons of mandatory product registry for dietary supplements. naturalproductsinsider.com/regulatory/experts-debate-pros-cons-mandatory-product-registry-dietary-supplements. Published 28 November 2018. Accessed May 28, 2020.
20. Council for Responsible Nutrition. CRN 2019 Consumer Survey on Dietary Supplements: Consumer Intelligence to Enhance Business Outcomes. www.crnusa.org/resources/2019-crn-consumer-survey-dietary-supplements-consumer-intelligence-enhance-business.
21. Long J. Trade group plans to lobby Congress on listing dietary supplement products with FDA. naturalproductsinsider.com/regulatory/trade-group-plans-lobby-congress-listing-dietary-supplement-products-fda. Published 6 January 2020. Accessed 28 May 2020.
22. Council for Responsible Nutrition. CRN 2019 Consumer Survey on Dietary Supplements: Consumer Intelligence to Enhance Business Outcomes. www.crnusa.org/resources/2019-crn-consumer-survey-dietary-supplements-consumer-intelligence-enhance-business.

 
About the author
Steve Mister, Esq, CAE, is the president and CEO of the Council for Responsible Nutrition. Mister also serves as president of CRN-International and leads the CRN Foundation. He was elected vice chair of the International Alliance of Dietary Supplement Associations, sits on the steering committee of the Dietary Supplement Quality Collaborative, and is a member of the US Chamber of Commerce’s Association Committee of 100. Mister is a practicing attorney, holds a law degree from the College of William and Mary, a master’s degree in political communication from the University of Maryland, and a bachelor of science degree from Towson University, MD. With 27 years of experience in trade association management, he holds Certified Association Executive credentials from the American Society of Association Executives. He can be contacted at SMister@crnusa.org.

Citation Mister S. A mandatory dietary supplement registry: Transparency as ‘disinfectant.’
Regulatory Focus. June 2020. Regulatory Affairs Professionals Society.