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Institutionalizing Visibility and Enforcement—The Dietary Supplement Listing Act of 2022

By Steve Mister

If you read much of the mainstream consumer press, you are likely to believe that dietary supplements aren’t regulated. But that would be wrong—yes, supplements are regulated contrary to an earlier Healthcare Business Today article by Dr. Leigh Vinocur. The US Food & Drug Administration (FDA) has oversight over supplements’ sourcing, manufacturing, and labeling, and other things. But dietary supplements are about to get even more regulated with a new tool called mandatory product listing (MPL). 

The issue made mainstream news recently, courtesy of bipartisan legislation introduced by Sens. Dick Durbin (D-IL) and Mike Braun (R-IN), entitled the “Dietary Supplement Listing Act of 2022.” Essentially, this bill would require dietary supplement manufacturers to enter their products’ labels into an online database housed at FDA and available to consumers. This database will allow FDA to see the size and breadth of the market and create enforcement priorities based on what’s actually in the marketplace. Sounds like a reasonable concept, right?

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The Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement and functional food industry, has been an ardent and vocal advocate for the transparency MPL would bring.  Unfortunately, the bill is being opposed by some in the medical community, among others, who believe it doesn’t go far enough. They want FDA to have premarket approval over all supplements but that strident position may sacrifice the opportunity to get anything done in this Congress. CRN, supported by our more than 200 members who manufacture the majority of supplements in the U.S., believes that passage of this legislation will bolster consumer safety and, subsequently, confidence in our products and industry. It’s an opportunity we shouldn’t let pass by.

One of the leading detractors of the bill is Pieter Cohen, M.D., who recently expressed his opinion in the New England Journal of Medicine opinion piece, “Institutionalizing Misinformation—The Dietary Supplement Listing Act of 2022.” Unfortunately, Dr. Cohen’s piece grossly misrepresents what the bill would do.

First, Dr. Cohen acknowledges FDA currently “doesn’t have a systematic approach for monitoring safety, nor can it track which supplements are currently being sold to consumers.” A requirement that all new dietary supplements provide their labels to FDA as they enter the market would fix that. While he seems to understand the problem, Dr. Cohen misses the point of what mandatory listing is intended to do. For example, he wrote, “The bill wouldn’t stop the promotion and sale of supplements that contain dangerous ingredients, are poorly manufactured, or are promoted using prohibited disease claims.” 

That’s simply not correct. Having increased visibility into the marketplace will allow FDA to find products it wouldn’t otherwise notice. Yes, some bad actors will retreat to the dark corners of the internet and refuse to list their products. However, for the majority of the industry, listing with FDA will become routine, and once in the registry, FDA can find them. The consequence for not listing would be too high, so companies will list their products. Separate from the potential for legal penalty of having FDA declare a product “misbranded,” large chain retailers, even online retailers, would likely just refuse to sell products that are not listed in the registry, so it becomes self-enforcing.

Dr. Cohen lists everything he wants FDA to do before accepting a new label, such as pre-screen the ingredient lists for questionable components, review label claims for suspect statements, test the contents that they match the label, etc. All of these obstacles necessitate some form of pre-market evaluation and approval of the product prior to it coming to market and being included in the registry. Dr. Cohen wants the same pre-market review that is required for drugs. Those desires are non-starters on Capitol Hill because Congress decided 28 years ago that FDA should not have pre-market approval over an entire class of products that contain ingredients already found in the food supply or have been trusted for decades in folk medicine. Nothing has changed today that would counsel Congress to rethink that decision, and the politics for affordable access to selfcare have only become stronger. Let’s do what is doable.

Interestingly, less than three years ago, Dr. Cohen supported the MPL legislation that is now on the table. In a Dec. 2019 piece for the New England Journal of Medicine, he wrote:

“… manufacturers should be required to submit all product labels to the FDA so that the agency is aware of, and can track, what products are on the market … FDA could determine if the ingredient is new and lacking adequate evidence of safety … The agency could also flag products containing such ingredients in the label database so that retailers would be able to easily confirm a product was properly listed with FDA.”

Dr. Cohen’s previous argument assumed all market entrants would be accepted and listed in the registry; as he described it, once visible to FDA, illegal products could be removed quickly using existing legal authority. That is the philosophy behind mandatory listing—when FDA can see the market, it can regulate the market. But now, Dr. Cohen now has moved from his original position and wants to weaponize the mandatory listing in ways that just won’t get out of a committee in Congress.

Mandatory listing as we envision it will not allow FDA to reject a listing because it disagrees about whether the product is a legal supplement. However, by virtue of the registry’s existence, FDA will have absolute visibility to find these products and pursue them under its existing legal enforcement authority. Mandatory listing would create visibility for the agency. How do I know this? CRN created a proof of concept several years ago called the Supplement OWL (Online Wellness Library) which is, for all intents and purposes, a template for construction of the mandatory database being considered. All of our members have been entering their product labels into the database for years, so this activity would not be new to them.

Dr. Cohen is justifiably concerned, as am I, about bad actors. However, the listing database is not intended to be an honor roll of products meeting certain levels of quality assurance. The database is intended to be an accurate reflection of the industry—a spotlight on good, bad and ugly—and a way for FDA to see the range of products in the market. Sunlight is the best disinfectant.

When retailers refuse to sell items that are not in the registry, then enforcement by FDA will become amplified, as companies will have no choice but to submit their listings if they want to keep their spot on the shelves or their product page on online retail platforms. Mandatory product listing solves the decades-old problem of giving FDA visibility into the industry without conferring pre-market approval or denying consumers access to safe products.

Steve Mister is the president and CEO of the Council for Responsible Nutrition.

Healthcare Business Today is a leading online publication that covers the business of healthcare. Our stories are written from those who are entrenched in this field and helping to shape the future of this industry. Healthcare Business Today offers readers access to fresh developments in health, medicine, science, and technology as well as the latest in patient news, with an emphasis on how these developments affect our lives.

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