'Supplemental' blog: What If There Were a Registry?

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May 16, 2022  | Join the conversation on LinkedIn

CRN and staff posts are intended for the education of the public, our industry, and our members. CRN welcomes differences of opinion and debate. We reserve the right to moderate comments containing misinformation or disrespect.

By Steve Mister, President & CEO, CRN 

Last week, FDA announced the issuance of 10 warning letters against marketers of certain dietary supplements because the agency alleges these products contain ingredients that are not lawful. The announcement was not particularly surprising, but I was surprised to read one of my industry colleagues suggest—without any supporting evidence—that the release of these letters was somehow improperly timed to draw attention to Senator Durbin’s legislation to create a mandatory product listing for supplements. 

A closer examination of these warning letters, however, demonstrates precisely why FDA needs mandatory product listing—without FDA even intending it. First, the FDA apparently misidentified one of the marketers of the suspect products and issued the warning letter to the wrong company. A day later, FDA issued a corrective announcement and acknowledged the mistake. FDA explained, “The error occurred because the website on which the products [names deleted] are sold incorrectly stated that the site was the property of [another company].” Hmmm. If only FDA had an authoritative source that indicated the company responsible for marketing a particular dietary supplement. 

Then, separately, another warning letter recipient has been complaining publicly that the product FDA called out already had been withdrawn from the market months ago. However, if FDA was relying on the Office of Dietary Supplement (ODS) Label Database—a platform assembled by a third party without necessarily informing the company of the listing—to identify the status of product in question, FDA would find that label cataloged as “On Market.” FDA wouldn’t know the product had been discontinued. The marketer has no obligation to notify ODS that the product has been withdrawn—if the company even knew its product label was included in the ODS registry. Hmmm…if only there was an authoritative label database that companies were required to keep current. 

Both of these apparent errors on the part of FDA are the result of the agency’s inability to see directly into the marketplace. If only the dietary supplement marketplace had, oh, I don’t know...maybe a database...but one that was compulsory...where companies were required to list their products, and to keep the entries current should they reformulate or withdraw the product....Hey, I’m just spitballing here, but what if there was a registry of dietary supplements...a complete listing...that reflected the actual breadth of the marketplace. One that prohibited FDA from rejecting a product it didn’t like, but served as an accurate representation of the U.S. market for dietary supplements and shined light on all the finished products that are being sold to consumers. FDA could use that registry to find companies for, say, warning letters, or locating a product(s) in a crisis, or prioritizing its enforcement actions.

Fortunately, that is exactly what Senator Durbin’s legislation would do. It creates a new requirement that marketers of dietary supplements provide the agency with a copy of their labels as they introduce new supplements and establishes a public-facing website so that retailers and consumers, as well as regulators, can access this information. Sounds like such a mandatory product listing would not only help FDA regulate more efficiently, but it might save the industry some misplaced heartache as well. 

FDA can’t regulate what it can’t see. Come work with us to create a mandatory listing.


Steve has written about MPL previously for CRN's blog, as well as in bylined articles for several publications.

Steve Mister has been President & CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, since 2005. Under his leadership, CRN has experienced increased membership each year, doubled its annual budget, sharpened its strategic focus to advance the industry, and launched new initiatives that increase industry responsibility and provide consumer education. During Mr. Mister’s tenure, CRN has been instrumental in enacting the adverse event reporting law for dietary supplements, the Designer Anabolic Steroid Control Act, and defeating several efforts in Congress that would have over-regulated dietary supplements, limiting consumer access. Mr. Mister led the association to launch the Supplement OWL, an industry-run online registry of dietary supplements and their labels. He is a member of the U.S. Chamber of Commerce’s Association Committee of 100, holds a Certified Association Executive (CAE) distinction, and is active in ASAE. Learn more about Steve.