The time is now to enact the mandatory product listing

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by Dietary Supplements Quality Collaborative (DSQC)

The dietary supplement market continues to experience rapid growth. By some estimates, for every product that was on the market when the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994, today there are now 20 more. The pandemic caused many consumers to place a greater emphasis on their personal health and wellness, with CRN (Council for Responsible Nutrition) surveys from 2021 reporting 80% of Americans take dietary supplements, and the Natural Marketing Institute (NMI) noting vitamin and supplement usage increased by 28% since the start of Covid-19.

While we’re able to estimate the growth of the industry, no one—not consumers, not retailers, not manufacturers—actually knows how many products comprise the U.S. dietary supplement market because there is no central required listing of these products. By enacting a mandatory product listing (MPL) for dietary supplements, we could address this issue and enhance transparency for all stakeholders.

That unknown market size should trouble consumers, retailers, industry members and regulators alike. This lack of transparency denies consumers the ability to quickly determine what products contain a particular ingredient of interest, without having to scour multiple websites and read hundreds (or thousands) of labels. Retailers never really know what products they might consider for their shelves, and responsible manufacturers who follow cGMPs (current good manufacturing practices) must compete for market share against a field of competitors with illegal ingredients, unreasonable label claims and less-than-reliable manufacturing practices.

Additionally, FDA does not have a good understanding of the extent of the market. The very agency that is congressionally mandated to implement DSHEA—and to provide consumers with a safe marketplace that allows for informed decisions—doesn’t have a firm grasp of the scope of the industry itself. Not knowing what is on the market means FDA’s already insufficient resources are spread thin working to address adulterated products containing illegal or undeclared ingredients that present harm to unknowing consumers.

One solution for this dilemma is to create a mandatory product listing for dietary supplements. An MPL would require manufacturers to provide FDA with the label information of each dietary supplement product they produce for the U.S. market, and would direct FDA to post these labels on a public website. Consumers would then have a centralized resource to be able to determine which products provide the ingredients they seek. Retailers would be confident that all the products on their shelves—those sold in-store and also online—are known to FDA. If products are offered for sale but not listed, FDA can more effectively focus its efforts to determine if such products contain any illegal ingredients, and take action if that is found to be the case. This would make it so that rogue products with illegal ingredients could no longer hide in plain sight. An MPL would thus help ensure consumers are protected and manufacturers indeed operate in a fair market.

This is not a radical idea nor is it new. In its last two federal budgets, the Trump administration asked Congress to provide FDA with funding for MPL, stating, “This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products.” In its first federal budget, the Biden administration again requested funding for MPL, and is expected to ask again in the next federal budget.

The public supports MPL: In a 2019 survey of U.S. adults on their use of and regard for dietary supplements, when they learned MPL does not exist, 95% of consumers who use dietary supplements thought it should, with 93% of Republicans and 97% of Democrats in support.

Other aspects of DSHEA need addressing as well, but MPL should not be held up while other reforms are debated. In fact, introducing MPL might just help to address other concerns in the marketplace. The Dietary Supplements Quality Collaborative (DSQC) firmly believes MPL will increase awareness of marketed products, allowing FDA’s Office of Dietary Supplement Programs (ODSP) to better focus its resources and allow for a rapid response if a safety concern is identified on the market.

If an ingredient is found to present safety concerns, the label information in the MPL will help consumers, retailers, manufacturers and FDA determine how many products are affected and notify their marketers for quick action. Currently, if a safety concern has been identified for a specific product or ingredient, FDA does not have insight into other marketed products that contain the ingredient(s) associated with that concern.

MPL would also help modernize FDA’s strategies in supplement regulation. When DSHEA was enacted, e-commerce barely existed. Today, consumers rightly want easy access to information that helps them navigate the market and make smarter purchasing decisions. MPL would consolidate that market knowledge by listing the label information of every available dietary supplement. Consumers could know what products interest them, perhaps being better able to discuss their options with a trusted health care provider. Retailers could more easily compare their inventory to the known market, providing the product assortment and the level of transparency their customers expect.

Ultimately, dietary supplement consumers want to know they are buying quality products that are safe and visible to FDA, the agency that oversees the category. Manufacturers and retailers want FDA to identify and take action against rogue products masquerading as something they are not. But FDA can only regulate what it can see. MPL will enable the agency to better hold up its end of the deal and provide consumers with the transparency they seek.

It’s time to enact the mandatory product listing.

DSQC (Dietary Supplements Quality Collaborative) is a multi-stakeholder, cross-sector collaborative, working together to improve the quality and safety of dietary supplements. The Collaborative brings together members’ expertise and networks to help promote supplement safety, advance transparency and embrace quality.