Modernizing Regulations for a Safer Dietary Supplements Industry

As the Biden Administration fills several positions in the Food and Drug Administration (FDA), it’s clear that the administration will, rightly, continue to focus on COVID-19 as its priority for the coming months. But the pandemic has changed many behaviors beyond our social practices, like distancing and mask wearing. For example, many of us are more concerned with immune health, taking a pro-active role in staying healthy at a time when e-commerce use has skyrocketed. This increased desire for dietary supplements has resulted in a 12.1% rise in sales in 2020, the largest annual increase since 1997.

To ensure that consumers have access to quality and safe dietary supplements, the Dietary Supplement Quality Collaborative (DSQC) is focused on advancing important legislative priorities and regulatory initiatives with the 117th Congress. As a diverse group of national stakeholder organizations across the public health spectrum, the DSQC sees a vital opportunity to implement important reforms to better protect consumers and responsible companies within the industry.

In the last 25 years, the dietary supplement industry grew from $4 billion with roughly 4,000 products to more than $50 billion with more than 50,000 products. Due to this rapid growth, both government and industry stakeholders are examining the Dietary Supplement Health and Education Act (DSHEA) to ensure that foundational law keeps pace with the industry’s growth, the science underlying these products, and the explosion of online marketing.

To protect consumers better and monitor industry practices, we must increase transparency in the marketplace and clarify the confusion around the FDA’s ability to regulate products marketed as dietary supplements. DSQC will be aggressively pursuing legislative actions from Congress and regulatory clarity by the FDA to achieve these goals.

In both of the FDA’s 2020 and 2021 budget justifications to Congress, FDA expressed interest in establishing a mandatory product listing for dietary supplements. This will require products marketed as dietary supplements to be listed in a national registry accessible to both the FDA and the public. Manufacturers, packers, or distributors would be required to submit a copy of their product labels and the particular information that appears on them, along with pertinent contact information, for the supplements they put into the market.

Implementing mandatory product listing will provide a much-needed tool for the FDA to enhance its ability to spot trends, identify products containing dangerous ingredients, and prioritize investigations of products and/or manufacturers that raise safety concerns. The listing will provide a “risk-based regulation” model enabling the agency to direct its resources toward the products, manufacturers, and marketers that pose the highest risk to public health.

A mandatory product listing accessible to the public is a win for all stakeholders. Consumers, pharmacists, and retailers would be able to access information about products and their ingredients, helping us determine which products are safe to consume, recommend, or store on shelves. If Congress enacts these safety measures, responsible industry actors would benefit from increased compliance with good manufacturing practices, ensuring a fairer and more competitive marketplace.

Some critics worry the listing could restrict new dietary supplements from entering the market or disrupt DSHEA’s balance of regulatory authority. To prevent this, the DSQC will support legislation that does not impose undue obstacles prohibiting or delaying the entry of new products to the listing. This will be achieved by clearly defining the limitations of the law in the policymaking process. Mandatory listing should not be an obstacle on the path to market, rather a way to illuminate the breadth of supplements available to consumers.

In addition to the mandatory product listing, Congress should eliminate the potential legal loophole in the statutory definition of a dietary supplement. The FDA has opined that products marketed as dietary supplements that contain illegal and sometimes undeclared ingredients do not meet the statutory definition of a dietary supplement, even if they carry a “Supplement Facts” label. The agency thus suggests that these products fall outside of its jurisdiction for dietary supplements. This creates a sort of regulatory limbo for suspect products, considered neither a supplement nor a drug, which can result in delayed action on unsafe products.

Clarifying the definition such that it covers all products marketed as dietary supplements will allow the FDA proper oversight and enforcement capabilities to investigate illegitimate products. Effective enforcement will increase consumers’ trust in dietary supplements.

While the COVID-19 pandemic appropriately remains center stage for federal agencies like the FDA, industry stakeholders and policy makers must continue legislative efforts to ensure the highest quality and safety of dietary supplements. Modernizing regulations to match the industry’s growth and changed purchasing habits will better protect consumers.

1 COMMENT

  1. Interesting article and it all makes sense. I do worry about the quality of the supplements I’m taking–is anyone making sure they are what they say they are. Sounds like we need the government to step in here..

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