Funding Boost Should Be Followed by Reform of FDA Dietary Supplement Oversight

In its 2022 appropriations package, Congress boosted funding for the Food and Drug Administration’s Office of Dietary Supplement Programs by $2 million to enhance oversight of a wide range of products, including many of questionable safety. Still, the historic 18% increase brings FDA’s budget for this essential work to only about $13 million—a small sum for a marketplace with more than 80,000 products and $46 billion in annual sales.

The Pew Charitable Trusts was among those calling for a funding increase, but lawmakers can and should do more. They should pass legislation that requires manufacturers to inform the agency of all supplements they make and their ingredients. Such a product listing requirement would help FDA stretch its resources further and protect consumers from harmful products.

Under current law, now decades old, FDA is responsible for overseeing supplement products—such as vitamins, herbs, and minerals—but cannot review or test their safety before they are sold. The agency therefore has limited insight into the market, and manufacturers are not required to provide basic information to the federal government about their supplements.

Instead, FDA can generally act only after a product is on the market—by, for example, conducting internet searches for illegal marketing claims, inspecting manufacturing facilities, and responding to consumer or company reports to identify products that may be causing harm.

These oversight gaps may not have been as concerning in 1994, when the current regulatory framework was established by the Dietary Supplement Health and Education Act and the supplement market was a small fraction of what it is now. But today, the gaps put people at serious risk.

From 2004 to 2013, FDA received more than 15,000 reports of health problems linked to supplements, including 339 deaths and nearly 4,000 hospitalizations. Additionally, 1 in 8 adults (12%) in a 2019 Pew survey said they or an immediate family member had experienced a severe side effect, such as a heart, kidney, or liver problem, from a supplement. Despite these realities, about half of supplement users overestimate the extent of FDA regulation; 28% said they believe that manufacturers must prove their products are safe before they can be marketed, while 23% said they thought FDA tested supplements before they are sold.

A product listing requirement would help to address regulatory shortcomings and provide FDA with a reliable mechanism to know what products are on the market, what ingredients they contain, whether they include any warnings or precautions, and whether there are allergen statements associated with the product. The agency would then be able to publish the data in a searchable website so that consumers, health professionals, and others can learn more about the supplement products in the marketplace.

Gathering and disseminating this information would help FDA to identify unsafe products, move quickly to warn the public about these dangers, and, where necessary, remove harmful supplements from the market. It also would help consumers to make informed decisions about the products they purchase and boost trust in a growing industry that has recently come under fire for exploitative and fraudulent practices.

Consumers understand what’s at stake. In the 2019 national survey, 95% of adults said supplement manufacturers should be required to give the agency a list of the products they make and their ingredients. With such broad support, Congress should act quickly to pass legislation that empowers the agency to better protect people from dangerous products and increases transparency in the market.

Liz Richardson directs The Pew Charitable Trusts’ health care products project.

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