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Everyone is likely aware that the FDA is one of the agencies tasked with the job of overseeing and ensuring the safety of the nation’s food supply.  Have you considered how the cost of the food safety regulatory work of the FDA is paid?  When it comes to the regulation of food safety, the FDA is entirely funded by Congress.  This is not the case for other products that the FDA regulates.  For example, the FDA also oversees the safety of medications and medical devices.  For that work, the FDA charges user fees to companies bringing those items to market to cover the cost of the FDA regulation.  According to the FDA’s summary of its 2025 budget, $3.5 billion of its $7.2 billion budget is derived from user fees.  A debate has emerged about whether the FDA should charge food manufacturers user fees.  

A recent article proposed that the FDA implement user fees for its food safety regulation efforts for several reasons:

  • Many new ingredients, some of which are associated with health concerns, are used in ultra-processed foods.  Ultra-processed foods make up a substantial percentage of the American diet.
  • States have begun to regulate and prohibit the use of many of the ingredients in ultra-processed foods.
  • States and Congress have shown more interest in removing ingredients in ultra-processed foods.
  • As food science has advanced, more information has come to light about the impact of diet on health.
  • Data shows that the FDA has experienced delays in meeting timelines for premarket review, affecting the approval or denial of items such as food additives, labeling, and new infant formulas.

How might the FDA add user fees?  The most obvious place to start is with the fees that the Food Safety Modernization Act (FSMA) already permits the FDA to collect.  Under FSMA, the FDA is permitted to collect user fees for reinspection activities.  The FDA does not currently do this because FSMA also requires the FDA to publish guidelines to consider the impact of user fees on small businesses and, if appropriate, provide reduced fees for small businesses.  The FDA has not yet issued final guidance on that topic, so it has not begun to collect those fees.  

With Congressional authorization, the FDA could also charge user fees for premarket approval of food additives and health claims, as well as for registration of food manufacturing facilities.  Statutory changes to FSMA could give the FDA more oversight of food ingredients and expand its ability to collect fees.  For example, it has been proposed that Congress could amend FSMA to:

  • Require the FDA to perform a premarket review of GRAS (Generally Recognized as Safe) ingredients.  [Currently, new GRAS ingredients may be submitted to the FDA for premarket review along with scientific evidence showing them to be safe.  However, this process is not required.  Food manufacturers may rely on internal data to determine for themselves whether ingredients are GRAS without any FDA review.];
  • Require the FDA to perform reviews of existing ingredients in the food supply for which safety concerns have been raised;
  • Require food manufacturers to grant the FDA access to all information about their food ingredients to determine if they contain concerning substances;
  • Require food manufacturers who make structure/function claims to provide proof to the FDA to support those claims.

User fees could be attached to all of these types of regulations.  While the addition of these tasks would add to the FDA’s workload, they could also generate revenue to support the FDA’s expanded duties.

There are, however, contrary concerns.  In the past, food industry trade groups have opposed user fees.  Since many user fees would require legislative action by Congress, would opposition by food industry groups effectively prevent the imposition of user fees?  Would user fees be a barrier for small food manufacturers and prevent them from even entering the market?  Further, would user fees impact the price of food for consumers?  If so, by how much?  Given the rise in food prices over the past several years, would any additional safety to the food supply from expanded FDA oversight make user fees worth the cost to consumers?  

While there is currently renewed interest and concern about food ingredients, overhauling the foods that make up the standard American diet is a costly undertaking.  Without more funds, the FDA will be limited in its ability to act.  The dilemma is how to go about that transformation while not pricing manufacturers or consumers out of the market.

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