— OPINION —
State leadership vs. a patchwork of regulations sums up of the controversy over the “FRESH Act” in a single phrase.
Due to its controversial provisions on federal food regulations superseding the states, amended GRAS allowances, and chemical ingredients, the proposed FDA Review and Evaluation for Safe, Healthy and Affordable Foods Act of 2026 (FRESH Act) is causing a new rift between the food industry and consumer advocates.
Of all of these, the greatest controversy is over the “National Uniformity and Preemption Standard,” stating that federal requirements regarding the use, labeling, sale, or marketing of food additives, infant food, and contaminants would supersede any state requirements or prohibitions.
Consumer groups argue that it is the states that are leading in the areas of protections against toxic chemicals (such as PFAS) and heavy metals in foods, and this provision would remove that layer of protection which states have used to fill the lag in federal regulations.
While certain states do tend to be ahead of federal rulemaking in many such areas, it is not beneficial for the industry or consumers to have a differing set of laws in every state. In fact, the issue takes us back to the GMO controversy through which various rules were starting to be passed by some of the states. As more and more states got onboard with their own set of rules, food manufacturers were having to adapt their processes and labeling to a patchwork of regulations, potentially spanning an array of 50 different sets of requirements if all the states were to follow suit. The issue was only settled with the 2016 Congressional act requiring USDA to establish a national regulatory standard for the disclosure of bioengineered foods, and the 2022 implementation of the National Bioengineered Food Disclosure Standard.
As the GMO situation shows, the states can – and do – set the tone for federal focus, and spur the agencies to accelerate their rulemaking. But it is beneficial to no one for manufacturers to have 50 different ways of assessing each food dye or ingredient in a product. It is, however, that same state-setting tone that got the ball rolling on federal GMO standards that is now occurring with the proposed FRESH Act. By pre-empting the various state laws, the proposal seeks to set a single standard for GRAS, additives, and chemicals –some of which are not all that different from what the states are proposing.
Along with the national pre-emption of state laws, bill provisions include:
GRAS. The bill provides for mandatory notification for the use of a new GRAS substance, along with a public registry of GRAS status conclusions.
Additionally:
The FDA is to be given only 90 days to review notifications and request additional data or approve the submission; after 90 days of nonresponse, the substance would be automatically approved.
Substances can instead be reviewed and approved by accredited “established scientific panel” (such as the Flavor Extract Manufacturers Association Expert Panel).
All information submitted in a GRAS notification is to be kept confidential for 120 days, except for certain “pivotal safety data.”
Food Additives. The bill amends the definition of food additives in the FDC Act (21 U.S.C. 321[s]) to exclude “common food ingredients,” defined as a food ingredient that was ordinarily consumed as a food, or available for purchase as an independent article of food, on or before January 1, 1958. That is, the same ingredients currently accepted as GRAS based on common use prior to the passage of the Food Additives Amendment of 1958.
Chemicals in Food. When the Secretary issues a rule against the use of a chemical in food that is deemed to be unsafe, the industry will have two years after the rulemaking to remove the chemical from foods, unless the Secretary determines there to be a severe and imminent risk of illness or death.
In essence, advocates are arguing that the provisions don’t go far enough to keep food safe, provide less stringency than the individual state requirements, and allow for potential bias in decision making (e.g., GRAS accredited panels).
The proponents see the bill as providing food safety through common federal standards that maintain a science basis without including a range of 50 different perspectives. As a whole, the controversy tracks back to the age-old dilemma of the federal/state relationship: who should hold the authority?
This is clearly a difficult and emotive topic which has created a polarity of opinions. One can understand why states move quickly when FDA appears to take ages to examine the same issues. Optically, to consumers, states may appear to do more to protect the public health than the FDA. Yet, the result of multiple different state laws is an unworkable mess of rules and regulations that are simply not practical for food manufacturers that make food for distribution in multiple states.
The simple solution is to fund FDA adequately to allow the agency to examine the science, determine the risks, and take appropriate action to protect the public – all a lot faster than happens now. But that suggestion may be a utopian view that will never come to be, because Congress is not going to fund FDA adequately in a way that allows the agency to move swiftly and effectively to protect public health. The end result is the current situation that leaves nobody really comfortable with the solution and causes the feeling that the balance between risk and food availability is still not adequately addressed.
Published with permission from TAG, founded by David Acheson. For original post, click here.