Home Food & Drink GRAS, Additives, Chemicals: Who Should Have the Power?

GRAS, Additives, Chemicals: Who Should Have the Power?

GRAS, Additives, Chemicals: Who Should Have the Power?

— opinion —

National Leadership vs. The controversy over the bundle of regulations, the ‘FRESH Act’, can be summarized in one word.

With its federal food regulations replacing the states, revised GRAS allowances, and controversial provisions on chemical ingredients, the proposed FDA Review and Evaluation of Safe, Healthy, and Affordable Foods Act of 2026 (FRESH Act) is creating a new rift between the food industry and consumer advocates.

The biggest controversy among these concerns the “state uniformity and preemption standard,” which states that federal requirements regarding the use, labeling, sale or marketing of food additives, infant foods and contaminants take precedence over any state requirements or prohibitions.

Consumer groups argue that it is the states that lead the way in protections against toxic chemicals (such as PFAS) and heavy metals in food, and that this provision would remove a layer of protection that states have used to make up for delays in federal regulations.

While certain states tend to stay ahead of federal rulemaking in many of these areas, it is not beneficial to the industry or consumers to have different laws in every state. In fact, this brings us to the GMO controversy, where various regulations are starting to be passed in some states. As more and more states adopt their own sets of rules, food manufacturers have had to adapt their processes and labeling to multiple regulations, potentially spanning 50 different sets of requirements if all states follow them. This issue was only addressed through a 2016 congressional bill requiring USDA to establish national regulatory standards for biotechnology food disclosure and the 2022 implementation of the National Biotechnology Food Disclosure Standard.

As the GMO situation shows, states can and do set the tone for federal focus and spur agencies to accelerate rulemaking. But it’s not in anyone’s interest to have 50 different ways for manufacturers to evaluate each food dye or product ingredient. But it’s that same state-setting tone that got the ball rolling on federal GMO standards, which is now happening with the proposed FRESH Act. By preempting various state laws, this proposal seeks to set a single standard for GRAS, additives, and chemicals, some of which are not significantly different from what states are proposing.

In addition to national preemption of state law, bill provisions include:

Grass. The bill provides for mandatory notification of uses of new GRAS substances along with public registration of GRAS status conclusions.

Additionally:
The FDA has only 90 days to review the notification and request additional data or approve the submission. If you do not respond within 90 days, your substance will be automatically approved.

Instead, substances may be reviewed and approved by a recognized “established scientific panel” (e.g., the Fragrance Extract Manufacturers Association Expert Panel).

All information submitted in a GRAS notification will remain confidential for 120 days, except for certain “critical safety data.”

improver. This bill amends the definition of food additives in the FDC Act (21 USC 321(s)) to exclude “common food ingredients,” defined as food ingredients that were commonly consumed as food or may be purchased as stand-alone food items on or before January 1, 1958. That is, these are the same ingredients currently accepted as GRAS as commonly used prior to the passage of the Food Additives Amendments of 1958.

Chemicals in Food. If the Secretary issues a rule prohibiting the use of a chemical in food that is deemed unsafe, industry must remove that chemical from food for two years after enactment of the rule, unless the Secretary determines that there is a serious and imminent risk of illness or death.
Essentially, advocates are arguing that this provision is not sufficient to maintain food safety, is less stringent than individual state requirements, and allows for potential bias in decision-making (e.g., GRAS certification panels).

Supporters see the bill as providing food safety through common federal standards that remain science-based rather than incorporating 50 different perspectives. Overall, this debate goes back to an old dilemma in federal/state relations: Who should have authority?

This is a difficult and emotional topic that has clearly created polarity of opinion. When the FDA seems to take a long time to investigate the same issue, it’s understandable why states are moving quickly. Optically, it may appear to consumers that states are doing more to protect public health than the FDA. However, the varying state laws have resulted in a mess of rules and regulations that are not practical for food manufacturers who make food for distribution in multiple states.

The simple solution is to properly fund the FDA so that it can examine the science, determine risks, and take appropriate action to protect the public. All of this will happen much faster than it does now. But such proposals may be utopian views that will never come to fruition. Because Congress will not adequately fund the FDA to allow it to move quickly and effectively to protect public health. The end result is a current situation where no one is truly satisfied with the solution and which creates a feeling that the balance between risk and food availability has not yet been adequately addressed.

Published with permission from TAG, founded by David Acheson. For the original post: Click here.

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