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The US Food and Drug Administration (FDA) is revisiting many food chemicals available on the market. As part of this post-market reassessment, the FDA is focusing on those approved through the GRAS (Generally Recognized As Safe) process. Brendan Niemira, chief science and technology officer at the Institute of Food Technologists, dives into the GRAS process, including what the FDA must prioritise during its reassessment to ensure the safety of the food supply, as well as what this reassessment will mean for food companies.

In February 2026, the FDA sent a message to food and beverage companies: the GRAS era of food chemicals, at least as they knew it, might be over. The regulatory agency’s latest step in its ongoing post-market assessment of chemicals in the food supply began with a reassessment of butylated hydroxyanisole (BHA), a food preservative which has been on the GRAS list since its inception in 1958.

The FDA’s GRAS designation indicates that experts consider a substance added to food to be safe under its intended use. This designation exempts the substance from the usual FDA food additive tolerance requirements. Essentially, GRAS status allows companies to use certain substances in food without pre-market approval from the FDA, but these substances still need to meet the same safety standards as other approved food additives.

A brief history of GRAS

The GRAS determination process has evolved significantly since the FDA created it in 1958, with two approaches to manage the concept. The FDA notification process involves submitting a comprehensive dossier that details the substance’s identity, composition, intended use, dietary exposure and safety information. Experts at the FDA evaluate the submission and respond with either a ‘No Questions’ approval letter; an indication of insufficient basis for GRAS status; or a cessation of evaluation request.

A second option, formalised in 2016 by the FDA through their GRAS Final Rule, allows self-determination of GRAS status.

Interested companies gather scientific data, consult experts and document the decision-making process, all of which is reviewed by the FDA. While this process can be quicker, it maintains confidentiality and allows flexibility in tailoring the process to specific needs. It also imposes challenges related to resource constraints and potential legal disputes. For example, this approach can have increased business and litigation implications if it later becomes known that the food component has heightened food safety/human health risks compared to those in the original self-determination scientific risk assessment for human safety.

That is how the FDA has arrived at this post-market reassessment, with increased evidence or scientific studies that have shown certain food chemicals previously approved as GRAS are connected with increased human health risks. The long-term future direction of GRAS determinations ultimately will depend on the FDA’s prioritisation of resources, external pressures, and the ability to adapt to new scientific evidence, but in the short-term, the FDA’s direction will focus on a few key areas.

Post-market reassessment priorities

The FDA has the authority to re-evaluate substances based on new evidence, even after they have been determined to be GRAS.

If new scientific data suggests that a substance may not be safe, the FDA can issue scientific memorandums and take regulatory action to address the potential risks. This post-market evaluation process ensures that GRAS determinations remain current and reflective of the latest scientific knowledge. As the FDA implements their 2026 updated process, IFT recommends the following key procedural steps to best serve the public interest.

It is essential that both pre- and post-market assessments ensure end-to-end transparency for approval of ingredients and foods. The FDA must continue to ground the review process in science, be transparent in their assessment and analysis, and be clear in their communication to the public.

Specifically, the FDA needs to bring forward transparency in its review of information, signal monitoring and horizon scanning efforts that identify and inform the FDA on potential ingredients that need review. The current monitoring process is vague and does not indicate what level of evidence, consumer concern, scientific publications and other activities would necessitate triage and consideration for assessment.

IFT also recommended that the FDA develop an advisory committee to help support prioritisation, review frequency and provide consultation on controversial topics. Any advisory committee should be appropriate to the needs, transparent in its makeup, selection and duration and should help support the FDA’s effort in a timely manner.

Ultimately, any post-market review must be prioritised based on scientifically validated epidemiological health data that shows which ones might be causing harm. Only incidental weight should be given to ancillary issues, such as how long an additive has been GRAS, the manufacturer's country of origin or how hard the additive is to pronounce.

The FDA must also be transparent in its communication with the public, in particular, about how long this process will take. Since January of 2025, numerous federal research laboratories have been shut down, and the workforce of federal scientists, engineers and technicians is down by 14% across the board. A reasonable concern is that a thorough reassessment of a food chemical is going to take much longer than it might have previously.

Impact on F&B companies

Until the FDA announces which GRAS additives will come under review, food companies are in a holding pattern. Separate regulatory actions on food dyes and colourants have already had an impact.

The FDA’s mandate of 2025, recommending food companies replace artificial dyes with natural food colours, coupled with the more recent 2026 announcement of the change in regulatory enforcement of the ‘no artificial colours’ language on labels, has sent many food and beverage companies back into the R&D lab to reformulate their products.

As that effort ramps up, potential uncertainty of the GRAS status of dyes and colourants can lead to costly delays and duplication of effort.

Clarity, consistency, and coherent focus on sound science are what is needed, and what IFT calls on the FDA to enact.