How the FDA Approves Food Additives: The Process Explained

The United States Food and Drug Administration (FDA) oversees the safety of more than 10,000 substances that can be added to food. The legal framework dates back to the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, which established the principle that food additives must be demonstrated safe before they enter the market. Understanding how this process works, including its strengths and its widely criticized shortcomings, is essential for anyone who wants to make informed decisions about what they eat.

The Two Pathways: Food Additive Petitions and GRAS

There are two primary routes by which a substance becomes legal to add to food in the United States. The first is the formal Food Additive Petition (FAP) process, which involves direct FDA review and a published regulation. The second is the Generally Recognized as Safe (GRAS) determination, which can be made by the manufacturer without FDA review.

This dual-track system is central to understanding both how the system is supposed to work and why critics say it has significant gaps.

The Food Additive Petition Process

When a company wants to use a new substance in food that is not GRAS, it must submit a Food Additive Petition (FAP) to the FDA. This is the more rigorous pathway and involves several stages:

1. Pre-submission consultation. Before filing a formal petition, companies typically engage in pre-submission meetings with the FDA's Center for Food Safety and Applied Nutrition (CFSAN). These meetings help companies understand what data the FDA will require.

2. Toxicological studies. The petition must include safety data, and the extent of testing depends on the "concern level" of the additive. The FDA uses a tiered system:

Concern Level I (low exposure, simple chemical structure): Requires short-term toxicity studies, typically 28-day feeding studies in rodents, and genotoxicity testing.
Concern Level II (moderate exposure): Requires subchronic (90-day) toxicity studies and reproductive toxicity data.
Concern Level III (high exposure, or structurally concerning): Requires chronic toxicity and carcinogenicity studies, typically two-year feeding studies in two species (usually rats and mice), plus developmental and reproductive toxicity studies.

3. ADI calculation. From the toxicological data, the FDA determines a No Observed Adverse Effect Level (NOAEL), which is the highest dose at which no adverse effects are seen in test animals. The NOAEL is then divided by a safety factor, typically 100 (10 for interspecies variation and 10 for intraspecies variation), to establish the Acceptable Daily Intake (ADI) for humans.

4. Exposure assessment. The FDA estimates how much of the additive consumers are likely to ingest, considering the intended use level, the types of food it will be added to, and consumption patterns from dietary surveys such as NHANES (National Health and Nutrition Examination Survey).

5. FDA review and regulation. If the FDA determines the additive is safe at the intended use level, it publishes a regulation in the Code of Federal Regulations (21 CFR) specifying the conditions under which the additive can be used, including maximum levels, permitted food categories, and labeling requirements. This process typically takes one to two years but can take longer.

The GRAS Pathway: Efficiency or Loophole?

The GRAS concept was originally designed for substances with a long history of safe use before 1958, such as vinegar, salt, and baking soda. These substances were "grandfathered in" because requiring formal petitions for them would have been impractical and unnecessary. The law defined GRAS as requiring "general recognition" of safety among qualified experts, based on either scientific procedures or common use in food before 1958.

Over time, however, GRAS has evolved into a pathway through which thousands of new substances have entered the food supply with limited or no FDA oversight. Here is how the modern GRAS process works:

Self-determination. A company convenes a panel of experts (typically toxicologists and food scientists) to review safety data and determine whether a substance is GRAS for its intended use. If the panel concludes that it is, the company can begin using the substance in food immediately, with no FDA notification required.

Voluntary GRAS notification. Since 1997, the FDA has operated a voluntary notification program. Companies can submit a GRAS notice to the FDA, which reviews the submission and responds with a letter stating either that it has "no questions" about the GRAS determination or that the notice did not provide a sufficient basis for a GRAS conclusion. Importantly, "no questions" is not an approval; it simply means the FDA did not object based on the information provided.

The scale of the issue is significant. A 2022 analysis by the Environmental Defense Fund found that approximately 99% of new food chemicals introduced between 2000 and 2022 entered the market through the GRAS pathway rather than through formal FDA review. The Government Accountability Office (GAO) has issued multiple reports criticizing the GRAS system, noting that the FDA lacks a comprehensive list of all GRAS substances in use and has no systematic process for re-evaluating their safety as new scientific evidence emerges.

Post-Market Surveillance

Once a food additive is on the market, the FDA can take action if new evidence indicates it is unsafe. The agency can revoke a regulation, withdraw a GRAS determination, or take enforcement action against adulterated products. However, the FDA's post-market surveillance capabilities are limited by funding and staffing constraints.

The most significant recent post-market action is the FDA's January 2025 revocation of the authorization for Red 3 (Erythrosine, E127). Red 3 had been approved for decades, but the FDA ultimately acted on evidence that it causes cancer in laboratory animals, invoking the Delaney Clause, a provision of the 1958 amendment that prohibits the approval of any food additive shown to cause cancer in humans or animals. The ban gives manufacturers until January 2027 (food) and January 2028 (ingested drugs) to reformulate. Track the full list of regulatory actions on our banned additives page.

How the FDA Process Compares to the EU (EFSA)

The European Food Safety Authority (EFSA) takes a fundamentally different approach in several key areas:

Pre-market authorization is mandatory. There is no GRAS equivalent in the EU. Every food additive must be explicitly authorized through EU Regulation (EC) No 1333/2008 before it can be used in food.
Systematic re-evaluation. EFSA is conducting a systematic re-evaluation of all food additives that were authorized before 2009. This program, mandated by EU regulation, has already led to the ban of titanium dioxide (E171) in 2022 and revised ADIs for several other additives. The FDA has no comparable systematic review program.
Precautionary principle. The EU can restrict or ban an additive when there is scientific uncertainty about its safety, even before definitive proof of harm exists. The US system generally requires stronger evidence of actual harm before taking action.
Transparency. EFSA publishes complete risk assessments, including the underlying data, as part of its commitment to transparency under Regulation (EU) 2019/1381. FDA safety reviews for food additive petitions are published, but the data underlying GRAS determinations is often proprietary and not publicly available.

Recent FDA Actions and What They Signal

The FDA has shown increased activity on food additive safety in recent years, reflecting growing public and Congressional pressure:

Red 3 ban (January 2025): The first color additive delisting in decades, affecting approximately 3,000 food products.
Brominated vegetable oil (BVO) ban (July 2024): After decades of use in citrus-flavored beverages, the FDA revoked BVO's authorization based on thyroid toxicity studies. Most major manufacturers had already removed it voluntarily.
PFAS investigations: The FDA has been working with manufacturers to voluntarily phase out per- and polyfluoroalkyl substances (PFAS) from food packaging, including grease-resistant paper and paperboard. By 2024, the FDA announced that all known PFAS-containing food contact materials had been voluntarily removed from the market.
GRAS reform proposals: The FDA has acknowledged the need for GRAS reform and has proposed, though not yet implemented, mandatory notification requirements and enhanced post-market monitoring.

For a comprehensive view of which additives are banned or restricted in different countries, visit our regulation comparison pages.

What This Means for Consumers

The FDA approval process provides a meaningful baseline of safety for food additives, particularly those that have gone through the formal petition process. However, the GRAS system means that some substances in your food have never been independently reviewed by the FDA. This does not automatically make them unsafe, but it does mean the level of regulatory scrutiny varies significantly from one additive to another.

Consumers who want to make informed choices should:

Use tools like our Ingredient Analyzer to quickly check the safety profile and regulatory status of additives in their food.
Pay attention to FDA announcements and regulatory changes, which often signal emerging safety concerns.
Recognize that "FDA approved" and "GRAS" represent different levels of review, and understand the distinction.
Support advocacy for stronger post-market surveillance and GRAS reform, if these are issues that matter to you.

Written by the AdditiveChecker Editorial Team. Last reviewed May 2026.