How Many Food Additives Are Currently Approved in the U.S. by the FDA?

December 9, 2025 •

3 min read

According to reports, over 10,000 chemicals and additives are allowed in the United States food supply, but the number of substances formally approved by the FDA is a much smaller subset. This complexity makes understanding how many food additives are currently approved in the U.S. by the FDA a nuanced task, requiring an understanding of the formal approval process and the "Generally Recognized as Safe" (GRAS) exemption.

Quick Summary

The FDA regulates food additives through a dual system, which includes both formally approved substances and a separate, more flexible Generally Recognized as Safe (GRAS) category.

Key Points

Dual Regulatory System: The FDA uses two primary pathways for regulating substances in food: a mandatory pre-market approval process for food additives and a separate exemption for Generally Recognized as Safe (GRAS) substances.
No Single Number: There is no definitive, single count of all food additives because thousands of GRAS substances can be self-affirmed by manufacturers without mandatory FDA notification.
Varying Oversight: The level of FDA oversight differs significantly; formally approved additives undergo rigorous FDA review, while many GRAS substances rely on the manufacturer's own expert safety assessments.
Limited Re-evaluation: Unlike the European system, the FDA has no legal mandate for a systematic re-evaluation of all food chemicals, meaning some additives cleared decades ago may not have recent scrutiny.
GRAS Transparency Issues: The self-affirmed GRAS process has been criticized for a lack of public transparency and oversight, as manufacturers are not required to inform the FDA.
Inventories Are Not Comprehensive: The FDA's public lists, such as the GRAS Notice Inventory and the EAFUS list, only cover specific subsets and do not reflect the total number of all substances in use.

The question of how many food additives are currently approved in the U.S. by the FDA is not a simple one, as the answer involves navigating a complex regulatory landscape that includes more than just formal approvals. The U.S. food supply contains thousands of substances, governed by a two-tiered system under the Federal Food, Drug, and Cosmetic (FD&C) Act. A substance is either a food additive requiring specific pre-market approval from the FDA, or it is Generally Recognized as Safe (GRAS) and exempt from that process. This distinction is crucial to understanding the full scope of substances used in food.

The Two-Tiered System of Food Substances

The U.S. regulatory framework was established by the Food Additives Amendment of 1958, creating two primary pathways for substances in food: the food additive petition (FAP) and the Generally Recognized as Safe (GRAS) designation. Substances widely recognized as safe before 1958, like salt and sugar, were exempted based on their history of use.

Formally Approved Food Additives

For substances not considered GRAS, manufacturers must submit a Food Additive Petition (FAP) to the FDA with scientific evidence of safety under intended use conditions. The FDA reviews this data, including chemistry, toxicology, and environmental evaluations. Approval results in a regulation in the Code of Federal Regulations (CFR) specifying conditions of use.

Generally Recognized as Safe (GRAS) Substances

GRAS substances are exempt from the formal pre-market approval because qualified experts consider them safe. Companies can self-affirm GRAS status based on expert review, or they can voluntarily notify the FDA, which then reviews the data. Self-affirmed GRAS does not require FDA notification, leading to less public oversight compared to the FDA-notified pathway or formal additive approval. This lack of transparency for self-affirmed substances has drawn criticism, as many chemicals have entered the food supply through this less-regulated route.

The Petition Process: What the FDA Considers

The FAP process requires manufacturers to provide detailed scientific evidence. The FDA reviews several key elements, such as the additive's identity, manufacturing process, proposed uses and levels, safety data, intended technical effect, and potential environmental impact.

A Comparison of Regulatory Pathways

The difference in regulatory oversight between the FAP and GRAS processes makes quantifying the number of additives complex. The table below highlights key distinctions:


Feature	Formally Approved (FAP)	Generally Recognized as Safe (GRAS)
Approval Process	Mandatory pre-market review and approval by the FDA.	Exempt from pre-market approval; relies on expert consensus.
Oversight Level	FDA conducts a thorough, publicly documented review culminating in a regulation.	Can be self-affirmed by manufacturers with or without notifying the FDA.
Basis for Safety	Robust scientific evidence submitted directly to the FDA.	Can be based on publicly available scientific evidence or a history of safe use before 1958.
Transparency	Public regulation detailing the conditions of use is published in the CFR.	FDA posts its "no questions" letters for notified substances; self-affirmed status can remain confidential.

Counting the Additives: Why the Number is Not Simple

The precise count of all U.S. food additives is unclear because the often-cited figure of over 10,000 substances includes those in the GRAS category, many without recent FDA review. This includes numerous flavorings and substances with long histories of use. While the FDA maintains public lists for formally approved additives (like the EAFUS list) and notified GRAS substances, these do not include the thousands of self-affirmed GRAS substances not voluntarily submitted to the FDA. The absence of a single, comprehensive list makes a definitive total impossible. Furthermore, unlike the EU, the U.S. has no legal requirement for the FDA to regularly re-evaluate the safety of all food chemicals.

Conclusion: Navigating a Complex System

Ultimately, there is no single figure for how many food additives are currently approved in the U.S. by the FDA due to the agency's dual regulatory pathways: mandatory formal approval and the GRAS exemption. The GRAS system, particularly self-affirmation, allows manufacturers significant flexibility, leading to a much higher number of substances in food than those formally approved. Understanding this system is crucial for consumers. The FDA's official GRAS notice inventory provides more information on substances notified to the agency. For more information on the GRAS system, the FDA maintains an official GRAS notice inventory of substances notified to the agency.

Frequently Asked Questions

A food additive is a substance that must undergo mandatory pre-market review and approval by the FDA before it can be used in food. A Generally Recognized as Safe (GRAS) substance is exempt from this requirement because it is deemed safe by qualified experts based on scientific procedures or a history of safe use.

No, the FDA does not approve GRAS substances. Manufacturers can voluntarily notify the FDA of a GRAS determination, and the FDA will respond with a letter, but this is not a formal approval process. Many GRAS determinations are not even submitted to the FDA.

The difficulty arises because thousands of substances are classified as GRAS, and manufacturers are not required to inform the FDA of a self-affirmed GRAS determination. This means there is no single, comprehensive, publicly available list of every substance added to food in the U.S..

A FAP is a formal request submitted to the FDA by a manufacturer seeking approval to use a new food additive or a new use for an existing one. It must include extensive safety data and is subject to a rigorous FDA review process.

Color additives have a separate, mandatory pre-market review and approval process and are not subject to the GRAS exemption. This means their use is strictly regulated and listed by the FDA.

Prior-sanctioned substances are those that were approved for use by the FDA or the U.S. Department of Agriculture before the 1958 Food Additives Amendment. They are exempt from the food additive definition, with examples including sodium nitrite and potassium nitrite.

The FDA is not legally mandated to regularly re-evaluate all food chemicals, many of which were approved or grandfathered in decades ago. Periodic re-evaluations, like the recent one for bisphenol-A (BPA), often occur in response to new scientific evidence or public petitions.