Why the FDA has never looked at some of the additives in our food

December 8, 2025 •

4 min read

According to the Environmental Working Group (EWG), an estimated 3,000 chemicals that have never been scrutinized by the FDA appear in food today. This astonishing figure reveals a systemic issue rooted in regulatory failures and industry self-policing, leaving many to wonder why the FDA has never looked at some of the additives in our food.

Quick Summary

The FDA's failure to review certain food additives stems from the GRAS loophole, which allows companies to self-certify ingredients as safe, bypassing mandatory pre-market approval and undermining robust federal oversight.

Key Points

The GRAS Loophole: An exemption created in 1958 for "Generally Recognized As Safe" (GRAS) substances allows companies to bypass the FDA's pre-market approval process.
Voluntary Self-Policing: Since 1997, a voluntary notification system has enabled companies to declare ingredients as GRAS based on their own expert reviews, without mandatory FDA oversight.
Secret Ingredients: The "secret GRAS" pathway allows companies to add substances to food without ever notifying the FDA, concealing these additives from both the public and regulators.
Industry Conflict of Interest: The self-affirmation process creates an inherent conflict of interest, where companies profiting from an ingredient are also responsible for its safety assessment.
Stricter European Regulation: The European Food Safety Authority (EFSA) operates with a more precautionary, hazard-based approach, resulting in the ban of many additives still permitted in the U.S.
Calls for Reform: Recent health incidents and legislative efforts in states like California, as well as new directives from the U.S. Department of Health and Human Services, are pushing for the reform or elimination of the self-affirmed GRAS pathway.

The Origins of the GRAS Loophole

The story of why the FDA has never looked at some of the additives in our food begins with a 1958 law. The Food Additive Amendment to the Federal Food, Drug, and Cosmetic Act was intended to ensure new additives were safe before entering the market. However, it included a critical exemption for substances "Generally Recognized As Safe" (GRAS), such as vinegar, salt, and baking soda. This was meant as a commonsense rule for ingredients with a long history of safe use. The statute stated that for a substance to be GRAS, it must be recognized as safe "among experts qualified by scientific training and experience". Congress left it up to the FDA to provide specific details on how this recognition should be carried out.

The Shift to Voluntary Notification

What was once a narrow exemption was exploited over decades. In 1997, the FDA formalized a voluntary notification system that fundamentally weakened its oversight. Under this system, companies could hire their own experts to declare an ingredient as GRAS, informing the FDA only if they chose to. The notification was not mandatory, and the FDA had a limited window to respond. Even if the FDA raised questions, a company could simply withdraw its notice and continue to use the ingredient, with the public and the FDA largely unaware. This voluntary system created what critics call the "secret GRAS" pathway, where thousands of ingredients have entered the food supply with little to no independent federal review.

The Problem of Self-Policing

The voluntary GRAS system introduces an inherent conflict of interest. When companies, or experts they fund, are solely responsible for determining an ingredient's safety, the incentive structure is skewed. An analysis by the Environmental Working Group (EWG) found that since 2000, nearly 99% of new food chemicals were introduced via the GRAS loophole or voluntary process, not the traditional, more rigorous food additive petition. The flavor industry, in particular, has widely exploited this loophole, hiding potentially untested GRAS substances behind generic terms like "natural flavor" or "artificial flavor".

Comparison: FDA vs. EFSA Approaches

The stark differences between the U.S. and European food safety systems highlight the issues with the FDA's approach.


Feature	U.S. Food and Drug Administration (FDA)	European Food Safety Authority (EFSA)
Core Philosophy	Risk-based: Focuses on the likelihood of harm under specific use conditions.	Hazard-based: Focuses on the inherent potential of a substance to cause harm, leading to stricter bans.
Pre-market Review	Required for most food additives, but bypassed by GRAS. GRAS is largely self-policed via a voluntary notification process.	Required for all new food additives. Uses a more comprehensive, centralized process.
Transparency	Public notification for full petitions and voluntary GRAS notices, but secret GRAS determinations are not disclosed.	Emphasizes transparency, with public consultations and published scientific opinions.
Number of Chemicals	Allows thousands of chemicals, with thousands never federally reviewed.	Allows a significantly smaller number of chemicals (~400 in contrast to thousands).
Re-evaluation	Insufficient resources and lack of mandate to re-evaluate many older substances.	Periodically re-evaluates all authorized additives based on new science.

Recent Calls for Reform and Action

Public outrage and adverse health events linked to unreviewed ingredients have intensified calls for change. In 2022, a food product containing tara flour, an ingredient that may have been a "secret GRAS" addition, was linked to a severe illness outbreak. This and similar events have galvanized legislative efforts. Some states, like California, have banned certain chemicals allowed in the U.S. but prohibited in Europe, forcing ingredient reform. On the federal level, in March 2025, the U.S. Department of Health and Human Services directed the FDA to explore changes to the GRAS system, specifically eliminating the "self-affirmed GRAS" pathway. This marks a potential shift toward greater oversight, though the process is slow and complex.

Conclusion: The Path Forward

The fundamental reason why the FDA has never looked at some of the additives in our food is the regulatory gap created by the GRAS provision. What began as a practical exemption for common ingredients became a systemic loophole for the food industry to circumvent safety scrutiny. The public and regulators are often left in the dark about potentially thousands of chemicals added to the food supply. While consumer awareness and recent governmental pressures are pushing for change, meaningful reform requires a federal mandate to close the loopholes that prioritize corporate convenience over consumer protection. Until the voluntary notification system is eliminated and a more robust, mandatory pre-market review is universally applied, the question of unchecked food additives will persist. To learn more about this issue, the Center for Science in the Public Interest provides additional resources on their website.

Frequently Asked Questions

The GRAS (Generally Recognized As Safe) loophole is a provision in the 1958 Food Additive Amendment that allows substances to be added to food without FDA pre-market approval. It was intended for common, obviously safe ingredients but has been expanded to allow companies to self-certify new chemicals as safe with minimal or no FDA review.

The 'secret GRAS' pathway is when a company determines an ingredient is GRAS and simply begins using it in food without notifying the FDA at all. Since there is no requirement to report these determinations, the ingredient can enter the food supply without any federal oversight.

In 1997, the FDA formalized the voluntary GRAS notification system as a way to manage the large number of GRAS substances. However, critics argue this move, combined with limited funding and resources, effectively handed control of many ingredient safety assessments to the food industry.

Yes. The flavor industry frequently utilizes the GRAS loophole. Many GRAS substances, which may or may not have been reviewed by the FDA, can be included under vague labeling terms like "natural flavor" or "artificial flavor," further obscuring them from public knowledge.

The U.S. system (FDA) is largely risk-based and relies heavily on industry self-policing via the GRAS process. The European system (EFSA) is more precautionary and hazard-based, requiring mandatory pre-market approval and periodic re-evaluation for all additives, resulting in a much smaller list of permitted chemicals.

Since 2000, nearly 99% of new food chemicals have entered the market through the GRAS process. This includes substances that were later identified as potentially harmful, such as propyl paraben and EGCG, which were self-designated by companies. Tara flour is another recent example that was implicated in a widespread illness outbreak.

The lack of robust federal oversight can result in potentially untested or unsafe chemicals entering the food supply, with potential long-term health risks such as cancer, infertility, and behavioral disorders. Consumers and regulators may be left unaware of these risks until adverse health events occur.