Red Dye 40: Is It Safe? What the FDA's Review Actually Found

The average American eats approximately 3–5 pounds of food additives every year. Most of those additives were never formally reviewed by the FDA — they were self-certified as safe by the companies that profit from using them.

That's not a conspiracy theory. That's the GRAS system, and it's been operating this way for decades.

The MAHA movement has put FDA food ingredient safety at the center of its health agenda. For the first time in years, there's real political momentum behind reforms that food safety advocates have been requesting for decades. Some specific ingredients are being reviewed or removed. The underlying system that allowed them in is also under examination.

Here's the complete breakdown: how food ingredients get approved, which ones are under review, and how the MAHA movement is actually moving the needle.

How Food Ingredients Get Into Your Food (The GRAS Problem)

Understanding food ingredient policy requires understanding the General Recognition as Safe (GRAS) designation — because it explains how thousands of ingredients are in the food supply with little to no independent federal review.

The Origin Story: 1958

The GRAS concept was created as part of the Food Additives Amendment of 1958. Congress recognized that requiring full pre-market approval for substances like salt, vinegar, and baking powder would be absurd. So they created an exemption: substances with a long history of safe use, or substances that the scientific community generally recognized as safe based on adequate evidence, could be used without going through the full food additive approval process.

The logic was sound. The implementation has not been.

What GRAS Became

Over decades, the GRAS designation evolved far beyond its original intent. The key problem: companies discovered they could self-certify novel ingredients as GRAS without ever notifying the FDA.

How it works:

1. A company develops a new ingredient or finds a new use for an existing one
2. The company convenes an expert panel — typically paid by the company — to review safety data
3. If the panel concludes the ingredient is GRAS, the company can use it immediately
4. The company may (voluntarily) notify FDA of its GRAS determination, but is not required to
5. FDA may (if it chooses) review the notification and respond — but its response is advisory, not mandatory

The result: an unknown number of food ingredients are in the U.S. food supply with no FDA review of any kind. The FDA itself has acknowledged it doesn't know how many ingredients are in food because voluntary notification is not comprehensive.

The Government Accountability Office documented these problems in 2010, 2015, and subsequent reports. Nothing changed.

The Scale of the Problem

The FDA has formally approved approximately 700 food additives. The GRAS list includes thousands more. And an unknown number of ingredients are in use under company self-certification that was never notified to FDA at all.

Environmental Defense Fund researchers in 2014 estimated that only about 38.5% of GRAS notifications received between 1997 and 2012 were for clearly new ingredients — meaning the majority were for existing uses or modifications. But without mandatory disclosure, the picture is necessarily incomplete.

📖 Related: The regulatory context expands with The Case for Ancestral Health Policy in Modern America, Federal Health Policy for Citizens: What You Need to Know, and The Gut-Brain-Fitness Connection: Why Gut Health Drives Performance.

Ingredients Under Scrutiny: What's Actually Being Reviewed

Already Acted On

Red Dye No. 3 (Erythrosine): The FDA's January 2025 revocation of Red Dye No. 3 in food is the most concrete recent action. Red 3 had been banned from cosmetics since 1990 because studies showed it caused thyroid tumors in male rats — a clear carcinogen signal under the Delaney Clause (which requires FDA to reject additives shown to cause cancer in humans or animals). Yet it remained in food — including maraschino cherries and certain candies — for 35 more years.

This is exactly the type of regulatory inconsistency the MAHA movement has highlighted. Red 3's food ban came under the current administration's political momentum but was legally required under existing statute for decades.

Brominated Vegetable Oil (BVO): FDA finalized the revocation of BVO's food use authorization in July 2024. BVO — used as an emulsifier in citrus-flavored drinks — had been under a "temporary" provisional authorization since 1970 that was never converted to permanent because safety concerns were never resolved. It was finally removed after 54 years of provisional use.

Potassium Bromate: Under review. This bread-dough conditioner has been banned in the EU, Canada, and many other countries due to carcinogenicity concerns. The FDA has been reviewing it for years without formal action; the current administration has signaled accelerated review.

Currently Under Heightened Review

Synthetic Food Dyes: The broader class of synthetic petroleum-derived food dyes is under review beyond Red 3. The list the MAHA movement has highlighted includes:

The ADHD-behavior link for some of these dyes has been studied for decades with mixed results. A 2007 Southampton study published in The Lancet found that a mixture of food dyes plus sodium benzoate was associated with increased hyperactivity in children — a finding that led the EU to require warning labels. The FDA reviewed the same data and concluded it didn't warrant regulatory action, a decision that has been contested by pediatric health advocates since.

PFAS in Food Packaging: Per- and polyfluoroalkyl substances (PFAS) — the "forever chemicals" — appear in grease-resistant food packaging (fast food wrappers, microwave popcorn bags, takeout containers). The FDA has been negotiating voluntary phase-outs with industry, but formal regulatory action has lagged behind the science. The MAHA movement has elevated this issue.

Titanium Dioxide: Permitted in the U.S. as a food whitening agent but banned as a food additive in the EU since 2022 based on genotoxicity concerns. Under MAHA movement pressure, U.S. review is accelerating.

The GRAS Ingredients the MAHA Movement Has Named

The MAHA movement — through public statements, advocacy documents, and Kennedy's HHS communications — has identified additional ingredients for scrutiny:

• Carrageenan: A seaweed-derived thickener in dairy products and dairy alternatives, linked by some research to gut inflammation and IBS-type symptoms. FDA consumer research has been ongoing.
• Propylparaben: A preservative found in some baked goods, with concerns about endocrine-disrupting properties. Already banned in EU food.
• Sodium nitrate/nitrite: Used in processed meats; linked to colorectal cancer risk in multiple studies. Already subject to some restrictions; under continued review.
• Artificial trans fats: Already banned in U.S. (PHOs revoked in 2018) — a prior success for food safety advocates that MAHA advocates cite as a model.

How the MAHA Movement Has Changed the Policy Environment

Even before formal regulatory actions, the MAHA movement has shifted the policy environment in measurable ways:

Voluntary Reformulation

Food companies are reformulating products ahead of regulatory action. This is how the food industry typically responds to regulatory risk — changing formulations quietly rather than waiting for formal bans that create news cycles.

Examples already in motion:

• Several beverage companies removed BVO before the formal ban
• Kellogg's and General Mills reformulated some cereals to remove artificial dyes following retail pressure
• McDonald's committed to removing certain additives from U.S. products in 2025

Increased Research Attention

Scientific journals have published more nutrition science examining specific additives and the GRAS system in 2024–2025 than in the prior five years combined. Political attention drives research funding attention, which drives publication.

Consumer Label Reading

The most immediate practical effect of the MAHA movement may be consumer behavior. Google searches for specific food ingredients — carrageenan, Red 40, BVO, titanium dioxide — have increased substantially as the policy conversation has raised mainstream awareness.

Consumers who read labels and make purchasing decisions based on ingredient content are a market signal that companies respond to faster than regulators.

What You Can Actually Do About Your Food

You don't have to wait for regulators to act. Here's the practical framework:

Read ingredient labels. The front of the package is marketing. The ingredient list is the product.

Minimize ultra-processed foods. The GRAS problem is concentrated in ultra-processed foods. A diet centered on whole, minimally processed foods automatically reduces exposure to most of the ingredients under review.

Use ingredient checker resources. The Environmental Working Group's Food Scores database (ewg.org/foodscores) and the Open Food Facts database allow ingredient-level research on specific products, though treat advocacy-oriented sources with appropriate skepticism.

Submit public comments. When FDA opens formal dockets on specific ingredients, citizen comments are accepted and must be reviewed.

📖 Related: What to eat instead is covered in Federal Health Policy for Citizens: What You Need to Know and The Gut-Brain-Fitness Connection: Why Gut Health Drives Performance.

Frequently Asked Questions

Q: How does the FDA decide an ingredient is safe enough to approve? A: For formal food additive approval, FDA requires a demonstration of "reasonable certainty of no harm" under intended conditions of use, based on scientific evidence the petitioner submits. For GRAS, the same standard applies but is evaluated by the manufacturer's experts — not FDA scientists — unless FDA chooses to conduct its own review of a voluntary notification.

Q: Why does the U.S. allow ingredients banned in Europe? A: Different regulatory philosophies and different risk assessment standards. The EU applies more of a precautionary principle — ingredients are restricted when significant safety concerns exist even without conclusive proof of harm. The U.S. FDA applies a "reasonable certainty of no harm" standard and has historically required stronger evidence of harm before acting. Different politics, lobbying landscapes, and consumer cultures also factor in.

Q: Are food additives actually making people sick? A: This is contested. Specific additives have specific evidence of harm at specific exposure levels. The cumulative effect of exposure to hundreds of additives simultaneously — the real dietary environment — is almost completely unstudied. The strongest evidence is for carcinogenic risk of specific compounds (Red 3, some nitrites) and for ultra-processed food consumption as a pattern (rather than any single additive) driving metabolic health outcomes.

Q: Is organic food free of these additives? A: USDA Certified Organic prohibits synthetic food additives, including most synthetic dyes, preservatives, and flavor enhancers. It's not a guarantee of zero additive exposure — some natural additives (carrageenan, for example) have been debated within organic standards. But it substantially reduces exposure to the synthetic additive categories under review.

The Bottom Line

The GRAS system is a real problem that food safety advocates have documented for decades. The MAHA movement has given that advocacy political momentum in a way it hasn't had before.

Real actions are happening — Red 3 revoked, BVO gone, other ingredients under formal review. The pace is slow relative to the rhetoric, as it always is in regulatory systems designed to withstand legal challenge.

The most immediate practical impact is a changed food culture — more label reading, more voluntary reformulation, more consumer awareness — that precedes and often exceeds what formal regulation achieves.

Eat whole foods. Read labels. Submit comments. In that order.

→ [How FDA food policy is changing under the new administration → /fda-food-policy-changes] → [USDA dietary guidelines: what's changing → /usda-dietary-guidelines]

This article is citizen journalism and policy commentary. It does not constitute health advice. For official FDA information on food additives, visit fda.gov/food.