The robust science-based framework established by Congress for regulating food and color additives is encountering significant challenges. Concerns about these additives, first raised by advocacy groups, have been picked up by state legislatures. These concerns have been further amplified by the Make America Healthy Again (MAHA) movement and U.S. Health and Human Services (HHS) Secretary Kennedy. As a result, a patchwork of additive standards and requirements is emerging, complicating compliance for food companies and increasing regulatory and litigation risks.
The U.S. is at a critical juncture where food manufacturers are losing the ability to make and distribute foods in a national market that uniformly regulates their products.
I. History of Food and Color Additive Regulation
Food (but not Color) Additives
In 1958, Congress enacted the Food Additives Amendment (FAA) to the Federal Food Drug and Cosmetic Act (FD&C Act). These amendments required that FDA preapprove a “food additive” (on its own initiative or via a submitted Food Additive Petition) before it may be used in food. The sole exception to this preapproval is for “[s]ubstances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food before January 1, 1958, through experience based on common use in food) to be safe under the conditions of their intended use.” These GRAS substances are outside the food additive pre-approval requirements.
In 1972, FDA established a process allowing manufacturers to petition for GRAS affirmation for substances not already reviewed by the agency. In 1997, the agency proposed replacing the GRAS affirmation petition process with a voluntary notification procedure, aiming to make the process more efficient.
In 2016, FDA published the “Generally Recognized as Safe (GRAS) Final Rule” to amend and clarify “the criteria in [FDA] regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements …because the substance is …GRAS under the conditions of its intended use.” Consistent with the FD&C Act, FDA set out in the Final Rule that GRAS substances are excluded from the definition of food additives because they meet the scientific standards to demonstrate safety. The Final Rule also replaced the voluntary GRAS affirmation petition process with a voluntary notification procedure, allowing stakeholders to voluntarily notify the FDA of a substance’s GRAS status.
Color Additives Must Be Approved
Importantly, this GRAS process is not available for color additives. Under § 721 of the FD&C Act, all color additives, except those derived from plant or mineral sources, must obtain FDA’s pre-approval before they can be used in foods as well as drugs, cosmetics, and medical devices. Additionally, for many such substances, including, FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Orange B, Yellow No. 5, Yellow No. 6, and previously Red No. 3, FDA must approve each batch (otherwise known as “batch certification”) before it may be used in foods.
II. Where We Are Now and How We Got Here
Despite this rigorous oversight, advocacy groups and social media influencers have attacked the safety of food and color additives. Their efforts led to the passage of, which banned three food additives (brominated vegetable oil (BVO), potassium bromate, and propylparaben) and one color additive (Red Dye No. 3). With success in California, the effort to ban FDA-approved ingredients has spread. Currently, over 80 bills are pending in approximately 27 states to ban, limit, or regulate the sale of various food and color additives and the products that rely on them. These state bills have created a wildly inconsistent and conflicting patchwork that has destroyed the ability to make and distribute affordable food in a single, national market.
How did we get here?
The reasons for this swift unraveling of a national, uniform food market are many. Distrust of FDA and the food industry, slow action by a resource-constrained FDA to conduct post-market assessments, and the rise of popular social media influencers with poor scientific literacy are all factors. Disinformation and unrefuted falsehoods have also contributed significantly (discussed more below).
There is also a widespread belief that a GRAS “loophole” allows manufacturers to “hide” behind self-affirmed GRAS determinations when they should be obtaining FDA pre-approval for all their ingredients. However, the primary reason the industry uses GRAS is not to bypass post-market approval or introduce unsafe additives, but because the agency, even with its best intentions, lacks the resources to review every pre-market petition. Furthermore, Congress did not impose transparency requirements, such as notifying the FDA or listing ingredients. Manufacturers may also be concerned with disclosing proprietary information in a self-affirmed GRAS notification.
Countering Common Misperceptions and Falsehoods
There are cogent responses to the misinformation that has fueled many of the state ingredient bans. Below we provide several examples:
- Assertion: Synthetic dyes are not permitted in the EU.
- FACT: There are 15 synthetic food dyes approved in the EU, including Red No. 3, now banned in the U.S. In contrast, FDA only permits 9 synthetic food dyes in U.S. foods.
- Assertion: Red. No. 3 is unsafe and causes cancer in humans.
- FACT: FDA delisted Red No. 3 due to an antiquated provision of the FD&C Act called the Delaney Clause, which does not consider actual exposures from a substance or risks to human health. The Delaney Clause has been described as outdated and inconsistent with science since the early 1980s. FDA found Red No. 3 complied with its general safety standard that there is a “reasonable certainty of no harm.” FDA further explained that the cancer was observed only in male laboratory rats, via a hormonal mechanism that does not occur in humans. The EU still permits Red No. 3.
- Assertion: There are 10,000 additives used in the US, and only 400 are used in the EU.
- FACT: While it is true that there are 400 approved food and color additives in the EU, the vast majority of EU food additives are used in food without regulatory approval. There are an estimated 9,000 additives used in foods in the EU.
- Assertion: FDA does not conduct meaningful reviews of food and color additives.
- FACT: FDA has conducted post-market safety assessments of ingredients, including BVO and Red Dye No. 3.) and when concerns are otherwise raised (e.g., by international bodies).
- Assertion: Color additives can be used in food if a manufacturer self-affirms it as GRAS.
- FACT: No. Under the FD&C Act all color additives and new uses for listed color additives must be approved by the FDA before they may be used in foods. FDA also certifies each batch of synthetic color additives, including FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 40, Yellow No. 5, and Yellow No. 6.
- Assertion: The GRAS “loophole” means there is no FDA oversight of ingredients manufacturers have self-affirmed as GRAS.
- FACT: The standards for self-affirming a substance as GRAS are rigorous and the same as for any additive submitted to FDA for approval. The manufacturer must be able to demonstrate through scientific procedures that the ingredient is safeunder the conditions of its intended use. FDA inspections, findings, and enforcement have not shown that manufacturers are abusing the GRAS self-affirmed process and failing to make the requisite safety demonstrations.
Unless law and policymakers begin heeding the misinformation that largely supports these efforts, we do not expect to see state bans of FDA-approved ingredients slowing down. Pressure is building at the federal level as well. Secretary Kennedy is applauding states for these bans. He appeared in West Virginia to commemorate Governor Morrisey’s signing of HB 2354, which bans Blue Dye No. 1, Blue Dye No. 2, Green Dye No. 3, Red Dye No. 3, Red Dye No. 40, Yellow Dye No. 5, Yellow Dye No. 6 by August 1, 2025, in school nutrition program meals specifically, and by January 1, 2027, more broadly. Secretary Kennedy has committed to the removal of all synthetic color additives in food, and FDA could potentially move to revoke the regulations permitting their use. Last month, Secretary Kennedy also directed FDA to explore “eliminating” the GRAS Notification Rule and the “self-affirmed GRAS pathway.”
It is important to keep in mind that there are guardrails around any FDA effort to revoke or amend a color additive regulation or the GRAS Rule. To revoke or amend a rule, FDA would have to comply with the Administrative Procedure Act (APA) and its own regulations. The agency would have to issue a notice proposing to amend or rescind a rule, solicit comments, and, in the final action, articulate a reasoned, scientific basis for the rescission or amendment of the rule. If FDA does not have a sound scientific basis, its decision can be challenged as arbitrary and capricious.
The agency may face additional legal impediments if it seeks to alter the current GRAS process. Congress established the GRAS category and exempted GRAS substances from the petition process in the 1958 Food Additives Amendment to the FD&C Act. Congress did not include in the FD&C Act any requirement for notification or any submission to FDA for these GRAS substances. If FDA seeks to impose such a notification requirement or to eliminate the GRAS process, it may be exceeding its statutory authority.
Of course, the APA and the promise of an ordered federal rulemaking process offer little relief in the short term for food companies faced with this patchwork of state ingredient bans. Manufacturers who have made and marketed safe and economical foods for decades that Americans have enjoyed are facing enormous compliance and operational challenges. While various legal arguments might be made to counter these bans, mounting such a defense is difficult and costly. If a manufacturer wishes to continue to market on a national basis, it must conform to each of these wildly different bans. This means sourcing new ingredients to replace banned ones; testing and reformulating products and changing packaging and labeling – all at significant cost and without disappointing loyal consumers.
Ultimately, relief may have to come from Congress in the form of new legislation. Members have proposed to amend the GRAS process for many years. Should this reform move forward, Congress will need to grapple with numerous issues, including enhancing transparency, protecting confidential trade secrets, and assuring adequate resources for FDA to conduct any required reviews. Additionally, we believe that any heightened GRAS processes must be balanced against federal preemption of conflicting state ingredient bans and Delaney Clause reform.
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OFW Law continues to monitor these developments. We are committed to keeping our clients informed and to vigorously advocating on your behalf. We will continue to defend your license and ability to operate, challenge rulemaking that is not supported by evidence or contrary to law, and will address proposed rescissions or amendments of rules as they arise, in accordance with established case law under the APA.
