Registrar Corp expert: How MAHA food regulation policies are reshaping the US food industry

The US regulatory F&B landscape is tightening up as Robert Kennedy Jr.’s policies crack down on synthetic food dyes, additives, artificial colorings, and more. Food companies are responding to tougher regulations governing ingredient formulations and making pledges to eliminate certain ingredients as part of the “Make America Healthy Again” initiative. Meanwhile, Kennedy is also revising how GRAS (Generally Recognized As Safe) will work going forward.

Several big-name food firms and manufacturers have already made a series of commitments to eliminate, reduce, or eradicate certain food dyes. Last week, the US FDA released an updated list of companies and what they have done so far with regard to phasing out petroleum-based food dyes (certified color additives) from the US food supply.

Earlier this year, the FDA revoked the authorization for FD&C Red No. 3, and the agency is taking action to swiftly remove the color additive regulations that allow for the use of Orange B and Citrus Red No. 2. At the same time, food regulation experts are watching closely to see Kennedy’s next move on GRAS. 

What does the future hold for GRAS?

Anna Benevente, director of Product, Label & Ingredient Reviews at Registrar Corp, the global leader in FDA compliance, is an expert in food safety and regulatory affairs, with knowledge of GRAS (Generally Recognized As Safe) determinations and compliance, as well as how FDA regulations are shaping food innovation. 

She speaks to Food Ingredients First about the regulatory landscape in the US and how Kennedy is reshaping some US food policies and considering plans to eliminate the “self-affirmed GRAS” pathway, which allows companies to independently assess the safety of their ingredients.

“Kennedy’s plan to phase out the synthetic color additives is one part of an overarching intent to change the food system in the US. His stated mission is to address the root causes of chronic disease and promote wellness. During the presidential campaign, Kennedy was very vocal in his criticisms of the US food system and the ingredient approval process.”

“His concerns center on the prevalence of synthetic food additives and his stance that they are marketed without knowing whether they are safe for human consumption. Recent actions by the FDA under his leadership have made it clear that they plan to follow through on these campaign statements, and the GRAS determination process is also under scrutiny.” 

“The most groundbreaking plan (or disruptive, depending on your viewpoint) from Kennedy is the stated intent to eliminate self-affirmation as a means to establish GRAS status for an ingredient. The FDA has announced plans to explore potential rulemaking to revise the GRAS final rule and is working with Congress to explore ways legislation can close what they call the “GRAS loophole”. 

Elimination of this pathway would force companies to notify the FDA and provide data to support an ingredient’s safety. “It is not entirely clear at this point if the FDA would force companies to submit GRAS Notices, or if they would collect this information by other means.” 

“Either way, it may place additional burdens on industry and could delay the introduction of novel ingredients (also good or bad, depending on your viewpoint) into the marketplace. This could result in hundreds, if not thousands, of filings, and there is the question of FDA resources being sufficient to handle an increased workload, especially in light of recent cuts to FDA staff.” 

With the MAHA campaign gaining traction, several Republican-led states have recently been enacting laws to ban certain food additives. Regulatory influence usually is “top down” from the federal to the state level, so it is not clear if these state-level initiatives will influence FDA action.

However, Benevente anticipates that this activity will influence the industry in a meaningful way.

“With a patchwork of regulatory requirements, the industry faces increased complexity in its supply and distribution channels to ensure that noncompliant products are not inadvertently sent into the wrong state or market. Companies may be ;seeing the writing on the wall’ and determine that it is in their best interest to remove these controversial ingredients entirely, rather than risk regulatory or enforcement action due to a mistake in distribution.” 

Earlier this year, the FDA revoked the authorization for FD&C Red No. 3, and the agency is taking action to  remove the color additive regulations that allow for the use of Orange B and Citrus Red No. 2. 

Snapshot of what’s happening

Companies are stepping up and reformulating their products with alternative colors derived from natural sources and setting ambitious timelines to complete the transition.

Beginning in January 2026, Kellogg’s will not launch any new products with certified color additives, and by the end of 2027. This includes Apple Jacks, Kellogg’s Corn Flakes, Frosted Flakes, Froot Loops, and Kellogg’s Raisin Bran.

The Kraft Heinz Company pledges to eliminate certified color additives from products (Crystal Light, Kool-Aid, MiO, Jell-O, Jet-Puffed) by the end of 2027.

The J.M. Smucker Company will not sell products with certified color additives to K-12 schools by the 2026-2027 school year, and will abolish certified color additives in its Dunkin, Folgers, Jif, and Twinkies brands by the end of 2027.

The Hershey Company’s brands Brookside, Dot’s Homestyle Pretzels, Jolly Rancher, KitKat, Skinnypop, and Twizzlers will eliminate certified color additives from snacks by 2027. Mars Inc. will offer product options without certified colors starting in 2026, while Danone has committed to erasing certified color additives from its US portfolio. 

The FDA is working closely with food manufacturers, retailers, and trade associations to eliminate six remaining certified color additives frequently used in the food supply - FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2 — by the end of 2027.

Reformulation challenges

Reformulation is complicated, as it is not as simple as exchanging one additive for another. The chemical makeup of an ingredient affects product texture and integrity, and natural ingredients may be more sensitive to pH levels, temperature, light, and oxidation, flags Benevente.

“In the case of color additives, the vibrancy of the color from natural sources may not reach the intensity offered by the synthetic alternatives. Natural ingredients may also cost more, be more difficult to source, and require special handling compared to their synthetic counterparts.”

She explains that when reformulating, a company will need to be cognizant of the regulatory status of the replacement. “If the GRAS self-affirmation pathway is removed by the FDA, then companies will need to ensure that the replacement has been approved as a food additive or has a firmly established GRAS status with the FDA.” 

“Color additives always require approval, even naturally sourced colors, so a careful regulatory review must be conducted to ensure that a color replacement is approved for its intended use. Commonly used colors such as safflower extract and curcumin are not approved as color additives in the US,” she continues.

At this time, only FD&C Red No. 3, Citrus Red No. 2, and Orange B have been targeted for actual revocation of their approval for use in food. Companies need to understand that the phase-out for the other synthetic colors is voluntary: they remain approved by regulation, an important distinction, says Benevente.

“If this phase-out should become mandatory, companies will have time to change their formulations. The January 2025 ban on FD&C Red No. 3, for example, gave industry until 2027 to comply.”

“That being said, some major companies have committed to removing these synthetic colors from their products. With all of the publicity around these large multinational corporations taking this step, consumer interest in natural alternatives appears to be high. So the more urgent matter may be for companies to gauge consumer demand for the natural alternatives and adjust accordingly.”