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Flurry of Activity from FDA in the First Four Months of 2025

Updates for food and beverage stakeholders, from dyes, allergens, GRAS, and food traceability to the revised "healthy" definition
By Kristi Wolff, Allison B. Condra, and Staci Gamble*
04.25.25
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It is an understatement to say the last four months have been a whirlwind. Cabinet confirmations, executive orders, policy changes, and more, including some developments that impact (or that will impact) the food industry. To help you keep track, here's a rundown of what's happened:

Synthetic Colors and Ingredients

Synthetic colors and ingredients have been making headlines—both at the federal and state levels. On January 15, the FDA announced its plan to revoke its authorization for the use of FD&C Red No. 3 in food products. Manufacturers that use FD&C Red No. 3 in foods will have until January 15, 2027, to reformulate their products.

Pink Donut

On April 22, 2025, the FDA announced its intention to phase out petroleum-based synthetic dyes, as follows: (1) establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives; (2) initiating the process imminently to revoke authorization for Citrus Red No. 2 and Orange B (which are no longer widely used anyway); (3) working with industry to eliminate six synthetic dyes from the food supply by the end of 2026 (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); (4) imminently authorizing four new natural color additives and accelerating review of others; (5) partnering with the National Institutes of Health to conduct comprehensive research on how food additives impact children's health and development; and, (6) requesting food companies to remove FD&C Red. No. 3 sooner than the 2027 deadline previously required.

To be clear, although this has been widely reported as a "ban" on food dyes, Health & Human Services Secretary Kennedy positioned it as an initiative that will be done with industry cooperation. Certain industry groups pushed back on the notion that food dyes have not been proven safe and asserted that the food industry has already been transitioning to natural colorants.

Of course, the federal government is not alone in pushing for changes in food dyes. A number of states have passed and more states have introduced legislation to prohibit the use in food or require labeling of certain substances. California was at the forefront in this, passing its law in 2023 that will ban, as of July 1, 2026, brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. Connecticut, Illinois, Missouri, Vermont, and Florida have introduced similar legislation. New York and Texas have each introduced legislation to require labeling of certain ingredients that the state has deemed harmful.

Food Traceability Rule

On March 20, 2025, FDA announced it intends to extend the compliance date for the Food Traceability Rule by 30 months. It has not yet published a proposed amendment to the rule in the Federal Register, which it is required to do in order to officially extend the compliance date.

Front-of-Pack Labeling

On January 14, 2025 (under the prior Administration), FDA issued a proposed rule for front-of-package nutrition labeling. Recent comments by FDA Commissioner Makary suggest the current FDA may take a different approach to the issue than the prior Administration did. At his confirmation hearing, Commissioner Makary noted that the prior Administration's proposal to focus on added sugars, sodium, and saturated fat only got "one" of those right. Expect more to come on this.

Updated Allergen and Safety Labeling Guidance

On January 6, 2025, the FDA announced updated guidance on allergen, food safety, and plant-based alternative labeling. Some highlights from the allergen labeling guidance include that coconut is no longer considered a tree nut (allergen disclosure no longer required for coconut), and the source(s) of eggs and milk should be disclosed (e.g., "duck eggs," "goat milk").

Revised Definition of "Healthy"

Although the updated definition of "healthy" was finalized in the prior Administration, the current Administration extended the effective date from February 25 to April 28, 2025. Companies must comply by February 25, 2028.

On April 10, FDA released a pre-recorded webinar discussing the "healthy" nutrient content claim rule. The discussion provided an overview of key requirements along with references to tools such as infographics and fact sheets to promote public education. FDA is also working to create a "healthy" symbol, which marketers can use to indicate that a particular food meets the new standards. Panelists also confirmed that not all references to "healthy" will fall under the rule as the full context of the label or labeling should be used to make that determination.

Self-Affirmed GRAS

On March 10, 2025, Health & Human Services Secretary Kennedy announced his intention to explore whether the FDA can eliminate the option companies have for determining whether a new ingredient is generally recognized as safe (GRAS) for consumption. The "Self-Affirmed GRAS" path allows companies to determine on their own whether an ingredient is generally recognized as safe for its intended use (subject to certain substantiation standards); this path does not require the company to submit its documentation to FDA for prior review or approval. Rumors abound that FDA is about to undertake a rulemaking relative to this, but nothing has been published in the Federal Register to date.

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How Should Stakeholders Prioritize?

For companies large and small, this is a lot to keep track of, not to mention considering the impact of tariffs and other business concerns. Of all of these topics, the changes to synthetic dyes potentially have the most significant impact because of the movement at both the state and federal levels (legal patchworks are always challenging), the eventual need for reformulation, and the time required to comply. In addition, companies that sell or handle foods on the traceability list will want to watch carefully for publication of any new compliance timelines. The other topics are either voluntary, i.e., whether to use a "healthy" claim, or subject to additional discussion and potential rulemakings. Stay tuned to DWT's food + beverage group updates for the latest.

*Staci Gamble is a law clerk in the Portland, Oregon, office of Davis Wright Tremaine.

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