Over the last week or so there have been several developments from the Trump Administration and Congress affecting the food industry. We outline several of those developments below and identify key ways industry stakeholders can engage.
Revocation of Food Standards of Identity
Yesterday, FDA announced a series of rulemakings that revoke, or propose to revoke, standard of identity (SOI) regulations for 52 foods. Specifically, the agency is immediately revoking 11 SOIs for canned fruits and vegetables through a direct-to-final rule and is proposing to revoke 18 SOIs for dairy products and 23 SOIs for other foods, including certain macaroni and noodle products, canned fruit juices, fish and shellfish, and dressings and flavorings. FDA is taking these actions consistent with the Trump Administration’s broader deregulatory agenda, under which federal agencies have been instructed to identify and eliminate “outdated or unnecessary” regulations.
FDA’s SOIs establish detailed requirements regarding the composition and manufacturing of food products. FDA has long recognized that many of these SOIs, most of which were issued in the mid-20th century, do not reflect the innovation in food and technology that has taken place in recent decades. Consistent with this, yesterday’s rulemakings acknowledge that many SOIs have become “duplicative,” “unnecessary,” and, in some cases, “an inappropriate impediment to adopting new technologies or food reformulation.”
SOIs affected by FDA’s announcement are largely some of the more esoteric SOIs, such as:
- specific canned fruits and vegetables (e.g., artificially sweetened canned figs and fruit cocktail);
- specific frozen or canned fruit juices (e.g., frozen concentrate for artificially sweetened lemonade, reduced acid frozen concentrated orange juice);
- goat’s milk ice cream and mellorine;
- certain cheeses and related cheese products (e.g., Caciocavallo, Gammelost, and Samsoe cheese, low sodium colby cheese, pasteurized blended cheeses with fruits, vegetables, and meats);
- acidified milk and sour cream;
- specific macaroni and noodle products (e.g., nonfat milk macaroni, vegetable noodle products);
- certain fish and shellfish products (e.g., Olympia oysters, frozen raw lightly breaded shrimp); and
- vanilla-vanillin extract, flavoring, and powder.
For these SOIs, FDA maintains there is little to no U.S. market for such products or the standardized food would adequately be covered by another SOI or FDA regulation such as FDA’s cross-cutting regulation, codified at 21 C.F.R. 130.10, which covers foods that deviate from an SOI to comply with an express FDA-defined nutrient content claim (e.g., “low sodium,” “fat free”).
While FDA has made numerous attempts to modernize its SOIs over the years, these efforts have not resulted in large-scale changes. This announcement could mark a new, and potentially more aggressive, chapter in these efforts. Indeed, FDA stated that, in addition to the 52 SOIs it plans to revoke under these rulemakings, it is conducting an ongoing review of its SOI regulations through which it may identify additional SOIs for revocation.
Importantly, revocation of these SOIs will not prevent companies from marketing these foods in the U.S., as long as they do so in compliance with FDA’s labeling requirements for non-standardized foods.[1] Interested stakeholders have 30 days to submit comments on FDA’s immediate revocation of certain canned fruit and vegetable SOIs and 60 days to submit comments on FDA’s other proposed revocations. Food manufacturers would be wise to also consider whether the bases FDA asserts for revocation of these SOIs could apply to other SOIs and the implications of such actions with respect to their products and commercial goals more generally.
FDA Updates on Synthetic Color Additives
As described in our previous client alert, FDA has proposed several actions related to transitions away from synthetic color additives. Earlier this week, FDA approved Gardenia (Genipin) Blue as a color additive “derived from natural sources” (FDA approved three other colors from “natural sources” in May). FDA also announced that it had sent a letter to industry encouraging the phase-out of FD&C Red No. 3 sooner than the January 15, 2027, required deadline.
Many of the actions taken by FDA to date have spurred industry to voluntarily transition from use of “synthetic” colors. It remains to seen whether FDA will revoke the authorizations for any of the other synthetic colors in addition to FD&C Red No. 3. There has also been a deluge of state actions on this issue (e.g., West Virginia law prohibiting the use of certain food dye ingredients) and this trend will likely continue as the HHS Secretary encourages continued action at the state level.
Food Chemical Reassessment Act of 2025
On July 10, 2025, Reps. Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT) reintroduced the Food Chemical Reassessment Act of 2025. The bill describes a process by which FDA should reassess food substances currently in the food supply, whether marketed as (approved) food or color additives, GRAS or prior sanctioned substances, or food contact substances.
The bill would require the FDA Office of Food Chemical Safety, Dietary Supplements, and Innovation to study not less frequently than every three years the safety of at least ten food substances added to food or food packaging. The bill requires FDA to reexamine the following substances first: Tert-butylhydroquinone (TBHQ), titanium dioxide, red dye 40, yellow dye 5, blue dye 1, blue dye 2, green dye 3, perchlorate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), trichloroethylene, methylene chloride, benzene, ethylene chloride, propyl gallate, sodium benzoate, and sodium nitrite. If any assessment demonstrates that the substance is not safe, as appropriate, FDA will amend or repeal the relevant regulation, or revoke the prior-sanctioned use, for the substance or additive. For GRAS substances reviewed, FDA will publish on its website the agency’s determination that the substance is safe under certain conditions of use or that it is unsafe under all conditions of use. If FDA determines that a food contact substance is unsafe, the pre-market notification will no longer be effective. In determining which substances or classes of substances to reassess, the bill requires FDA to prioritize substances or classes based on “public health need.” The bill would also require that the Food Advisory Committee be reestablished to advise with respect to the standards and processes for such reassessments.
Of course, this is an exercise FDA itself is already undertaking with its proposed Post-market Assessment. As part of this exercise, FDA has also released a Post-Market Assessment Prioritization Tool to determine which food substances or contaminants to prioritize for review as part of its Post-market Assessment, which we described in our client alert here. Earlier this week, FDA extended the comment period for the prioritization tool to August 18. Stakeholders, if they have not already done so, should consider submitting a comment on the prioritization tool. In its current version, the current criteria include Public Health Criteria but also Other Decisional Criteria such as how much attention a substance is receiving from external groups and organizations (e.g., based on social media and national news coverage) and actions taken by state governments.
We note that some have reported that the Schakowsky/DeLauro bill is intended to limit the ability of food companies to make their own GRAS determinations, but the bill itself does not address this issue. While food substances and contaminants have historically been an issue for Democrats in Congress, it is now also a priority for MAHA Republicans. We expect bills to continue to be introduced in Congress on these issues.
DOJ Suit Against California’s Prop 12, Asserting Preemption
On July 9, 2025, The Department of Justice filed a lawsuit against California asserting that the Egg Products Inspection Act (EPIA) preempts the State’s Animal Confinement Laws for Egg-Laying Hens (also known as Prop 12). Specifically, the complaint argues that these laws are preempted under the express preemption provision of the EPIA because they impose quality and labeling standards on eggs that are “in addition to” and “different from” federal egg standards under the EPIA. The EPIA has an express preemption provision that prohibits states from “requiring the use of standards of quality, condition, weight, quantity, or grade which are in addition to or different from the official Federal Standards” or imposing “[l]abeling, packaging, or ingredient requirements, in addition to or different than those made under [the PPIA], the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.”[2]
This will be a case to watch as it advances a different legal theory than the unsuccessful dormant commerce clause challenge in National Pork Producers Council v. Ross. The outcome in this case may have consequences for state-imposed food ingredient bans and labeling requirements.
FDA’s Letter to Industry on Recalls for Infant Formula, Baby Foods, and Food Intended for Children
On July 9, 2025, FDA Commissioner Makary issued a letter directed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of infant formula, baby foods, and foods intended for children. The letter encourages theses stakeholders to enhance communications with the public and work with FDA during product recalls.
The letter sets forth various short term and long term goals, including:
- Creating a centralized, consumer-focused webpage for access to recall information;
- Evaluating internal and external recall communication protocols on public communications;
- Upgrading the FDA Enforcement Report system to be more user-friendly;
- Leveraging focus group research and other stakeholder feedback on risk communication strategies;
- Increasing the speed of recall classification; and
- Redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis.
As many have experienced, the recall process of notifying FDA and receiving feedback from the agency has not always been smooth sailing. Industry should consider engaging with FDA as it updates its recall processes and communications.
USDA APHIS Environmental Impact
On July 9, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) issued a bulletin announcing that it will no longer consider environmental impacts under the National Environmental Policy Act (NEPA) when reviewing petitions seeking a determination of nonregulated status for food crops and other organisms altered or produced through genetic engineering (modified organisms) under 7 C.F.R. part 340 (Part 340). At a high level, APHIS reviews such petitions pursuant to its plant pest authority under the Plant Protection Act (PPA) to determine whether the modified crop or other organism is unlikely to pose a greater plant pest risk relative to an appropriate comparator, and therefore is not subject to regulation under Part 340. Although APHIS historically has assessed the environmental impacts of granting these petitions as part of its review process pursuant to NEPA, APHIS now takes the position that it is not obligated to conduct such a NEPA analysis based upon two recent developments. APHIS first points to the fact that Congress amended NEPA in 2023 by adding a section describing the circumstances under which federal agencies are not required to prepare environmental analyses that includes when “the proposed agency action is a nondiscretionary action with respect to which such agency does not have authority to take environmental factors into consideration in determining whether to take the proposed action.” [3] Here, APHIS underscores that the PPA does not authorize the agency to consider or mitigate environmental impacts once APHIS determines that a modified organism does not pose a greater plant pest risk relative to an appropriate comparator and thus is not subject to Part 340. Said another way, APHIS maintains that once it makes such a determination, it must deregulate (making the action nondiscretionary) and it does not have the authority under the PPA to consider or mitigate environmental impacts in doing so. Second, APHIS cites a May 2025 U.S. Supreme Court decision in which the Court reiterated the “NEPA canon” that “where an agency has no ability to prevent a certain effect due to its limited statutory authority over the relevant actions, the agency cannot be considered a legally relevant ‘cause’ of the ‘effect.’”[4] “In other words, agencies are not required to analyze the effects of projects over which they do not exercise regulatory authority.”[5] APHIS relies upon this decision to assert that “there is no role for NEPA in the agency’s response to a petition for determination of nonregulated status because APHIS has no ability to consider any factors or environmental impacts beyond the factual and scientific information that is relevant to determining whether an article is a ‘regulated article’ under [Part 340].” A likely consequence of APHIS’s position will be that the review process for petitions for nonregulated status should proceed more quickly, though it remains to be seen whether APHIS’s interpretation will be challenged in court.
As these issues are fast-tracked through Congress, USDA, HHS, FDA, and even the courts, industry stakeholders should consider engaging on these important issues at appropriate opportunities, especially through comments or potentially directly with government officials. The food industry will want to ensure that actions being taken fully consider and properly weigh scientific evidence (e.g., the history of safe use), public health risk-benefit calculations, or feasibility.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
[1] FDCA § 403 (21 U.S.C. § 343); 21 C.F.R. § 101.3.
[3] Pub. L. No. 118-5, § 321(b); see also 42 U.S.C. § 4336(a)(4).
[4] Seven Cnty. Infrastructure Coal. v. Eagle Cnty., Colorado, No. 23-975, 2025 WL 1520964, at *11 (May 29, 2025) (quoting Dep’t of Transp. v. Pub. Citizen, 541 U.S. 752, 770 (2004)).