Highlights
- The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) have announced plans to phase out the use of certain food additives by the end of 2026.
- The FDA will likely seek to use the full extent of its legal and regulatory capabilities to remove those additives from food products.
- This Holland & Knight alert examines potential HHS and FDA actions for a range of food additives.
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes, from food and drug products in the U.S. by the end of 2026 and replace them with naturally derived alternatives. Removing food additives such as synthetic dyes from food and drug products in the U.S. has been a focus of HHS Secretary Robert F. Kennedy Jr. and is now a key pillar of the Trump Administration's Make America Healthy Again (MAHA) agenda.
Absent congressional action to implement meaningful changes to the FDA's statutory framework for overseeing additive ingredients, the FDA will likely seek to use the full extent of its regulatory capabilities to remove certain additives from food products and initiate changes to long-standing rules for when substances may be considered "generally recognized as safe" (GRAS). (See Holland & Knight's previous alert, "HHS Explores Stronger FDA Oversight for Food Ingredients," March 12, 2025.)
Actions Announced
The HHS and FDA announced six major actions they will take to phase out the use of synthetic dyes from food and drug products in the U.S.:
- establishing a transition timeline to phase out the use of petrochemical-based dyes
- initiating a process to revoke the authorization for the use of Citrus Red No. 2 and Orange B from products in the U.S.
- accelerating the review of naturally derived additive ingredients, specifically calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract
- eliminating the use of six other synthetic dyes by the end of 2026: Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2
- initiating comprehensive research in coordination with the National Institutes of Health (NIH) on how food additives impact the health and development of children, potentially through creation of a new federal grant program
- requesting that food companies voluntarily remove Red Dye No. 3 from products earlier than the 2027-2028 deadline set by the Biden Administration's order revoking authorization for its use
Next Steps
The FDA will likely seek to use the full extent of its legal and regulatory capabilities to remove certain additives from food products. One potential pathway to do so falls under Sections 409(i) and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 348(i) and 371(a), which allows the HHS Secretary to issue a proposed rule to revoke the authorization for the use of certain additive ingredients in food products unilaterally. The Biden Administration used that pathway to revoke the authorization for the use of brominated vegetable oil in food, giving the Trump Administration recent precedent to use as a foundation for removing the eight synthetic dyes from food products as outlined in the announcement. Though the Trump Administration could set fast-moving deadlines for public comments on proposals, revoking the authorization for food additives through rulemaking is required and could take at a minimum several months to complete from proposed to final rule per additive. Reductions in workforce at the FDA that have resulted in more than 2,500 staff members being laid off, including staff involved with the FDA's food programs, may also contribute to lengthier rulemaking processes. In the interim, the HHS is expected to lean heavily on food companies to voluntarily remove synthetic dyes, such as Red Dye No. 3, from their products.
It also remains increasingly likely that the FDA will seek to revise an Aug. 17, 2016, final rule that clarified long-standing rules regarding when substances may be considered GRAS, as well as the related "self-affirmed" pathway companies may use to independently conclude whether a substance is GRAS. Because the GRAS framework is considered a final agency action, the FDA would be required to make changes to the final rule through the notice and comment rulemaking process or through congressional action. Secretary Kennedy announced in a previous directive to the then-acting FDA commissioner to pursue potential rulemaking opportunities to address GRAS but left open the potential for working with Congress to identify a legislative solution. In addition, Secretary Kennedy recently acknowledged the FDA may not be able to accomplish its goals on its own, noting that they will "one by one [...] get rid of every ingredient and additive we can legally address."
Stakeholder reactions to the HHS announcement have been mixed. Stakeholders have commended the intent of HHS and FDA to phase out certain food additives; however, many public health entities have stated that the FDA's actions are not strong enough because they do not include an outright ban on the use of synthetic dyes or hold companies accountable to a higher regulatory standard to prove the ingredients they use are safe. Moreover, some food companies are supportive of the FDA utilizing its authorities to oversee the nation's food supply. Yet, it remains to be seen if many companies will voluntarily comply with requests to remove synthetic dyes from their products or pursue wholesale reformulations without a statutory requirement or increased enforcement. Whatever the case, this announcement marks another pivotal step toward enhancing food safety and transparency.
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