SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Description of the Proposed Order

III. Proposed Effective Date of a Final Order

IV. Analysis of Environmental Impact

V. Paperwork Reduction Act of 1995

VI. References

I. Background

President Trump has directed the heads of executive departments and agencies to eliminate unnecessary and burdensome regulations (Executive Order 14192, “Unleashing Prosperity Through Deregulation” (90 FR 9065, Feb. 6, 2025)). Independently, Secretary Kennedy has expressed support for deregulatory initiatives across all HHS components to focus on the core mission to Make America Healthy Again (see “Request for Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again” (90 FR 20478, May 14, 2025)). Removing the color additive regulation for Citrus Red No. 2, which we tentatively conclude is no longer used for its authorized use in food in the United States, is consistent with these directives. It is also consistent with Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, Jan. 21, 2011), which requires agencies to periodically conduct retrospective analyses of existing regulations to identify those “that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them,” accordingly.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to regulate “color additives” (see section 721(b) of the FD&C Act (21 U.S.C. 379e(b))). The FD&C Act defines “color additive,” in relevant part, as a material which is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and that when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting color (see section 201(t) of the FD&C Act (21 U.S.C. 321(t))). Color additives used in or on a food, drug, cosmetic, or certain medical devices are deemed unsafe and prohibited except to the extent that we approve their use through issuance of a regulation and, when subject to certification, are batch certified, unless an exemption applies (see section 721(a) and (c) of the FD&C Act).

Sections 701(e), (f), and (g) of the FD&C Act (21 U.S.C. 371(e), (f), and (g)) apply to the issuance, amendment, or repeal of color additive regulations (see section 721(d) of the FD&C Act). Section 701(e) of the FD&C Act provides that any action for the issuance, amendment, or repeal of a color additive regulation may be initiated by a proposal made by the Secretary or by a petition of any interested persons. It further requires that FDA publish such a proposal, provide an opportunity for interested parties to present their views, and then by order act upon such proposal.

FDA may issue a regulation listing a color additive for use in or on food, drugs, devices, or cosmetics only if it determines that the additive is suitable and safe for such use (see section 721(b)(2)(A) of the FD&C Act). The regulation that permits the use of a color additive includes appropriate limitations and requirements for its safe use and specifies whether certification is required (see section 721(a)(1), (c) of the FD&C Act; 21 CFR 71.20). (For additional information on certification of color additives, see Color Certification FAQs, available at: https://www.fda.gov/​industry/​color-certification/​color-certification-faqs.)

FDA determines the need for batch certification based on whether the color additive composition needs to be controlled to protect the public health (see 21 CFR 71.20(b)). Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern. When batch certification is required for a color additive, the color additive must be batch certified by FDA. If it is not batch certified, it is deemed unsafe under the relevant adulteration provision, for example, under section 402(c) of the FD&C Act (21 U.S.C. 342(c)) for food (see section 721(a)(1) of the FD&C Act). To receive certification for a color additive, a request must be filed with FDA, along with a batch sample. FDA assesses the information in the request and analyzes whether the batch sample conforms to the applicable identity and specifications stated in the listing regulation for the color additive. If FDA finds that the batch sample meets the applicable requirements for composition and purity stated in the listing regulation, FDA will issue a certificate indicating the lot number for the batch and stating that the batch is certified (see 21 CFR 80.21, 80.31). ( printed page 46332)

II. Description of the Proposed Order

On May 22, 1963 (28 FR 5082),^[1] we issued a regulation allowing for the use of Citrus Red No. 2 as a color additive on the skins of oranges that are not intended or used for processing (or, if so used, are designated in the trade as “packing-house elimination”), and that meet minimum maturity standards established by or under the laws of the States in which the oranges are grown ( i.e., mature oranges), subject to certain specifications, restrictions, labeling requirements, and certification. Under 21 CFR 74.302, Citrus Red No. 2, oranges colored with Citrus Red No. 2 must bear not more than 2.0 parts per million of the color additive, calculated on the basis of the weight of the whole fruit. Citrus Red No. 2 is not authorized for other uses as a color additive. The regulation also specifies that all batches of Citrus Red No. 2 must be certified in accordance with our regulations under 21 CFR part 80.

Our records indicate that Citrus Red No. 2 was last batch certified in 2020 and that FDA has not received any requests to batch certify Citrus Red No. 2 since that time (Ref. 1). We tentatively conclude that the absence of requests to certify a batch of Citrus Red No. 2 since 2020 indicates that the color additive is no longer manufactured for uses established in § 74.302. Without a certification, Citrus Red No. 2 may not be used as a color additive in food in the United States. Considering this information, we tentatively conclude that the authorized use of Citrus Red No. 2 has been abandoned. Therefore, we tentatively conclude that the color additive listing for Citrus Red No. 2 at § 74.302 is outdated and unnecessary and we propose to repeal this color additive regulation. To facilitate the phase-out of any remaining batch certified Citrus Red No. 2 supply that may be in use, we propose to provide an extended effective date and a compliance date to allow for its depletion.

If this proposed order is finalized, in accordance with 21 CFR 80.32(h), all certificates for any existing batches and portions of batches of Citrus Red No. 2 would cease to be effective for use in food on the effective date for the removal of § 74.302, and any lots of Citrus Red No. 2 would be regarded as uncertified after that date. The use of Citrus Red No. 2 in any food after its certificate ceases to be effective would result in such food being adulterated. However, as indicated below, we propose to provide a compliance date to allow for depletion of any remaining certified batches of Citrus Red No. 2, after the effective date.

III. Proposed Effective Date and Compliance Date of a Final Order

We propose that any final order based on this proposed order be effective 90 days following its publication in the Federal Register . In the event that the food industry needs time to use up existing reserves of certified batches of Citrus Red No. 2, FDA proposes to not enforce applicable requirements of a final order with regard to food products manufactured (domestically and internationally) until one year after the effective date of that final order. We request comments on whether to provide such a compliance period and the appropriate duration.

IV. Analysis of Environmental Impact

We have determined under 21 CFR 25.32(m) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment (Ref. 2). Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VI. References

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

1. Memorandum from S. West-Barnette, Division of Food Ingredients, Regulatory Review Branch, Human Foods Program, FDA, to M. Honigfort, Division of Food Ingredients, Regulatory Management Branch, Human Foods Program, FDA, June 26, 2026.

2. Memorandum from M. Pfeil, Environmental Review Team, Office of Pre-Market Additive Safety, Human Foods Program, FDA, to S. West-Barnette, Division of Food Ingredients, Regulatory Review Branch, Human Foods Program, FDA, June 26, 2026.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose to amend 21 CFR part 74 as follows:

1. The authority citation for part 74 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

2. Remove § 74.302.