FOR IMMEDIATE RELEASE

January 15, 2025

FDA REVOKES AUTHORIZATION FOR FD&C NO 3

AND PLC'S WEBINAR EXPANDS TO INCLUDE NEW FDA UPDATES



Washington D.C., (Jan 15, 2025) - Today FDA announced that the authorization for FD&C Red No 3 will be revoked for food and ingested drugs based on a petition from the Center for Science in the Public Interest (CSPI) submitted in 2023. Red No. 3, approved for use in foods in 1907 yet barred from cosmetics 35 years ago, is a synthetic dye that has been linked to cancer in animals. FDA's move to revoke the petroleum-based dye, still used in thousands of food products, has been in the works for decades.


For industry, this aligns the California Food Safety Act and will create some consistency by eliminating the color additive nationally rather than through a state-by-state patchwork. Industry has until January 15, 2027 to reformulate foods.


Other New FDA Updates:

In addition to revoking FD&C Red No 3, the FDA has been very busy publishing many updates pertinent to the food labeling community:

  • 01/14/2025: Proposed Rule on Front-of-Package Nutrition Labeling
  • 01/14/2025: High-Protein Yogurt Request for Information
  • 01/06/2025: Guidances on Allergen, Food Safety, and Plant-Based Alternatives
  • 12/19/2024: Updated “Healthy” Nutrient Content Claim
  • 12/3/2024: Food Date Labeling Request for Information


Expanded PLC Webinar: FDA's Front-of-Pack Proposal & Other New Updates

To inform Industry and discuss these important updates, Prime Label Consultants is hosting a webinar on Thursday, January 23 at 1 pm ET. Jesse Zuehlke, PhD, will primarily discuss FDA's new Front-of-Pack Proposed Rule, but will also address the flurry of other new regulatory actions, particularly on Allergens, Date Labeling, and FD&C Red No. 3. Join PLC for a preview of the proposed front-of-pack requirements and insights on its potential impacts, along with the other recent agency actions and recommended next steps.

New Trump Administration Updates:

If you are interested in learning more about these initiatives and how the New Administration is prioritizing them, we invite you to attend the Annual Food Label Conference June 1 - 4 in Washington DC. From the brand new Front-of-Pack and "Healthy" rules to "Ingredients in the Hot Seat", the Conference will analyze and discuss critical regulatory, enforcement, and policy topics with regulators, top food law attorneys and industry experts. Registration is available here.


Next Steps:

In the meantime, PLC recommends that food companies begin to familiarize themselves with the new final “Healthy” rule announced last month and effective February 25, 2025. Companies should re-evaluate their product portfolio for any current and potentially new claims. PLC Regulatory Consultants are available today to help you with this project. For more information, go to our website, Services Order form or contact us at labels@primelabel.com or (202) 546-3333. 


We will continue to monitor developments on agency actions with our contacts at the FDA and notify our Label Alert subscribers as soon as new information is available.


Stay tuned for more developments!

About Prime Label Consultants

Prime Label Consultants (PLC) has been helping companies navigate food labeling since 1972 and has hosted the nation's premier food labeling conference since 1989. PLC is an industry leader in labeling compliance and software, working with over 3,500 clients for both FDA and USDA-regulated products (including about half of the top 100 food manufacturers in the United States). 


As a full-service consulting firm, PLC leverages 50 years of food and beverage regulatory and nutrition expertise in client support ranging from general guidance to complete project development. The combination of systems, automation, training, and expertise results in an unparalleled level of compliance, efficiency, and cost savings for our customers.

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