Skip to main content

CRA Reminds Licensees of Impending FDA Ban of FDC Red No 3 Color Additive

The CRA announced today that it is requiring licensee compliance by January 15, 2027 with  the Food and Drug Administration’s recent January 15, 2025 announcement that authorization for the use of FD&C Red No. 3 in foods, supplements, and drugs has been revoked.

CRA licensed producers may be affected by the prohibition of Red No. 3, which is added to products to impart red coloring. Products such as candies, gummy base, powders, and capsules used by CRA licensed producers in edible marijuana products may currently contain Red No. 3.

Producers must work with their suppliers to source alternative color additives and ingredients to those containing Red No. 3. Producers currently incorporating Red No. 3, or an ingredient containing Red No. 3, into products should expect to change written product formulations and labeling to reflect the new ingredient(s) and color additive(s) utilized.

Food and supplement manufacturers must discontinue use of Red No. 3 in products by January 15, 2027, and drug manufacturers must discontinue their use by January 18, 2028.

As the CRA defines edible marijuana products as any product containing marijuana that is intended for human consumption in a manner other than inhalation, all edible marijuana products that currently contain Red No. 3 must be reformulated by the earliest compliance date of January 15, 2027. This includes items that may be offered in forms similar to traditional drugs, such as capsules or powders.

Licensees should note that producers may continue to find that their suppliers offer items containing Red No. 3, as the prohibition for traditional drugs containing the color additive is not in effect until 2028.  Additionally, Red No. 3 may still be listed in the Food and Drug Administration’s Inactive Ingredient Search for Approved Drug Products until 2028.

Any questions for the CRA regarding the use of Red No. 3 color additive may be directed to CRA-Enforcement@michigan.gov.

Media Inquiries

 

Media Contact: