🎨FDA Guidance on Replacing Color Additives in Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Replacing Color Additives in Approved or Marketed Drug Products." This draft guidance provides recommendations for replacing color additives in approved or marketed drug products. If a color additive is replaced in a drug product, information to support the change should be retained and available at the manufacturing facility. Additionally, this draft guidance recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit information to support color additive replacements in changes being effected in 30 days (CBE-30) supplements. Although a qualitative or quantitative change to an inactive ingredient is generally considered a major change, in many cases, replacing a color additive with one that is listed in the color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug product. Therefore, this draft guidance recommends a CBE-30 for such a change.
Learn More🍖FDA Confirms Myoglobin Color Additive Regulations for 2025
The Food and Drug Administration (FDA or we) is confirming the effective date of February 19, 2025, for the final order that appeared in the Federal Register of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.
Learn More🍉Galdieria Extract Blue Approved as Food Color Additive by FDA
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
Learn More🍗FDA Approves Calcium Phosphate as Safe Color Additive
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
Learn More🌸FDA Expands Use of Butterfly Pea Flower Extract as Food Color Additive
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).
Learn More🌱FDA Accepts Impossible Foods' Color Additive Petition for Plant-Based Products
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive to include use in plant-based meat, poultry, and fish analogue products (ground and whole cut).
Learn More🥩FDA Regulation on Myoglobin as Color Additive for Meat Alternatives
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner).
Learn More🚫FDA Revokes FD&C Red No. 3 for Food and Ingested Drugs
The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.
Learn More