❌FDA Terminates Arthritis Advisory Committee – Regulatory Update
The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.
Learn More🍗New Color Additive Regulations
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends 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.
Learn More🌈FDA Regulation on Butterfly Pea Flower Extract Color Additive
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive at levels consistent with good manufacturing practice (GMP) 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.
Learn More🍹FDA Confirms Galdieria Extract Blue as Safe Color Additive
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of galdieria extract blue as a color additive at levels consistent with good manufacturing practice (GMP) in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).
Learn More🎨FDA Corrects Color Additive Listing for Gardenia Blue
The Food and Drug Administration (FDA or we) is correcting the order entitled "Listing of Color Additives Exempt from Certification; Gardenia (Genipin) Blue". In the order, FDA amended the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). The order inadvertently misstated the methanol specification. This document corrects that error.
Learn More🍏FDA Approves Gardenia (Genipin) Blue Color Additive for Foods
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG).
Learn More🎨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🌸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🍉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).
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