Butterfly Pea Flower Extract Color Additive Expansion
Summary
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.
Compliance Requirements
- #1
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.; To file an objection, persons must, among other things, specify with particularity the provision(s) of the regulation to which they object and the grounds for the objection; Within each objection, persons also must specifically state whether they request a hearing
Deadline: 2025-06-26(June 26, 2025)
Market Impacts
Expanded safe use of butterfly pea flower extract as a color additive at levels consistent with good manufacturing practice (GMP) in specified food categories
Validated Company Impacts
GENERAL MILLS INC
General Mills operates as a global packaged foods company that produces ready-to-eat cereals, crackers, and snack products, which are directly specified in the FDA rule's expanded use of butterfly pea flower extract as a color additive. The company's food manufacturing operations clearly fall under this regulation's jurisdiction and would be significantly affected by compliance requirements for color additive usage in their product categories. The FDA rule specifically addresses color additive regulations for food products, which does not align with any of the company's disclosed risk factors focused on financial reporting, acquisitions, and currency translation. The company's minimal regulatory compliance risks (only 4 identified) show no overlap with food safety or additive regulations, indicating virtually no risk factor alignment.
HERSHEY CO
Hershey's North America Salty Snacks segment produces pretzels and other snacks, directly aligning with the rule's coverage of hard pretzels and snack mixes. The company's snack bites and mixes in the North America Confectionery segment also fall under the snack mixes category specified in the regulation. The FDA rule on butterfly pea flower extract as a color additive primarily addresses regulatory compliance and manufacturing standards for specific food products, which does not align with the company's disclosed risk factors focused on financial pressures, supply chain disruptions, consumer demand shifts, labor constraints, and data integration challenges. There is no overlap with the company's identified risks, as the rule pertains to food safety and additive usage rather than the operational, market, or financial risks the company has highlighted.
Kraft Heinz Co
Kraft Heinz operates in the food and beverage industry and produces numerous snack and cereal products that fall directly under this rule's scope, including ready-to-eat cereals, crackers, and snack mixes. As a major food manufacturer, they would be directly affected by the expanded safe use regulations for butterfly pea flower extract in these product categories. The FDA rule on butterfly pea flower extract as a color additive primarily addresses food safety and manufacturing compliance risks, which are not reflected in the company's disclosed risk profile. The company's risks focus on cybersecurity, economic conditions, supply chain disruptions, data privacy, and workforce illness, with no mention of food safety, ingredient compliance, or FDA regulatory requirements.
MCCORMICK & CO INC
McCormick & Co operates in the flavor solutions segment that develops seasonings and flavors for snack products, directly aligning with the rule's focus on color additives for ready-to-eat cereals, crackers, snack mixes, and chips. The company's business model includes new product innovation and food product development, making them likely users of color additives like butterfly pea flower extract in their flavor formulations. The FDA rule addresses food additive safety and manufacturing compliance for specific snack food categories, while the company's only identified risk is cybersecurity threats related to technology operations. There is no overlap between the regulatory compliance requirements for food additives and the company's cybersecurity risk profile.