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FDA Color Additive Petitions

Secure FDA approval for your color additives with expert petition preparation and regulatory strategy from dicentra.

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What Is a Color Additive Petition?

A color additive petition is the formal process for obtaining FDA authorization to use a specific color additive in foods, dietary supplements, drugs, or cosmetics. This petition provides the FDA with technical, manufacturing, and safety data that support the proposed use and ensures public safety.

When Is a Color Additive Petition Required?

You may need to file a color additive petition when:

  • A new color additive is introduced for a use not yet authorized by the FDA.
  • You wish to expand or modify existing permitted uses of a color additive.
  • Manufacturing or specifications for an approved colorant are updated.
  • You are seeking to establish new safety data for an existing color additive.

Petitions ensure that colorants meet FDA safety, composition, and labeling standards for their intended use.

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Our FDA Color Additive Petition Services

dicentra provides end-to-end support for FDA color additive petitions, including:

  •  Regulatory strategy and project planning
  • Technical data gap assessment
  • Preparation of chemistry, manufacturing, and safety sections
  • Analytical method validation review
  • Dossier compilation and FDA submission
  • Post-submission follow-up and FDA communication support

Industries and Use Cases We Support

  • Food and beverage manufacturers
  • Dietary supplement companies
  • Pharmaceutical ingredient suppliers
  • Cosmetic and personal care brands
  • Ingredient developers introducing new colorants or natural pigments

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Why Choose dicentra?

  • Over two decades of regulatory experience with the FDA and Health Canada
  • Deep expertise in toxicology, ingredient safety, and chemistry data evaluation
  • Proven success in regulatory submissions for color additives, GRAS, and food ingredients
  • Strategic guidance to minimize data requests and review delays
  • A multidisciplinary team supporting science, compliance, and safety documentation

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