Guidance for Industry: Colored Sea Salt

Description

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

Scope & Applicability

• 21CFR71.1§ 71.1 Petitions.

  (a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate (quadrupRead full regulation →

• 21CFR70.3§ 70.3 Definitions.

  (a) Secretary means the Secretary of Health and Human Services.Read full regulation →

• Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (Status: Final)
• Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
• Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
• Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
• Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (Status: Final)
• Redbook 2000: I Introduction (Status: Final)
• Redbook 2000: III Recommended Toxicity Studies (Status: Final)