Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food

Description

This list of frequently asked questions (FAQ) is intended to be a convenient place to find answers to common questions about the food substance classification known as "generally recognized as safe" or "GRAS."

Scope & Applicability

Regulatory Context

• 21CFR170.3§ 170.3 Definitions.

  For the purposes of this subchapter, the following definitions apply:Read full regulation →

• 21CFR170.30§ 170.30 Eligibility for classification as generally recognized as safe (GRAS).

  (a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →

• 21CFR570.3§ 570.3 Definitions.

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

• 21CFR570.30§ 570.30 Eligibility for classification as generally recognized as safe (GRAS).

  (a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →

• 21CFR70.3§ 70.3 Definitions.

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

• 21CFR184.1245§ 184.1245 Beta -carotene.

  (a) Beta- carotene (CAS Reg. No. 7235-40-7) has the molecular formula C 40 H 56 . It is synthesized by saponification of vitamin A acetate. The resulting alcohol is either reacted to form vitamin A Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A Wittig reagent and vitamin A aldehyde are Read full regulation →

• Adulterated Human Foods/Misbranded

  STNR Creations, LLC

  2025-09-30

• Adulterated Human Foods/Misbranded

  Blue Forest Farms, LLC

  2025-09-16

• Adulterated Human Foods/Misbranded

  TKO Distribution, LLC

  2025-08-12

• Unapproved New Drug/Human Food/Adulterated

  Hydroxie, LLC

  2025-07-15

• Unapproved New Drug/Misbranded

  Royal Diamond Imports, Inc.

  2025-07-15

• CGMP/Dietary Supplement/Adulterated/Misbranded

  Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ

  2025-07-15

• Adulterated Human Foods/Misbranded

  Latro Inc.

  2025-06-03

• Unapproved New Animal Drug Products

  Holista LLC dba HolistaPet

  2025-04-29

• Unapproved New Animal Drug Products

  Bailey’s Wellness, LLC dba Bailey’s CBD

  2025-04-29

• Adulterated Human Foods/Unapproved New Drugs

  White Label Leaf, LLC/Flying Monkey US, LLC

  2024-07-23

• Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies (Status: Final)
• Redbook 2000: I Introduction (Status: Final)
• Redbook 2000: III Recommended Toxicity Studies (Status: Final)
• Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions (Status: Final)
• 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)
• Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) (Status: Final)
• Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2) (Status: Draft)
• Guidance for Industry: Best Practices for Convening a GRAS Panel (Status: Final)