CPG Sec 540.700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. The purpose of this document is to provide guidance for FDA staff on the proper labeling for processed and blended seafood products made primarily with fish protein.

Scope & Applicability

• 21CFR101.4§ 101.4 Food; designation of ingredients.

  (a)Read full regulation →

• 21CFR101.100§ 101.100 Food; exemptions from labeling.

  (a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).Read full regulation →

• 21CFR101.3§ 101.3 Identity labeling of food in packaged form.

  (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →

• CGMP/Dietary Supplement/Adulterated/Misbranded

  Time Challenger Labs International, Inc.

  2025-09-30

• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

  CR Grupo Comercial Alvacora S.A.

  2022-09-13

• Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

  H2 Beverages, Inc.

  2022-07-19

• Unapproved New Drugs/Misbranded

  Nutrishus Brands, Inc.

  2021-07-28

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