Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon

Description

This document provides guidance intended to assist food manufacturers that wish to voluntarily label their food products or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon. This document also provides guidance on voluntary statements that may be appropriate for species of salmon that have no GE counterparts. FDA’s main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading.

Scope & Applicability

Regulatory Context

• 21CFR102.5§ 102.5 General principles.

  (a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →

• 21CFR501.3§ 501.3 Identity labeling of animal food in package 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 →

• 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 →

• 21CFR589.2000§ 589.2000 Animal proteins prohibited in ruminant feed.

  (a) Definitions —Read full regulation →

• 21CFR101.17§ 101.17 Food labeling warning, notice, and safe handling statements.

  (a) Self-pressurized containers.Read full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.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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