Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants

Description

Manufacturers often voluntarily provide information on their labels beyond the information required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or FDA regulations. Their reasons for doing so may have to do with marketing or providing information of specific interest to their customers. This guidance addresses the voluntary labeling of plant-derived foods with information concerning whether the food was or was not produced using genetic engineering. Some consumers are interested in knowing whether a food was produced using genetic engineering and some manufacturers want to respond to this consumer interest. FDA is providing this guidance to assist food and feed manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering. FDA's main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading.

Scope & Applicability

Regulatory Context

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

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

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

  (a) Definitions —Read full regulation →

• 21CFR101.13§ 101.13 Nutrient content claims—general principles.

  (a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.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 →

• 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 →

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

  (a)Read full regulation →

• 21CFR101.2§ 101.2 Information panel of package form food.

  (a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions:Read full regulation →

• 21CFR501.4§ 501.4 Animal food; designation of ingredients.

  (a) Ingredients required to be declared on the label of a food, including foods that comply with standards of identity that require labeling in compliance with this part 501, except those exempted by § 501.100 , shall be listed by common or usual name in descending order of predominance by weight onRead full regulation →

• 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 →

• 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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• CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (Status: Final)
• CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm (Status: Final)
• CVM GFI #158 Use of Material from Deer and Elk in Animal Feed (Status: Final)