Regulatory Information

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

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How to Comment

Submit electronic comments to https://www.regulations.gov in docket folder FDA-2000-D-0075.

Submit written comments to
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2000-D-0075.

Issued November 2015
Revised March 2019

Contains Nonbinding Recommendations

This guidance represents the current thinking of the Food and Drug Administration 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.

INTRODUCTION

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.

In this guidance, we use the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology. Modern biotechnology means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants (Ref. 1). The term “modern biotechnology” may alternatively be described as “recombinant DNA (rDNA) technology” (Ref. 2), “genetic engineering” (Ref. 3), or “bioengineering.” These terms are often used interchangeably by industry, federal agencies, international bodies, and other interested stakeholders and are used in this guidance to refer to foods derived from new plant varieties developed using modern biotechnology. The term “genetic modification” is also sometimes used to refer to the use of modern biotechnology (e.g., Ref. 4), although FDA’s longstanding position, as discussed later in this guidance, is that such use of the term is less accurate because the term encompasses the broad spectrum of genetic alterations that can be made in plants (see, e.g., Ref. 5).

Because technically it is the plant that is genetically engineered rather than the food, for simplicity we use the term “food derived from genetically engineered plants” in this guidance to refer to products that are derived from genetically engineered plants. (For reasons discussed in more detail later in this guidance, FDA does not use the terms “genetically modified” or “genetically modified organism” (GMO) when referring to foods derived from genetically engineered plants.) Because section 201(f)(1) of the FD&C Act defines “food” in relevant part as “articles used for food or drink for man or other animals,” the food derived from genetically engineered plants addressed in this guidance include plant-derived foods for animals as well as such foods for humans.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.

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