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FDA Guidance for Industry: Voluntary Labeling for Foods Derived from Genetically Engineered Plants

Food labels are the face of a product and manufacturers use them to provide consumers with FDA mandated information, such as product name, net weight, nutrition facts, etc. But food companies also use labels as a way to advertise and voluntarily share additional information that consumer may want to see.

Often, consumers want to know the sources of their food, one recent discussion has been focused on the genetic engineering of plant-based foods. The FDA uses the terms “genetic engineering” and “bioengineering” to identify foods made with the use of modern technology. The guidance defines modern biotechnology as the application of in vitro nucleic acid techniques that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants. There are many terms used in the industry to describes the use of modern technology food production. For various statement examples and details about food types, see the FDA guidance.

In 1992, the FDA determined that bioengineered foods are not different from other foods in any meaningful or uniform way or are a different or greater safety concern. Therefore, bioengineering information is not required to be disclosed on the food label. The FDA encourages food producers to use labeling terminology that most accurately describes the meaning of the scientific technology used to produce the foods. Overall, the FDA guidance emphasizes that all information (including voluntary information) on a food label must be truthful and not misleading.

The Tentamus Group, in particular, Tentamus North America, offers various services to assist in ensuring your food label is compliant:

  • Product label claim review
  • Product full label review for FDA compliance
  • Product full label review for USDA compliance
  • Product nutritional analysis and nutrition fact creation and review

The FDA guidance about the voluntary labeling of foods derived from genetically engineered plants can be found here: https://www.fda.gov/media/120958/download

Get in touch with our experts. We’re ready to discuss your requirements.


Vy Goddard, Regulatory Affairs Specialist

Tentamus North America


(540) 684-9211

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