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FDA Releases Labeling Guidance for Genetically Engineered Foods

Nov 24, 2015

The Food and Drug Administration (FDA) issued final guidance last week for voluntary labeling to indicate whether or not a food has been derived from genetically engineered (GE) plants. The agency also issued draft guidance on voluntary labeling to show whether food contains newly approved GE salmon. Along with issuing these guidance documents and approval of the first GE animal intended for food, FDA denied a citizen petition that requested FDA mandate GE labels on biotech food products.

“These newly issued guidance documents reaffirm FDA’s long-standing policy that the agency cannot mandate labeling of foods derived from GE sources unless there is a material difference – such as a different nutrient profile – between the GE product and its non-GE counterpart,” said Cary Frye, IDFA vice president of regulatory and scientific affairs. “Although this guidance does not have the same authority as regulations, it does represent the agency’s current thinking for GE labeling.”

Labeling Guidance

In the final labeling guidance, FDA outlined that food manufacturers may voluntarily label their foods as not being produced using genetic engineering or biotechnology as long as the information is truthful, not misleading and contains information in a context that clearly refers to biotechnology but does not imply that the food is safer than GE foods. For example, food manufactures could use statements on non-GE foods such as:

  • “Not bioengineered;”
  • “Not genetically engineered;”
  • “Not genetically modified through the use of modern technology;” and
  • “We do not use ingredients that were produced using modern biotechnology.”

FDA would allow for the use of other terms such as “not genetically modified” and the acronym “GMO,” but food manufacturers should ensure that the use of the acronym is not false or misleading when being used. FDA counsels against using the terms “GMO free,” “GE free,” “does not contain GMOs” and similar claims.

Likewise, food manufacturers may also voluntarily label foods to indicate that the products contain GE ingredients. Some examples are:

  • “Genetically engineered;”
  • “This product contains cornmeal from corn that was produced using modern biotechnology;” and
  • “Some of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant.”

FDA stated that labeling of a food to indicate GE content may be required to reveal the material fact of GE production when the food has significant nutritional properties or includes an allergen that consumers might not expect.

A manufacturer that makes a non-GE or GE claim on their food product or ingredient should be able to substantiate that the claim is not false or misleading. FDA suggests that this can be done by maintaining accurate records of handling practices and procedures, sourcing certified organic foods or using validated test methods.

It is important to note that FDA’s guidance only considers the food itself and does not address agricultural inputs like feed or hormones used in the production of food.

In conjunction to releasing these guidance documents, FDA approved the first GE animal for human consumption– a genetically altered salmon. No genetically engineered livestock or dairy cattle exist in the food supply.

Petition Denial

In addition to releasing the guidance documents, FDA also denied a citizen petition filed by the Center for Food Safety that requested FDA to require GE labels on biotech food products.

FDA denied the petition and refused to compel food manufacturers to label their products as being derived from GE products due to First Amendment concerns, and the petition not showing GE-derived foods present a different or greater safety concern than foods produced through conventional means.

This denial of the petition and these guidance documents are significant to advocates who continue to propose mandatory labeling, and could influence the decision of states with pending GE labeling laws. However, the guidance documents and petition denial do not have an effect on Vermont’s law, set to take effect in July 2016, or the underlying litigation challenging that law.  

Federal GE Legislation

Congress is still considering passing legislation that would pre-empt states from putting in place mandatory state labeling laws. The U.S. House of Representatives passed a bill, H.R. 1599, last July that included federal preemption, but the Senate has yet to take action. The House bill included provisions on voluntary labeling, and would require the FDA to define “natural” claims. The impact of all of the FDA releases last week could influence how and whether Congress decides to move forward on legislation.

Members with questions about the GE labeling guidance may contact Cary Frye, IDFA vice president of scientific and regulatory affairs, at , or Michelle Matto, IDFA nutrition and labeling consultant, at

Members with questions about the federal GMO labeling legislation may contact Ruth Saunders, IDFA vice president of policy and legislative affairs, at

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