November 20, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Publishes Final Guidance on the Voluntary Labeling of GE Foods; FDA Denies Petition to Require GE Food Labeling; FDA's Fortification Policy Guidance - Hogan Lovells Memo; FDA Proposed Rule on Gluten-Free Labeling - Hogan Lovells Memo
FDA Publishes Final Guidance on the Voluntary Labeling of GE Foods
JPA members were previously notified that the Food and Drug Administration (FDA) had issued a draft guidance related to the voluntary labeling of genetically engineered foods. Yesterday, the Agency issued a press release, available here, announcing the availability of two guidance documents pertaining to the labeling of foods containing GE ingredients. Of particular note, the Agency published the final guidance, “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants,” available here. The Agency has also approved a GE salmon (AquAdvantage Salmon) intended food, and released a draft guidance, available here, regarding the labeling foods derived from Atlantic salmon. This communication will focus on the FDA’s final guidance on the voluntary labeling of GE foods from plants.
The final guidance notes, “Food manufacturers may voluntarily label their foods with information about whether the foods were not produced using bioengineering, as long as such information is truthful and not misleading.” The Agency provides the following examples of acceptable statements.”
• “Not bioengineered.”
• “Not genetically engineered.”
• “Not genetically modified through the use of modern biotechnology.”
• “We do not use ingredients that were produced using modern biotechnology.”
• “This oil is made from soybeans that were not genetically engineered.”
• “Our corn growers do not plant bioengineered seeds.”
Instead of using the term “GMO” (genetically modified organism), the FDA recommends that manufacturers use terms such as “not bioengineered,” “not genetically engineered,” and “not genetically modified through the use of modern biotechnology.” The FDA notes it does not intend to take enforcement action against a label using “GMO” in a statement indicating that the product or ingredient was not produced through the use of modern biotechnology, as long as the food is not derived from a GE plant and the food’s labeling is not otherwise false or misleading.
Statements Regarding “Not Genetically Modified” or “Non-genetically Modified”
The FDA notes the term “genetically modified” can encompass any alteration to the genetic composition of a plant, including alterations achieved through traditional hybridization or breeding techniques and as such, that term could apply to most cultivated food crops since most food crops are the product of selective breeding. The Agency recommends that manufacturers use labeling claims that state that a plant-derived food product or its ingredients was not developed using bioengineering, genetic engineering, or modern biotechnology. Alternatively, the terms bioengineering, genetic engineering, or modern biotechnology could be used in conjunction with claims using the term “genetically modified” or “genetic modification” to indicate that a plant-derived food has not been genetically engineered or bioengineered (e.g., “not genetically modified through the use of modern biotechnology”).
Statements Related to “GMO free,” “GE free,” “does not contain GMOs,” “non-GMO,” and Similar Claims
The FDA recommends that manufacturers not use food labeling claims that indicate that a food is “free” of ingredients derived through the use of biotechnology as the term “free” conveys zero or total absence. The FDA recommends that manufacturers consider the use of other types of statements to indicate that a plant-derived food has not been produced using bioengineering, as described above and below.
FDA Denies Petition to Require GE Food Labeling
JPA previously notified members that the Center for Food Safety (CFS) had submitted a petition to the FDA requesting that the Agency require the labeling of GE foods. According to an article published yesterday on FoodProcessing.com, available here, the FDA has denied the request, as there is no sufficient basis to do so. The article notes the FDA stated:
"The petition does not provide evidence sufficient to show that foods derived from genetically engineered plants, as a class, differ from foods derived from non-GE plant varieties in any meaningful or uniform way, or that as a class, such foods present any different or greater safety concerns than foods developed by traditional plant breeding."
"…while we appreciate consumer interest in the labeling of food derived from genetically engineered plants, consumer interest alone does not provide a sufficient basis to require labeling disclosing whether a food has been produced with or without the use of such genetic engineering. Absent a sufficient basis to require such labeling, the agency cannot compel food manufacturers to label their foods with information regarding whether such foods were produced through the use of genetic engineering."
A copy of the FDA letter to CFS is available here.
FDA's Fortification Policy Guidance - Hogan Lovells Memo
On November 6, 2015, JPA members were notified that the FDA had published a new guidance, “Questions and Answers on FDA’s Fortification Policy,” available here. JPA's legal counsel, Hogan Lovells, recently issued a memorandum, available here, providing additional details regarding the policy.
FDA's Proposed Rule on Gluten-Free Labeling - Hogan Lovells Memo
On November 18, 2015, JPA members were notified that the FDA had published a proposed rule regarding use of the claim "gluten-free" on fermented, hydrolyzed or distilled foods. Hogan Lovells has published a memorandum, available here, providing key details related to the proposed rule.
As always, please contact me with questions or comments.
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