The Federal Food, Drug and Cosmetic Act (FD&C Act) provides that a food is misbranded if its labelling is false or misleading in any particular, which includes the failure to reveal facts that are material in light of express or implied representations. The Federal Food and Drug Administration (FDA) does not require a food derived from genetically engineered plants to be labelled to disclose the use of genetic engineering, if the food is substantially equivalent to its conventional counterpart, relying on scientific consensus regarding the safety of marketed foods produced using genetic engineering.

FDA’s ‘Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants’ (2015) includes general principles and recommendations for voluntary statements. FDA discourages use of the term ‘genetically modified organism’ (GMO) when referring to foods derived from genetically engineered plants, given that the acronym applies to traditional breeding and selection as well as to modern biotechnology, but does not intend to take enforcement action against a label statement using the acronym if the statement is true and the labelling is not otherwise false or misleading.

Proponents of ‘right-to-know’ GMO labelling, frustrated by the lack of a federal requirement, supported numerous efforts in recent years to enact mandatory GMO labelling at the state level. Some states passed such laws but with trigger clauses that prevented implementation unless neighbouring states also passed mandatory GMO labelling laws. Legislation was unsuccessfully introduced in many other states. And ballot initiatives failed in four states.

Jan-Mar 2017 Issue

Keller and Heckman LLP