After years of silence, FDA issues new guidance on GMO labeling.

  • In 1992, FDA published a “Statement of Policy” which addressed, among other things, the labeling of foods derived from plants developed by bioengineering. The 1992 policy states that FDA has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.  Accordingly, the 1992 policy did not establish special labeling requirements for bioengineered foods.  In 2001, FDA published a guidance document reaffirming the Agency’s decision to not require special labeling of all bioengineered foods.  The document also offered guidance on the use of voluntary labeling indicating whether foods have or have not been developed using bioengineering.
  • In guidance released today, FDA revisited the topic of voluntary labeling regarding whether food is derived from genetically engineered plants.  Today’s guidance is largely consistent with that issued in 2001; although FDA no longer takes the position, as it did in 2001, that the terms “GM” and “GMO” should be avoided because consumers do not understand these acronyms, the Agency continues to discourage use of the terms “GM” and “GMO,” though it does not intend to take enforcement action against either claim at this time, provided the statement is true and the food’s label is not otherwise misleading.
    • The agency discourages use of the unqualified terms “not genetically modified” or “no genetic modification” because these terms can encompass any alteration to genetic composition, including traditional breeding techniques. In place of these terms, the Agency recommends the terms “not genetically engineered,” “not bioengineered,” and “not genetically modified through the use of modern biotechnology.”
    • FDA discourages use of the term “genetically modified organism” and the abbreviation “GMO” because most foods do not contain entire organisms.
  • FDA also reiterated its position that the terms “free” or similar terms, such as “does not contain GMOs” and “non-GMO,” convey “zero or total absence” and, given the potential for adventitious presence of bioengineered material, the Agency is skeptical as to whether a “GMO-free” claim could be substantiated.  Today’s guidance did not indicate that the Agency intends to exercise enforcement discretion with respect to “free” claims.
  • Whether FDA’s action will have an impact in Congress, where Sen. Debbie Stabenow (D-Mich.) and Rep. Mike Pompeo (R-Kan.) are working to address the issue of federal preemption of state GMO labeling laws, remains to be seen.  Although litigation over Vermont’s GMO labeling law is ongoing, many industry leaders see federal legislation as the more promising avenue to prevent the labeling law from going into effect, given the approaching July 2016 effective date.