Hospitals

Proposed GMO labeling bill would block state laws

By Riëtte van Laack – Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states. If enacted, these state laws may expose companies to a patchwork of different…

By Riëtte van Laack

Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states.  If enacted, these state laws may expose companies to a patchwork of different GMO labeling requirements. 

On April, 10, 2014, Representatives Mike Pompeo (R-KS) and G. K. Butterfield (D-NC) introduced legislation that would nullify the efforts in multiple states to require labeling of GMOs.  H.R. 4432, the “Safe and Accurate Food Labeling Act of 2014” (“SAFLA”), would amend the FDC Act to include a provision preempting any state requirement regarding the sale, distribution, or marketing of a bioengineered organism intended for food use or application, and regarding food products from, containing, or consisting of a bioengineered organism.  We note that this clause does not appear to allow state laws that are identical to the federal law. 

SAFLA would require premarket review the safety of GMOs.  A company would be required to submit a premarket biotechnology notification to FDA at least 210 days before introduction into commerce of a GMO.  This notification would provide FDA with information about the notifier’s determination that food produced from or containing the GMO is as safe as the food from the non-GMO variety.  FDA would get 30 days to inform the notifier that the notification is complete or identify missing information.  Once FDA has informed the notifier that the notification is complete, the Agency would get 180 days for substantive review of the notification.  If FDA decides that the GMO variety is safe but materially different from the non-GMO variety and that disclosure of this material difference is necessary to product health and safety of the consumers or to prevent the labeling from being false and misleading, FDA may require specific labeling for the GMO variety.

Although the bill essentially would prohibit mandatory GMO labeling unless FDA determines that such labeling is necessary, it specifically would allow “non-GMO” claims.  Such claims would be permitted only if the ingredients are subject to certain supply chain process controls and meet certain limits for the presence of inadvertent GMOs.  FDA is to promulgate regulations that specify a maximum level of inadvertent GMOs that would be permissible in non-GMO foods.

The bill also addresses natural claims.  It would require that FDA issue regulations defining “natural” within 12 months after enactment of the law.  FDA has previously declined to address the term for courts (see our prior post here), but was recently petitioned to promulgate a regulation.

Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.

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