FDA proposes new biotech food policies

FDA plans to release a proposed rule this week that would for the first time legally require that manufacturers notify the agency prior to marketing biotech foods. It also will propose a guidance setting terms for voluntary labeling of biotech foods.

Under the proposed rule, manufacturers would be required to submit data regarding plant-derived bioengineered foods intended for human or animal consumption at least 120 days prior to commercial distribution. The policy, which formalizes the current voluntary system, was widely expected. FDA emphasized that it is not suggesting that the existing consultation process be replaced with mandatory requirements for pre-market approval of biotech foods, a step requested by consumer groups and biotech opponents that would significantly increase both the cost and time required to develop biotech products. The agency indicated that the proposed rule is a response to concerns raised by the public and state governments and is intended to ensure that FDA "remains aware of new bioengineered foods entering commercial distribution." ...