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Biotech Foods Must Now Get FDA Clearance Before Going To Market

Date: Mar 01, 2001


Concurrently with releasing the draft guidance for voluntary labeling of biotech foods, the Food and Drug Administration (FDA) is proposing a new rule that will require food producers to notify FDA prior to marketing a food derived from biotechnology. The proposal converts the current voluntary premarket notification system for bioengineered foods into a mandatory program requiring the submission of safety data and related information in the form of a premarket biotechnology notification (PBN) 120 days prior to marketing.

Under the proposal, biotech foods cannot be sold until a favorable response is issued by FDA. If foods are marketed prior to receiving an FDA clearance, FDA will scrutinize the legal status of the food and take appropriate enforcement action if it decides that the food is adulterated, misbranded or otherwise not in full compliance with the law. FDA has also suggested it will also use the bully pulpit to keep notifiers in check.

"Bioengineered food" is defined expansively to include any food derived from a plant that is developed using a "transformation event," which is, in turn, defined as "the introduction into an organism of genetic material that has been manipulated in vitro." Bioengineered foods that have gone through the voluntary premarket notification process would not have to be reevaluated under the mandatory procedure, nor would new products that are essentially identical to previously evaluated products in both their derivation and their use.

Comments on the proposal are due on or before April 3, 2001. [66 Fed. Reg. 4706 (January 18, 2001)]

Used with permission. Copyright FOOD & DRUG PACKAGING, March, 2001.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.