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Concurrently with releasing the draft guidance for voluntary labeling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
"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,
For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at email@example.com.