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FDA Asks For Voluntary Labeling Of Biotech Foods

Date: Mar 01, 2001


The Food and Drug Administration (FDA) has released a draft guidance for industry on voluntary labeling for biotech foods. With this guidance, titled "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering," FDA intends to ensure that biotech-related labeling is truthful and not misleading.

The guidance does not require special labeling for biotech foods. FDA maintains its position that a food product's development through bioengineering is not a material fact requiring disclosure on the label. Thus, FDA's current biotech labeling policy remains the same. Special labeling for biotech foods is required only when the product contains potential allergens or otherwise differs significantly from traditional food.

FDA discourages the use of terms such as "GMO free" and "not genetically modified," on the basis that such claims are generally inaccurate. Because traditional methods of cross-breeding cause genetic modifications, FDA cautions that it may be inaccurate to state that a food was "not genetically modified" unless the claim is qualified to make clear that the statement applies to bioengineering. With regard to "GMO free," FDA believes that such a claim is misleading because food products do not ordinarily contain organisms.

To indicate that a food was developed without the use of biotechnology, FDA recommends claims such as "our tomato growers do not plant seeds developed using biotechnology" or "we do not use ingredients that were produced using biotechnology."

Additionally, such claims must not imply that food is superior "such as, safer or of higher quality" simply because it was not bioengineered. Regardless of the wording, claims that foods or ingredients are not bioengineered must be substantiated through validated testing or" in the event that testing is not available or reliable" through the use of other documentation.

The guidance is available on the Internet at http://vm.cfsan.fda.gov/~dms/biolabgu.html. Comments on the draft guidance may be submitted to FDA by March 19, 2001. [66 Fed. Reg. 4839 (Jan. 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.