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The Food and Drug Administration (FDA) has released a draft guidance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
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
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Comments on the draft guidance may be submitted to FDA by March 19, 2001.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,
For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at firstname.lastname@example.org.