From: Koontz, Devin J Sent: Monday, January 22, 2001 12:24 PM To: Butler, Jennie C Subject: FW: Label Genetically Engineered Food Jennie- Please add this to the other comments received. Devin Koontz Public Affairs Specialist Denver District Office Food and Drug Administration phone: 303-236-3020 fax: 303-236-3551 e-mail: dkoontz@ora.fda.gov -----Original Message----- From: Judy Reed [mailto:judyreedco@earthlink.net] Sent: Friday, January 19, 2001 10:14 PM To: vwalker@ora.fda.gov; dkoontz@ora.fda.gov Subject: Label Genetically Engineered Food January 19, 2001 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm 1061 Rockville, MD 20852 Office of Consumer Affairs FDA, (HFE-88) 5600 Fishers Lane Rockville, MD 20857 Phone: 301-827-5006 Fax: 301-443-9767 1-888-INFO-FDA (1-888-463-6332) Food and Drug Administration Denver Federal Center Building 20, Room B-1121 6th Ave. and Kipling Denver, CO 80225-0087 Fax: (303) 236-3551 Virlie Walker (303) 236-3018 vwalker@ora.fda.gov Devin Koontz (303) 236-3020 dkoontz@ora.fda.gov Re: Docket No. 00D-1598 "Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering" Dear FDA: I am deeply disappointed that the FDA continues to make labeling of genetically engineered foods mandatory. The FDA ignores the will of the public when it says the 50,000 comments it received last year requesting mandatory disclosure that food or its ingredients was bioengineered, or was produced from bioengineered food, "did not provide data or other information regarding consequences to consumers from eating the food." The truth is there has been ample evidence submitted to the FDA that reveals these foods are NOT "substantially equivalent" to non-genetically engineered foods. Yet the FDA continues to ignore the evidence. Studies have shown that biotech soybeans contain altered levels of nutrients such as isoflavones. They have been shown to have higher levels of Kunitz trypsin inhibitor, a known antinutrient and allergen. Genetically engineered foods contain antibiotic marker genes and many contain built-in pesticides. Monsanto admitted to finding "unexpected gene fragments" in their genetically engineered soybeans. What other "unexpected gene fragments" are contained in other genetically engineered foods? The truth is that the FDA does not know, because these experimental foods have not been adequately tested. New proteins never before consumed by humans are being created and brought to market without any extensive tests being done to show that they are not causing allergies, cancer or other diseases. I do not want to eat these biotech foods. Without mandatory labeling I have no choice. In the case of genetically engineered foods, the FDA has done a poor job of protecting the safety of consumers. Please remember that the potential allergies created by the ingestion of StarLink corn completely escaped the FDA regulatory guidelines. It was the EPA that discovered the digestive problems associated with StarLink corn. The FDA has been accused of being a pawn of biotech industry. Documents such as the Draft Guidance for Industry leads many of us to believe it is true. In the Draft Guidance, the FDA questions whether manufacturers who choose not to use genetically engineered ingredients should be able to label their products as GMO Free. It is bad enough that the FDA does not require the mandatory labeling of genetically engineered foods. Now the FDA is even exploring the restricting of the ability of a manufacturer to advise consumers that products are not genetically engineered. Such regulatory restrictions would be an outrageous act of censorship by the FDA. Genetically engineered foods are required to be labeled in the European Union nations, in Japan, Australia, New Zealand and other countries. Recently, both the E.U.-U.S. Biotechnology Consultative Forum and the Consumer Federation of America recommended mandatory labeling of genetically engineered foods. Stop working on behalf of the manufacturers of genetically engineered foods and work for the safety of the American public. I insist that genetically engineered foods be labeled! Sincerely, -- Judy Reed 7267 So Clermont Drive Littleton CO 80122 303-694-9329 judyreedco@earthlink.net ...