Docket Management
Docket: 00D-1598 - Voluntary Labeling Indicating Whether Foods Have Been Developed Using Bioengineering
Comment Number: EC -187

Accepted - Volume 43

Comment Record
Commentor Ms. Katherine Houston Date/Time 2001-02-27 16:13:31
Organization Ms. Katherine Houston
Category Individual

Comments for FDA General
1. General Comments This draft guidance represents FDA's current thinking on voluntary labeling of foods indicating whether foods have or have not been developed using bioengineering. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This is a ridiculous proposal! Since when has any voluntary sharing of information benefited the *consumer* rather than the producer?! I DEMAND that ALL food products containing ANY ingredients derived from genetic altering be so identified, with labels that are UP FRONT AND OBVIOUS! I have a right - no, a duty - to know what I'm eating. Any business which provides a product considered food should be required to inform me of ALL that product's ingredients, period. I do not want to be another government guinea pig because my government won't come down on the side of safety! REQUIRE labelling of ALL food ingredients. Tell us what we're eating, then let us decide whether or not we want to take the risk. To fully understand the agency's mandate and authority in requiring labeling of foods, one must refer to the Federal Food, Drug, and Cosmetic Act (the act) to determine the extent to which the agency is charged with governing labeling of foods. Section 403 governs the labeling of foods. Under section 403(a)(1), a food is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the act provides additional guidance on how labeling may be misleading. It states that labeling is misleading if it fails to reveal facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food to which the labeling relates under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual. Don't cloud the issue by quibbling over the definition of food, unless you want to be compared to Bill Clinton! If we put it in our mouths, chew it and/or just swallow it, it should be classified as either food or medication. If such food contains something that might be harmful, to even a portion of the consuming population, it should be so labelled! Since we don't yet know what effect genetically altered food may have when consumed, we should at least be forewarned. If we choose to eat such food anyway, then let the buyer beware. At least then we are acting under informed consent. Most of the comments that addressed labeling requested mandatory disclosure of the fact that the food or its ingredients was bioengineered or was produced from bioengineered food. However, these comments did not provide data or other information regarding consequences to consumers from eating the foods.... How could *anyone* - scientist or not - provide data for long-term adverse effects? The products haven't been available long enough to determine this! How many people have to have severe reactions or even DIE before you decide the product is significantly altered or materially different? Until long-term effects can be determined, it would be irresponsible of the FDA *not* to require labelling of such products. There will be plenty of consumers who *don't* read labels. Let them be studied for a few decades... then you'll have your data. The agency is still not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact that must be disclosed under sections 403(a) and 201(n) of the act. FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods. Whose side are you on, anyway?! Think Thalidomide! Fen-Phen! Quit experimenting on us! Kate Houston Box 495 Ephraim, WI 54211 PS The following paragraph is nonsense. If an ingredient is genetically altered, it's no longer the commonly known ingredient, so it can't be listed as an ingredient. If it's described separately as genetically altered, under the optional terms information section, that violates the law re: intervening material. It sounds as though even optional labelling would be a violation of the regulation. So much for consumer notification, voluntary or otherwise! A real Catch 22! FDA reminds manufacturers that the optional terms that describe an ingredient of a multi-ingredient food as bioengineered should not be used in the ingredient list of the multi-ingredient food. Section 403(i)(2) of the act requires each ingredient to be declared in the ingredient statement by its common or usual name. Thus, any terms not part of the name of the ingredient are not permitted in the ingredient statement. In addition, 21 CFR 101.2(e) requires that the ingredient list and certain other mandatory information appear in one place without other intervening material. FDA has long interpreted any optional description of ingredients in the ingredient statement to be intervening material that violates this regulation.

EC -187