FDA Petition

Word Doc Version

Citizen Petition

The undersigned submits this petition under the proposed rules regarding gluten free labeling as proposed in 21 CFR Part 101 and for the 2004 law
of conforming amendments found in Sec 201-21 U.S.C. 321 (c) regarding food items that must be included on labels per federal law.

Action requested

CFR Part 101 states in volume 72 number 14 Pages 2795-2817, Sec.101.91(a)(3) in the federal register proposes that the definition of the term 
``Gluten-Free” to mean that a food bearing the claim in its labeling does not contain any of the following: (1) An ingredient that is a prohibited grain; 
(2) an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten; (3) an ingredient that is derived from a
prohibited grain and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 ppm or more gluten in the food
(i.e., 20 micrograms or more gluten per gram of food); or (4) 20 ppm or more gluten.

Food Allergen Labeling and Consumer Protection Act of 2004, Section 201 Act 21 U.S.C. 321 (6)(C) states the term `major food allergen' means
any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans,
or walnuts), wheat, peanuts, and soybeans.

I, ___________________, suffer from ______________ , which makes it very difficult for my family and me to purchase manufactured products.

In the first regulation listed above, the FDA proposes that manufactures can list a product as gluten free if the presence of gluten is less than 20 ppm of
gluten. This is absolutely not acceptable to the celiac community as any amount of gluten is considered toxic to our systems. If a product is to be listed as
gluten free, consumers should be assured that no gluten is in that product, not even a negligible amount. This type of labeling can have serious
ramifications to an individual with food allergies, the most serious consequence being asphyxiation from undisclosed ingredients. I, along with many
other individuals who suffer from food allergies, urge the FDA to require manufacturers to list all ingredients including trace amounts and only be able
to state gluten free if the product is truly 100 % gluten free.

In the second regulation which revolutionized food labels to contain the top eight allergens on all labels is to be applauded, but this does not help
all individuals who suffer from allergens, diseases and intolerances. As consumers, we should be able to purchase a product and know exactly what
we are consuming. Celiacs for example cannot consume wheat, barley, spelt, and rye and with the current labeling laws we are able to determine if
wheat is present, but still struggle to know if we are truly purchasing and consuming a gluten free product. Individuals with food allergies and intolerances
need accurate labeling for all ingredients and not just the top eight allergens. Again this type of labeling can have serious ramifications to an individual
with food allergies, the most serious consequence being asphyxiation from undisclosed ingredients. I, along with many other individuals who suffer
from food allergies, urge the FDA to require manufacturers to list all ingredients, including trace amounts on all food labels.

My recommendation would be simply to add a line after the words modified food starch, natural flavorings, artificial flavoring, and/or any ingredient that is not listed in a clear manner, by telling what it is derived from. An example of this would be "modified food starch (derived from wheat, barley, spelt, corn);" or to substitute the vague term with a more specific term. An example of this would be "modified wheat starch" instead of "modified food starch," or "garlic oil" rather than "spices."

Possible environmental impact: None known

Possible economic impact: We believe that initially this may cause some economic strain, as manufacturers may be required to investigate more into what ingredients are present in their products. Individuals with allergies may also refrain from purchasing products that they discover, via more in-depth labeling, contain their allergens.

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which is unfavorable to the petition.

Melissa Taylor
www.angelfire.com/mi/FAST
Food Allergy Survivors Together Co-founder

Contacts:

Lucy Shriver
www.glutenfreekitchen.org
The Gluten-Free Kitchen Founder and Petition Author

Please add your own comments to the FDA. They are interested in your suggestions and experiences.

__________________________________________________________________________________________

_________________________________________________________________________________________

Signature___________________________

Name Printed _______________________

Mailing Address______________________

City, State, Zip ______________________

Telephone Number____________________

Please print and mail to: FDA Dockets Management Branch, HFA-305 Food and Drug Administration 5630 Fishers Lane, Rm 1061. Rockville, MD 2085