FDA labeling final proprosal

[Guest guest]

Okay so the lawyer wanna be in me read (aka skimmed) through the actual regulation and proposal.

Bottom line - they had issue with saying that 20ppm was low gluten or gluten free due to how many people actually would have an adverse reaction to that amount.

Kinda interesting how they offset the cost celiacs would incur by not being able to truly follow the labeling. How they would have to search elsewhere and those who don't suffer would not necessarily benefit. If you feel the need - go check out the link.

But the end result was very nicely attached at the very end.

Here it is.

Melita

Federal Register: January 23, 2007 (Volume 72, Number 14)][Proposed Rules][Page 2795-2817]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr23ja07-10]

PART 101--FOOD LABELING 1. The authority citation for 21 CFR part 101 continues to read asfollows: Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,343, 348, 371; 42 U.S.C. 243, 264, 271. 2. Section 101.91 is added to subpart F to read as follows: Sec. 101.91 Gluten-free labeling of food. (a) Definitions. (1) The term ``prohibited grain'' means any one ofthe following grains or their crossbred hybrids (e.g., triticale, whichis a cross between wheat and rye): (i) Wheat, including any species belonging to the genus Triticum; (ii) Rye, including any species belonging to the genus Secale; or (iii) Barley, including any species belonging to the genus Hordeum. (2) The term ``gluten'' means the

proteins that naturally occur ina prohibited grain and that may cause adverse health effects in personswith celiac disease (e.g., prolamins and glutelins). (3) The labeling claim ``gluten-free'' or similar claim (e.g.,``free of gluten,'' ``without gluten,'' ``no gluten'') means that thefood bearing the claim in its labeling does not contain any of thefollowing: (i) An ingredient that is a prohibited grain (e.g., spelt wheat); (ii) An ingredient that is derived from a prohibited grain and thathas not been processed to remove gluten (e.g., wheat flour); (iii) An ingredient that is derived from a prohibited grain andthat has been processed to remove gluten (e.g., wheat starch), if theuse of that ingredient results in the presence of 20 parts per million(ppm) or more gluten in the food (i.e., 20 micrograms or more glutenper

gram of food);

(iv) 20 ppm or more gluten. ( Requirements. (1) A food that bears the claim ``gluten-free''or similar claim in its labeling and fails to meet the conditionsspecified in paragraph (a)(3) of this section will be deemedmisbranded. (2) With the exception of foods made from oats, a food that doesnot inherently contain any gluten from a prohibited grain (e.g., milk,corn, frozen concentrated orange juice) and that bears the claim``gluten-free'' in its labeling will be deemed misbranded unless: (i) The claim refers to all foods of that same type (e.g., ``milk,a gluten-free food,'' ``all milk is gluten-free''); and (ii) The food does not contain 20 ppm or more gluten. (3) A food made from oats that bears the claim ``gluten-free'' orsimilar claim in its labeling will be deemed

misbranded if the claimrefers to all foods of the same type (e.g., ``all oats are gluten-free'') or if the food contains 20 ppm or more gluten. © Compliance. When compliance with paragraph ( of this sectionis based on an analysis of the food, FDA will use a method that canreliably detect the presence of 20 ppm gluten in a variety of foodmatrices, including both raw and cooked or baked products. Dated: January 16, 2007. Shuren,Assistant Commissioner for Policy.[FR Doc. E7-843 Filed 1-22-07; 8:45 am] BILLING CODE 4160-01-S