Update Nov Dec 2013 - (Page 25)

Enforcement condition make food choices with confidence and allow them to better manage their health."9 What is "Gluten"? FDA has defined the term ''gluten'' to mean "the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with Celiac Disease".10 The term ''gluten-containing grain'' is defined as "any one of the following grains or their crossbred hybrids: * Wheat, including any species belonging to the genus Triticum11; * Rye, including any species belonging to the genus Secale12; or * Barley, including any species belonging to the genus Hordeum13. What is "Gluten Free"? FDA has determined that the labeling claim ''gluten free'' means the food bearing the claim in its labeling does not contain any of the following: * An ingredient that is a gluten-containing grain14; * An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten15; or * An ingredient that is derived from a gluten-containing 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. 16 "Gluten free" claims also mean that the food inherently does not contain gluten and "any unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten".17 A food that bears the claim "gluten free", "no gluten", "free of gluten", or "without gluten" in its labeling and fails to meet the requirements of the final rule will be deemed misbranded.18 FDLI Misbranding occurs if a food product's labeling is false or misleading.19 Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled "gluten-free" if they inherently don't have any gluten.20 adminiStration, (Aug. 2, 2013) available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm363474.htm (last visited Aug. 25, 2013) [hereinafter "FDA Gluten-Free Press Release"] 2. What is Celiac Disease?, Nation- Gluten Free Compliance Deadline for Food Manufacturers is August 5, 2014 al Foundation for Celiac Aware- The final rule for gluten-free labeling becomes effective on September 4, 2013.21 The compliance deadline for the final rule is August 5, 2014, giving food manufacturers one year after the rule is published to bring their product labels into compliance.22 Food manufacturers with products bearing such claims should use the next twelve months to conduct testing on these products, to verify the eligibility of gluten-free claims on its labeling and the ppm of gluten that is present in the respective products. "We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with Celiac Disease to identify foods that meet the federal definition of 'gluten-free'," said Michael R. Taylor, FDA's deputy commissioner for foods and veterinary medicine.23 Food manufacturers with questions regarding compliance with this final rule are encouraged to e-mail their questions to FDA directly. FDA has established an inquiry email address specifically for gluten regulation questions at GlutenFreeFinalRuleQuestions@fda.hhs.gov. liac%20Disease%202-2011.pdf (last ness, available at http://www. celiaccentral.org/SiteData/docs/ NFCAWhatis/97976cf09194b986/ NFCA%20-%20What%20is%20Cevisited Aug. 25, 2013). 3. Id. 4. Id. 5. 65 Food Drug L.J. 367 (2010). 6. Id. at 367, 368. 7. FDA Consumer Update: What is Gluten-Free? FDA Has an Answer, U.S. Food and drUg adminiStration available at http://www.fda.gov/ downloads/ForConsumers/ConsumerUpdates/UCM363276.pdf (last visited Aug. 25, 2013). 8. Id. 9. FDA Gluten-Free Press Release, supra note 1. 10. 21 C.F.R. § 101.91(a)(2) (2013). 11. 21 C.F.R § 101.91(a)(1)(i) (2013). 12. 21 C.F.R § 101.91(a)(1)(ii) (2013). 13. 21 C.F.R § 101.91(a)(1)(iii) (2013). 14. 21 C.F.R. § 101.91(a)(3)(i)(A)(1) (2013). 15. 21 C.F.R. § 101.91(a)(3)(i)(A)(2) (2013). 16. 21 C.F.R. § 101.91(a)(3)(i)(A)(3) (2013). 17. 21 C.F.R. § 101.91(a)(3)(i)(B) (2013). 18. 21 C.F.R. §§ 101.91(b)(1)-(2) (2013). 19. 21 U.S.C. §§ 343 (a)(1)-(2); 21 C.F.R. § 101.18 (Apr. 1, 2012) available at http:// www.gpo.gov/fdsys/pkg/CFR-2012title21-vol2/pdf/CFR-2012-title21-vol2sec101-18.pdf (last visited Aug. 25, 2013). 20. FDA Consumer Update: What is Gluten-Free? FDA Has an Answer, supra note 7. 1. 78 FR 47154 (Aug. 5, 2013) available at http://www.gpo.gov/fdsys/pkg/ FR-2013-08-05/pdf/2013-18813.pdf (last visited Aug. 25, 2013) [hereinafter "New FDA Regulation"]; Press Release: FDA Defines "Gluten-Free" for Food Labeling, U.S. Food and drUg 21. FDA Gluten-Free Press Release, supra note 1. 22. New FDA Regulation, Sec. II.B.4 comment 35 and response 35, supra note 1. 23. FDA Gluten-Free Press Release, supra note 1. November/December 2013 Update 25 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm http://www.celiaccentral.org/SiteData/docs/NFCAWhatis/97976cf09194b986/NFCA%20-%20What%20is%20Celiac%20Disease%202-2011.pdf http://www.fda.gov/downloads/ForConsumers/Consumer-Updates/UCM363276.pdf http://www.gpo.gov/fdsys/pkg/CFR-2012-title101-18.pdf http://www.gpo.gov/fdsys/pkg/FR-2013-08-05/pdf/2013-18813.pdf http://www.gpo.gov/fdsys/pkg/FR-2013-08-05/pdf/2013-18813.pdf

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013