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
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