978-1285770178 Case Printout Case CPC-24-05 Part 2

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page-pf1
ing its own requirements for nutrition information
labeling, see 21 U.S.C. § 343-1(a)(4), but it does
generally preempt it from adopting different rules for
boards are “claims” falling under Section 343(r) and
are thus preempted, or are “nutrition information”
information listed in Section 343(q), would not be
preempted by the NLEA.
FN7. NYSRA argues that the doctrine of
tion, we do not reach this question.
page-pf2
page-pf3
© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.
*126 Information that is required or permitted ... to
be declared in nutrition labeling, and that appears
as part of the nutrition label, is not a nutrient con-
tent claim and is not subject to the requirements of
this section. If such information is declared else-
where on the label or in labeling, it is a nutrient
content claim and is subject to the requirements for
“simple factual information” from the definition of
“nutrient content claim” on the theory that such a
The agency advises that while it can agree
(October 24, 1990)). Moreover, the state-
ment in section 403(r)(1) of the act re-
ferred to by the comment as excluding
from coverage statements of the type con-
tained in nutrition labeling, in fact ex-
cludes “a statement of the type required
by paragraph (q) that appears as part of
the nutrition information required or per-
mitted by such paragraph * * *.” FDA
stated in the general principles proposal
(56 FR 60421 at 60424), that the legisla-
403(r)(2)(A)(i) through (r)(2)(A)(v), “a
statement in the label or labeling of food
claims. Furthermore, section
of a nutrient in food.
page-pf4
58 Fed.Reg. 2302-01, 2303-04 (1993)
information under Section 343(q); otherwise the “nu-
trition information” becomes a “claim,” subject to
Section 343(r), and preempted by Section 343-
1(a)(5). Thus, NYSRA goes one step further than the
pressed the view that the NLEA recognizes
the authority of states to require restaurants
page-pf5
to disclose nutrition content to their custom-
www. cfsan. fda. gov/~ dms/ nutrcal. html
(last visited Jan. 13, 2009) [hereinafter Key-
stone Report ] (“[T]he FDA does not have
regulatory authority to require nutrition in-
formation in restaurants. The U.S. Congress
and state legislatures do have the authority
Thus, since the regulations noted in Regulation
101.13-101.9 and 101.36-do not apply to nutrition
information mandated by state or local law to be
placed on restaurant food, the “third prong's” refer-
page-pf6
© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.
ence to “such information” does not speak to “infor-
mation” relating to restaurant food.FN14 Finally, the
“second prong” which references information that
appears “as part of the nutrition label,confirms this
reading. The FDCA defines “label” as any “display
of written, printed, or graphic matter upon the imme-
diate container of any article,” 21 U.S.C. § 321(k)
“The following foods are exempt from this
sion simply recognizes that food served in
ant to Section 343(q)(2)(A), in addition to
Our above analysis perhaps simply comes down to
this: accepting NYSRA's position-that states or mu-
nicipalities choosing to regulate nutrition information
labeling by restaurants may do so only by adopting
labeling requirements that are identical to those listed
in Section 343(q) and Regulation 101.9-would render
Section 343-1(a)(4)'s exception for preemption mean-
ingless.FN15 See FDA v. Brown & Williamson Tobac-
co Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146
tions,” Hillsborough County, 471 U.S. at 718, 105
S.Ct. 2371. Therefore, if there is any ambiguity in the
permit localities to mandate restaurants to disclose
100.1(d) (listing requirements to obtain
the requisite waiver, and Section 343-1(b)
addresses regulations that are actually
© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.
*126 Information that is required or permitted ... to
be declared in nutrition labeling, and that appears
as part of the nutrition label, is not a nutrient con-
tent claim and is not subject to the requirements of
this section. If such information is declared else-
where on the label or in labeling, it is a nutrient
content claim and is subject to the requirements for
“simple factual information” from the definition of
“nutrient content claim” on the theory that such a
The agency advises that while it can agree
(October 24, 1990)). Moreover, the state-
ment in section 403(r)(1) of the act re-
ferred to by the comment as excluding
from coverage statements of the type con-
tained in nutrition labeling, in fact ex-
cludes “a statement of the type required
by paragraph (q) that appears as part of
the nutrition information required or per-
mitted by such paragraph * * *.” FDA
stated in the general principles proposal
(56 FR 60421 at 60424), that the legisla-
403(r)(2)(A)(i) through (r)(2)(A)(v), “a
statement in the label or labeling of food
claims. Furthermore, section
of a nutrient in food.
58 Fed.Reg. 2302-01, 2303-04 (1993)
information under Section 343(q); otherwise the “nu-
trition information” becomes a “claim,” subject to
Section 343(r), and preempted by Section 343-
1(a)(5). Thus, NYSRA goes one step further than the
pressed the view that the NLEA recognizes
the authority of states to require restaurants
to disclose nutrition content to their custom-
www. cfsan. fda. gov/~ dms/ nutrcal. html
(last visited Jan. 13, 2009) [hereinafter Key-
stone Report ] (“[T]he FDA does not have
regulatory authority to require nutrition in-
formation in restaurants. The U.S. Congress
and state legislatures do have the authority
Thus, since the regulations noted in Regulation
101.13-101.9 and 101.36-do not apply to nutrition
information mandated by state or local law to be
placed on restaurant food, the “third prong's” refer-
© 2009 Thomson Reuters. No Claim to Orig. US Gov. Works.
ence to “such information” does not speak to “infor-
mation” relating to restaurant food.FN14 Finally, the
“second prong” which references information that
appears “as part of the nutrition label,confirms this
reading. The FDCA defines “label” as any “display
of written, printed, or graphic matter upon the imme-
diate container of any article,” 21 U.S.C. § 321(k)
“The following foods are exempt from this
sion simply recognizes that food served in
ant to Section 343(q)(2)(A), in addition to
Our above analysis perhaps simply comes down to
this: accepting NYSRA's position-that states or mu-
nicipalities choosing to regulate nutrition information
labeling by restaurants may do so only by adopting
labeling requirements that are identical to those listed
in Section 343(q) and Regulation 101.9-would render
Section 343-1(a)(4)'s exception for preemption mean-
ingless.FN15 See FDA v. Brown & Williamson Tobac-
co Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146
tions,” Hillsborough County, 471 U.S. at 718, 105
S.Ct. 2371. Therefore, if there is any ambiguity in the
permit localities to mandate restaurants to disclose
100.1(d) (listing requirements to obtain
the requisite waiver, and Section 343-1(b)
addresses regulations that are actually

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