Label Me Wise: Nutrition Labeling Update€¦ · Nutrition Labeling – FDCA 403(q) If [FDA]...
Transcript of Label Me Wise: Nutrition Labeling Update€¦ · Nutrition Labeling – FDCA 403(q) If [FDA]...
Label Me Wise: Nutrition Labeling Update
The Legal Framework Governing the FDA Rulemaking Process --
Key Issues Presented in the Nutrition Labeling Context
July 17, 2013
Sarah Roller JD, RD, MPH
Partner – Kelley Drye & Warren LLP
www.kelleydrye.com
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Agenda
U.S. Constitution
Admin.
Procedure Act
Federal Food Drug &
Cosmetic Act (FDCA)
Implementing Regulations & Enforcement
Policies
Key Requirements that
FDA’s Nutrition Labeling
Regulations Must Satisfy:
Federal Food Drug &
Cosmetic Act (FDCA),
as amended by the
Nutrition Labeling &
Education Act (NLEA)
Administrative
Procedure Act (APA)
First Amendment
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Nutrition Labeling – FDCA 403(q)
FDCA 403(q) provides that a food is
“misbranded” “unless its label or
labeling bears nutrition information
that provides –”
“the serving size which is an amount
customarily consumed and which is
expressed in a common household
measure that is appropriate to the food, or
. . . if the use of the food is not typically
expressed in a serving size, the common
household unit of measure that expresses
the serving size of the food” and
“the number of servings or other units per
container”
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Nutrition Labeling – FDCA 403(q)
FDCA 403(q) provides that a food is “misbranded”
“unless its label or labeling bears nutrition
information that provides –” (cont.)
“the total number of calories . . . derived from any source,
and . . . derived from the total fat, in each serving size or
other unit of measure of the food”
“the amount of the following nutrients: Total fat, saturated fat,
cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein contain
in each serving size or other unit of measure” and
“any vitamin, mineral, or other nutrient required to be placed
on the label and labeling of food under this Act before
October 1, 1990, if [FDA] determines that such information
will assist consumers in maintaining healthy dietary
practices.”
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Nutrition Labeling – FDCA 403(q)
If [FDA] determines that
another “nutrient . . . should be
included in the label or labeling
of food . . . For purposes of
providing information regarding
the nutritional value of such
food that will assist consumers
in maintaining healthy dietary
practices, [FDA] may by
regulation require that
information relating to such
additional nutrient be included
in the label or labeling of such
food.”
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Nutrition Labeling – FDCA 403(q)
If FDA determines that “the
information relating to a
[required] nutrient . . . is not
necessary to assist consumers
in maintaining healthy dietary
practices, [FDA] may by
regulation remove information
relating to such nutrient from
such requirement.”
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Nutrition Labeling – FDCA 403(q)
FDA “may by regulation require
any information required to be
placed on the label or labeling by
this subparagraph or
subparagraph (2)(A) to be
highlighted on the label or labeling
by larger type, bold type, or
contrasting color if [FDA]
determines that such highlighting
will assist consumers in
maintaining healthy dietary
practices.”
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Administrative Law Requires Agencies to Exercise
Authority in Accordance with Standards & Procedures
The APA requires federal agencies
to comply with defined substantive
standards and procedures when
undertaking agency actions,
including:
Promulgating Regulations
Issuing Policy Guidance
Ruling on Applications &
Petitions
Taking Enforcement Action
Establishes standards and
procedures governing judicial
review of agency actions.
Unlawful agency action may be
deemed:
“Abuse of Discretion”
“Arbitrary & Capricious”
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Substantive Requirements under the APA
• Agency must convince court that
they’ve taken a “hard look” at all
counter reasons and counter
studies – Motor Veh. Mfrs. Ass'n v.
State Farm Ins., 463 U.S. 29 (1983)
• Agency must adequately respond
to all critical comments – U.S. v.
Nova Scotia Food Prods. Corp., 568
F.2d 240 (2d Cir. 1977).
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Substantive Requirements under the APA
• Action must be supported by
evidence on the administrative
record & record must show that
the agency adequately considered
alternatives.
• Citizens to Preserve Overton Park
v. Volpe, 401 U.S. 402, 420
(1971) (“review is to be based on
the full administrative record that
was before the Secretary at the
time he made his decision”)
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Substantive Requirements under the APA
• Considerations:
• Does the evidence on the
record establish that the
proposed labeling regulation
“will assist consumers in
maintaining healthy dietary
practices”?
• Would supplying additional
evidence for the rulemaking
record be helpful?
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Constitutional Law Requires Agencies to Exercise
Authority in Accordance with Constitutional Standards
The First Amendment Limits the
Power of Federal & State
Governments to Restrict the
Freedom of Speech, Including
Commercial Speech:
Speech Bans
Speech Specifications
Compelled Speech
Other Content Restrictions Food Labels & Labeling
Food Advertising
Other Food Marketing Promotions Websites
Social Media
Mobile Apps
Other
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First Amendment Considerations
The First Amendment protects both the freedom to speak and refrain
from speaking.
Thompson v. W. States Med. Ctr., 535 U.S. 357, 373 (2002):
“Regulating speech must be a last – not first – resort.”
The First Amendment establishes an efficacy test that must be satisfied
by restrictions on commercial speech.
Edenfield v. Fane, 507 U.S. 761, 770-71 (1993):
The government’s burden “is not satisfied by mere speculation or conjecture; rather, a governmental body seeking to sustain a restriction on commercial speech must demonstrate that the harms it recites are real and that its restriction will in fact alleviate them to a material degree.” (emphases added).
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First Amendment Considerations The First Amendment Limits The Power of Governmental Agencies To
Regulate Commercial Speech To Shape Consumer Purchasing
Behaviors With Respect to Lawful Products.
R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) (invalidating FDA regulations on First
Amendment grounds).
The labeling would have “convey[ed] the state’s subjective – and perhaps
even ideological – view that consumers should reject this otherwise legal,
but disfavored, product.”
“These inflammatory images and the provocatively-
named hotline cannot rationally be viewed as pure
attempts to convey information to consumers. They are
unabashed attempts to evoke emotion (and perhaps
embarrassment) and browbeat consumers into quitting.”
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First Amendment Considerations
The First Amendment Limits The Power of Governmental Agencies To Regulate Commercial Speech In Ways That Compel Companies To Convey Objectionable Information.
National Comm’n on Egg Nutrition v. FTC, 570 F.2d 157, 164 (7th Cir. 1977), cert. denied,
439 U.S. 821 (1978) (striking down FTC disclosure requirement on First Amendment
grounds).
FTC lacks authority to require egg producers “to argue the other side of the controversy, thus interfering unnecessarily with the effective presentation of the pro-egg position.”
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Takeaway
FDA’s authority to regulate nutrition labeling must be exercised in a manner that accounts for --
FDA’s Authority under the FDCA
Procedural and Substantive Requirements under the APA
First Amendment
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Thank You
Sarah Roller
Partner & Chair
Food & Drug Law Practice
Kelley Drye & Warren LLP
(202) 342-8582
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