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

SRoller@KelleyDrye.com

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