Label Me Wise: Nutrition Labeling Update

Transcription

1 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

2 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 2

3 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 3

4 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. 4

5 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. 5

6 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. 6

7 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. 7

8 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 Unlawful agency action may be deemed: Abuse of Discretion Arbitrary & Capricious Establishes standards and procedures governing judicial review of agency actions. 8

9 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). 9

10 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 ) 10

11 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? 11

12 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 12

13 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, (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). 13

14 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 provocativelynamed 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. 14

15 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 proegg position. 15

16 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 16

17 Thank You Sarah Roller Partner & Chair Food & Drug Law Practice Kelley Drye & Warren LLP (202) Connect with Kelley Drye Web: Blogs: NEW YORK, NY WASHINGTON, DC LOS ANGELES, CA CHICAGO, IL STAMFORD, CT PARSIPPANY, NJ BRUSSELS, BELGIUM AFFILIATE OFFICE MUMBAI, INDIA 17