FOP Study - 0910-0655 - Memo to OMB May 17 2010

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Date

DEPARTMENT OF HEALTH &. HUMAN SERVICES

Public Health Service
Food and Drug Administration

Memorandum
MAY 17 2010

From

Acting Director, Center for Food Safety and Applied Nutrition, HFS-l

Subject

Experimental Studies of Nutrition Symbols on Food Packages

(OMB Control No. 0910-0655) - Request for OMB Exception

To

Chief Statistician Office of Management and Budget (OMB)

Office of Information and Regulatory Affairs

RECOMMENDATION:
That OMB except research sponsored by FDA concerning nutrition symbols on food

packages from OMB's moratorium on household surveys during the 2010 Census of

Population and Housing period of March 1, 201 0 through August 30, 2010.

BACKGROUND:
On January 19,2010, OMB approved the proposed research entitled, "Experimental

Studies of Nutrition Symbols on Food Packages." The research is intended to assess

quantitatively consumer reactions to various front-of-package (FOP) nutrition labeling

schemes. The studies will be a critical input to ensure the usefulness of FOP nutrition

information provided to U.S. consumers.

Data collection commenced immediately after approval. Recently, while checking the
data and conducting preliminary analyses of the data, FDA determined that an important
piece of information was not reliably collected due to a contractor error. The data
collection protocol of study 1, which examined examples of the existing symbols, was
designed to record whether respondents clicked to see the Nutrition Facts label and when
they did so. Unfortunately, the data collection operation failed to record such data
consistently throughout the sample. Hence, the study collected no reliable data on this
behavior. The data would inform how frequently respondents consulted the Nutrition
Facts label when answering various questions about the products and whether there was
any difference in this behavior between symbols.
NEED TO CONDUCT RESEARCH BEFORE SEPTEMBER 2010
The overall purpose of the studies is to help enhance FDA's understanding of consumer
understanding and use of a selected sample of nutrition labeling schemes currently in use
in the domestic market, and to examine whether certain schemes are better ways to
impart useful nutrition information to U.S. consumers. The studies are part of the
agency's continuing effort to enable consumers to make informed dietary choices and
construct healthful diets.

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Page 2 - Acting Director, Center for Food Safety and Applied Nutrition, HFS-I

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Given the importance and value of the data, we would like to have the contractor repeat
study 1 as soon as possible, with the same specifications (e.g., 2,400 respondents from
the same online consumer panel, same instrument, same labels), and including up to 200
pretests to make sure the click data are collected and collected correctly. The contractor
has agreed to repeat the study.

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FDA recognizes the importance of OMB 's policy to minimize the collection of federal
agency-sponsored household surveys in order to encourage cooperation with the 2010
Census of Population and Housing. However, it would adversely affect the quality and
utility of the research to wait to repeat study 1 until after August 30, 2010, the end of the
OMB policy. The quality of the research depends in part on conducting study 1 as close
in time as possible to FOP labeling study 2, which examined examples of symbols that do
not yet exist in the marketplace. The utility of the research is dependent on having the
results available to policymakers working on the First Lady Michelle Obama's Let's
Move campaign.

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Michael M. Landa

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