Federal Register: December 18, 2006 (Volume 71, Number 242)
DOCID: FR Doc E6-21486
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 2006N-0036]
NOTICE: NOTICES
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel
DATES: Fax written comments on the collection of information by December 18, 2006.
DOCUMENT SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
SUMMARY:
Agency information collection activities; proposals, submissions, and approvals,
SUPPLEMENTAL INFORMATION
In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for review and clearance.
Experimental Study of Possible Footnotes and Cueing Schemes to Help
Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel(OMB Control Number 09100532Reinstatement)
FDA is requesting OMB approval of an experimental study of possible footnotes and cueing schemes intended to help consumers interpret quantitative trans fat information on the Nutrition Facts Panel (NFP) of a food product. The purpose of the experimental study is to help FDA's Center for Food Safety and Applied Nutrition formulate decisions and policies affecting labeling requirements for trans fat disclosure.
In the Federal Register of July 11, 2003 (68 FR 41434), FDA issued a final rule requiring disclosure on the Nutrition Facts Panel of quantitative trans fat information on a separate line without any accompanying footnote. At the same time, the agency issued an advance notice of proposed rulemaking entitled ``Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements'' (68 FR 41507) which requested comments about possible footnotes to help consumers better understand trans fat declarations on the product label. The agency sought comments about whether it should consider requiring statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote on the Nutrition Facts Panel to enhance consumers' understanding about such cholesterolraising lipids and how to use information on the label to make healthy food choices. Comments received in response to the notice contained suggested footnotes and cueing schemes. The proposed experimental study will evaluate the ability of several possible footnotes and cueing schemes to help consumers make hearthealthy food choices. The results of the experimental study will provide empirical support for possible policy decisions about the need for such requirements and the appropriate form they should take.
FDA or its contractor will use information gathered from Internet panel samples to evaluate how consumers understand and respond to possible footnote and cueing schemes. The distinctive features of Internet panels for the purpose of the experimental study are that they allow for controlled visual presentation of study materials, experimental manipulation of study materials, and the random assignment of subjects to condition. Experimental manipulation of labels and random assignment to condition makes it possible to estimate the effects of the various possible footnotes and cueing schemes while controlling for individual differences between subjects. Random assignment ensures that mean differences between conditions can be tested using wellknown techniques such as analysis of variance or regression analysis to yield statistically valid estimates of effect size. The study will be conducted using a convenience sample drawn from a large, national consumer panel of about one million households.
Participants will be adults, age 18 and older, who are recruited for a study about foods and food labels. Each participant will be randomly assigned to 1 of the 54 experimental conditions derived from fully crossing 8 possible footnotes/cueing schemes, 3 product types, and 2 prior knowledge conditions.
FDA will use the information from the experimental study to evaluate regulatory and policy options. The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from this experimental study will be used to estimate consumer comprehension and the behavioral impact of various footnotes and cueing schemes intended to help consumers better understand quantitative trans fat information.
The experimental study data will be collected using participants of an Internet panel of approximately one million people. Participation in the experimental study is voluntary.
In the Federal Register of February 6, 2006 (71 FR 6079), FDA
published a 60day notice requesting public comment on the information
collection that will take place as part of the experimental study. FDA
received two letters in response to the notice, each containing multiple comments.
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(Comment 1) One comment stated that the organization concurs with
the objectives of the study and believes the information from this
study will be useful to FDA in developing labeling policy to assist
consumers with interpretation of trans fat claims in food labeling.
Another comment expressed concern that the NFP of only one of the three product pairs (margarine) showed polyunsaturated fat and
monounsaturated fat content and recommended that the NFPs for all three products tested in the study show the fuller fat profile.
(Response) FDA disagrees with the recommendation that the NFPs for
all three products tested in the study disclose a fuller fat profile.
Most NFPs do not include the optional polyunsaturated fat and
monounsaturated fat content. Typically, this information is disclosed
on NFPs for products that are entirely or largely composed of fat
(e.g., butter, margarine, and cooking oils). In these cases, the fat
profile may be shown in greater detail because consumers may use this
information to select among alternative food products. The NFPs for the
product pairs tested in the study are consistent with actual donut,
margarine, and frozen lasagna labels. Because the recommended change
would limit products tested in the study to those such as butter,
margarine and cooking oils, FDA will retain the NFPs as proposed.
(Comment 2) One comment suggested that the NFPs should not reflect
rounding, to minimize potential consumer confusion. The comment
specifically recommended that FDA edit the study NFPs containing
declarations of polyunsaturated and monounsaturated fats (i.e., for the
margarine product pair) to declare total fat grams in an amount equal to the sum of the four listed fatty acids.
(Response) FDA agrees that for the margarine labels, which include
the four fatty acids under total fat, the fatty acids gram (g) amounts
declared should add up to the total fat gram amount to avoid raising
questions or distracting the participants in the margarine conditions. We made the requested change.
(Comment 3) One comment suggested that, for the margarine labels,
FDA should edit the polyunsaturated and monounsaturated values to be as
equal as possible in the product pairings to ensure that the focus is on the saturated fat and trans fat content.
(Response) FDA disagrees with the suggested change to the NFPs for
the margarine product pairs. In order to keep the values for the
polyunsaturated and monounsaturated fats identical in the margarine
pairs, the saturated fat content would become unrealistically high in
one label because it is the only fat component that could increase when
trans fat equals zero. FDA will retain the NFPs as proposed.
(Comment 4) One comment noted that only one of the NFPs for the
three products tested in the study showed some cholesterol present in
the product; the other two products disclosed cholesterol as zero. In
particular, the comment identified lasagna as unlikely to contain 0 milligrams of cholesterol.
(Response) FDA agrees that zero cholesterol is not likely to be a
realistic amount of cholesterol disclosed on a NFP for a lasagna
product and has revised the NFPs for the lasagna pairs. In addition,
FDA changed a product category from cookies to donuts and edited the
NFPs for the new donut product pair to add a disclosure of cholesterol.
(Comment 5) One comment critiqued the draft Full Information
treatment language. The comment criticized the onepage summary
because: (1) It did not identify calories in the discussion of fat as a
major source of energy and (2) it did not relate the calorie
contribution of fat to that of carbohydrates and protein. The comment
also criticized the information about sources of trans fat because it
omitted mention of natural sources of trans fat in the diet, which the
comment suggested would help ensure factually correct and balanced
information about sources of trans in the diet. The comment questioned
the value of stating that trans fat extends shelflife and has desirable
taste characteristics since many saturated fat sources are relatively shelf stable and have desirable taste characteristics.
(Response) FDA agrees and has revised the Full Information
treatment in response to these concerns. Calories and other sources of
energy are now mentioned in the introductory passage. Natural sources
of trans fat are now mentioned and the similarity between trans fat and
saturated fat in terms of shelflife and taste are now addressed. The
revised draft will be included in the study pretest and further
revisions will be made if FDA determines they are needed based upon pretest results.
(Comment 6) One comment suggested consumer confusion may be caused
when a NFP for a product discloses 0 g of trans fat but the ingredient
list discloses an ingredient that contains trans fat, as is permitted
by the trans fat labeling regulations. The comment concluded that FDA
should add experimental conditions in which this occurs. The comment
suggested that for this situation the study should test language for a
footnote to the ingredient list to explain that there may be a trans
fat ingredient in the product when the NFP shows trans fat as zero.
(Response) FDA disagrees with the proposed addition to the study's
experimental conditions. Under existing trans fat labeling regulations,
food manufacturers are allowed to list amounts of trans fat less than
0.5 g per serving as zero on the NFP. While such situations occur in
the marketplace and are permitted by the trans fat labeling
regulations, whether this causes consumer confusion is an issue outside
the scope of the proposed research, which focuses on the effects of NFP
footnotes and alternative presentations of trans fat information in the
NFP on consumers' ability to correctly identify more healthful food
products. The Office of Nutritional Products, Labeling and Dietary
Supplements has received and responded to a separate letter on this topic from the commenter.
Table 1.Estimated Annual Reporting Burden\1\
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
Pretest 40 1 40 .25 10
Study 3,240 1 3,240 .25 810
Total ................. ................. ................. ................. 820
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E621486 Filed 121506; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Jonna Capezzuto, Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018274659.