[Federal Register: March 30, 2005 (Volume 70, Number 60)]
[Page 16291-16292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0097]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Qualified Health Claims: 
Consumer Inferences About Omega-3 Fatty Acids and Monounsaturated Fatty 
Acids From Olive Oil

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a voluntary experimental study of consumer 
inferences about qualified health claims for omega-3 fatty acids and 
monounsaturated fatty acids from olive oil.

DATES: Submit written or electronic comments on the collection of 
information by May 31, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Experimental Study of Qualified Health Claims: Consumer Inferences 
About Omega-3 Fatty Acids and Monounsaturated Fatty Acids From Olive 

    FDA regulates the labeling of food products under the Nutrition 
Labeling and Education Act of 1990 (NLEA) and dietary supplements under 
the Dietary Supplement Health and Education Act of 1994 (DSHEA). NLEA 
regulations establish general requirements for health claims in food 
labeling. A manufacturer is required to provide a description of the 
scientific evidence supporting a proposed health claim to FDA for 
review and authorization before the claim may appear in labeling. NLEA 
health claims must be ``complete, truthful, and not misleading'' 
(Sec. 101.14(d)(iii) (21 CFR 101.14 (d)(iii)). NLEA also mandates that 
``the claim enables the public to comprehend the information provided 
and to understand the relative significance of such information in the 
context of a total daily diet'' (Sec. 101.14 (d)(v)).
    In 2003, an FDA Task Force on Consumer Health Information for 
Better Nutrition issued a report that provided guidance on an interim 
review process

[[Page 16292]]

for health claims on food labels that do not meet a standard of 
significant scientific agreement (SSA). These claims, referred to as 
``qualified health claims,'' are assigned a specific level of 
scientific support according to an interim evidence-based ranking 
system for scientific data. The report also identified the need for 
consumer research to examine ways to communicate the level of 
scientific support associated with health claims that do not meet the 
traditional SSA standard. In the fall of 2004, FDA issued letters of 
enforcement discretion for two qualified health claims. The claims 
relate to the reduction of risk of coronary heart disease from the 
consumption of monounsaturated fatty acids from olive oil and omega-3 
fatty acids. The qualified health claims appear below:
    1. Limited and not conclusive scientific evidence suggests that 
eating about 2 tablespoons (23 grams) of olive oil daily may reduce the 
risk of coronary heart disease due to the monounsaturated fat in olive 
oil. To achieve this possible benefit, olive oil is to replace a 
similar amount of saturated fat and not increase the total number of 
calories you eat in a day. One serving of this product [Name of food] 
contains [x] grams of olive oil.
    2. Supportive but not conclusive research shows that consumption of 
EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart 
disease. One serving of [name of food] provides [x] grams of EPA and 
DHA omega-3 fatty acids. [See nutrition information for total fat, 
saturated fat and cholesterol content.]
    The study proposed here is part of an ongoing effort by FDA to 
collect data concerning qualified health claims and their impact on 
consumer perceptions and behavior. Previous FDA studies have examined 
hypothetical qualified health claims to evaluate ways to communicate 
the strength of scientific evidence supporting a claim. This study will 
examine two issued health claims to evaluate whether consumers 
comprehend the information contained within the claim and whether 
consumers understand the relative significance of the information in 
the context of a total diet. In addition, the study will broaden FDA's 
understanding about how consumers interpret qualified health claims, 
particularly as they pertain to the level of scientific evidence 
conveyed by the message and to any differences there may be between 
qualified health claims on dietary supplements versus foods.
    The experimental study data will be collected using participants of 
an Internet panel of approximately 600,000 people. Participation in the 
experimental study is voluntary.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                             Annual Frequency per    Total Annual      Hours per
    No. of Respondents             Response            Responses       Response       Total Hours
30 (Pre-test)                                    1              30            .167               5
1,600 (Experiment)                               1           1,600            .167             267
Total                      .......................  ..............  ..............             272
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with internet 
panel experiments similar to the study proposed here.

    Dated: March 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6203 Filed 3-29-05; 8:45 am]