Food and Drug Administration, HHS.
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.
Submit written or electronic comments on the collection of information by May 31, 2005.
Submit electronic comments on the collection of information 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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 Oil
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” (§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” (§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 Start Printed Page 16292for 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 follows:
|No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|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.Start Signature
Dated: March 21, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-6203 Filed 3-29-05; 8:45 am]
BILLING CODE 4160-01-S