Skip to Content


Solicitation of Written Comments on Proposed Definition of Bioactive Food Components

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Office of Public Health and Science, Office of the Secretary, HHS.



Start Printed Page 55822


The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Department of Health and Human Services (HHS), acting on behalf of an ad hoc Federal working group, is soliciting written comments on a proposed definition of “bioactive food components.”


Submit written or electronic comments by November 1, 2004.


Submit a single copy of electronic comments or two paper copies of any mailed comments to Leila G. Saldanha at or Department of Health and Human Services, c/o Office of Dietary Supplements, 6100 Executive Blvd., Rm 3B01, MSC 7517, Bethesda, MD 20892-7517.

Start Further Info


Leila G. Saldanha, Department of Health and Human Services, 6100 Executive Blvd., Rm 3B01, MSC 7517, Bethesda, MD 20892-7517, Phone: 301-496-0168, Fax: 301-480-1845, e-mail:

End Further Info End Preamble Start Supplemental Information


Background: Foods provide numerous chemical constituents that may influence health and disease prevention, in addition to those usually characterized as essential nutrients. The physiological implications of these food components have been the subject of recent scientific inquiries and publications. Widespread scientific, governmental, and consumer attention to these components, referred to here as “bioactive food components,'' has sparked an interest about how they should be defined and how best to evaluate their significance in promoting health and disease prevention.

Bioactive food components exist not only in commonly consumed foods but also as ingredients in fortified foods and dietary supplements. Bioactive food components may have multiple sites of action, may interact with one or more dietary constituents, and may act directly or indirectly to produce the functional outcome. Some examples of these components include lycopene, long-chain omega-3 fatty acids, epigallocatechin gallate (EGCG), isoflavones, sulphorophane, and resveratrol. Food sources of these components include, respectively, tomatoes, fatty fish, green tea, soybeans, broccoli, and red grapes, but other foods may be significant sources of bioactive food components.

An ad hoc Federal working group that includes representatives from the Departments of Health and Human Services (HHS), Defense, and Agriculture, and agencies within these departments such as the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration, is interested in establishing a definition for “bioactive food components” as a first step toward developing approaches that might be used to assess their health effects. Currently, there is no generally accepted definition about what should be classified as a bioactive food component. Further, there are no generally accepted approaches for evaluating the health effects resulting from consuming these components. Establishing a definition for bioactive food components may help in guiding and encouraging future research with these components. An approach to assess the health effects of bioactive food components may need to take into account the complex nature of this category of components. In addition, it may provide science-based information to help guide public health policy on how Americans may choose diets that promote good health.

Written Comments: By this notice, ODPHP, on behalf of the ad hoc Federal working group, is soliciting submission of written comments on the following proposed definition of “bioactive food components:'

Bioactive food components are constituents in foods or dietary supplements, other than those needed to meet basic human nutritional needs, that are responsible for changes in health status.

In making comments on the proposed definition, please provide the rationale for your comments. Comments are specifically requested on the following questions:

(1) What categories/classes of compounds should be considered as bioactive food components?

(2) What categories/classes of compounds should not be considered as bioactive food components? How should the definition be modified to reflect exclusion of these compounds?

(3) Should essential nutrients be included as bioactive food components?

(4) Should synthetically derived components used in fortified foods and dietary supplements be considered under this definition?

Written comments received in response to this notice will be reviewed by the ad hoc Federal working group and considered in refining the proposed definition of “bioactive food components” and in future plans involving the use of this definition.

(Authority: 42 U.S.C. 300u.)

Start Signature

Dated: September 10, 2004.

Cristina V. Beato,

Acting Assistant Secretary for Health, Department of Health and Human Services.

End Signature End Supplemental Information

[FR Doc. 04-20892 Filed 9-15-04; 8:45 am]