[Federal Register Volume 69, Number 179 (Thursday, September 16, 2004)]
[Notices]
[Pages 55821-55822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on Proposed Definition of 
Bioactive Food Components

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

ACTION: Notice.

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[[Page 55822]]

SUMMARY: 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.''

DATES: Submit written or electronic comments by November 1, 2004.

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

FOR FURTHER INFORMATION CONTACT: 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: [email protected].

SUPPLEMENTARY 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.)

    Dated: September 10, 2004.
Cristina V. Beato,
Acting Assistant Secretary for Health, Department of Health and Human 
Services.
[FR Doc. 04-20892 Filed 9-15-04; 8:45 am]
BILLING CODE 4150-32-P