[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Notices]
[Pages 17397-17399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-0391]
International Standard-Setting Activities; Codex Alimentarius
Commission; Committee on Nutrition and Foods for Special Dietary Uses;
Background Paper to Identify Perspectives and Issues Pertaining to
International Guidelines on Vitamin and Mineral Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is asking interested
persons to submit comments that will be used by the U.S. delegate to
the Codex Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU) to prepare a background paper to be considered by the CCNFSDU
prior to its considering the appropriateness of establishing guidelines
for vitamin and mineral supplements for the purposes of international
trade. The background paper will discuss the range of concerns and the
differences in rationales on this topic. The United States, which has
indicated its opposition to the development of such guidelines, has
been asked to participate in the development of this background paper
along with other governments. FDA is accepting this request in its role
as the agency representing the United States in the CCNFSDU.
DATES: Submit written comments by June 8, 1999.
ADDRESSES: Submit written comments and recommendations to the Dockets
Management Branch (HFA-305), Food
[[Page 17398]]
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4605.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Codex Alimentarius Commission (Codex) is the joint food
standards program of the Food and Agriculture Organization of the
United Nations (FAO) and the World Health Organization (WHO). This
program was established in 1962 and develops food standards, codes of
practice, and other guidelines to help protect the health and economic
interests of consumers and to facilitate and encourage fair
international trade in food. The Codex accomplishes these actions
through the use of subordinate committees that develop food standards,
codes of practice, and other guidelines for consideration and adoption
by the Codex and member countries.
In the United States, the U.S. Department of Agriculture (USDA),
FDA, and other agencies manage and carry out U.S. Codex activities.
Executive direction of this effort comes from the U.S. manager for
Codex, a responsibility of the Food Safety and Inspection Service
(FSIS) of USDA. For more information on U.S. Codex activities and the
responsibilities of the U.S. delegates to Codex committees, see the
Federal Registers of May 27, 1998 (63 FR 28966), and February 12, 1998
(63 FR 7118), respectively. Under section 491 of the Trade Agreements
Act of 1979 (19 U.S.C. 2578), as amended, and the Uruguay Round
Agreements Act, Pub. L. 103-465, 108 Stat. 4809, FSIS must inform the
public of the sanitary and phytosanitary standard setting activities of
international standard-setting organizations, such as Codex. The most
recent annual notice was published in the May 27, 1998, Federal
Register. That notice identified FDA as the responsible agency for the
United States with respect to the activities of the CCNFSDU (63 FR
28966 at 28973). Accordingly, the U.S. delegate to the CCNFSDU is from
FDA.
This notice solicits information and comments relative to the
content of a background document that is intended to identify the
nature of and basis for differences in perspectives on establishing
guidelines for vitamin and mineral supplements in international trade.
This document is a component of the sanitary and phytosanitary
standard-setting activities of the CCNFSDU with regard to its
consideration of guidelines for vitamin and mineral supplements (Ref.
1).
II. Background
Germany proposed a process to consider the development of
guidelines for vitamin and mineral supplements at the October 1995
meeting of the CCNFSDU. Germany submitted the draft proposed guidelines
(Ref. 2), which were intended to address such issues as the composition
and labeling of vitamin and mineral supplements, including lists of
allowable vitamins and minerals and their sources, minimum and maximum
levels, permissible additives, packaging, labeling requirements, and
permissible claims. Codex circulated the proposal to member governments
for comment, and it was considered at the October 7 to 11, 1996,
CCNFSDU committee meeting (Ref. 3).
At that meeting, the United States, through its delegate, indicated
its opposition to the development of the guidelines. Such guidelines
would not affect dietary supplements within the United States, whose
sale and marketing is regulated under the Federal Food, Drug, and
Cosmetic Act, as amended by the Dietary Supplement Health and Education
Act of 1994. However, such guidelines, were they developed and adopted
by other countries, could affect international trade in vitamin and
mineral supplements. In particular, such guidelines could have
ramifications for those U.S. manufacturers of dietary supplements that
export their products to countries that adopt such guidelines.
CCNFSDU did not reach consensus on many aspects of the draft
proposed guidelines, but nonetheless, they forwarded the draft proposed
guidelines to Codex and recommended that the draft proposed guidelines
be advanced to the next level of consideration. Codex considered the
recommendation of the committee at its June 23 to 28, 1998, meeting in
Rome, Italy (Ref. 4). The United States, through its delegate, again
indicated its opposition to the advancement of the guidelines during
the Codex meeting.
Codex did not advance the draft proposed guidelines to the next
level of consideration, but instead Codex returned them to the CCNFSDU
for further discussion and consideration. Codex also advised the
CCNFSDU to reconsider whether there was a need to proceed with the
development of the guidelines.
The CCNFSDU considered the draft proposed guidelines again at its
September 21 to 25, 1998, meeting (Ref. 1). A copy of this document may
be downloaded from the internet at ``www.fao.org/es%2A/esn/codex/
reports.htm''. The CCNFSDU discussed the draft proposed guidelines and
decided that while it was premature to stop work on the draft proposed
guidelines, there was not enough agreement to advance the proposed
draft guidelines for vitamin and mineral supplements to the next level
of consideration. Consequently, the draft proposed guidelines remained
at their current level of consideration. Because there was no consensus
on the need for the proposed guidelines or what they should contain,
the CCNFSDU decided that it would be useful to reconsider the basis for
continuing work on the draft proposed guidelines. The CCNFSDU believed
that it would facilitate its work if it could prepare a background
paper that would: (1) Provide ``a neutral and objective presentation on
the issues that should be considered on this subject'', (2) ``help
understand the rationale behind the different approaches'', and (3)
``be useful to study in depth the principles justifying each particular
position in order to find a common ground for discussion'' (Ref. 1).
The CCNFSDU chair asked the U.S. Government to contribute to this
background paper, which will be considered at the next meeting of the
CCNFSDU in the year 2000. The U.S. delegate agreed to this request. The
U.S. delegate concluded that there is value in assisting with the
development of an objective background paper that addresses the various
perspectives, approaches, and difficulties associated with developing
guidelines for international trade in vitamin and mineral supplements.
This activity is consistent with the U.S. interests in this matter and
will facilitate the decisionmaking process of the CCNFSDU.
III. Request for Comments
Interested persons may, on or before June 8, 1999, submit to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Based on the interest of the CCNFSDU in identifying the pros and
cons of developing guidelines for vitamin and mineral supplements and
in identifying
[[Page 17399]]
the various factors and principles pertaining to international
guidelines for vitamin and mineral supplements, FDA is asking for
comments that identify the range of perspectives associated with the
manufacture, use, and regulation of such products, as well as the
specific issues that the paper should address. Moreover, the CCNFSDU
intends to develop a paper that considers only issues relevant to
vitamin and mineral supplements. The CCNFSDU does not intend that the
paper will consider the addition of vitamins and minerals to
conventional foods nor products containing other ingredients or
substances, for example herbs or other botanicals. Accordingly,
comments on such matters will not assist the U.S. delegate to
contribute to the CCNFSDU paper.
For the purposes of international trade, FDA has identified topics
that should be addressed in the background paper. The topics identified
for comment are as follows: (1) Topic 1 focuses on terminology, such as
the use of the terms ``food supplements'' or ``dietary supplements,''
as compared to ``vitamin and mineral supplements;'' (2) topic 2 focuses
on the purpose and role of vitamin and mineral supplements; (3) topic 3
focuses on the concept of ``approved nutrients'' (i.e., a positive or
negative list of nutrients for use in the supplements of issue); (4)
topic 4 focuses on setting maximum levels for vitamins and minerals in
supplement form; (5) topic 5 focuses on setting minimal limits for
vitamins and minerals in such products; (6) topic 6 focuses on purity
and good manufacturing practices; (7) topic 7 focuses on labeling,
warning statements, and claims; and (8) topic 8 focuses on packaging
and marketing.
For each topic, specific comments would be most helpful if they
addressed the following: (1) Is there a need for the topic? (2) What
are the various perspectives on the topic and what the difficulties in
addressing these perspectives? and (3) What are the options for making
decisions about the topic?
We also welcome comments on the inclusion of additional topics. It
would be most helpful if the additional topic(s) could be addressed in
a fashion so as to respond to the three basic questions identified for
the other topics listed previously.
IV. References
The following references have been placed on display in the
Dockets Management Branch (address above) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Codex Alimentarius Commission, ``Report of the Twenty-First
Session of the Codex Committee on Nutrition and Foods for Special
Dietary Uses,'' ALINORM 99/26, FAO/WHO, Rome, 1998.
2. Codex Alimentarius Commission, ``Report of the Twentieth
Session of the Codex Committee on Nutrition and Foods for Special
Dietary Uses,'' ALINORM 97/26, FAO/WHO, Rome, 1996.
3. Codex Alimentarius Commission, ``Report of the Nineteenth
Session of the Codex Committee on Nutrition and Foods for Special
Dietary Uses,'' ALINORM 95/26, FAO/WHO, Rome, 1995.
4. Codex Alimentarius Commission, ``Report of the Twenty-Second
Session of the Codex Alimentarius Commission,'' ALINORM 97/4, FAO/
WHO, Rome, 1997.
Dated: April 2, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8796 Filed 4-8-99; 8:45 am]
BILLING CODE 4160-01-F
