[Federal Register Volume 65, Number 39 (Monday, February 28, 2000)]
[Proposed Rules]
[Pages 10434-10436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4572]
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DEPARTMENT OF THE TREASURY
Bureau of Alcohol, Tobacco and Firearms
27 CFR Parts 4, 5, and 7
[Notice No. 892; Re: Notice No. 884]
RIN 1512-AB97
Health Claims and Other Health-Related Statements in the Labeling
and Advertising of Alcohol Beverages (99R-199P); Public Hearing
AGENCY: Bureau of Alcohol, Tobacco and Firearms (ATF), Department of
the Treasury.
ACTION: Notice of public hearings on a proposed rule.
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SUMMARY: ATF is announcing the dates and locations of five public
hearings that it will hold concerning health claims and other health-
related statements in the labeling and advertising of alcohol
beverages. In an earlier notice published in the Federal Register, we
detailed a proposal to, among other things, prohibit the appearance on
labels or in advertisements of any statement that makes a substantive
claim regarding health benefits associated with the consumption of
alcohol beverages unless such claim is properly qualified, balanced,
sufficiently detailed and specific, and outlines the categories of
individuals for whom any positive health effects would be outweighed by
numerous negative health effects. In consideration of the comments
received, ATF has determined that the public interest would be best
served by the holding of public hearings on this matter. One purpose of
the hearings is to gather additional information to determine whether
the negative consequences of alcohol consumption or abuse disqualify,
as misleading, these products entirely from entitlement to any health-
related statements.
DATES: See Supplementary Information section for hearings dates.
ADDRESSES: See Supplementary Information section for hearings
addresses.
Letter notifications and written comments are to be submitted to:
Chief, Regulations Division; Bureau of Alcohol, Tobacco and Firearms;
P.O. Box 50221; Washington, DC 20091-0221; ATTN: Notice No. 892. Submit
e-mail comments to: [email protected]. E-mail comments must
contain your name, mailing address, and e-mail address. They must also
reference this notice number and be legible when printed on not more
than three pages 8\1/2\"x11" in size. We will treat e-mail as originals
and we will not acknowledge receipt of e-mail. See the Participation
section of this notice for alternative means of providing letter
notifications and written comments.
FOR FURTHER INFORMATION CONTACT: Nancy Kern or Jim Ficaretta,
Regulations Division, Bureau of Alcohol, Tobacco and Firearms, 650
Massachusetts Avenue, NW., Washington, DC 20226 (202-927-8210).
SUPPLEMENTARY INFORMATION:
Background
In February 1999, ATF approved two directional statements on wine
labels. One directed consumers to their family doctors for information
regarding the ``health effects of wine consumption.'' The second
referred consumers to the Federal Government's ``Dietary Guidelines for
Americans'' for such information. Based on the evidence before us,
including a consumer survey conducted by the Substance Abuse and Mental
Health Service Administration's Center for Substance Abuse Prevention
(CSAP), we concluded that we had an insufficient record to disapprove
the labels. The CSAP survey concluded that the drinking patterns of
most of those who participated in the study would not be influenced by
these messages.
The approval of these labels generated considerable interest from
Federal health officials, members of Congress, and public advocacy
groups, who expressed concern about consumer perception of the label
statements. Surgeon General David Satcher, in particular, stated that
people might draw an incorrect message from these labels. Moreover, we
have become aware of a number of press accounts interpreting the
directional statements as actual health claims about the benefits of
alcohol consumption and the government's approval of the labels as an
endorsement of drinking.
On October 25, 1999, we invited comments on our current policy on
health claims and health-related statements by publishing the policy as
a proposed regulation in the Federal Register (Notice No. 884; 64 FR
57413). The regulation would specifically prohibit the use of any
health claim in the labeling or advertising of alcohol beverages unless
it is balanced, properly qualified, sufficiently detailed and specific,
and outlines the categories of persons for whom any positive effects
would be outweighed by the numerous negative health effects.
We also sought comments on whether even such balanced and qualified
[[Page 10435]]
statements should be prohibited because the negative consequences of
alcohol consumption are so serious as to make any health-related
statement on labels or in advertisements inherently misleading. In
addition, we sought comments on whether directional health statements
such as those approved in February 1999, tend to mislead consumers
about the health consequences of alcohol consumption.
The comment period for Notice No. 884 was scheduled to close on
February 22, 2000.
Hearings
On December 9, 1999, we announced in a press release that after the
close of the comment period we would hold public hearings in cities and
dates to be announced. The hearings would provide us with a
comprehensive record on which to base final regulations on health
claims.
Due to the adverse consequences of alcohol abuse, ATF is concerned
about any risk of misperception resulting from the two approved label
statements. Because we are seeking public comments on this very issue,
we also announced that we would suspend action on any new applications
for label approval bearing similar ``directional'' health-related
statements pending the completion of the rulemaking proceedings.
The schedules of dates and locations of the five public hearings
have been set as follows:
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Cities Dates Locations
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Washington, DC........................ April 25-April 27....................... Washington Convention Center,
900 Ninth St., NW.,
Washington, DC.
San Francisco, CA..................... May 23-May 25........................... Embassy Suites San Francisco
Airport, 150 Anza Blvd.,
Burlingame, CA.
Atlanta, GA........................... June 27-June 29......................... Embassy Suites Hotel at
Centennial Olympic Park, 311
Marietta St., NW., Atlanta,
GA.
Chicago, IL........................... July 25-July 27......................... Radisson Hotel & Suites
Chicago, 160 East Huron St.,
Chicago, IL.
Dallas, TX............................ August 22-24............................ Radisson Hotel & Suites, 2330
West Northwest Highway,
Dallas, TX.
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The number of days for each hearing may change depending on the
volume of requests to testify. The hearing schedule for each site will
be as follows: 9:30 a.m.-12 noon and 1:30 p.m.-5 p.m. (an evening
session(s) may be held if necessary)
Persons desiring to make oral comments at the hearings should
submit a letter, on or before April 7, 2000, notifying ATF of their
intent to comment. Any person unable to attend the hearings or who
prefers not to present oral comments may submit written (or e-mail)
comments before or after the hearings. ATF will accept written (or e-
mail) comments until September 29, 2000. Written (or e-mail) comments,
including comments addressing Notice No. 884, must be received on or
before September 29, 2000.
Participation
Any person desiring to testify at the hearings should notify ATF by
submitting a letter. Such letter must contain the name of the person
who will testify, the company/organization represented (if any),
address, and daytime telephone number where such person can be
contacted. Persons requesting to testify will also indicate in the
letter a preference for the date and time (morning or afternoon) they
wish to testify. To the extent possible, we will honor these
preferences. The letter must be accompanied by an outline which briefly
summarizes the topics the commenter will discuss and the information to
be presented. Each topic to be discussed should be separately numbered
and each numbered topic should specify the information to be presented.
You may submit letter notifications and written comments by
facsimile transmission to (202) 927-8602. Facsimile comments must:
Be legible;
Reference this notice number;
Be 8\1/2\"x11" in size;
Contain a legible written signature; and
Be not more than three pages long.
We will not acknowledge receipt of facsimile transmissions. We will
treat facsimile transmissions as originals.
Any person unable to attend the hearings or who prefers not to
present oral comments may submit written (or e-mail) comments before or
after the hearings. ATF will accept written (or e-mail) comments until
September 29, 2000. In written (or e-mail) comments, each topic to be
discussed should be separately numbered and each numbered topic should
specify the factual basis supporting the views, data, or arguments
presented. Written (or e-mail) comments addressing Notice No. 884 will
also be accepted until September 29, 2000. All written (or e-mail)
comments received on or before September 29, 2000, will be considered
in the development of a decision on this matter.
Special Accommodations
The hearing rooms are physically accessible to people with
disabilities. A sign language interpreter will be present at all
hearings. Requests for other auxiliary aids should be directed to Nancy
Kern at (202) 927-8210 at least 10 days prior to the hearing date.
General Information on Hearing Procedure
The hearings will be conducted under the procedural rules contained
in 27 CFR 70.701(a)(3) and will be open to the public, subject to the
limitations of space. In the event attendance exceeds available seating
space, persons scheduled to present oral comments will be given
preference in respect to admission. Time limitations make it necessary
to limit the length of oral presentations to five (5) minutes; however,
the actual time available will be determined in part by the number of
registered speakers. While it is anticipated that all persons who
desire to comment will have an opportunity to speak, time limits may
not allow this to occur. For this reason, we encourage organizations to
have one representative comment rather than individual members.
Commenters will not be permitted to trade their time to obtain a longer
presentation period. However, the hearing officer may allow any person
additional time after all other commenters have been heard. To the
extent that time is available after presentation of oral comments by
those who are scheduled to comment, others will be given an opportunity
to be heard.
[[Page 10436]]
In order to ensure that ATF will have the full benefit of their
views, even if time constraints limit an oral presentation, persons
presenting oral comments are urged to supplement their oral statement
with a more complete written statement. A written statement submitted
to ATF at the time of presentation of the oral comment will be
considered part of the hearing record.
After making an oral presentation, a person should be prepared to
answer questions from the hearing panel on not only the topics
presented but also on matters relating to any written comments which he
or she has submitted. Other persons will not be permitted to question a
commenter. However, questions may be submitted, in writing, to the
hearing officer who will evaluate their relevance. If the hearing
officer determines that elicitation of further discussion would be
beneficial, they may be presented to a commenter for a response.
Persons will be scheduled, if possible, according to the date and
time preferences mentioned in their letter notification to us. We will
confirm by telephone the date and time a person is scheduled to present
oral comments. Letter notifications received after the cutoff date, and
up to two (2) working days preceding a scheduled hearing, will be
honored to the extent practicable on a first-come-first-serve basis.
Any scheduled commenter not present at a particular hearing when called
will lose his or her place in the scheduled order, but could be
recalled after all other scheduled commenters have been heard.
We will prepare an agenda listing the persons scheduled to comment
at a particular hearing and copies will be available at the hearing. In
addition, copies of the notice of proposed rulemaking and all received
written comments in response to the notice will be available at each
hearing for public inspection.
Other formats for holding the hearings are being considered. For
example, the hearing officer would oversee testimony presented by a
panel of several persons during a specified time period (e.g., morning
session) who share or represent similar views, e.g., members of the
medical profession, representatives from health care organizations,
representatives of various industry trade organizations, and
representatives from consumer advocacy organizations. We will determine
the format for the hearings once we know the number of people
interested in presenting oral testimony and the content of their
testimony.
Comments
Any person participating in the hearings or submitting written
comments may present such data, views, or arguments as they desire.
Comments that provide the factual basis supporting the views or
suggestions presented will be particularly helpful in developing a
reasoned regulatory decision on this matter. However, comments
consisting of mere allegations or denials are counterproductive to the
rulemaking process. We specifically request that commenters consider
making comments on the following questions:
1. How do consumers perceive the two ``directional'' health-related
statements approved by ATF?
2. Do consumers interpret the approved directional statements as
actual substantive health claims about the benefits of alcohol
consumption? Explain.
3. Do consumers interpret the Government's approval of the
directional statements on labels as an endorsement of drinking?
Explain.
4. Do directional health-related statements such as those approved
by ATF tend to mislead consumers about the health consequences of
alcohol consumption? Explain.
5. Do the negative consequences of alcohol consumption or abuse
disqualify, as inherently misleading, any health-related statements on
alcohol beverage labels, including directional statements? Explain.
6. The proposed regulations would prohibit any health claim in the
labeling or advertising of alcohol beverages unless it is balanced,
properly qualified, sufficiently detailed and specific, and outlines
the categories of persons for whom any positive effects would be
outweighed by the numerous negative health effects. Given the space
limitations of an alcohol beverage label, what types of health claims
would meet this standard? Explain.
Drafting Information
The author of this document is James P. Ficaretta, Regulations
Division, Bureau of Alcohol, Tobacco and Firearms.
List of Subjects
27 CFR Part 4
Advertising, Consumer protection, Customs duties and inspection,
Imports, Labeling, Packaging and containers, and Wine.
27 CFR Part 5
Advertising, Consumer protection, Customs duties and inspection,
Imports, Labeling, Liquors, and Packaging and containers.
27 CFR Part 7
Advertising, Consumer protection, Customs duties and inspection,
Imports, and Labeling.
Authority and Issuance
This notice of hearing is issued under the authority of 27 U.S.C.
205.
Signed: February 22, 2000.
Bradley A. Buckles,
Director.
[FR Doc. 00-4572 Filed 2-25-00; 8:45 am]
BILLING CODE 4810-31-P