[Federal Register: March 23, 2004 (Volume 69, Number 56)]
[Notices]
[Page 13530-13531]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr04-67]
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FEDERAL TRADE COMMISSION
[File No. 012 3248]
Creative Health Institute, Inc., et al.; Analysis to Aid Public
Comment
AGENCY: Federal Trade Commission
ACTION: Proposed consent agreement.
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SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair or deceptive acts or
practices or unfair methods of competition. The attached Analysis to
Aid Public Comment describes both the allegations in the draft
complaint that accompanies the consent agreement and the terms of the
consent order--embodied in the consent agreement--that would settle
these allegations.
DATES: Comments must be received on or before April 16, 2004.
ADDRESSES: Comments filed in paper form should be directed to: FTC/
Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW.,
Washington, DC 20580. Comments filed in electronic form should be
directed to: consentagreement@ftc.gov, as prescribed in the
Supplementary Information section.
FOR FURTHER INFORMATION CONTACT: Heather Hippsley or Shira Modell, FTC,
Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW.,
Washington, DC 20580, (202) 326-3285 or 326-3116.
SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec. 2.34 of
the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given
that the above-captioned consent agreement containing a consent order
to cease and desist, having been filed with and accepted, subject to
final approval, by the Commission, has been placed on the public record
for a period of thirty (30) days. The following Analysis to Aid Public
Comment describes the terms of the consent agreement, and the
allegations in the complaint. An electronic copy of the full text of
the consent agreement package can be obtained from the FTC Home Page
(for March 17, 2004), on the World Wide Web, at http://www.ftc.gov/os/2004/03/index.htm.
A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington,
DC 20580, either in person or by calling (202) 326-2222.
Public comments are invited, and may be filed with the Commission
in either paper or electronic form. Comments filed in paper form should
be directed to: FTC/Office of the Secretary, Room 159-H, 600
Pennsylvania Avenue, NW., Washington, DC 20580. If a comment contains
nonpublic information, it must be filed in paper form, and the first
page of the document must be clearly labeled ``confidential.'' Comments
that do not contain any nonpublic information may instead be filed in
electronic form (in ASCII format, WordPerfect, or Microsoft Word) as
part of or as an attachment to email messages directed to the following
e-mail box: consentagreement@ftc.gov. Such comments will be considered
by the Commission and will be available for inspection and copying at
its principal office in accordance with Section 4.9(b)(6)(ii) of the
Commission's Rules of Practice, 16 CFR 4.9(b)(6)(ii)).
Analysis of Proposed Consent Order To Aid Public Comment
The Federal Trade Commission has accepted, subject to final
approval, an agreement containing a consent order from Creative Health
Institute, Inc., and Kyl L. Smith, individually and as an officer of
the corporation.
The proposed consent order has been placed on the public record for
thirty (30) days for receipt of comments by interested persons.
Comments received during this period will become part of the public
record. After thirty (30) days, the Commission will again review the
agreement and the comments received, and will decide whether it should
withdraw from the agreement or make final the agreement's proposed
order.
This matter involves practices relating to the advertising and
promotion of Focus Factor, a dietary supplement containing, among other
things, vitamins, minerals, botanicals, and amino acids. Marketing
materials for Focus Factor claimed that the product enhanced brain
function and improved the focus, memory, mood, concentration, and
energy of children, adults, and seniors.
According to the FTC complaint, the respondents failed to have
substantiation for their claims that Focus Factor: (a) Improves the
focus, memory, and concentration of healthy adults; (b) alleviates
stress and combats the fatigue, irritability and mood swings that
healthy adults experience; (c) makes children and teenagers feel more
alert, focused, and mentally sharp; (d) improves students' ability to
concentrate and their academic performance; (e) improves senior
citizens' memory, mental clarity, and energy; (f) improves adults'
ability to absorb information in books and to recall facts, figures and
names; and (g) works in as little as one to ten days.
The complaint also alleges that the respondents failed to disclose
that certain of the endorsers who appeared in advertising for Focus
Factor had material connections with the product.
The proposed consent order contains provisions designed to prevent
the respondents from engaging in similar acts and practices in the
future.
Part I of the order prohibits claims that Focus Factor or any
substantially similar product (defined as any ingestible dietary
supplement containing one or more specified ingredients): (a) Improves
the focus, memory, and concentration of healthy adults; (b) alleviates
stress, fatigue, irritability and mood swings in healthy adults; (c)
makes children and teenagers feel more alert, focused, and mentally
sharp; (d) improves students' ability to concentrate and their academic
performance; (e) improves senior citizens' memory, mental clarity, and
energy; (f) improves adults' ability to absorb information in books and
to recall facts, figures and names; or (g) works in as little as one to
ten days, unless the claims are substantiated by competent and reliable
scientific evidence.
Part II requires that the respondents possess competent and
reliable scientific evidence to support any future claims about the
benefits, performance, or efficacy of any food, drug, or dietary
supplement for: (a) The brain or any
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mental functions or processes (including, but not limited to cognitive
function, memory, focus, learning or concentration); (b) stress,
anxiety, energy, mood or behavior; (c) academic or business
performance; (d) longevity, age-related memory impairment or dementia;
or (e) the treatment, cure, mitigation, alleviation of the symptoms,
prevention or reduction in the risk of any mental, brain, or central
nervous system disease or disorder.
Part III requires disclosure of any material connection that exists
between an endorser and the respondents or any other person or entity
involved in marketing or selling the food, drug or dietary supplement
that is the subject of the endorsement.
Part IV permits any representation for any product that is
permitted in labeling for such product by the FDA pursuant to the
Nutrition Labeling and Education Act of 1990, and any representation
for any drug that is permitted in labeling for such drug under any
tentative or final standard promulgated by the FDA or under any new
drug application approved by the FDA.
Part V states that nothing in the order shall be constituted as a
waiver of the respondents' rights to engage in speech protected by the
First Amendment to the Constitution.
Part VI provides for the payment of $60,000 to the Commission.
Part VII requires the respondents to retain certain records for
five (5) years after the last date of dissemination of any
representation covered by the order: (1) All advertisements and
promotional materials containing the representation; (2) all materials
relied upon in disseminating the representation; and (3) all evidence
in respondents' possession or control that contradicts, qualifies, or
calls into question the representation or the basis for the
representation.
Part VIII requires the respondents for ten (10) years to provide
copies of the order to personnel having responsibilities relating to
the subject matter of the order, and to obtain signed copies
acknowledging receipt of the order.
Part IX requires that the Commission be notified of changes in
corporate structure that might affect compliance obligations arising
under the order.
Part X requires that the individual respondent notify the
Commission for five (5) years of any changes in employment that might
affect his compliance obligations arising under the order.
Part XI requires the respondents to file compliance reports with
the Commission.
Part XII provides that the order will terminate after twenty (20)
years under certain circumstances.
The purpose of this analysis is to facilitate public comment on the
proposed order, and it is not intended to constitute an official
interpretation of the agreement and proposed order or to modify in any
way their terms.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 04-6460 Filed 3-22-04; 8:45 am]
BILLING CODE 6750-01-M