[Federal Register Volume 68, Number 77 (Tuesday, April 22, 2003)]
[Notices]
[Pages 19831-19833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9854]


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FEDERAL TRADE COMMISSION

[File No. 022 3247]


Snore Formula, 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 May 15, 2003.

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ADDRESSES:  Comments filed in paper form should be directed to: FTC/
Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, N.W., 
Washington, D.C. 20580. Comments filed in electronic form should be 
directed to: [email protected], as prescribed below.

FOR FURTHER INFORMATION CONTACT: Jonathan Cowen or Jock Chung, FTC, 
Bureau of Consumer Protection, 600 Pennsylvania Avenue, N.W., 
Washington, D.C. 20580, (202) 326-2533 or 326-2984.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 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 April 15, 2003), on the World Wide Web, at ``http://www.ftc.gov/
os/2003/04/index.htm.'' A paper copy can be obtained from the FTC 
Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, N.W., 
Washington, D.C. 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, N.W., Washington, D.C. 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 email box: [email protected]. 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 an agreement, subject to 
final approval, to a proposed consent order from Snore Formula, Inc., 
its officers Dennis H. Harris, M.D., and Ronald General, and Gerald L. 
``Jerry'' Harris, also doing business as KJ Enterprises (``proposed 
respondents''). Proposed respondents market ``Dr. Harris' Original 
Snore Formula'' tablets, which are advertised to be taken by persons 
who snore.
    The proposed consent order has been placed on the public record for 
thirty (30) days for reception 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 and take other appropriate action or make 
final the agreement's proposed order.
    The Commission's complaint charges that proposed respondents failed 
to have a reasonable basis for claims they made about Dr. Harris' 
Original Snore Formula tablets' efficacy in (1) preventing sleep apnea 
in adult and child users of the product who would otherwise develop 
sleep apnea, (2) treating the ``early stages'' of sleep apnea, and (3) 
eliminating, preventing, or significantly reducing snoring. Proposed 
respondents are also charged with failing to disclose or failing to 
disclose adequately that persons who have symptoms of sleep apnea 
should consult a physician because sleep apnea is a potentially life-
threatening condition. Proposed respondents are further charged with 
making false claims that scientific testing establishes that the 
product can eliminate, prevent, or significantly reduce snoring in 86% 
of users. The complaint also alleges that Snore Formula, Inc., and its 
named officers provided the means and instrumentalities to others to 
disseminate false or deceptive claims about the product. Finally, the 
complaint alleges that Dr. Dennis H. Harris, M.D., misrepresented, by 
acting as an expert endorser for the product, that he had exercised his 
represented expertise in snoring treatment, in the form of an 
examination or testing of the product at least as extensive as an 
expert in the field would normally conduct.
    Part I of the consent order requires that proposed respondents 
possess competent and reliable scientific evidence to substantiate 
representations that Dr. Harris' Original Snore Formula tablets or any 
other food, drug, device, service, or dietary supplement prevents sleep 
apnea in adult or child users who would otherwise develop sleep apnea; 
treats sleep apnea; or eliminates, prevents, or reduces snoring. It 
further requires that Dennis H. Harris, M.D., posses and rely upon 
competent and reliable scientific evidence and an actual exercise of 
his represented expertise to substantiate representations he makes as 
an expert endorser.
    Part II of the order requires that, for any product or service that 
has not been shown to be effective in the treatment of sleep apnea, 
proposed respondents must affirmatively disclose, whenever they 
represent that a product is effective in eliminating, preventing, or 
reducing snoring, a warning statement about sleep apnea and the need 
for consultation with a physician or a specialist in sleep medicine.
    Part III of the order requires scientific substantiation for any 
future claim about the effect of any food, drug, device, service, or 
dietary supplement on any disease, or about the effect of any food, 
drug, device, service, or dietary supplement on the structure or 
function of the human body, or about any other health benefit, or the 
safety, of any covered product or service. It further requires that 
Dennis H. Harris, M.D., posses and rely upon competent and reliable 
scientific evidence and an actual exercise of his represented expertise 
to substantiate representations he makes as an expert endorser.
    Part IV prohibits Snore Formula, Inc., and its named officers from 
providing to any person or entity ``means and instrumentalities'' that 
contain any claim about the benefits, performance, efficacy, or safety 
of any food, drug, device, service, or dietary supplement, unless such 
claim is true and substantiated by competent and reliable scientific 
evidence. ``Means and instrumentalities'' is defined as any 
information, including but not necessarily limited to any advertising, 
labeling, or promotional materials, for use by distributors in their 
marketing or sale of Dr. Harris' Original Snore Formula or any other 
food, drug, device, service, or dietary supplement covered under the 
order.
    Part V prohibits false claims about scientific support for any 
product or service.
    Part VI requires Snore Formula, Inc., and its named officers to 
disseminate a notice (``Attachment A'') about the order to distributors 
who have purchased Dr. Harris' Original Snore Formula tablets from 
respondents or from one of respondents' other distributors on or after 
January 1, 2001. This notice

[[Page 19833]]

indicates that Snore Formula, Inc., has agreed to cease making 
challenged representations, and warns distributors that they may be 
terminated if they do not conform their representations to the 
requirements placed on Snore Formula, Inc. Part VII of the order 
requires dissemination of Attachment A to future distributors, and that 
Snore Formula, Inc., monitor their distributors, and terminate sales to 
distributors who make representations prohibited by the order.
    The remainder of the proposed order contains standard requirements 
that proposed respondents maintain advertising and any materials relied 
upon as substantiation for any representation covered by substantiation 
requirements of the order; distribute copies of the order to certain 
company officials and employees; notify the Commission of any change in 
the corporation that may affect compliance under the order; notify the 
Commission of any change in employment by the individual proposed 
respondents, and file one or more reports detailing their compliance 
with the order. Part XIV of the proposed order is a provision whereby 
the order, absent certain circumstances, terminates twenty years from 
the date of issuance.
    This proposed order, if issued in final form, will resolve the 
claims alleged in the complaint against the named respondents. It is 
not the Commission's intent that acceptance of this consent agreement 
and issuance of a final decision and order will release any claims 
against any unnamed persons or entities associated with the conduct 
described in the complaint.
    The purpose of this analysis is to facilitate public comment on the 
proposed order, and 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. 03-9854 Filed 4-21-03; 8:45 am]
BILLING CODE 6750-01-S