[Federal Register Volume 66, Number 65 (Wednesday, April 4, 2001)]
[Notices]
[Pages 17897-17898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8300]


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FEDERAL TRADE COMMISSION

[File No. 002 3211]


Med Gen, 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 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 30, 2001.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 600 Pennsylvania Ave., NW., Washington, D.C. 20580.

FOR FURTHER INFORMATION CONTACT: Lemuel Dowdy or Walter Gross, FTC/S-
4302, 600 Pennsylvania Ave., NW., Washington, D.C. 20580, (202) 326-
2981 or 326-3319.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 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 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 29, 2001), on the 
World Wide Web, at ``http://www.ftc.gov/os/2001/03/index.htm.'' A paper 
copy can be obtained for the FTC Public Reference Room, Room H-130, 600 
Pennsylvania Avenue, NW., Washington, D.C. 20580, either in person or 
by calling (202) 326-3627.
    Public comment is invited. Comments should be directed to: FTC/
Office of the Secretary, Room 159, 600 Pennsylvania Ave., NW., 
Washington, D.C. 20580. Two paper copies of each comment should be 
filed, and should be accompanied, if possible, by a 3\1/2\ inch 
diskette containing an electronic copy of the comment. Such comments or 
views 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 Med Gen, Inc. and its 
president, Paul Kravitz (``proposed respondents''). Proposed 
respondents market ``Snorenz,'' a dietary supplement consisting of oils 
and vitamins that is sprayed on the back of the throat of 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 the product's 
efficacy in (1) reducing or eliminating snoring or the sounds of 
snoring, (2) reducing or eliminating snoring or the sounds of snoring 
for six to eight hours, and (3) treating the symptoms of sleep apnea. 
The complaint also alleges that proposed respondents lacked a 
reasonable basis to substantiate representations that testimonials from 
consumers who used Snorenz represented the typical and ordinary 
experience of users of the product. Proposed respondent are also 
charged with making false claims that clinical proof establishes the 
efficacy of Snorenz. Further, the complaint alleges that the proposed 
respondents failed to disclose adequately that the product is not 
intended to treat sleep apnea; that sleep apnea is a potentially life-
threatening disorder characterized by loud snoring, frequent 
interruptions of sleep, and daytime tiredness; and that persons 
experiencing those symptoms should seek medical attention. Finally, the 
complaint alleges that proposed respondents failed to disclose that a 
material connection existed between Med Gen, Inc. and a physician who 
appeared in the informercials to endorse Snorenz. Such claims appeared 
in informercials promoting Snorenz that proposed respondents produced, 
or caused to be produced for them,\1\ on Med Gen, Inc.'s website, and/
or on labeling for the product.
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    \1\ A separate consent settlement with a producer of several 
infomercials for Snorenz, Tru-Vantage International, L.L.C. (File 
No. 002-3210), is also being placed on the public record for 
comment.
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    Part I of the consent order requires that proposed respondents 
possess competent and reliable scientific evidence to substantiate 
representations that Snorenz or any other food, drug, or dietary 
supplement reduces or eliminates snoring or the sounds of snoring; 
reduces or eliminates snoring or the sounds of snoring for any 
specified period of time through a single application; or eliminates, 
reduces or mitigates the symptoms of sleep apnea. Part II of the order 
requires that, for any product 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 reducing or eliminating snoring or the sounds of snoring, 
a warning statement about sleep apnea and the need for physician 
consultation. Part III of the order requires proposed respondents to 
substantiate any representation about the benefits, performance, 
efficacy, or safety of Snorenz or any other food, drug, or dietary 
supplement. Part IV prohibits false claims about scientific support for 
any product, service, or program. Part V requires that, for any 
consumer endorsement or testimonial proposed respondents use to promote 
a

[[Page 17898]]

product, service or program, they must either possess competent and 
reliable scientific evidence that the testimonial represents the 
typical or ordinary experience of users or make an affirmative 
disclosure that the testimonial is not typical. Part VI requires an 
affirmative disclosure of any material connection between proposed 
respondents and any endorser of their products. Parts VII and VIII of 
the proposed order permit proposed respondents to make certain claims 
for drugs or dietary supplements, respectively, that are permitted in 
labeling under laws and/or regulations administered by the U.S. Food 
and Drug Administration.
    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 under 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 obligations under the order; 
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. 01-8300 Filed 4-3-01; 8:45 am]
BILLING CODE 6750-01-M