[Federal Register Volume 61, Number 242 (Monday, December 16, 1996)]
[Notices]
[Pages 66042-66043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31805]


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FEDERAL TRADE COMMISSION
[File No. 942-3251]


Natural Innovations, Inc.; William S. Gandee; World Media T.V., 
Inc.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreements.

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SUMMARY: In settlement of alleged violations of federal law prohibiting 
unfair or deceptive acts or practices and unfair methods of 
competition, these two consent agreements, accepted subject to final 
Commission approval, would, among other things, require the respondents 
to have scientific proof to back up any pain relief or other health or 
medical benefit claims they make in the future. The agreement settles 
Commission allegations stemming from the advertising and sale of 
Natural Innovation's ``The Stimulator,'' a purported pain relief device 
widely advertised in an informercial titled ``Saying No To Pain,'' 
which was created and distributed by World Media.

DATES: Comments must be received on or before February 14, 1997.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT: Lesley Anne Fair, Federal Trade 
Commission, S-4002, 6th and Pennsylvania Ave., NW, Washington, DC 
20580. (202) 326-3081.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46, and Sec. 2.34 of the 
Commission's rules of practice (16 CFR 2.34), notice is hereby given 
that the above-captioned consent agreements containing consent orders 
to cease and desist, having been filed with and accepted, subject to 
final approval, by the Commission, have been placed on the public 
record for a period of sixty (60) days. The following

[[Page 66043]]

Analysis to Aid Public Comment describes the terms of the two consent 
agreements, and the allegations in the accompanying complaints. 
Electronic copies of the full text of the consent agreement packages 
can be obtained from the Commission Actions section of the FTC Home 
Page (for December 5, 1996), on the World Wide Web, at ``http://
www.ftc.gov/os/actions/htm.'' Paper copies can be obtained from the FTC 
Public Reference Room, Room H-130, Sixth Street and Pennsylvania 
Avenue, NW., Washington, DC 20580, either in person or by calling (202) 
326-3627. Public comment is invited. 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 Sec. 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, agreements to a proposed consent order from Natural 
Innovations, Inc. (``Natural Innovations'') and its officer and 
director, Ohio chiropractor William S. Gandee (``Dr. Gandee''), and a 
proposed consent from World Media T.V., Inc. (``World Media'') 
(collectively ``respondents'').
    The proposed consent orders have been placed on the public record 
for sixty (60) days for reception of comments by interested persons. 
Comments received during this period will become part of the public 
record. After sixty (60) days, the Commission will again review the 
agreements and the comments received and will decide whether it should 
withdraw from the agreements or make final the agreements' proposed 
orders.
    The Commission's complaint against respondents Natural Innovations 
and Dr. Gandee alleges that they deceptively advertising the 
Stimulator, a purported pain relief device, primarily through an 
infomercial entitled ``Saying No To Pain.'' The Stimulator is a 
syringe-shaped device that purports to relieve pain by emitting an 
electrical spark when applied to the skin. The complaint against World 
Media TV alleges that it served as an advertising agency, production 
company, and media buyer for Natural Innovations, Inc., and 
participated in the creation and dissemination of advertisements for 
the Stimulator.
    The complaints further allege that respondents made unsubstantiated 
representations that the Stimulator will significantly relieve or 
eliminate a wide variety of pain, including musculoskeletal pain, 
carpal tunnel syndrome, abdominal pain, pain caused by allergies and 
sinus conditions, diverticulosis, menstrual cramps, and headaches, 
including but not limited to occipital, frontal, migraine, cluster, and 
stress headaches, and headaches caused by benign tumors.
    The complaints also allege that respondents represented without 
substantiation that pain relief from the device is immediate; that the 
device provides long-term relief; and that the device is as effective 
as, or more effective than, prescription and over-the-counter 
medications, physical therapy, chiropractic treatment, acupuncture, 
acupressure, and reflexology.
    The proposed consent orders contain provisions designed to remedy 
the violations charged and to prevent respondents from engaging in 
similar acts and practices in the future. Part I of both orders 
requires respondents to possess well-controlled clinical testing to 
support any claim that a device relieves or eliminates pain, relieves 
pain immediately, or is as effective as or better than over-the-counter 
pain medication or physical treatments. For representations that a 
device is effective for temporary relief of minor aches and pains due 
to fatigue or overexertion, easing and relaxing tired muscles, or 
temporary increase of local blood circulation, Part I requires that 
respondents possess competent and reliable scientific evidence.
    Part II requires respondents to possess competent and reliable 
scientific evidence for any claims about the health or medical benefits 
of any product.
    Part III of both orders forbids respondents from representing that 
an endorsement represents the typical experience of users of the 
product unless respondents possess competent and reliable scientific 
evidence substantiating that representation or they disclose clearly 
and prominently either the results that consumers can generally expect 
or that consumers should not expect to achieve results similar to the 
endorsers.
    Part IV allows respondents to make representations for any drug 
that are permitted in labeling for that drug under any tentative or 
final FDA standard or under any FDA-approved new drug application.
    Parts V through VIII and X of the Natural Innovations Order and 
Parts V through VII and IX of the World Media Order relate to 
respondents' obligations to make available to the Commission materials 
substantiating claims covered by the order; to notify the Commission of 
changes in Natural Innovation's or World Media's corporate structure; 
to notify the Commission of changes in Dr. Gandee's employment or 
business affiliations; to provide copies of the orders to certain 
Natural Innovations and World Media personnel; and to file compliance 
reports with the Commission. Part IX of the Natural Innovations Order 
and Part VIII of the World Media Order provide that the orders will 
terminate after twenty years under certain circumstances.
    The purpose of this analysis is to facilitate public comment on the 
proposed orders, and it is not intended to constitute an official 
interpretation of the agreements and proposed orders or to modify in 
any way their terms.
Donald S. Clark,
Secretary.
[FR Doc. 96-31805 Filed 12-13-96; 8:45 am]
BILLING CODE 6750-01-P