[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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