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

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