33088 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

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 made false

claims that their Colloidal Silver

product had been (1) medically proven

to kill over 650 disease-causing

organisms in the body; and (2)

successfully used to treat all known

infections. The Commission’s complaint

also charges that proposed respondents

failed to have a reasonable basis for

claims they made about the Colloidal

Silver product’s (1) efficacy in treating

and curing cancer, multiple sclerosis,

HIV/AIDS, and other specific illnesses;

(2) superiority to antibiotics in healing

and curing infections; (3) safety for

human consumption without side

effects; and (4) superiority in treating

various medical and health problems in

animals. Proposed respondents have

also been charged with failing to have

a reasonable basis for claims they made

about the efficacy of their Chitosan with

vitamin C product, the safety claims for

their Ultimate Energizer product

containing Mahuang, and other

substances. Such claims, promoting

dietary supplements, appeared on the

website that proposed respondents

produced or caused to be produced.

Part I of the consent order prohibits

proposed respondents from

misrepresenting, including by means of

metatags, any claims that Colloidal

Silver or any service, program, dietary

supplement, food, drug, or device, has

been medically proven to kill diseasecausing organisms or any number of

infections in the body. Part II of the

order requires competent and reliable

scientific evidence to substantiate

representations that Colloidal Silver or

any covered product (1) treats and cures

cancer, multiple sclerosis, HIV/AIDS,

and other specific illnesses; (2) is

superior to antibiotics in healing and

curing infections; (3) is safe for human

consumption and has no side effects; (4)

treats various medical and health

problems in animals; and (5) enables

consumers to lose substantial weight

without the need for a restricted diet.

Part III of the order prohibits proposed

respondents from misrepresenting,

including by means of metatags, the

existence, contents or interpretation of

any test, study, or research. Part V of the

order requires that for any future

advertisement of products containing

ephedra or ephedrine, proposed

respondents must include affirmative

warnings concerning safety issues. This

warning was developed after

discussions with the Food and Drug

Administration. FDA has announced

that it intends to initiate a rulemaking

for dietary supplements for women who

are or who may become pregnant. In the

event that FDA issues a final rule

requiring a warning for pregnant women

on dietary supplements, respondents

may substitute that warning for the

disclosure on that topic required under

the proposed order. Part IV of the

proposed order permits 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

business entity that may affect

compliance obligations under the order;

and file one or more reports detailing

their compliance with the order. Part XII

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. 01–15550 Filed 6–19–01; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

[File No. 002 3226]

ForMor, Inc., et al.; Analysis To Aid

Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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 July 16, 2001.

ADDRESSES: Comments should be

directed to: FTC/Office of the Secretary,

Room 159, 600 Pennsylvania Ave., NW.,

Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Michael Bloom or Donald D’Amato,

Federal Trade Commission, Northeast

Region, One Bowling Green, Suite 318,

New York, NY 10004. (212) 607–2801 or

607–2802.

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

June 14, 2001), on the World Wide Web,

at ‘‘http://www.ftc.gov/os/2001/06/

index.htm.’’ A paper copy can be

obtained from the FTC Public Reference

Room, Room H–130, 600 Pennsylvania

Avenue, NW., Washington, DC 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, DC 20580. Two

paper copies of each comment should

be filed, and should be accompanied, if

possible, by a 31⁄2 inch diskette

containing an electronic copy of the

comment. Such comments or views will

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33089

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, subject to final approval, an

agreement to a proposed consent order

from ForMor, Inc. (‘‘ForMor’’), a

corporation, and Stan Goss, individually

and as an officer of the corporation

(‘‘proposed respondents’’).

The proposed consent order has been

placed on the public record for thirty

(30) days for the receipt 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 comments received and

will decide whether it should withdraw

from the agreement and take appropriate

action or make final the agreement’s

proposed order.

This matter involves proposed

respondents’ making of health-related

advertising claims on the Internet and

elsewhere for their St. John’s Kava Kava

(a dietary supplement that contains St.

John’s Wort), colloidal silver, and shark

cartilage products. The proposed

complaint alleges that proposed

respondents violated sections 5 and 12

of the Federal Trade Commission Act by

making deceptive claims for these

products.

The proposed complaint alleges that

proposed respondents made the

unsubstantiated claim that ingestion of

St. John’s Kava Kava is effective in the

treatment of HIV/AIDS, colds, syphilis,

tuberculosis, dysentery, whooping

cough, mania, hypochondria, fatigue,

and hysteria. Further, the proposed

complaint alleges that proposed

respondents represented that ingestion

of St. John’s Kava Kava is effective in

the treatment of HIV/AIDS, but

deceptively failed to disclose the

material fact that ingestion of St. John’s

Wort is not compatible with use of

protease inhibitors and other drugs used

in the treatment of HIV/AIDS. The

proposed complaint also alleges that

proposed respondents falsely

represented that ingestion of St. John’s

Kava Kava has no serious drug

interactions.

The proposed complaint further

alleges that proposed respondents

falsely claimed that ingestion of

colloidal silver is proven effective in the

treatment of over 650 infectious

diseases, and that medical tests prove

that ingestion of colloidal silver is safe

and has no adverse side effects. In

addition, the proposed complaint

alleges that proposed respondents made

the unsubstantiated claims that

ingestion of colloidal silver is effective

in the treatment of arthritis, blood

poisoning, cancer, cholera, diphtheria,

diabetes, dysentery, gonorrheal herpes,

influenza, leprosy, lupus, malaria,

meningitis, rheumatism, shingles, staph

infections, strep infections, syphilis,

tuberculosis, whooping cough, and

yeast infections, and that a testimonial

from a consumer appearing in the

advertisement for proposed

respondents’ colloidal silver reflects the

typical or ordinary experiences of

persons with cancer who use the

product.

Further, the proposed complaint

alleges that proposed respondents made

the following unsubstantiated claims

regarding their shark cartilage products:

Ingestion of shark cartilage is effective

in the treatment of arthritis and other

degenerative and inflammatory

conditions; ingestion of shark cartilage

is effective in the treatment of brain

cancer; and a testimonial from a

consumer appearing in the

advertisement for proposed

respondents’ Ultimate II Shark Cartilage

Concentrate reflects the typical or

ordinary experience of persons with

brain cancer who use the product.

Finally, the proposed complaint alleges

that proposed respondents falsely

represented that scientific research

establishes that ingestion of shark

cartilage is effective in the treatment of

arthritis and other degenerative and

inflammatory conditions.

For purposes of the proposed order a

‘‘covered product or service’’ means any

service, program, dietary supplement,

food, drug, or device.

The proposed order defines ‘‘St.

John’s Wort products’’ as ForMor’s St.

John’s Kava Kava or any covered

product or service for which the term

‘‘Hypericum Perforatum’’ or ‘‘St. John’s

Wort’’ appears on the covered product

or service label or in any advertising or

promotion, and any covered product or

service containing ‘‘Hypericum

Perforatum’’ or ‘‘St. John’s Wort.’’

Part I of the proposed consent order

prohibits proposed respondents from

representing that ingestion of a St.

John’s Wort product or any covered

product or service is effective in the

treatment of HIV/AIDS, colds, syphilis,

tuberculosis, dysentery, whooping

cough, mania, hypochondria, fatigue, or

hysteria unless, at the time the

representation is made, respondents

possess and rely upon competent and

reliable scientific evidence that

substantiates the representation. Part II

of the proposed consent order prohibits

proposed respondents from representing

that ingestion of a St. John’s Wort

product has no serious drug

interactions.

Part III provides that in any

advertisement, promotional material, or

product label for any St. John’s Wort

product, that contains any

representation about the efficacy,

performance, or safety of such product,

and in any discussion, communicated

via electronic mail or any telephone

line, that contains any representation

about the efficacy, performance, or

safety of any St. John’s Wort product,

proposed respondents shall make,

clearly and prominently, the following

disclosure:

Warning: St. John’s Wort can have

potentially dangerous interactions with some

prescription drugs. Consult your physician

before taking St. John’s Wort if you are

currently taking anticoagulants, oral

contraceptives, anti-depressants, anti-seizure

medications, drugs to treat HIV or prevent

transplant rejection, or any other prescription

drug. This product is not recommended for

use if you are or could be pregnant unless a

qualified health care provider tells you to use

it. The product may not be safe for your

developing baby.

unless respondents possess competent

and reliable scientific evidence that

such product produces no adverse drug

interactions or side effects. This

disclosure was developed after

discussions with the Food and Drug

Administration. FDA has announced

that it intends to initiate a rulemaking

for dietary supplements for women who

are or who may become pregnant. In the

event that FDA issues a final rule

requiring a warning for pregnant women

on dietary supplements, respondents

may substitute that warning for the

disclosure on that topic required under

the proposed order. Part III specifies

that the product label requirements of

this Part shall not apply to products that

are shipped to consumers or purchasers

for resale less than thirty (30) days after

the date of service of this order, and that

with regard to products shipped after

thirty (30) days of the date of service of

this order, respondents may affix the

disclosure clearly and prominently by

sticker or other device on the labels of

products manufactured prior to thirty

(30) days after the service of this order.

The proposed order defines ‘‘colloidal

silver product’’ as ForMor’s colloidal

silver or any covered product or service

for which the term ‘‘colloidal silver’’ or

‘‘silver salts’’ appears on the covered

product or service label or in any

advertising or promotion, and any

covered product or service containing

‘‘colloidal silver’’ or ‘‘silver salts.’’ In

33090 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

connection with the advertising or sale

of a colloidal silver product, Part IV

prohibits proposed respondents from

representing that ingestion of colloidal

silver is proven effective in the

treatment of disease or any number of

diseases, or representing that medical

studies demonstrate that ingestion of

colloidal silver is safe or has no adverse

side effects. Part V prohibits proposed

respondents from representing that

ingestion of colloidal silver is effective

in the treatment of arthritis, blood

poisoning, cancer, cholera, diptheria,

diabetes, dysentery, gonorrheal herpes,

influenza, leprosy, lupus, malaria,

meningitis, rheumatism, shingles, staph

infections, strep infections, syphilis,

tuberculosis, whooping cough, or yeast

infections unless, at the time the

representation is made, proposed

respondents possess and rely upon

competent and reliable scientific

evidence that substantiates the

representation.

The proposed order defines ‘‘shark

cartilage product’’ as ForMor’s Ultimate

II Shark Cartilage Concentrate or any

covered product or service label for

which the term ‘‘shark cartilage’’

appears on the covered product or

service label or any advertising or

promotion, and any covered product or

service containing ‘‘shark cartilage.’’

Part VI requires proposed respondents,

in connection with the advertising or

sale of any shark cartilage product or

any covered product or service, from

representing that ingestion of such

product is effective in the treatment of

arthritis or other degenerative or

inflammatory conditions, or is effective

in the treatment of brain cancer, unless,

at the time the representation is made,

proposed respondents possess and rely

upon competent and reliable scientific

evidence that substantiates the

representation.

Part VII prohibits proposed

respondents, in connection with the

advertising or sale of any covered

product or service, from

misrepresenting the existence, contents,

validity, results, conclusions, or

interpretations of any test, study, or

research. Part VIII prohibits proposed

respondents from representing that the

experience represented by any user

testimonial or endorsement of a covered

product or service represents the typical

or ordinary experience of members of

the public who use the covered product

or service, unless: (a) At the time the

representation is made, proposed

respondents possess and rely upon

competent and reliable scientific

evidence that substantiates the

representation; or (b) proposed

respondents disclose, clearly and

prominently, and in close proximity to

the endorsement or testimonial, either

what the generally expected results

would be for users of the covered

product or service, or the limited

applicability of the endorser’s

experience to what consumers may

generally expect to achieve, that is, that

consumers should not expect to

experience similar results.

Part IX provides that proposed

respondents, in connection with the

advertising or sale of any St. John’s Wort

product, colloidal silver product, shark

cartilage product, or any covered

product or service, shall not make any

representation that such product or

service is effective in the mitigation,

treatment, prevention, or cure of any

disease or illness, or about the health

benefits, performance, safety, or efficacy

of any such product or service, unless,

at the time the representation is made,

proposed respondents possess and rely

upon competent and reliable scientific

evidence that substantiates the

representation.

Part X requires proposed respondents

to send a notice to all purchasers of St.

John’s Kava Kava, colloidal silver, and

Ultimate II Shark Cartilage Concentrate

informing them of the Commission’s

complaint allegations and describing the

terms of the settlement. Part XI requires

proposed respondents to provide

refunds upon request to purchasers of

colloidal silver and Ultimate II Shark

Cartilage Concentrate, and Part XII

requires proposed respondents to

submit a report specifying the steps they

have taken to comply with Part X

(purchaser notice provisions) and Part

XI (purchaser refund provisions).

Part XIII requires proposed

respondents to take reasonable steps to

ensure that all employees and agents

engaged in sales, order verification, and

other customer service functions

comply with Parts I through IX of the

proposed order. It further requires

proposed respondents to terminate any

employee who knowingly engages in

conduct that violates these parts of the

order. Part XIV requires proposed

respondents to send each purchaser for

resale—defined as any purchaser of any

of respondents’ St. John’s Wort,

colloidal silver, or shark cartilage

products who orders five or more units

of any such product at any one time or

twenty or more units of any such

products in any three-month period—

the purchaser notice provisions required

by Part X. In the event that proposed

respondents receive any information

that subsequent to receipt of such notice

a purchaser is using or disseminating

any advertisement or promotional

material or making any oral statement

that contains any prohibited

representation or that does not contain

the disclosure required pursuant to Part

III, proposed respondents are required

to investigate such information and

upon verification terminate, and not

resume, sales or shipments to such

purchaser for resale. Part XV would

allow proposed respondents to make

any representation that is specifically

permitted in the labeling for any

product by regulations promulgated by

the FDA pursuant to the Nutrition

Labeling and Education Act of 1990,

and would allow respondents to make

any representation for any drug that is

permitted by the FDA in the drug’s

labeling.

Part XVI of the proposed order

contains record keeping requirements

for materials that substantiate, qualify,

or contradict claims covered by the

proposed order. Part XVII of the

proposed order requires distribution of

a copy of the order to current and future

officers and agents. Part XVIII provides

for Commission notification upon a

change in the corporate respondent and

Part XIX requires Commission

notification when the proposed

individual respondent changes his

business or employment. Part XX

requires the proposed respondents to

file with the Commission a report

demonstrating compliance with the

terms and provisions of the order. Part

XXI provides for the termination of the

order after twenty (20) years under

certain circumstances.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and the proposed order or

to modify in any way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 01–15547 Filed 6–19–01; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

[File No. 012 3091]

Michael Forrest, d/b/a Jaguar

Enterprises of Santa Ana; Analysis To

Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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