Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33093

Part II of the order requires that future

claims that any test or device provides

a clinical gauge of an individual’s

overall healthiness or youthfulness be

true and substantiated by competent

and reliable scientific evidence.

Part III of the order requires

competent and reliable scientific

evidence as substantiation for future

claims that LSF or any other food, drug,

device, service, or dietary supplement

provides any of the specific health

benefits challenged above as

unsubstantiated. In addition, Part III. L

requires scientific substantiation for any

future claim about the effect of covered

products or services on any disease, on

the structure or function of the human

body, or about any other health benefit,

or the safety, of any covered product or

service.

Part IV of the order prohibits MaxCell

from providing to any person or entity

‘‘means and instrumentalities’’ that

contain any claim about the effect of any

product or service on any disease, or

about the effect of any product or

service on the structure or function of

the human body, or about any other

health benefit, or the safety, of any

product or service, unless such claim is

true and substantiated by competent

and reliable scientific evidence. ‘‘Means

and instrumentalities’’ is defined as any

information, including but not

necessarily limited to any advertising,

labeling, or promotional materials, for

use by distributors in their marketing or

sale of the ACI test or LSF or any other

product or service covered under the

order.

Part V of the order prohibits MaxCell

from misrepresenting the existence,

contents, validity, results, conclusions,

or interpretations of any test, study, or

research.

Part VI of the order requires

dissemination of a notice (‘‘Attachment

A’’) about the order to MaxCell’s

distributors who have purchased the

ACI Test or LSF since January 1, 2000.

This notice indicates that MaxCell has

agreed to cease making challenged

representations, and warns distributors

that they may be terminated if they do

not conform their representations to the

requirements placed on MaxCell.

Part VII of the order requires

dissemination of Attachment A to future

distributors, and that MaxCell monitor

their distributors, and terminate sales to

distributors who make representations

prohibited by the order.

Part VIII of the order permits FDAapproved drug claims and claims for

food or dietary supplements authorized

under the Nutrition Labeling and

Education Act of 1990.

Part IX of the order requires that

MaxCell make a payment of $150,000 to

the Commission, which funds the FTC

can forward to the U.S. Treasury as

disgorgement or use for purposes of

consumer redress.

Parts X, XI, XII, and XIV of the order

require MaxCell to keep copies of

relevant advertisements and materials

substantiating claims made in the

advertisements, to provide copies of the

order to certain of its personnel, to

notify the Commission of changes in

corporate structure, and to file

compliance reports with the

Commission. Part XIII requires Stephen

Cherniske to notify the Commission of

his employment status, and Part XV

provides that the order will terminate

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 proposed order or to

modify in any way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 01–15548 Filed 6–19–01; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

[File No. 002 3229]

Panda Herbal International, 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

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 Panda Herbal International, Inc.

(‘‘Panda’’), a corporation, and Everett L.

Farr III, 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 Herbal Outlook (a

dietary supplement that contains St.

33094 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

John’s Wort) and HerbVeil 8 (a topical

ointment) products. The proposed

compliant 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

respondents’ claims that ingestion of

Herbal Outlook is effective in the

treatment of HIV/AIDS, herpes simplex,

tuberculosis, influenza, and hepatitis B

infections are unsubstantiated. Further,

the proposed complaint alleges that

responents deceptively fail to disclose

significant adverse drug interactions in

light of respondents’ implied drug

compatibility claim (‘‘ingestion of St.

John’s Wort, an ingredient in Herbal

Outlook, is effective in the treatment of

HIV/AIDS’’). The proposed complaint

also alleges that respondents’ claim that

ingestion of St. John’s Wort, an

ingredient in Herbal Outlook, has no

known contraindications or drug

interactions is false because there is

substantial information available

documenting significant adverse drug

interactions. In addition, the proposed

complaint alleges that respondents’

HerbVeil 8 claims that topical

application of HerbVeil 8 is effective in

the treatment of carcinomas,

adenocarcinomas, and melanomas are

unsubstantiated.

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 ‘‘Herbal

Outlook product’’ as respondents’

Herbal Outlook or any other 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 any

Herbal Outlook product or any covered

product or service is effective in the

treatment of HIV/AIDS, herpes simplex,

tuberculosis, influenza, or hepatitis B

infections, unless, at the time the

representation is made, respondents

possess and rely upon competent and

reliable scientific evidence that

substantiates the representation.

The proposed order defines ‘‘HerbVeil

8 product’’ as respondents’ HerbVeil 8

or any covered product or service for

which the term ‘‘HerbVeil 8’’ appears on

the product label or in any advertising

or promotion, any covered product or

service containing ‘‘HerbVeil 8,’’ and

any covered product or service

promoted for the topical treatment of

any cancer. Part II of the proposed

consent order prohibits proposed

respondents from representing that

application of any HerbVeil 8 product,

or any covered product or service, is

effective in the treatment of any cancer

unless, at the time the representation is

made, respondents possess and rely

upon competent and reliable scientific

evidence that substantiates the

representation. Part III of the proposed

consent order prohibits proposed

respondents from representing that

ingestion of any Herbal Outlook product

has no known contraindications or drug

interactions.

Part IV provides that in any

advertisement, promotional material, or

product label for any Herbal Outlook

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 Herbal Outlook 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 IV 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.

Part V provides that proposed

respondents, in connection with the

advertising or sale of any Herbal

Outlook product, HerbVeil 8 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.

The proposed order defines

‘‘purchaser for resale’’ as any purchaser

of any proposed respondents’ Herbal

Outlook product or HerbVeil 8 product,

who: (a) Is a distributor of, or operates

a wholesale or retail business that sells,

any such product(s); or (b) orders

twenty (20) or more units of any such

products(s) in any three (3) month

period. Parts VI A and VI B of the

proposed consent order require

proposed respondents to deliver to the

Commission lists containing

information regarding purchasers for

resale and consumers of Herbal Outlook,

respectively. Parts VI C and VI D require

proposed respondents to deliver to the

Commission lists containing

information regarding purchasers for

resale and consumers of HerbVeil 8,

respectively. Parts VI E and VI F require

proposed respondents to send a notice

to all purchasers of Herbal Outlook and

HerbVeil 8 informing them of the

Commission’s complaint allegations and

the terms of the settlement. Part VII of

the proposed order requires proposed

respondents to provide refunds upon

request to consumer purchasers of

HerbVeil 8. Part VIII requires proposed

respondents to submit a report

specifying the steps it has taken to

comply with Part VI (notice provisions)

and Part VII (refund provision).

Part IX requires proposed respondents

to take reasonable steps to monitor and

ensure that all employees and agents

engaged in sales, order verification, and

other customer service functions

comply with Parts I through V of the

order and requires proposed

respondents to terminate any employee

who knowingly engages in conduct that

violates these parts of the order. Part X

A requires proposed respondents to

send each purchaser for resale for a

period of five years following entry of

the order, the notice provisions required

by Part VI E (to the extent such

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33095

purchasers for resale have not already

received such notice pursuant to Part VI

E). Part X B requires proposed

respondents to institute a purchaser for

resale order compliance surveillance

program and Part X C states that

proposed respondents must terminate

sales to those purchasers for resale they

know or should know are violating Parts

I through V of the proposed order. Part

XI would allow proposed respondents

to make any representation for any drug

that is permitted by the FDA in the

drug’s labeling, and 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.

Part XII of the proposed order

contains record keeping requirements

for materials that substantiate, qualify or

contradict claims covered by the

proposed order. Part XIII of the

proposed order requires distribution of

a copy of the order to current and future

officers, employees, and agents. Part

XIV provides for Commission

notification upon a change in the

proposed corporate respondent and Part

XV requires Commission notification

when the proposed individual

respondent changes his business or

employment. Part XVI requires the

proposed respondents to file with the

Commission a report demonstrating

compliance with the terms and

provisions of the order. Part XVII

provides for the termination of the order

after twenty (20) years under certain

circumstances.

The purpose of this analysis is to

facilitate the 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. 01–15546 Filed 6–19–01; 8:45am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01106]

Addressing Asthma From a Public

Health Perspective; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for ‘‘Addressing Asthma from a

Public Health Perspective.’’ This

program addresses the ‘‘Healthy People

2010’’ focus areas Environmental

Health, Respiratory Diseases and

Occupational Safety and Health.

The purpose of the program is: Part A:

Developing State Capacity to Address

Asthma and Part B: Implementation of

State Asthma Plans.

This funding is not to be used for any

type of research.

B. Eligible Applicants

Assistance will be provided only to

health departments of States or their

bona fide agents, including the District

of Columbia, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Commonwealth of the Northern Mariana

Islands, American Samoa, Guam, the

Federated States of Micronesia, the

Republic of the Marshall Islands, the

Republic of Palau, and federally

recognized Indian tribal governments.

In consultation with States, and with

the written concurrence of the State,

assistance may be provided to political

subdivisions of States.

Part A: Eligible applicants are those

entities listed above that do not have a

finalized comprehensive asthma plan or

a well developed asthma surveillance

system. Grantees currently funded by

CDC Announcement #99109

(Attachment 1) are not eligible to apply.

Part B: Eligible applicants are those

entities listed above that have a

completed comprehensive asthma plan

and have an operational surveillance

system for asthma. Grantees currently

funded by CDC Announcement #99109

are eligible to apply. However, if

awarded funds under Part B of this

announcement, applicant will lose

funds under Announcement #99109.

An eligible applicant may apply for

both Part A and Part B; however, only

one award per applicant will be made.

To apply for both parts of this

announcement, applicants must submit

separate applications for Part A and Part

B.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $3,600,000 is available

in FY 2001 to fund awards under this

announcement. Funding estimates may

change.

Part A: Developing State Capacity to

Address Asthma. Approximately

$2,000,000 is available to fund

approximately 7–12 awards. It is

expected that the average award will be

$200,000. Additionally, $100,000 is

available to increase Part A awards up

to $10,000 each, if an occupational

component is included in the

application and is favorably reviewed.

Part B: Implementation of State

Asthma Plans. Approximately

$1,500,000 is available to fund

approximately 2–4 awards. It is

expected that the average award will be

$700,000.

It is expected that the awards will

begin on or about September 30, 2001

and will be made for a 12-month budget

period within a project period of up to

3 years for Part A and 5 years for Part

B.

Continuation awards within the

approved project periods will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Applicant should document

assurance of ability of project staff to

travel to Atlanta to participate in the

CDC National Asthma Conference and/

or grantee meetings and willingness to

share innovations, information, data and

materials.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

Part A. Developing State Capacity to

Address Asthma

1. Recipient Activities:

a. Develop or finalize a

comprehensive State asthma plan.

b. Develop and organize collaborative

linkages with appropriate agencies and

organizations.

c. Implement a new (or enhance an

existing) asthma surveillance system.

d. Begin the statewide intervention

program upon completion of the plan.