[Federal Register Volume 74, Number 67 (Thursday, April 9, 2009)]
[Notices]
[Pages 16210-16212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8140]


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FEDERAL TRADE COMMISSION

[Docket No. 9328]


Native Essence Herb Company, et al.; Analysis of Proposed Consent 
Order to Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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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 and 
the terms of the consent order--embodied in the consent agreement--that 
would settle these allegations.

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DATES: Comments must be received on or before May 4, 2009.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form. Comments should refer to``Native 
Essence, Docket No. 9328'' to facilitate the organization of comments. 
Please note that your comment--including your name and your state--will 
be placed on the public record of this proceeding, including on the 
publicly accessible FTC website, at (http://www.ftc.gov/os/publiccomments.shtm).
    Because comments will be made public, they should not include any 
sensitive personal information, such as an individual's Social Security 
Number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. Comments also 
should not include any sensitive health information, such as medical 
records or other individually identifiable health information. In 
addition, comments should not include any ``[t]rade secret or any 
commercial or financial information which is obtained from any person 
and which is privileged or confidential. . . .,'' as provided in 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 
4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which 
confidential treatment is requested must be filed in paper form, must 
be clearly labeled ``Confidential,'' and must comply with FTC Rule 
4.9(c).\1\
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    \1\ FTC Rule 4.2(d), 16 CFR 4.2(d). The comment must be 
accompanied by an explicit request for confidential treatment, 
including the factual and legal basis for the request, and must 
identify the specific portions of the comment to be withheld from 
the public record. The request will be granted or denied by the 
Commission's General Counsel, consistent with applicable law and the 
public interest. See FTC Rule 4.9(c), 16 CFR 4.9(c).
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    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please consider submitting your comments 
in electronic form. Comments filed in electronic form should be 
submitted by using the following weblink: (http://secure.commentworks.com/ftc-NativeEssence) (and following the 
instructions on the web-based form). To ensure that the Commission 
considers an electronic comment, you must file it on the web-based form 
at the weblink: (http://secure.commentworks.com/ftc-NativeEssence). If 
this Notice appears at (http://www.regulations.gov/search/index.jsp), 
you may also file an electronic comment through that website. The 
Commission will consider all comments that regulations.gov forwards to 
it. You may also visit the FTC website at http://www.ftc.gov to read 
the Notice and the news release describing it.
    A comment filed in paper form should include the ``Native Essence, 
et al., Docket No. 9328`` reference both in the text and on the 
envelope, and should be mailed or delivered to the following address: 
Federal Trade Commission, Office of the Secretary, Room H-135, 600 
Pennsylvania Avenue, NW, Washington, DC 20580. The FTC is requesting 
that any comment filed in paper form be sent by courier or overnight 
service, if possible, because U.S. postal mail in the Washington area 
and at the Commission is subject to delay due to heightened security 
precautions.
    The Federal Trade Commission Act (``FTC Act'') and other laws the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC website, to the extent practicable, 
at (http://www.ftc.gov/os/publiccomments.shtm). As a matter of 
discretion, the Commission makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC website. More information, including 
routine uses permitted by the Privacy Act, may be found in the FTC's 
privacy policy, at (http://www.ftc.gov/ftc/privacy.shtm).

FOR FURTHER INFORMATION CONTACT: Erika Wodinsky, Western Region, 600 
Pennsylvania Avenue, NW, Washington, D.C. 20580, (415) 848-5100.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  3.25(f) 
the Commission Rules of Practice, 16 CFR 3.25(f), notice is hereby 
given that the above-captioned consent agreement containing a consent 
order to cease and desist, having been filed with and accepted, subject 
to final approval, 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 April 3, 2009), on the World Wide Web, at (http://www.ftc.gov/os/2009/04/index.htm). A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, 
D.C. 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. All comments should be filed as 
prescribed in the ADDRESSES section above, and must be received on or 
before the date specified in the DATES section.

Analysis of Agreement Containing Consent Order to Aid Public Comment

    The Federal Trade Commission has accepted, subject to final 
approval, an agreement containing a consent order from Native Essence 
Herb Company, a corporation, Mark J. Hershiser, individually, d/b/a 
Native Essence Herb Company, and as an officer of the corporation, and 
Marianne Hershiser, individually, d/b/a Native Essence Herb Company, 
and as an officer of the corporation (``respondents'').
    The proposed consent order has been placed on the public record for 
thirty days for reception of comments by interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will again review the agreement and 
the comments received and will decide whether it should withdraw from 
the agreement or make final the agreement's proposed order.
    This matter concerns the respondents' advertising and promotion of 
Native Essense (Rene Caisse) Formula tea and extract, Native Essense 
Plus tea and extract, Native Essense with Cat's Claw tea and extract, 
chaparral herb, Maitake mushroom extract, and Mai-T Mushroom Plus 
Formula extract. The complaint alleges that respondents have made a 
number of deceptive claims regarding the efficacy of these products in 
the prevention, treatment or cure of cancer.
    Specifically, the Commission's complaint alleges that respondents 
have claimed that their Native Essense Original Formula, Native Essense 
Plus, and Native Essense with Cat's Claw products are effective in 
treating and curing cancer, including but not limited to lymphoma, 
colon cancer, rectal cancer, and prostate cancer. The complaint also 
alleges that respondents have claimed that these products are effective 
in reducing the size of, or eliminating, cancerous tumors. The 
complaint further alleges that respondents have claimed that Native 
Essense Plus is effective in preventing breast cancer. The complaint 
alleges that respondents did not have a

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reasonable basis for these claims. The complaint also alleges that 
respondents falsely claimed that scientific research proves that Native 
Essense Plus prevents breast cancer, and that scientific studies prove 
that Native Essense with Cat's Claw is effective in the treatment of 
cancer.
    Regarding chaparral herb, the Commission's complaint alleges that 
respondents claimed that chaparral herb is effective in treating and 
curing cancer, is effective in causing people with cancer to go into 
complete remission without the need for any other form of treatment, 
and is effective in shrinking or eliminating cancerous tumors. The 
complaint alleges that respondents lacked a reasonable basis for these 
claims.
    The complaint also alleges that respondents lacked a reasonable 
basis for the claims that Mai-T Mushroom Plus is effective in 
preventing, treating and curing cancer, including but not limited to 
lung cancer, stomach cancer, hepatocellular cancer, leukemia, and 
Kaposi's sarcoma; and that Mai-T Mushroom Plus is effective in 
inhibiting the growth of cancerous tumors. Finally, the complaint 
alleges that respondents falsely claimed that clinical studies prove 
that Maitake mushrooms and Mai-T Mushroom Plus prevent and treat lung 
cancer, stomach cancer, hepatocellular cancer, leukemia, and Karposi's 
sarcoma, and inhibit tumor growth.
    The proposed consent order contains provisions designed to prevent 
respondents from engaging in similar acts and practices in the future. 
Part I requires respondents to have competent and reliable scientific 
evidence substantiating any claim that Native Essense (Rene Caisse) 
Formula tea or extract, Native Essense Plus tea or extract, Native 
Essense with Cat's Claw tea or extract, chaparral herb (or any product 
containing chaparral herb), Maitake mushroom extract, or Mai-T Mushroom 
Plus Formula extract, or any other covered product or service, is 
effective in the treatment or cure of cancer; prevents or lowers the 
risk of cancer; is effective in reducing the size of, or eliminating, 
cancerous tumors; or is safe or non-toxic or has no side effects. A 
``covered product or service'' is defined as any food, dietary 
supplement, or drug, including, but not limited to any of the above 
products, or any other health-related product, service, or program.
    Part II requires that any future claim about the efficacy, 
performance, or health-related benefits of any covered product or 
service be truthful and supported by competent and reliable scientific 
evidence. Part III requires that respondents, in connection with the 
advertising of any product, shall not misrepresent, in any manner, 
expressly or by implication, the existence, contents, validity, 
results, conclusions, or interpretations of any test, study, or 
research.
    Part IV of the proposed order provides that the order does not 
prohibit respondents from making representations for any drug that are 
permitted in labeling for the drug under any tentative or final Food 
and Drug Administration (``FDA'') standard or under any new drug 
application approved by the FDA, and representations for any product 
that are specifically permitted in labeling for that product by 
regulations issued by the FDA under the Nutrition Labeling and 
Education Act of 1990.
    Part V of the proposed order requires respondents to compile a list 
of all consumers who purchased Native Essense (Rene Caisse) Formula tea 
or extract, Native Essense Plus tea or extract, Native Essense with 
Cat's Claw tea or extract, chaparral herb (or any product containing 
chaparral herb), Maitake mushroom extract, or Mai-T Mushroom Plus 
Formula extract from respondents since July 1, 2005, and to mail a 
letter (attached to the proposed order as Attachment A) to each such 
purchaser describing the scientific evidence related to these products. 
Part V also prohibits respondents from providing any identifying 
information about these purchasers to anyone other than the Commission, 
another law enforcement agency, or as required by law.
    Part VI of the proposed order requires respondents to keep copies 
of relevant advertisements and materials that substantiate claims made 
in the advertisements. Part VII requires respondents to provide copies 
of the order to certain of their employees. Part VIII requires the 
corporate respondent to notify the Commission at least thirty days 
prior to any change in the corporation that may affect compliance 
obligations arising under this order. Part IX requires the individual 
respondents to notify the Commission of their affiliation with any new 
business or employment. Part X requires respondents to file compliance 
reports with the Commission. Part XI of the proposed order is a 
``sunset'' provision, dictating that the order will terminate twenty 
years from the date it is issued or twenty years after a complaint is 
filed in federal court, by either the United States or the FTC, 
alleging any violation of the order.
    The purpose of this analysis is to facilitate public comment on the 
proposed order. 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.

Richard C. Donohue,
Acting Secretary.
[FR Doc. E9-8140 Filed 4-8-09: 8:45 am]
BILLING CODE: 6750-01-S