FTC regulatory letters to Rejuvenu Since  Rejuvenu
salespeople have decided to attack
me personally rather than respond to my factual reports on
their violations
of federal regulations, I am now branching out from my work
lobbying the FDA to include other state and federal regulatory
agencies.
Below is a 1999 letter sent by the Federal Trade Commission to
International
Hair Removal Systems (now Rejuvenu), reminding them of action
FTC has taken against Removatron,
a similar company making similar claims of painless and permanent
hair removal.
No doubt Mr. Cole will continue to promote his Rejuvenu device
in violation of federal regulations. I will be doing what I can
to get Rejuvenu slapped with fines for defrauding consumers like
this.
If you have been a victim of transcutaneous or transdermal manufacturers
or practitioners (Rejuvenu or anyone else), I can help you reclaim
your money in small claims court. I have assisted consumers in
reclaiming thousands of dollars from Rejuvenu practitioners. Please
contact
me for details.
United States of America
FEDERAL TRADE COMMISSION
Washington, DC 20580
Bureau of Consumer Protection
Division of Enforcement
Walter C. Gross
Senior Attorney
Direct Dial
202-326-3319
FAX 202-326-3259
August 10, 1999
Lee Cowl [sic], President
International Hair Removal System
160 South May Street
Suite 2
Southern Pines, NC 28387
Dear Mr. Cowl [sic]:
This letter is to inform you about a Federal Trade Commission
law enforcement action against a seller of a radio frequency energy
(RFE) tweezer-type epilation device. This product is similar to
others on the market including, it appears, products sold by your
company.
In November 1988, the Commission issued a final decision and order
against Removatron International Corporation, Docket No. 9200.
Copies of the Commission’s complain, and order along with
a copy of an order modifying the final order (dated November 20,
1991) are enclosed. The Complaint sets forth the kinds of advertising
claims for RFE tweezer-type epilation devices that the Commission
had reason to believe may be deceptive and therefore in violation
of Section 5 of the Federal Trade Commission Act (15 U.S.C. 45).
Copies of the advertisements and promotional materials that the
Commission challenged are appended to the complaint.
The challenged claims may be summarized as follows:
1. The device permanently removes hair; and
2. The device is effective in removing hair on a long-term, not
temporary basis.
The Commission alleged that the respondent did not possess and
rely upon a reasonable basis that substantiated these representations,
as it was required by law to do.
We advise you to examine advertising and promotional materials
for the hair removal devices that your company markets to determine
whether the same or similar claims are made and, if so, whether
they can be substantiated. Performance claims for hair removal
devices, like those for any other product, require substantiation
consisting of competent and reliable evidence. When appropriate,
as for example when products that affect the structure or function
of the human body are advertised, this evidence must be scientific
evidence. Moreover, when expert opinion is clear as to the level
of scientific evidence that is necessary to substantiate a claim,
the Commission often will specify that level in the order. Hence,
in the Removatron order, the Commission has defined “scientific
evidence” as “adequate and well-controlled, double-blind
clinical testing conforming to acceptable designs and protocols
and conducted by a person or persons qualified by training and
experience to conduct such testing.” Unsubstantiated claims
are considered deceptive and are subject to enforcement action
by the Federal Trade Commission. Therefore, claims that are not
substantiated, or are otherwise deceptive, should be changed to
representations that are truthful and non-deceptive.1
While the Removatron order applies only to that company, the complaint
and order represent the Commission’s views about certain
types of claims for hair removal devices and the importance of
assuring that performance and efficacy claims are truthful and
substantiated. Please note that the original order that was issued
on November 4, 1988, was modified by the Commission on November
20, 1991, to eliminate the requirement for a disclosure about
lack of reliable evidence of anything but temporary hair removal.
As modified, this complaint and order can provide guidance to
others in the industry on their responsibilities in this area.
The FTC staff is currently monitoring advertising in this industry
and is ready to work with industry members that are committed
to advertising their products in a truthful and non-deceptive
manner.
If you have any questions about this letter or enclosed consent
order, please contact me at 202-326-3319. If you wish to meet
with us to discuss advertising claims and appropriate substantiation,
we would be pleased to meet with you.
Sincerely,
Walter C. Gross
Attachments
CERTIFIED MAIL – RETURN RECEIPT REQUESTED
____________________
1 As you are no doubt aware, when the Food and Drug Administration
reclassified the tweezer-type epilator from class III to class
I devices, it indicated that it agrees with the comments [filed
on the reclassification proposal] that “there is no body
of significant information establishing the effectiveness of the
device to permanently remove hair.” In addition the FDA specifically
removed from the device identification the statement “the
tweezer type epilator is a device intended to remove hair by destroying
the papilla of a hair” because it believes that the use of
the statement was misleading and inaccurate. 63
Fed. Red. 57058 (October 26, 1998)
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