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
August 10, 1999
Lee Cowl [sic], President
International Hair Removal System
160 South May Street
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.
Walter C. Gross
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)