FOR IMMEDIATE RELEASE: November 9, 1988 FTC FINDS MAKER OF ELECTRONIC HAIR-REMOVAL DEVICE MADE FALSE AND UNSUBSTANTIATED CLAIMS; REQUIRES COMPANY TO HAVE SCIENTIFIC EVIDENCE FOR FUTURE CLAIMS The Federal Trade Commission has ruled that Removatron International Corp., the largest maker of high-frequency, tweezer-type hair-removal devices, made false and deceptive claims that its devices permanently remove hair and lacked a reasonable basis for making such permanency claims. The Commission issued an order prohibiting the company from making unsubstantiated claims about its product and requiring it to possess clinical testing as substantiation for future permanency claims. The Commission decision, written by Commissioner Terry Calvani, upholds a July 1987 ruling by Administrative Law Judge Montgomery K. Hyun. Judge Hyun's decision in turn upheld a 1985 FTC administrative complaint issued because the Commission had "reason to believe" that Removatron and its president, Frederick E. Goodman, were violating the law. The FTC complaint alleged that respondents claimed, without a reasonable basis, that the Removatron device permanently removed hair. The Commission also charged respondents with falsely claiming that they possessed a reasonable basis for their permanency claims. Removatron International Corp. sells an electronic device called "Removatron," that removes hair with tweezers that transmit radio waves to individual hair roots. Respondents claimed that the Removatron hair removal method eventually destroys the hair tissue and prevents regrowth of the hair. The company sells its devices to beauty salons, skin care establishments, and other businesses for about $4,000. They, in turn, sell hair-removal treatments to customers for $30-35 per hour. In 1986, Removatron had an estimated 80 per- cent share of the market for its product. The Commission upheld Judge Hyun's finding that respondents' advertising and promotional materials made express and implied claims that the Removatron device permanently removes hair and that their claims were supported by a reasonable basis consisting of scientific proof. (More) In addition, the Commission concluded, because the company represented that its claims were based on scientific evidence, Removatron was required to possess evidence that would satisfy the scientific community that the particular claims were true. In this case, the Commission determined, the evidence had to consist of "controlled clinical testing." In concluding that respondents possessed "no clinical evidence whatsoever," the Commission affirmed the Judge's finding that respondents did not have competent and reliable scientific tests in support of their claims. Based on these conclusions, the Commission upheld Judge Hyun's finding that Removatron's failure to possess adequate substantiation rendered its advertising false and deceptive under the FTC Act. The Commission further stated, "we affirm Judge Hyun's finding's concerning the seriousness and deliberateness of Respondent's violations." The Commission order is identical to Judge Hyun's, except for modifying the substantiation provision and deleting a provision requiring notification of future purchasers. The order prohibits Removatron and Goodman from making claims that any hair removal device, product, or treatment will achieve permanent, long-term, or effective hair removal, unless they rely on "competent and reliable scientific" evidence to substantiate such claims. The order defines "competent and reliable scientific" evidence as "adequate and well-controlled, double-blind clinical testing." The Judge's order had specified that the company was required to substantiate its claims with at least two well- controlled clinical tests. The order also prohibits Respondents from misrepresenting the existence, contents, or conclusions of any test or study. In addition, the order requires that, for a period of five years, the company and Goodman include the following disclosure with any claim that the Removatron or any similar device can remove hair: "IMPORTANT: There is no reliable evidence that (name of device) provides anything more than temporary hair removal." The order further requires respondents to send a copy of the order to each purchaser of the Removatron device since January 1986. However, the Commission deleted the Judge's requirement that the company provide future purchasers with a copy the order. The Commission stated that it believes the order is sufficiently broad that it will achieve the Judge's goal of preventing future purchasers of the device from making prohibited claims to treatment purchasers. (More) „Finally, the Commission upheld the Judge's decision that respondents' claim that the Removatron device was "FCC-approved" falsely and deceptively implied that the Federal Communications Commission had approved the company's hair-removal method. The order prohibits the company and Goodman from claiming that the Removatron or any similar device is FCC-approved unless they disclose that the FCC has only approved the use of a certain radio frequency by the device and has not approved its safety or effectiveness. Commissioners Mary L. Azcuenaga and Andrew J. Strenio, Jr., issued separate statements concurring in part and dissenting in part from the Commission opinion and order. Commissioner Azcuenaga said she agreed that Removatron made unsubstantiated claims that its product removed hair permanently, but would have required two clinical tests to substantiate claims. She said in her statement, "I do not agree that one controlled clinical test would provide sufficient substantiation for Removatron's permanency representations. I also dissent from the Commis- sion's failure to require respondents to provide a copy of the order to future purchasers of the Removatron device. Finally, unlike the majority, I would not order respondents to continue to disclose that there is no reliable evidence that their device removes hair permanently even if they are able to produce such evidence at some future time." Commissioner Strenio said in his separate statement that he agreed with the finding that respondents made unsubstantiated claims that Removatron removes hair permanently. He also said he agreed with the majority that in ads where respondents claim to have scientific evidence, they must have proof that would satisfy the scientific community. However, Commissioner Strenio agreed with Commissioner Azcuenaga that for claims not asserting possession of scientific proof, "respondents should be required to rely upon at least two well-controlled clinical tests" before making claims that the Removatron epilator removes hair permanently. Both Removatron and Goodman are located in Boston. Copies of the Commission decision and order are available from the FTC's Public Reference Branch, Room 130, 6th St. and Pennsylvania Ave. N.W. Washington, D.C. 20580; 202-326-2222, TTY 2020-326-2502. # # # MEDIA CONTACT: Dee Ellison, Office of Public Affairs, 202-326-2177 [REMOVDEC] €