Title: FDA submission Authors: Manufacturer Journal: PMID: Affiliated institution: Bristol-Meyers Squibb/Gillette Cited in: Prescription insert at vaniqa.com Two randomized double-blind studies involving 594 female patients (393 treated with VANIQA, 201 with vehicle) treated twice daily for up to 24 weeks evaluated the efficacy of VANIQA in the reduction of unwanted facial hair in women. Women … Continue reading “Vaniqa FDA data, 2000 (unpublished clinical report)”
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FDA, 1990 In 1989, FDA investigators made several inspections of D’Plume manufacturer Carol Block. These inspections uncovered "serious violations of the Federal Food, Drug, and Cosmetic Act," including: No approved clearance to market by 510(k) Illegal export of an unapproved device Misbranding the device as permanent Illegal references to FDA in sales material Inadequate directions … Continue reading “FDA, 1990 (regulatory letter)”
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FDA, 1996 Title: Radiation Biology Research Authors: FDA Center for Devices and Radiological Health, Office of Science and Technology Journal: 1996 Annual Report PMID: — Affiliated institution: The US Food and Drug Administration (FDA) Cited on: FDA website As quoted in the report: Health issues concerning exposure to electric and magnetic fields (EMF) are … Continue reading “FDA, 1996 (EMF radiation effects)”
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FDA regulatory letters to Rejuvenu Throughout the 1990’s and into the new century, International Hair Removal Systems (IHRS) has been making claims that their SuperPhaser Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause permanent hair removal and are FDA approved. This is untrue and in violation of federal regulations. Rejuvenu was claiming they had … Continue reading “Rejuvenu cited for violations by FDA”
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FDA regulatory letter to International Hair Removal Systems Below is the text and scan of the FDA letter sent to International Hair Removal Systems (IHRS). The company changed their name to Rejuvenu International Limited soon after. For years, IHRS has been making claims that their SuperPhaser Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause … Continue reading “IHRS cited for violations by FDA”
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FDA regulatory letter to Rejuvenu Below is a scan of the FDA letter sent to Rejuvenu International Limited (formerly International Hair Removal Systems (IHRS). For years, Rejuvenu has been making claims that their SuperPhaser Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause permanent hair removal. Rejuvenu claims about Super Phaser Gold are untrue and … Continue reading “Rejuvenu cited for violations by FDA”
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IHRS response to FDA regulatory letter Below is a scan of Lee Cole’s response to the Food & Drug Administration in May 2001. FDA told International Hair Removal Systems (also known as Rejuvenu International Limited) that their claims of permanent hair removal were in violation of federal regulations. For years, IHRS has been making claims … Continue reading “IHRS cited for violations by FDA”
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GHR cited by FDA for violations Instructed that "All references to FDA clearance should be removed." GHR likes to refer to their FDA clearance all the time, because they know it adds legitimacy to their claims. Unfortunately, they are in violation of FDA regulations regarding misbranding. In 1997, FDA decided to take action regarding these … Continue reading “GHR cited by FDA for violations (text)”
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GHR cited by FDA for violations Scan of letter from FDA The Certified letter below was sent to Judith Stephens on January 15, 1997. Stephens still makes illegal claims of painlessness and refers frequently to FDA in promotional material. When asked about her non-response to this letter in 1998, Stephens claimed she never got this … Continue reading “GHR cited by FDA for violations (scan)”
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