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 violations.
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 certified letter.
Below is the complete text of FDA’s letter. Click here to view a scan of the actual letter
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JAN 15 1997
Judith G. Stephens
Stephen’s Manufacturing Co
5303 Richard Avenue
Dallas, Texas 75206
Re: Guaranty Hair Removal System, K905125
Dear Ms. Stephens:
The Food and Drug Administration (FDA) has reviewed promotional materials currently appearing on the Internet for the Guaranty Hair Removal System (GHRS). This product is manufactured by Stephen’s Manufacturing Co. (Stephen’s) and is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The Agency has determined that promotional materials appearing on the Internet are subject to the same regulations and statutes materials distributed by other means. Our review of Stephen’s home page at the Internet address http://www.wow-me.com/GHR/info.htm, claims that "with the GHR No-Needle Electrolysis(TM) there are no needles, scabs, scars, infections, nerve damage, change to the skin color or pain of the needle."
The GHRS epilator device was cleared under section 510(k) of the act as a high frequency tweezer-type epilator intended to destroy the roots of unwanted hair with an electrical current for the purpose of permanent hair removal. This device has not been cleared for claims of no scabs, scars, infection, nerve damage change to skin color, or pain using the GHR system. We believe these claims may be misleading because Stephen’s has not supplied supporting data to the Agency to substantiate these claims. Please provide this office with data to support the claims identified above.
Additionally, we note that your home page also contains the statement, on the basis of the studies, the U.S. Food and Drug Administration (FDA) found the GHR epilator to be "Substantially equivalent" to or as permanent as needle epilators." You should be aware that references to FDA, in advertisements or other promotional materials for medical devices, is prohibited by the Act and represents misbranding under section 502(a). The reference for this may be found under 21 CFR 807.97, "Any representation that creates an impression of official approval because of complying with the premarket notification regulations is misleading and constitutes misbranding." All references to FDA clearance should be removed from Stephen’s promotional materials.
Please submit a prompt response in writing addressing these issues and discussing Stephen’s plans to remove the violative materials. You may forward your response to the undersigned at the Promotion and Advertising Policy Staff, Office of Compliance (HFZ-302), at the letterhead address.
Steven E. Budabin, M.S.
Consumer Safety Officer
Promotion and Advertising Policy Staff
Office of Compliance
Center for Devices and Radiological Health