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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JAN 15 1997
CERTIFIED MAIL
RETURN REQUESTED
Judith G. Stephens
President
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.
Sincerely yours,
[signed]
Steven E. Budabin, M.S.
Consumer Safety Officer
Promotion and Advertising Policy Staff
Office of Compliance
Center for Devices and Radiological Health
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