Cole, 1990 Electric tweezer American Hair Removal System (AHRS) was cleared
to market by FDA in August 1990, based on four unpublished, anecdotal,
in-house reports with no peer review. These reports submitted
by owner Lee Cole discuss nine human subjects, four of whom were
observed for less than one hour.
AHRS made three attempts before being cleared by FDA, characterized
by FDA as "very deficient," "theoretically impossible,"
and "inconceivable," respectively.
Their fourth attempt contained four unpublished, anecdotal, in-house
reports:
 pH analysis of hair: This poorly-designed
test is meaningless because samples are contaminated in the
course of the experiment.
Synopsis of conduction study: This
poorly-designed test contains contaminated data with no controls
for variables in the circuit being tested.
Comparison of effectiveness: This test
is based on a 9-week observation period, and the scientific
protocol is based on a 4-page sales brochure.
Microscopic analysis: This test was
conducted by someone claiming to be a "dermologist,"
which fooled FDA reviewers into thinking he was a dermatologist.
There is no such medical specialty as "dermology."
FDA stated in 1998 that
there is no body of significant information establishing the effectiveness
of electric tweezers to permanently remove hair.
FDA's decision has left some unanswered questions about the status
of what AHRS can and cannot claim. I have analyzed this faulty
submission and reported my findings to FDA in a petition for administrative
reconsideration.
Download my full AHRS petition from
FDA's website (warning: extremely large Adobe Acrobat file--
11.6 MB)
http://www.fda.gov/ohrms/dockets/dailys/052699/prc0001.pdf
99P-1614 PRC for K892514 Epilator 629 by American Hair Removal
System
In addition, a copycat tweezer called the Guaranty Hair Removal
System (GHR) claims AHRS data submitted to FDA is theirs.
Discussion
of GHR/AHRS disputed data
|
hair removal
facts
for consumers
