Stephens, 1990 Electric tweezer AHRS was cleared to market by FDA in August,
1990. Three months after AHRS was cleared, a copycat device called
GHR was submitted to FDA (November, 1990).
As with the  AHRS submission, Guaranty
Hair Removal manufacturer Judith Stephens submitted unreviewed
in-house reports as part of GHR's electric tweezer submission
to FDA.
Because there are no published clinical studies on electric tweezers
that demonstrate they can work as claimed, Stephens' lawyer included
four published articles on needle electrolysis in an attempt to
connect the GHR tweezer with legitimate hair removal methods ( Richards, 1986
Hinkel, 1968 Kligman, 1984
Hobbs, 1987). FDA didn't buy
it.
GHR's unreviewed in-house efficacy data is almost completely
censored in the best available copy from FDA. Two studies cited
by GHR in their submission actually show that GHR cannot work
as claimed:
LeMaster 1990).
This unpublished report was sponsored by GHR and shows that
electricity travels along the outer hair shaft, not through
it.
Feughelman, 1982
As with LeMaster, this published study shows hair is a poor
conductor of electricity.
Other unpublished reports also show that GHR cannot work as claimed
van Orden, 1998
van Orden states: "Soaking or coating the hair shaft with
an electrolyte can, of course, provide a conductive path along
the outside surface of the hair, but studies indicate
that such applied current would likely dissipate through the
skin at the follicle opening and not penetrate fully to the
papilla. Any test of hair conductivity must eliminate the effects
of possible current flow along the hair surface through a conductive
coating."
Schuster, 1992
Unfortunately, LeMaster's unpublished findings have little
or no bearing on human hair as it would react on a live subject.
LeMaster's unpublished report concerns itself with the conductivity
of hairs that are not in vivo.
Not only did GHR copy the AHRS tweezer design, they've even copied
AHRS data submitted to FDA and claimed it as their own, stealing
two of AHRS's unpublished reports and passing them off as their
own.
Discussion
of GHR plagiarism
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 GHR can and cannot claim. I have analyzed
this faulty submission and reported my findings to FDA in a petition
for administrative reconsideration, which is currently under review.
Download my full GHR petition from
FDA's website (warning: extremely large Adobe Acrobat file--
11.6 MB)
http://www.fda.gov/ohrms/dockets/dailys/052699/prc001.pdf
99P-1615 PRC for K905125 Guaranty Hair Removal System by Stephens
Mfg
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