FDA on GHR: Alderton, 1998 On 26 October 1998,  "Katherine Cook"
asked FDA to clarify their position on the status of the GHR electric
tweezer following FDA's electric tweezer reclassification.
This FDA Final Rule states:
FDA acknowledges that there is no statistically significant
scientific data available at this time to support promotional
claims of permanent or long-term removal of hair through use
of the device.
This raised a new question: since FDA allowed AHRS and copycat tweezer
GHR to claim they were permanent based on questionable data,
were they still allowed to make this claim?
On 28 October 1998, FDA Public Health Advisor Bonnie Alderton
replied:
Stephens Manufacturing received FDA clearance on August 5,
1991 to market their Guaranty Hair Removal System (FDA #K905125),
a tweezer-type epilator device that is intended to destroy the
roots of unwanted hair for the purpose of permanent hair removal.
On October 26, 1998, FDA issued a Final Rule reclassifying
tweezer-type epilators from class III (requiring premarket approval)
to class I (general controls) when intended to remove hair.
This rule does not invalidate the status of the above mentioned
device.
On 19 May 1999, I submitted a petition asking why AHRS
and GHR could claim to be permanent when the Final Rule included
a statement saying electric tweezers aren't proven permanent.
On 5 January 2000, FDA responded:
This statement was included in the preamble because there was
insufficient information submitted in support of the reclassification
to establish "permanent" or "long term"
removal and because there is no universally accepted definition
for these words when used in the context of hair removal.
That means FDA allows manufacturers to make up their own definition
of permanent hair removal. AHRS proposed 9 weeks in their submission,
and the FDA reviewer agreed.
So for the time being, FDA allows AHRS and copycat device GHR to
claim they're permanent, if you consider 63 days to be long enough
to tell if hair removal is permanent.
Below is a scan of the FDA letter from Alderton.
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