FDA on GHR: Alderton, 1998
On 26 October 1998,
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
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
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
Below is a scan of the FDA letter from Alderton.