Electric tweezer petition to FDA In 1989, electric tweezer manufacturer American Hair Removal
Systems (AHRS) submitted FDA Docket  K892514 to the U.S. Food and Drug
Administration for an electric tweezer called the TE 629. This
device used galvanic current and made claims of permanent hair
removal.
Following several failed submissions rejected by FDA reviewer
Theodore Stevens, AHRS submitted an unpublished in-house report on 5 subjects followed for
9 weeks. On August 8, 1990, the new FDA reviewer, Paul Tilton, allowed
9 weeks as a performance standard for permanent hair removal.
Subsequently, AHRS (and a clone called GHR, which Tilton cleared
in 1991) could claim they're "permanent."
Since that time, FDA no longer considers 9 weeks an acceptable
standard for permanent hair removal, but they have been unwilling
to rescind clearance for these two electric tweezers.
In 1998, FDA published a Final
Rule reclassifying electric tweezers, stating:
"FDA acknowledges that the published literature contains
no evidence of statistically significant data showing that the
device is effective in achieving permanent removal of hair.
Additionally, 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."
While this was welcome news for consumers, FDA stated that despite
a lack of statistically significant data and no published clinical
evidence of permanence, they were going to allow AHRS and GHR
to continue to claim they were permanent.
I couldn't believe this, so in 1999, I filed a petition with
FDA to reconsider this decision.
For an extensive critical analysis of the Tilton decision, as
well as the original AHRS submissions and FDA correspondence,
you can download my petition as Docket 99P-1614. (Huge PDF file, requires
Adobe Acrobat)
Below is the full text and scan of the first response I received
from FDA regarding this petition. Highlights are in
bold.
Essentially, their argument is that the performance standard
submitted by AHRS was "commonly used in the context of hair
removal at that time." This performance standard is in fact
a promotional brochure that was put out by an electrolysis trade
group called the International Guild of Professional Electrologists
(IGPE). This IGPE standard was not scientifically sound and was
not commonly used at the time, and in fact had been condemned
by the largest electrolysis trade group. This standard has since
been rescinded by IGPE, although the original author continues
to use the same sales brochure almost verbatim to promote his
own electrolysis practice.
The Tilton decision is an unfortunate footnote in the history
of hair-removal regulation and a triumph of quackery over good
science. Both the AHRS submission and the IGPE "standard"
do not pass scientific scrutiny and would never have made it past
a competent FDA reviewer.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
[stamped] JAN –5 2000
Andrea J. James
Chicago, IL
Re: Petition for Reconsideration of K892514 and K905125
Dear Ms. James:
This letter responds to your petition dated May 19, 1999, requesting
reconsideration of our clearance of premarket notifications K892514
for the AHRS Epilator 629 and K905125 for the Guaranty Hair Removal
(GHR) System. For each of these devices, you are requesting the
following actions: 1) rescission of the device clearance as substantially
equivalent to predicate needle-type epilators, 2) revision of
device identification to match other tweezer-type epilators, 3)
revision of language in device intended use, and 4) prohibition
of implied device labeling claims of permanent hair removal. We
are denying your requests for the reasons that follow:
First, you request that we rescind the device clearances as substantially
equivalent to predicate needle-type epilators. The
initial classification of the AHRS Epilator 629, as a needle-type
epilator, was made in error. We corrected this mistake
shortly after we determined the device to be substantially equivalent
to a preamendment tweezer-type epilator. We accomplished the correction
by issuing a revised order to the manufacturer that reflects the
proper classification of the device. Concerning the GHR System,
our records show that the device was not cleared for marketing
as a needle-type epilator, but was also cleared as a tweezer-type
epilator. Therefore, your request is
based on an erroneous assumption that these devices have been
found substantially equivalent to needle-type epilators.
Second, you request that we revise the identification of the
devices to match other tweezer-type epilators. Both of these devices
are already classified as tweezer-type epilators under classification
regulation 21 CFR § 878.5360 (copy enclosed). Complete documentation
to support this classification can be obtained through our Freedom
of Information office by writing to the following address: Freedom
of Information Staff (HFI-35), Food and Drug Administration, 5600
Fishers Lane, Room 12A-16, Rockville, MD 20857.
With respect to your requested actions 3 and 4, FDA does not
believe the identification language should be changed or that
regulatory actions are currently warranted. FDA published the
final rule reclassifying the tweezer-type epilator (21 CFR 878.5360)
into class I in the Federal Register of October 26, 1998 (63 FR
57059). FDA also exempted these types of devices from premarket
notification (section 510(k)) requirements subject to the routine
limitations on exceptions (2 l CFR 878.9)
In this final rule FDA identified the tweezer-type epilator as
"an electrical device intended to remove hair. The energy
provided at the tip of the tweezer used to remove hair may be
radio frequency, galvanic (direct current), or a combination of
radio frequency and galvanic energy." The intended use of
the device in the device identification is to remove hair. The
words "permanent" or "long-term" are not part
of the definition in the classification of tweezer-type epilators.
The supplementary information section of the final rule, however,
states that there is no statistically significant data available
to support promotional claims of permanent or long-term removal
of hair through use of the tweezer-type epilator. 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.
While claims for permanent and long-term
hair removal appeared in 510(k)s K892514 and K905125, these words
were used in accordance with a definition that was commonly used
in the context of hair removal at the time that the clearances
were granted. Although a debate over the proper use of these words
in the context of hair removal has ensued, FDA does not believe
that there is sufficient justification to change the regulatory
status of these devices, or to take immediate regulatory action
against manufacturers using the words "permanent" or
"long-term" in their promotion and advertising materials.
In summary, at this time needle-type and tweezer-type epilators
are class I, low risk devices that do not require 510(k) clearance
before going to market as long as they do not exceed the routine
limitations on the exemption. Like all class I devices exempt
from the 510(k) requirements of the Federal Food, Drug, and Cosmetic
Act, they remain subject to the remaining general controls such
as the registration and listing, good manufacturing practices
and prohibitions against adulteration and misbranding. Manufacturers
making claims related to device performance must maintain information
to substantiate each claim.
Although we have not granted the relief requested in your petition,
I hope that you find this letter responsive to your inquiry. If
you have any questions regarding this letter or FDA's regulation
of epilators, please contact Commander Stephen P. Rhodes, Chief,
Plastic and Reconstructive Surgery Devices Branch, in our Office
of Device Evaluation's Division of General and Restorative Devices.
Commander Rhodes can be reached at (301) 594-3090.
Sincerely,
[signed]
Linda Kahan
Deputy Director for Regulations and Policy
Center for Devices and Radiological Health
Enclosure
|
hair removal
facts
for consumers
