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Following several failed submissions rejected by FDA reviewer Theodore Stevens, AHRS submitted an unpublished in-house report on 5 subjects followed for 9 weeks.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
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.
Deputy Director for Regulations and Policy
Center for Devices and Radiological Health