When is a tweezer not a tweezer?
When you ask the FDA
In the United States, if you want to know the official classification of a device, or how it is cleared to market, you naturally turn to the Food and Drug Administration (FDA) and it's Federal Register, where all that Agency's rulings are published. Usually that would be the definitive source for your answer. Not so, in the case of the tweezer-type epilators.
In June 1997, in the Federal Register, the FDA proposed a new definition for tweezer-type epilators.
In October 1998, following commentary from the industry, the FDA issued a "Final Ruling" on the definition of tweezer-type epilators, which contained a revised version of their original proposal.
In May 1999, when members of the Electrologists' Association of California (and more recently the International Hair Route) requested from the FDA a copy of the Agency's definition of tweezer-type epilators, they were referred to an April 1998 definition that is totally unlike the June 1997 proposal or the "Final Ruling" of October 1998. How can that be possible?
The FDA muddle appears to have had its start in 1997, when the FDA announced its intention to reclassify electronic tweezer-type epilators from Class III (which requires premarket approval of devices) to Class I (which exempts devices from the FDA premarket notification requirements). At the same time, the FDA suggested that a new "device description" be given to these devices. In the Federal Register (Vol. 62, No. 112) for June 11, 1997, the Agency proposed that tweezer-type epilators should be officially described as follows [all stressed words are by IHR for clarification]:
"The tweezer-type epilator is a device intended to remove hair by destroying the dermal papilla of a 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."
In the same bulletin, the FDA added, "This new device description reflects the entire array of energy sources of tweezer-type epilators on the market." Comment from the hair removal community was invited.
Almost 18 months later - after taking eight opposing comments from the hair removal community into consideration - the FDA published its "Final Ruling" on the reclassification of tweezer-type epilators in the Federal Register (Vol. 63, No. 206) for October 26, 1998. In this bulletin the FDA agreed with the comments that " . . . there is no body of significant information establishing the effectiveness of the [tweezer-type epilator] to permanently remove hair," and conceded that ". . . the phrase destroying the papilla of a hair [in the original device identification] is widely accepted by many to be equivalent to stating the device permanently removes hair. FDA now believes that the use of this phrase in the device identification statement was inaccurate, and in this final rule, is removing this phrase from the device identification."
In the "Final Ruling" that became effective November 25, 1998, the wording of the device description (Section 878.5360) reads as follows:
"The tweezer-type epilator is 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 phrase "destroying the dermal papilla of a hair" is gone.
It is assumed that the FDA's comment in the original (June 1997) proposal for reclassification, which says this new device description " . . . reflects the entire array of energy sources of tweezer-type epilators on the market," still applies. But when you contact the FDA today to verify the facts in the Code of Federal Regulations, you discover a previously unseen third device description, that only identifies tweezers using "high frequency electric current at the tip of a tweezer used for removing hair." The dateline on this document reads, "Revised as of April 1, 1998," which means it pre-dates the FDA's "Final Ruling" (Nov. 25, 1998) by eight months!?
Why is the Code of Federal Regulations not updated to reflect the "Final Ruling"? And where does this device description come from? Whatever the answer, the result is the same. Two electronic tweezer manufacturers in North America ‹ American Hair Removal System Co. (AHRS) and Guaranty Hair Removal (GHR) ‹ claim they do not fall under the FDA tweezer-type epilator ruling because they both manufacture "galvanic tweezers," not "high frequency" tweezers, as the definition states. Which raises yet another question: What classification do non-high frequency tweezer-type devices fall under?
Questions to the FDA regarding these devices further confuse the issue when we are told, " . . . the matter is complicated by the fact that some of the [tweezer] devices do in fact have clearance for claims of permanent hair removal." But when we look up the Device Classification Name for these devices we find that they are classified as "epilator, high frequency, tweezer-type."
Does anyone at the FDA know what they are doing?
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