IHRS response to FDA regulatory letter Below is a scan of Lee Cole's response to the Food & Drug
Administration in May 2001. FDA told  International Hair Removal
Systems (also known as Rejuvenu
International Limited) that their claims of permanent hair
removal were in violation of federal regulations.
For years, IHRS has been making claims that their Super-Phaser
Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause
permanent hair removal. This claim about Super Phaser Gold is
untrue and in violation of federal regulations. Mr Cole's response
below was rejected by FDA in a response
sent in October 2001.
Click here for more background.
You can also read FDA's
rejection of Mr. Cole's response.
Complete text follows these scans.
May 23, 2001
Patricia L. Jahnes
Consumer Safety Officer
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Promotion and Advertising Policy Staff
2098 Gaither Road
Rockville, Maryland 20850
Dear Ms. Jahnes:
We are writing to respond to your letter dated April 2, 2001
regarding International Hair Removal System, Inc.'s (IHRS) Super-Phaser
Gold Hair Removal Machine. We apologize for this belated response.
You stated in your letter that you reviewed promotional labeling
materials for the Super-Phaser Gold and determined that the
Super-Phaser Gold requires a 510(k) premarket notification clearance.
You additionally stated that IHRS claim in its labeling materials
that the Super-Phaser Gold permanently removes hair "misbrands
and adulterates" the device. As set forth below, the Super-Phaser
Gold does not require a 510(k) premarket notification clearance
because it is a modification of, and is used and intended to
be used in the same matter as, a tweezer type epilator, which
is exempt from the 51O(k) premarket notification process. Furthermore,
IHRS’ claim that the Super-Phaser Gold permanently removes
hair does not change the intended use of the device, so the
Super-Phaser Gold is not adulterated or misbranded.
FDA's regulation on the limitation of device exemptions from
premarket notification states that the agency based exemptions
of "generic type" class I devices "upon existing
and reasonably foreseeable characteristics of commercially distributed
devices within that generic type." 21 C.F.R. § 878.9.
The regulation further provides that the agency "cannot
anticipate every change in intended use or characteristic that
could significantly affect a device's safety or effectiveness"
and that, therefore, manufacturers should still submit a 51O(k)
notification to FDA when either:
1) the device is intended for a use different from its intended
use before May 28, 1976, or the device is intended for a use
different from the intended use of a preamendments device to
which it has been determined to be substantially equivalent;
or
2) the modified device operates using a different fundamental
scientific technology than that in use in the device before
May 28, 1976 ....
Id. § 878.9. As further discussed below, IHRS is not required
to submit a 510(k) premarket notification for its Super-Phaser
Gold because the device is merely a modified tweezer-type epilator
that still has the same intended use. In addition, the Super-Phaser
Gold uses the same "fundamental scientific technology."
Thus, a 510(k)premarket notification is not required.
I. The Super-Phaser Gold Is a Modified Tweezer-Type Epilator
The Super-Phaser Gold system is essentially a tweezers galvanic
hair removal device that can be modified to accommodate different
apparatuses to apply a galvanic current to hair follicles for
hair removal. The device operator has the option of using a
tweezer-type apparatus, a blunt probe, or a surface electrode
apparatus to apply the galvanic current. IHRS has provided these
options to operators because both the blunt probe and surface
electrode apparatuses provide more ease of use to operators
and more comfort to clients. In addition, the blunt probe and
surface electrode apparatuses treat a greater number of hairs
than do tweezers apparatuses. This feature is attractive to
both operators and clients. However, this does not change the
basic technology or mechanism of action.
II. The Super-Phaser Gold Has the Same Intended Use as a Tweezer-Type
Epilator
The Super-Phaser Gold has the same intended use as a tweezers-type
epilator. A tweezers-type epilator "is an electrical device
intended to remove hair."' 21 C.F.R § 878.5360(a).
The Super-Phaser Gold is also an electrical device intended
to remove hair. Thus, there is no difference in intended use.
You stated in your letter that "practitioners making claims
of permanent and/or painless hair removal for epilators change
the intended uses of the device ... and make them subject to
the premarket notification requirements." However, the
claim that the Super-Phaser Gold removes hair "permanently"
does not change the intended use of the device. The intended
use of the Super-Phaser Gold is to remove hair; the reference
to "permanent" does not change the intended use of
the device.
When FDA cleared IHRS 510(k) for its galvanic tweezers-type
epilator, FDA also cleared the marketing claims for the device,
which are identical to the claims of needle electrology, including
permanent hair removal claims. See 21 C.F.R. § 807.92(a)(4);
see also letter to "The Record” from Paul Tilton,
FDA (Aug. 9, 1990) (attachment 1); letter from Paul Beninger,
CDRH, FDA, to Lee Cole, American Hair Removal System (Oct 13,
1993) (attachment 2). Furthermore, FDA’s subsequent reclassification
of tweezers-type epilators from class III to class I should
not invalidate FDA’s 510(k) clearance for the claims of
the device.
Furthermore, to the extent that FDA is going to take action
against epilator manufacturers who make permanent hair removal
claims, FDA should not single out IHRS because there are numerous
other epilator manufacturers making the same types of claims.
Enclosed as Exhibit 3 are numerous advertising materials from
multiple companies advertising permanent hair removal with various
techniques including needle, tweezer, probe, and electrodes.
It is fundamentally unfair for FDA to single out IHRS for making
permanent hair removal claims when numerous other epilator manufacturers
are making the same claims. Clearly, epilator manufacturers
believe the claim of permanent hair removal is acceptable. If
the agency believes that this claim is inappropriate, it should
notify all industry members at once and apply a uniform approach.
FDA should create a level playing field that holds all epilator
manufacturers, including needle epilator manufacturers, to the
same promotional standards.
Additionally, as stated in the final rule governing these epilators,
“there is no universally accepted medical definition of
what constitutes permanent removal of hair”. How can claims
of permanent hair removal that have been well accepted by the
industry manufacturers be refuted before a universally accepted
definition of permanent hair removal is accepted by the medical
community and the FDA.
III. The Super-Phaser Gold Uses the Same Scientific Technology
as Do Tweezers-Type Epilators
The letter from the agency rests on the premise that the Super-Phaser
Gold is different from other tweezers type epilators utilizing
galvanic current. The Super-Phaser Gold, however, uses the same
scientific technology as do other tweezers-type epilators using
a galvanic current. The only difference is that with the Super-Phaser
Gold the operator has the option of using a different apparatus
to apply the galvanic current.
To operate the Super-Phaser Gold, the user applies a gel to
the skin where hair removal is desired. The user then applies
a galvanic current to the surface of the skin by using tweezers,
a blunt probe, or a surface electrode. When using a blunt probe,
the probe contacts the gel instead of the tweezers. Similarly,
when using a surface electrode, the electrode contacts the gel
instead of the tweezers. In each case, the galvanic current
is
transmitted through the apparatus and through the gel until
it reaches the base of the hair follicle, where the salt water
of the hair follicle is converted to sodium hydroxide, or lye.
The lye disrupts the dermal papilla cells so that the hair cannot
re-grow.
Users of the Super-Phaser Gold calculate the current required
for hair removal in the same manner as do users of other galvanic
current tweezers. That is, "Hinkel units,"' or "units
of lye" of electrolysis treatment, are calculated using
the formula as set out in Arthur Hinkel's Electrolysis, Thermolysis,
and the Blend: Principles and Practice of Permanent Hair Removal(1968).
Mr. Hinkel discovered that an average of 60-80 "units of
lye" must be
produced at each follicle to effect permanent hair removal.
A unit of lye is defined as one-útenth of a milliamp,
of galvanic current flowing for one second.
Based on Mr. Hinkel's formula, an operator adjusts the amount
of time that the current flows based on the amount of current
used. For example, if ten hairs of the same size are treated
simultaneously with 1 milliamp of current, then the operator
would pass the current for 60 to 90 seconds to get the proper
number of units of lye to permanently remove the 10 hairs. (Each
hair would receive approximately one-tenth of a milliamp of
current because the current divides equally among the hairs).
Operators of the Super-Phaser Gold - whether using the tweezers,
the blunt probe, or the surface electrode - as well as operators
of all other galvanic electrolysis equipment, including needle
electrolysis, calculate how long to do a treatment based on
how much current is used. (Each apparatus of the Super-Phaser
Gold delivers an identical flow of current.) This is just as
true for the Super-Phaser Gold as for other equipment. While
the Super-Phaser Gold allows the treatment of multiple hairs,
that does not represent a significant change in technology.
Other galvanic current tweezers products that transmit current
through gel also remove more than one hair at a time. Multiple
needle machines, capable of treating numerous hairs at one time
were first developed in 1916 (see Mr. Hinkel’s book referenced
above). No matter how the current is applied or how many hairs
the operator is seeking to remove, the end result is the same:
disruption of the dermal papilla cells in the hair follicle.
IV. References to FDA Approval
In your letter, you said there are instances that our marketing
literature contains the words FDA approval. We were not aware
of this and have instructed our marketing representatives to
remove any reference to the FDA from our marketing materials.
IV. Conclusion
FDA contemplated that class I devices exempt from premarket
notification requirements would be modified and that some modifications
would not require the submission of a 5l0(k). The Super-Phaser
Gold is one of those devices not requiring a 510(k). Although
it is a modified tweezers-type epilator device, it has the same
intended use and employs the same scientific technology as other
tweezers-type epilator devices. Its use of different apparatuses
to deliver the galvanic current does not change the safety or
effectiveness of the device.
We hope that the above information clarifies your concerns about
the status of IHRS’s Super-Phaser Gold Hair Removal Machine.
If you have any questions or require further information, please
contact us at our offices in Southern Pines, NC.
Sincerely,
Lee Cole, CEO
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