IHRS cited for violations by FDA

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.
Lee Cole, CEO