FDA ruling on electric tweezers The following is the full text of a ruling made by FDA on 26
October 1998, reclassifying the electric tweezer device and stating
the devices have shown no published scientific data demonstrating
that the device permanently removes hair.
Notable comments are in bold (emphasis
mine).
The original docket is also available at:  http://www.fda.gov/ohrms/dockets/98fr/102698a.txt
[Federal Register: October 26, 1998 (Volume 63, Number 206)]
[Rules and Regulations]
[Page 57059-57060]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc98-8]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 97N-0199]
General and Plastic Surgery Devices: Reclassification of the
Tweezer-Type Epilator
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA)
is issuing a final rule to reclassify the tweezer-type epilator
from class III (premarket approval) to class I (general controls)
when intended to remove hair. FDA is also exempting this device
from the premarket notification (510(k)) requirements. This action
is taken on the Secretary of Health and Human Services' own initiative
based on new information. This action is being taken under the
Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments), the
Safe Medical Devices Act of 1990 (the SMDA), and he Food and Drug
Administration Modernization Act of 1997 (FDAMA).
DATES: This regulation is effective November
25, 1998.
FOR FURTHER INFORMATION CONTACT: Stephen P.
Rhodes, Center for Devices and Radiological Health (HFZ-410),
Food and Drug Administration, 9200 Corporate Blvd., Rockville,
MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 1997 (62
FR 31771), FDA issued a proposed rule to reclassify the tweezer-type
epilator from class III to class I based on new information respecting
such device. FDA also proposed to exempt the device from premarket
notification procedures. Interested persons were given until September
9, 1997, to comment on the proposed rule. During the comment period,
FDA received 10 comments.
One comment supported the proposed reclassification from class
III to class I without providing any specific reason for endorsing
the proposed reclassification. Nine comments were opposed to the
proposed reclassification.
1. Two comments raised concerns about the device's safety. They
stated that the device could cause burns and scars on the skin
if it was improperly manufactured or used. One of these comments
mistakenly believed that FDA was also proposing that the device
be exempt from the current good manufacturing practices (CGMP's)
regulation.
FDA agrees that improper manufacturing and use of the device
could result in burns and scars on the skin. FDA also is clarifying
for the record that the device was not proposed to be exempt from
the CGMP's regulation (21 CFR part 820). FDA, however, believes
that these risks can be controlled by general controls such as
the CGMP requirements and labeling requirements.
2. Eight comments (from professional associations, a professional
magazine, practitioners, a former patient, and a manufacturer)
opposed reclassification because they believe the device is not
effective in permanently removing unwanted hair. Four of these
eight comments stated that there are no published scientific data
demonstrating that the device permanently destroys hair. Three
of these comments stated that hair is a dielectric material, i.e.,
a nonconductor of electricity so that it is impossible for electricity
to descend through the hair to the dermal papilla and destroy
it. Two of these three comments stated that there is no evidence
that the device destroys the dermal papilla of hair. Another comment
indicated that the effectiveness claims for the device are anecdotal
and that there is much information that the device is ineffective.
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. In the proposed rule, FDA described the
one published study using the device (Ref. 1) that reported that
the difference in the hair counts before and after treatment was
not significant. Also in the proposed rule, the agency described
the results of two unpublished studies (Refs. 2 and 3) and evaluated
these results as being only suggestive of effectiveness in permanently
removing hair. Thus, FDA agrees
with the comments that there is no body of significant information
establishing the effectiveness of the device to permanently remove
hair. FDA, however, still believes that the device
can be reclassified into class I, because claims for the device
can be addressed by the misbranding provision of section 502 of
the act (21 U.S.C. 352).
3. Three comments stated that the first sentence of the revised
identification statement that ``the tweezer-type epilator is a
device intended to remove hair by destroying the papilla of a
hair'' is misleading because the phrase ``destroying the papilla
of a hair'' is equivalent to stating the device permanently removes
hair. They pointed out that this phrase is part of the identification
statement of another device intended to remove hair, the needle
epilator, 21 CFR 878.5350.
Although there is no universally accepted medical definition
of what constitutes permanent removal of hair, FDA
acknowledges that the phrase ``destroying the papilla of a hair''
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.
4. Six comments related to the promotional material for the device.
They stated that this material frequently contains false and misleading
claims, specifically that the device is effective for permanent
or long-term removal of hair. Five of these six comments also
stressed that it is FDA's duty to protect the public from false
and misleading claims regarding a product's effectiveness and
that reclassification into class I could increase the number of
such claims.
FDA takes seriously its responsibility to protect the public
from false and misleading claims about a product's effectiveness;
however, false and misleading claims may be controlled by a general
control, namely the misbranding provision of section 502 of the
act. 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.
II. FDA's Conclusion
FDA has concluded based on review of the available information
that use of the tweezer-type epilator removes hair and that use
of the device does not present a potential unreasonable risk to
the public health. FDA has also concluded that general controls
would provide reasonable assurance of the safety and effectiveness
of the device, and therefore, the device should be regulated as
a class I device.
On November 21, 1997, the President signed FDAMA into law. Section
206 of FDAMA, in part, added a new section 510(l) to the act (21
U.S.C. 360(l)). Under section 501 of FDAMA, new section 510(l)
became effective on February 19, 1998. New section 510(l) provides
that a class I device is exempt from the premarket notification
requirement under section 510(k) of the act, unless the device
is intended for a use which is of substantial importance in preventing
impairment of human health or it presents a potential unreasonable
risk of illness injury (hereafter ``reserved criteria''). FDA
has determined that the device does not meet the reserved criteria,
and, therefore, it is exempt from the premarket notification requirements.
FDA also notes that 21 CFR 878.9(a), Limitations of exemptions
from section 510(k) of the act, requires manufacturers to submit
a premarket notification for any tweezer-type epilator whose intended
use is different from the intended use of legally marketed tweezer-type
epilators.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this final
rule is of a type that does not individually or cumulatively have
a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement
is required.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts;
and equity). The agency believes that this final rule is consistent
with the regulatory philosophy and principles identified in the
Executive Order. In addition, the final rule is not a significant
regulatory action as defined by the Executive Order and so is
not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze regulatory
options that would minimize any significant impact of a rule on
small entities. Because this final rule would reduce a regulatory
burden for all manufacturers of tweezer-type epilators covered
by this rule, the agency certifies that the final rule will not
have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act,
no further analysis is required.
V. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, and may be seen by interested persons between 9 a.m.
and 4 p.m., Monday through Friday.
- Verdich, J.,
``A Critical Evaluation of a Method for Treatment of Facial
Hypertrichosis in Women,'' Dermatologica, 168:87-89, 1984.
- 515(i) Submission submitted by the
Helen [sic] Edgar Corp., received September 10,
1996.
- 515(i) Submission submitted by Removatron
International Corp., received September 24, 1996.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs,
21 CFR part 878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
1. The authority citation for 21 CFR part 878 continues to read
as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Section 878.5360 is revised to read as follows:
Sec. 878.5360 Tweezer-type epilator.
(a) Identification. 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. (b) Classification. Class I (general controls). The device
is exempt from premarket notification procedures in subpart E
of part 807 of this chapter subject to Sec. 878.9.
Dated: October 8, 1998.
D.B. Burlington, Director, Center for Devices and Radiological
Health.
[FR Doc. 98-28579 Filed 10-23-98; 8:45 am]
BILLING CODE 4160-01-F
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