[Federal Register Volume 91, Number 50 (Monday, March 16, 2026)]
[Proposed Rules]
[Pages 12524-12525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-05103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2015-N-1765]
RIN 0910-AH14
General and Plastic Surgery Devices: Restricted Sale,
Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of the proposed rule titled ``General and Plastic Surgery
Devices: Restricted Sale, Distribution, and Use of Sunlamp Products,''
which published in the Federal Register of December 22, 2015. FDA is
taking this action because it no longer intends to finalize the
proposed rule.
DATES: The proposed rule published on December 22, 2015 (80 FR 79493)
is withdrawn as of March 16, 2026.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this document into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Daniel Schieffer, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993-0002, 301-
796-3350, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of December 22, 2015
(80 FR 79493), FDA (the Agency or we) issued a proposed rule titled
``General and Plastic Surgery Devices: Restricted Sale, Distribution,
and Use of Sunlamp Products'' (the Proposed Rule). Sunlamp products are
both ``devices'' under section 201(h)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)(1)) and ``electronic
products'' under section 531(2) of the FD&C Act (21 U.S.C. 360hh(2)).
They are designed to incorporate one or more ultraviolet (UV) lamps
intended for irradiation of any part of the living human body, by UV
radiation with wavelengths in air between 200 and 400 nanometers, to
induce skin tanning (see Sec. Sec. 878.4635(a) and 1040.20(b)(9) (21
CFR 878.4635(a) and 1040.20(b)(9))). Sunlamp products include tanning
beds and tanning booths. Sunlamp products as defined in the Proposed
Rule did not include ultraviolet lamps for dermatological disorders
regulated under 21 CFR 878.4630.
FDA has undertaken several regulatory initiatives related to
sunlamp products. Previously, in a final reclassification order that we
issued on June 2, 2014 (79 FR 31205), FDA reclassified sunlamp products
and UV lamps intended for use in sunlamp products from class I to class
II, making them subject to premarket notification (510(k))
requirements, and established special controls under the device
authorities of the FD&C Act. The special controls consist of, among
other requirements, performance testing and labeling requirements,
including a warning that sunlamp products should not be used on persons
under the age of 18 years. That order was effective on September 2,
2014.
Second, in a proposed rule issued simultaneously with the Proposed
Rule, FDA proposed amendments to the sunlamp products and UV lamps
performance standard at 21 CFR 1040.20, which includes technical and
labeling requirements issued in large part under the electronic product
radiation control provisions of the FD&C Act (80 FR 79505). Those
proposed amendments, if finalized, would update the electronic product
performance standard to reflect current science and harmonize with
certain consensus standards. FDA's proposed amendments to the sunlamp
products and UV lamps performance standard at 21 CFR 1040.20 are not
affected by this withdrawal.
Finally, in the Proposed Rule, FDA proposed to establish device
restrictions under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)),
which authorizes FDA to issue regulations imposing restrictions on the
sale, distribution, or use of a device. The Proposed Rule contained
three types of proposed restrictions on the use of sunlamp products.
First, the Proposed Rule proposed restricting the use of sunlamp
products to individuals age 18 and older under proposed Sec.
878.4635(c)(1). Second, in proposed Sec. 878.4635(c)(4), the Proposed
Rule proposed requiring
[[Page 12525]]
tanning facilities to only allow adults to use a sunlamp product if the
prospective user had signed a risk acknowledgement certification in the
past six months, and proposed the form of this certification. Third,
the Proposed Rule contained two proposed user-manual related
provisions. In proposed Sec. 878.4635(c)(2), the Proposed Rule
proposed requiring tanning facility operators to provide a sunlamp
product's user manual to users or prospective users of sunlamp products
upon request, and in proposed Sec. 878.4635(c)(3), the Proposed Rule
proposed requiring 510(k) holders to provide a sunlamp product's user
manual to tanning facility operators and sunlamp product users or
prospective users upon request.
FDA received more than 8,100 comments on the Proposed Rule from
entities including industry associations, medical and healthcare
professional associations, law firms, cancer advocacy groups, and other
interested parties, including individuals. In general, the comments
discussed the dangers of UV radiation from sunlamp products; scientific
aspects of the Proposed Rule; vulnerability of young people to the
risks of sunlamp products; support for personal choice and parental
decision-making; availability and relative safety of sunlamp product
alternatives; and compliance burdens on small businesses.
In light of the scientific and technical concerns raised in the
comments on the Proposed Rule, concerns regarding possible unintended
consequences of certain proposals in the Proposed Rule, and potential
alternatives proposed in comments received on the Proposed Rule, FDA is
withdrawing the Proposed Rule in order to reconsider the best means for
addressing the issues covered by the Proposed Rule and related issues
regarding access to sunlamp products. Therefore, effective on the date
of publication of this document, the Proposed Rule is withdrawn.
FDA continues to consider regulatory initiatives related to sunlamp
products. The withdrawal of the Proposed Rule does not preclude the
Agency from reinstituting rulemaking concerning the issues addressed in
the proposal. Should we decide to undertake such rulemaking in the
future, we will issue a proposed rule and provide a new opportunity for
comment. Furthermore, this withdrawal is only intended to address the
Proposed Rule ``General and Plastic Surgery Devices: Restricted Sale,
Distribution, and Use of Sunlamp Products'' published in the Federal
Register of December 22, 2015, and not any other pending proposals that
the Agency has issued or is considering. If you need additional
information about the subject matter of the withdrawn Proposed Rule,
you may review the Agency's website (www.fda.gov) for any current
information on the matter.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-05103 Filed 3-13-26; 8:45 am]
BILLING CODE 4164-01-P