IA #95-01, 8/13/01 "DWPE OF SUNLAMP AND SUNLAMP PRODUCTS"
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE)
Guidance
NOTE: This import alert represents the Agency=s current guidance
to FDA field personnel regarding the manufacturer(s) and/or
products(s) at issue. It does not create or confer any rights for
or on any person, and does not operate to bind FDA or the public.
***
PRODUCT: Sunlamps and Sunlamp Products
PRODUCT
CODE: *** 95U[][]19 ***
PROBLEM: Nonconformance with performance standard
PAF: LBL (Labeling)
PER (Performance)
PAC: *** 86007 ***
COUNTRY: All (ZZ)
MANUFACTURER
OR SHIPPER
ID: All
IMPORTER'S
ID: N/A
CHARGES: If the device is noncompliant with an applicable standard and/or
lacks certification, charge:
"The article is subject to refusal of admission pursuant to
Section 536(a) of the Federal Food, Drug and Cosmetic Act (FFDCA)
in that it appears to be an electronic product which fails to
comply with an applicable standard as prescribed under this
subchapter or to which is not affixed a certification in the form
of a label or tag in conformity with Section 534(h)."
If no reporting is done, charge:
"The article is subject to refusal of admission pursuant to
Section 536(a) of the Federal Food, Drug and Cosmetic Act (FFDCA)
in that it appears to be an electronic product that does not
comply with an applicable standard as prescribed by Section 534
because no reporting has been provided as required by Section
537(b)."
OASIS CHARGE
CODE: No TAG
No REGISTR
RECOMMENDING
OFFICE: CDRH, OC, DE III (HFZ-312)
REASON FOR
ALERT: During the past decade, new types of sunlamp products (tanning
beds and facial units) incorporating high and medium pressure
intensity discharge lamps (HID) were introduced into the United
States from Europe. These types of products are intended to
decrease the time needed for tanning and/or to increase the
tanning effect for those areas of the body which are reportedly
harder to tan.
According to data obtained from manufacturers' reports and
promotional literature, the HID lamp emits short wave UV-B and UV-
C radiation that is harmful to human eyes and skin. Since these
lamps operate at an over-pressure, the possibility of an explosion
cannot be entirely excluded. High intensity discharge lamps are
identified as being much shorter and smaller in diameter
(approximately 2" long x 1/2" in diameter) as compared to the long
fluorescent type bulb and are contained in a reflector which may
have a transparent blue or clear filter cover.
***
GUIDANCE: Districts may detain without physical sampling devices with no
certification label or lacking required labeling. Contact CDRH at
(301) 427-1172 for information regarding submission of required
reports and guidelines for detention.
Refuse entry unless the importer adequately corrects deficiencies
or is able to show that the product is properly certified and
meets the performance standard (21 CFR 1040.20). It may be
necessary to field test some products for compliance with the
performance standard to establish that the importer has effected
correction of a detained product. CDRH may be contacted at (301)
427-1172 for guidance.
Please send copies of all detention notices to HFZ-331 so that
appropriate foreign manufacturers and their products may be added
to the Radiation Emitting Products detention list. When field
tests are performed, please send copies of the field test record
to HFZ-312 (Attention: Manny Karos).
In accordance with Compliance Program 7386.007, "Imported
Electronic Products," districts should continue to review all
entries and Declarations (FDA-2877) for sunlamp and sunlamp
products to determine if the products have been properly
certified. Detention should be issued in accordance with the
Compliance Program.
In addition, physical examination should be performed on all
sunlamps and sunlamp products that have entered under Affirmation
B of the Compliance Program and under circumstances where
applicable as follows:
I. SUNLAMP PRODUCTS/Tanning Beds, Facial Units, Home Use Units,
etc.
- CERTIFICATION LABEL: Determine if the certification label is
present on the product in accordance with 21 CFR 1010.2.
- LAMP LABEL: Each ultraviolet lamp should have a label which
reads: "Sunlamp-DANGER-Ultraviolet Radiation. Follow instructions.
Use only in a fixture equipped with a timer", along with model
designation.
- SUNLAMP PRODUCT LABEL: Each sunlamp product should have a
"DANGER" label which reads: "DANGER-ULTRAVIOLET
radiation.......sensitive to sunlight."
- GOGGLES: Check for presence of protective goggles.
- USERS INSTRUCTIONS: Check for the presence of an instruction
booklet in English.
- HID LAMPS: If HID lamps are used, obtain lamp model
identification information and contact CDRH, (301) 427-1172, to
determine if the lamps have been certified.
II. LAMPS- FLUORESCENT & HID LAMPS
- LAMP CERTIFICATION LABEL: Determine if the certification label
is present on the label in accordance with CFR 1010.2.
- LAMP LABEL & USERS INSTRUCTIONS: Check for the presence of a
lamp label, model designation, and user's instruction pamphlet for
each lamp in the shipment.
- FLUORESCENT LAMPS: These lamps are usually shipped as packages
of 25 lamps each. The certification label will usually be found on
the outside of the box.
- HID LAMPS: These lamps may be shipped in any quantity. Depending
on the design, the certification label will be on the lamp
packaging, but for large lamp configurations it may be on the lamp
housing. Contact CDRH at (301)427-1172 giving lamp identification
information so that CDRH can determine whether the HID lamps are
certified.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required
KEYWORDS: Sun Lamps, Sunlamp Products, Tanning Beds, HID lamps
PREPARED
BY: Linda A. Wisniowski, DIOP, 301-443-6553.
DATE LOADED
INTO FIARS:
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