Import Alert 95-01
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(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).
Import Alert # 95-01
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Sunlamp and Sunlamp Products"
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.
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) 796-6600.
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) 796-6600.
Product Description:
Sunlamps and Sunlamp Products
Charge:
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)."
OASIS charge code - NO TAG
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 REGISTR
"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)."
OASIS charge code - NO TAG
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 REGISTR
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