Import Alert 95-01
(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: 03/30/2023
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Sunlamp and Sunlamp Products"
Reason for Alert:
The revision of this Import Alert dated 11/22/2022 updates the subtype of the alert from countrywide to a firm alert. Additional updates include the guidance section regarding release and removal from Detention Without Physical Examination (DWPE), and the charge code section to include updated charge statement language and an additional charge (NON STD). Changes are noted and bracketed by three asterisks (***)
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.
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:
*** Divisions may detain without physical examination, shipments of specified sunlamp or sunlamp products from the firms identified on the Red List of this alert. ***
*** The firms listed on the Red List for this alert have been found to have one or more of the following objectionable conditions:
1) do not appear to comply or have been determined to not comply with the applicable performance standards prescribed pursuant to Section 534 of the FD&C Act and as specified in 21 CFR Part 1010, and 21 CFR 1040.20, as applicable, and/or;
2) do not appear to have or have been determined not to have the certification in the form of a label or tag required by Section 534(h) of the FD&C Act and as specified in 21 CFR 1010.2, and/or;
3)do not appear to have or have been determined not to provide an initial product report as required by Section 537(b).
These conditions may include products without a permanently affixed label or tag, products for which evidence of a valid test and quality control program is lacking in accordance with section 534(h), and the firm has failed to provide requested information of records including testing records as required in Section 537(b). ***
*** Released of Article Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide FDA documentation to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. For example, when appropriate, the request should include information for FDA to adequately assess whether the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control Act (Federal Food, Drug and Cosmetic Act, Chapter V, Subchapter C) and 21 CFR 1010.2 and their products comply with the performance standard for sunlamp products (21 CFR 1040.20).
In addition, under 21 CFR 1002.10(k), the importer must provide other information CDRH may reasonably require to determine whether the importer is in compliance with the Act, the Electronic Product Radiation Control Act, and any applicable standards.
The owner, consignee, importer, and/or another responsible party to the shipment, may request release of their shipment that has been detained without physical examination per this import alert after they bring their electronic product into compliance by relabeling, providing requested information, and/or other action (e.g., reconditioning by submitting a Form FDA 766). Divisions may coordinate a review of such applications related to this alert to the Division of Radiological Imaging Devices and Electronic Products, OHT8: Office of Radiological Health, CDRH. ***
*** Removal from Detention without Physical Examination:
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is to ensure the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
Requests for removal may include the following information:
1. Documentation, such as a product report under 21 CFR 1002.7 and 1002.10, whether by submitting a new product report or by supplementing a prior product report with additional information demonstrating compliance
2. Documentation showing that the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control provisions of the FD&C Act (see Chapter V, Subchapter C of the FD&C Act) and 21 CFR 1010.2 and their sunlamp products comply with the performance standard for sunlamp products per 21 CFR 1040.20.
3. Other information CDRH may reasonably require, under 21 CFR 1002.10(k), to determine whether the importer is in compliance with the Act, the Electronic Product Radiation Control provisions, and any applicable standards.
If a firm, and/or a representative thereof would like to request removal from detention without physical examination under this import alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH, OHT8: Office of Radiological Health RadHealth@fda.hhs.gov.***
***Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
***
*** The firms listed on the Red List for this alert have been found to have one or more of the following objectionable conditions:
1) do not appear to comply or have been determined to not comply with the applicable performance standards prescribed pursuant to Section 534 of the FD&C Act and as specified in 21 CFR Part 1010, and 21 CFR 1040.20, as applicable, and/or;
2) do not appear to have or have been determined not to have the certification in the form of a label or tag required by Section 534(h) of the FD&C Act and as specified in 21 CFR 1010.2, and/or;
3)do not appear to have or have been determined not to provide an initial product report as required by Section 537(b).
These conditions may include products without a permanently affixed label or tag, products for which evidence of a valid test and quality control program is lacking in accordance with section 534(h), and the firm has failed to provide requested information of records including testing records as required in Section 537(b). ***
*** Released of Article Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide FDA documentation to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. For example, when appropriate, the request should include information for FDA to adequately assess whether the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control Act (Federal Food, Drug and Cosmetic Act, Chapter V, Subchapter C) and 21 CFR 1010.2 and their products comply with the performance standard for sunlamp products (21 CFR 1040.20).
In addition, under 21 CFR 1002.10(k), the importer must provide other information CDRH may reasonably require to determine whether the importer is in compliance with the Act, the Electronic Product Radiation Control Act, and any applicable standards.
The owner, consignee, importer, and/or another responsible party to the shipment, may request release of their shipment that has been detained without physical examination per this import alert after they bring their electronic product into compliance by relabeling, providing requested information, and/or other action (e.g., reconditioning by submitting a Form FDA 766). Divisions may coordinate a review of such applications related to this alert to the Division of Radiological Imaging Devices and Electronic Products, OHT8: Office of Radiological Health, CDRH. ***
*** Removal from Detention without Physical Examination:
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is to ensure the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
Requests for removal may include the following information:
1. Documentation, such as a product report under 21 CFR 1002.7 and 1002.10, whether by submitting a new product report or by supplementing a prior product report with additional information demonstrating compliance
2. Documentation showing that the manufacturer's quality control and testing program is in compliance with the Electronic Product Radiation Control provisions of the FD&C Act (see Chapter V, Subchapter C of the FD&C Act) and 21 CFR 1010.2 and their sunlamp products comply with the performance standard for sunlamp products per 21 CFR 1040.20.
3. Other information CDRH may reasonably require, under 21 CFR 1002.10(k), to determine whether the importer is in compliance with the Act, the Electronic Product Radiation Control provisions, and any applicable standards.
If a firm, and/or a representative thereof would like to request removal from detention without physical examination under this import alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email: Importalerts2@fda.hhs.gov
DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH, OHT8: Office of Radiological Health RadHealth@fda.hhs.gov.***
***Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
***
Product Description:
*** Sunlamps and Sunlamp Products such as: Tanning Beds/Booths, Tabletop Sunlamp System/Facial Units,
Portable Units ***
Portable Units ***
Charge:
*** For sunlamps and sunlamp products that appear to fail to comply with applicable performance standards:
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 offered for importation into the
United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the
FFDCA. [Section 536(a),(b) NON STANDARD]
OASIS charge code: NON STD
and/or
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 to which is not affixed a
certification in the form of a label or tag in conformity with section 534(h). [Section 536(a),(b);
NOT CERTIFIED]
OASIS charge code: NO TAG
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 offered for importation into the
United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the
FFDCA. [Section 536(a),(b) NON STANDARD]
OASIS charge code: NON STD
and/or
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 to which is not affixed a
certification in the form of a label or tag in conformity with section 534(h). [Section 536(a),(b);
NOT CERTIFIED]
OASIS charge code: NO TAG
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 ***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
Guangzhou Merican Optoelectronic Technology Co., Ltd.
Date Published : 03/30/2023
Building A Yimei Ind District , No 8 Fuyuan 3rd Road Jignhu Street
, Huadu District,
CHINA
79 R - - EF Suntan bed
Date Published: 03/30/2023
Desc: Tanning Bed