| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Ave. White Oak #66 - 4621 Silver Spring, MD 20903-0002 |
Department of Health and Human Services
MAR 4 2010
WARNING LETTER
VIA FEDERAL EXPRESS
Mr. Ron Denny
Sun Technologies
1320 Wards Ferry Road
Suite G.
Lynchburg, Virginia 24506
Dear Mr. Denny:
The Center for Devices and Radiological Health (CDRH) has evidence that your firm has introduced non-compliant tanning beds into commerce. These tanning beds include the following models: SOLAR STORM 16, SOLAR STORM 24R, SOLAR STORM 28C and SOLAR STORM 32C. This letter is to advise you of items of noncompliance encountered during review of the tanning beds.
1. 21 CFR 1010.20 Certifitation. There is no certification label on the beds or their packaging. Sun Technologies failed to certify that the sunlamp products comply with 21 CFR 1040.20 based upon a testing program which is in accordance with good manufacturing practices.
2. 21 CFR 1010.30 ldentifitation. There are no identification labels on beds or their packing.
3. 21 CFR 1040.20(d)(1) Label Requirements. There is no evidence of a warning statement on the device with the words "DANGER-Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product."
Furthennore, there is no evidence of labels on the device for recommended exposure positions, directions for achieving the recommended exposure positions, a recommended exposure schedule, a statement of the time it may take before expected results appear, or designation of the ultraviolet lamp type to be used in the device.
In addition, review of your records determined that the exposure schedules are inadequate. For example, the erythema time (Te) for SOLAR STORM 16, SOLAR STORM 24R, SOLAR STORM 28C and SOLAR STORM 32C are 17 minutes, 21 minutes, 15 minutes, and 12 minutes, respectively. However, the exposure schedules in the manual exceed these limits and indicate the maximum exposure times as follows: 30 minutes, 28 minutes, 20 minutes, and 18 minutes, respectively, for SOLAR STORM 16, SOLAR STORM 24R, SOLAR STORM 28C and SOLAR STORM 32C. These inadequate exposure schedules result in unnecessary over exposure to ultraviolet radiation.
4. Sections 501(c) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Since the tanning beds fail to comply with the performance standards, the devices are considered adulterated because their quality falls below that which they are represented to posses.
5. Section 502(a) and 502 (c) of the FFDCA. The devices are misbranded because their labeling is false and misleading and the warning statement required by the Act is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs or devices in the labeling.
6. Section 502(f)(1) and 502(f)(2) of the FFDCA. The tanning beds are misbranded because their labeling failed to bear adequate warnings against unsafe methods or manner and form as necessary for protection of the users from potentially harmful exposure to ultraviolet radiation.
7. Section 502(0) of the FFDCA. The tanning beds are misbranded because Sun Technologies has failed to register with the FDA as required by section 510, and failed to list the devices as required by Section 510(j).
Section 538(a) of the FFDCA, Chapter V, Subchapter C [21 U. S. C. § 360oo(a)], prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the standard. This section also states it is unlawfulfor any manufacturer to fail to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of Section 538(a)(4) of the Act [21 U. S. C. § 360oo(a)(4)]. The Food and Drug Administration (FDA) is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in Section 539 of the FFDCA, [21 U. S. C. § 360pp]. Persons failing to correct violations and/or continued violations of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
Please be advised that, by authority of the FFDCA, Chapter V, Subchapter C - Electronic Product Radiation Control, these sunlamp products are subject to all the applicable requirements of Title 21, Code of Federal Regulations (CFR), Part 1000-1005, which includes reporting requirement in 21 CFR Part 1002. Therefore, we request that you apprise CDRH promptly of the following: (a) which models you currently have in stock; (b) which models and how many ofeach model was shipped from your place of manufacture; and (c) the full address of where the products are manufactured. You are advised that 21 CFR 1002.10 requires submission of a Radiation Safety Product Report prior to introduction into commerce of any of these products. Additionally, please indicate if the firm manufactures any other sunlamp products with intended uses that are subject to additional requirements.
You must respond in writing within 15 working days of receipt of this letter to one of the options listed below. In your response, you must also provide the number of the referenced products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas.
1. Refutation - You may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request - You may request an exemption from user and dealer/distributor notification and from obligation to correct the violative products. Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31).
3. Purchaser Notification and Corrective Action - If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) to fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter - Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan - Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11 (c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
When you have completed any production changes necessary to assure compliance of future units and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the noncompliance on all sold products with an approved CAP.
Your response should be sent to: Chief, Electronic Products Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W066-4621, Silver Spring, MD 20993-0002. If you have further questions on these requirements, please contact LCDR Varsha B. Savalia of the Electronic Products Branch at (301) 796-5867.
Sincerely yours,
/S/
Lynne L. Rice, Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and Radiological Health
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