Presentation on theme: "Proposed Amendments to FDA Sunlamp Product Performance Standard"— Presentation transcript:
1 Proposed Amendments to FDA Sunlamp Product Performance Standard Presentation to TEPRSSCOctober 1, 2003
2 Background 1998 – Advanced Notice of Proposed Rulemaking Concerns about melanoma being related to sunlamp useReports of melanoma ’epidemic’AMA petition to ban sunlampsCitizen’s petition to increase enforcementInternational Harmonization (IEC TC 61, )Technology and our knowledge base has changed since 1985 (orig. std. published 1979)
3 ANPRM Proposals Update recommended exposure schedule (Current FDA addressing this)Make new recommended exposure schedule part of the actual standardClarify the definition of “manufacturer” i.e. that it includes “significant modification” of a sunlamp product
4 ANPRM Proposals – ct’d 4. Update warning label 5. Require warning label to be reproduced in catalogs, advertising literature, etc6. Develop a uniform rating scale for replacement lamps to:simplify the tasks of salon owners and inspectors, andincrease safety(FDA has sponsored 2 mtgs. re: this issue since 1998)
5 Review of Recent History May, 2002 TEPRRSCSimplified Warning LabelRequire Label be reproduced in advertising literature, brochures, etcDefinition of ManufacturerRevised specifications for eyewear
6 TEPRSSC gave tentative go-ahead on all but 3rd proposal – understanding there would be 90 to 120-day comment period after the official proposed rule published in Federal Register(Proposals 1, 3 and 4 have been ‘fine-tuned’ since 2002 meeting in order to better harmonize with IEC)
7 Relevant Events since May 2002 October, 2002 – International committee for sunlamp standards (IEC TC 61, MT 16) met in London(Sharon Miller and Janusz Beer from FDA attended)June, 2003 – IEC TC 61, MT 16 met in Helsinki, FinlandJune, 2003 – Joint meeting of the FDA, American Academy of Dermatology (AAD) and the American Society for Photobiology (ASP) on indoor tanning(Organized by Howard Cyr; Sharon Miller, Janusz Beer, Marilyn Lightfoote and Jerry Dennis attended)
8 October, 2002 IEC Meeting Items discussed: Incorporation of the new CIE action spectrum for Non-melanoma skin cancer (NMSC).Classification of sunlamp products according to NMSC-effective output. Additional class (Type 5) was added to include products that had been previously excluded.Absolute cap on UV irradiance (1 W/cm2 – NMSC-weighted) from sunlamp products accepted.Decision to liaise with IEC TC 34 (lamp measurement committee) to develop acceptable replacement lamp coding scheme.
9 June, 2003 IEC Meeting Items discussed: Detailed evaluation and modification of the Instructions for Use, including limiting the use of products by minors.Replacement Lamps. Members of IEC TC 34A attended and a compromise was reached re: how to evaluate and designate low-pressure UV lamps according to their biologically-effective output.
10 June, 2003 Meeting with AAD and ASP FDA presented information about regulations on sunlamp products and current research in this area.AAD concerned:seeing increased use of sunlamp products over last few decades, especially among young women and even children.increased rates of skin cancer among Americans.AAD members asked FDA to make warnings against indoor tanning stronger and plan to send petitions to the FDA Commissioner to this effect.
11 Proposed Amendment 1 Warning Label Existing Label: 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 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 use of this product.
12 Proposed Revised Label: WARNING - Ultraviolet radiation may cause:injury to the eyes and skinskin agingskin cancer.Read instructions carefully.Wear protective eyewear provided.Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation. Consult your physician.* Lettering of at least ten (10) millimeters height for the word “Warning” and five (5) millimeters for the rest of the label information is recommended to meet the visibility requirements specified in
13 Proposed Amendment 2Inclusion of warning label into catalogues, specification sheets and descriptive brochuresConsistent with req. in the laser std
14 Proposed Amendment 3Significant modification of a sunlamp product means recertification as a “manufacturer”Consistent with req. in the laser std.
15 The modification of a sunlamp product, previously certified under Sec The modification of a sunlamp product, previously certified under Sec , by any person engaged in the business of manufacturing, assembling, or modifying sunlamp products shall be construed as manufacturing under the act if the modification affects any aspect of the product's performance or intended function(s) for which this section has an applicable requirement. The manufacturer who performs such modification shall recertify and re-identify the product in accordance with the provisionsof Secs and
16 Examples of “significant modification” Replacing original lamps with lamps that are “incompatible”Increasing the maximum timer settingRemoving required labeling or replacing original labeling with labeling that would render the product ‘noncompliant’
17 Proposed Amendment 4 Protective Eyewear Requirements: Current language in standard:“the spectral transmittance shall not exceed a value of over the wavelength region 200 to 320 nm, and a value of 0.01 for 320 to 400 nm, and shall be sufficient over the wavelength region > 400 nm to enable the user to see clearly enough to reset the timer”
18 Proposed Revised Requirements Same UV limitsFor Visible region (> 400 nm), a more quantitative definition:”the luminous transmittance shall not be less than 1% over the 380 to 780 nm wavelength region”
20 Where: Y(l) = Relative Luminous Efficiency Function of the Human Eye S(l) = Relative Spectral Emittance of Standard Illuminant A as defined by CIE
21 Cap on Spectral Transmittance “and the unweighted transmittance (< 5 nm intervals) over the 400 to 550 nm region shall not exceed 5%”.This second requirement is currently part of the International Standard for sunlamp products(IEC ).
22 However, recent data obtained from our FDA laboratory in Winchester, MA reveals that some eyewear currently on the market cannot meet the 5% cap.So, we propose that these types of products be required to bear a tag reading:"Does not provide adequate eye protection in sunlamp products with high pressure lamps in the facial area" In addition, these types of eyewear could not be sold with a high pressure sunlamp product.Rationale: high pressure lamps are more likely to pose a hazard to the retina from visible light than fluorescent lamps because of their smaller image size.
23 Proposed Amendment 5 (a) Replace the currently-used (by FDA) ‘CIELYTLE’ erythema action spectrum with the internationally-accepted CIE Reference action spectrum for erythema.This action spectrum has been extensively studied and confirmed as accurate in several laboratories worldwide.Used by FDA in Sunscreen MonographUsed by meteorological groups and National Weather Service who define UV Index for solar irradianceHarmonize with international standards for sunlamps
25 Proposed Amendment 5 (b) Adopt internationally-accepted definition of Minimal Erythemal Dose (MED)MED = 200 J/m2(FDA currently uses 156 J/m2)Maximum Timer Limit is currently 4 MEDsIn order to maintain same biological dose, new timer limit = 3 MEDs using ‘new’ action spectrum and ‘new’ definition of MED ( » 600 J/m^2-eff)
26 Proposed Amendment 6 Replacement Lamps – Coding Scheme Current situation relies on relative comparison; i.e. two individual lamps must be within +/- 10% of erythemal and melanogenic effectiveness in order to be considered ‘compatible’Absolute system that involves lamp code is needed to solve problems associated w/ current system
27 Current Labeling SUNLAMP - DANGER- ULTRAVIOLET RADIATION. FOLLOW INSTRUCTIONS.USE ONLY IN FIXTURE EQUIPPED WITH A TIMER.
29 Reflector code O for non-reflector lamps B for lamps with a broad reflector angle a > 230°N for lamps with a narrow reflector angle a < 200°R for lamps with a regular reflector ° < a < 230°
30 UV Code UV Code = X/Y X = total erythemal-effective irradiance (250 to 400 nm)Y = ratio of NMSC-effective irradiance(250 to 320 nm/320 to 400 nm)
31 SOP for lamp measurements Irradiance shall be measured under standardized conditions as specified in IEC 1228 – Method of Measuring and Specifying Fluorescent Ultraviolet Lamps used for TanningIrradiance from a single lamp shall be either measured at a distance of 25 cm or corrected to irradiance at 25 cm
33 Acceptable RangesLamps will be considered to be acceptable replacements if ‘X’ and ‘Y’ components are within +/- 10% of those of the original lamps.For example, in sunbed where original lamp code = 100 W – R – 47/3.2Suitable replacements:100 W – R – (42 to 52)/(2.3 to 3.8)e.g. 100 W – R – 42/2.3100 W– R – 52/3.8
34 Future Proposals?Recommended Exposure Schedules (when FDA study complete)Additional changes instituted by International Committee during our standards promulgation process
35 Request for vote on proposals Warning Label – revisedRequire warning label be reproduced in catalogues, brochures, etcClarify definition of manufacturerRevised protective eyewear specsAdopt CIE erythema a.s. and new MEDReplacement Lamp coding scheme