Presentation on theme: "Proposed Amendments to FDA Sunlamp Product Performance Standard Presentation to TEPRSSC October 1, 2003."— Presentation transcript:
Proposed Amendments to FDA Sunlamp Product Performance Standard Presentation to TEPRSSC October 1, 2003
Background 1998 – Advanced Notice of Proposed Rulemaking –Concerns about melanoma being related to sunlamp use –Reports of melanoma epidemic –AMA petition to ban sunlamps –Citizens petition to increase enforcement –International Harmonization (IEC TC 61, 335-2-27) –Technology and our knowledge base has changed since 1985 (orig. std. published 1979)
ANPRM Proposals 1. Update recommended exposure schedule (Current research @ FDA addressing this) 2. Make new recommended exposure schedule part of the actual standard 3. Clarify the definition of manufacturer i.e. that it includes significant modification of a sunlamp product
ANPRM Proposals – ctd 4. Update warning label 5. Require warning label to be reproduced in catalogs, advertising literature, etc 6. Develop a uniform rating scale for replacement lamps to: –simplify the tasks of salon owners and inspectors, and – increase safety (FDA has sponsored 2 mtgs. re: this issue since 1998)
Review of Recent History May, 2002 TEPRRSC 1.Simplified Warning Label 2. Require Label be reproduced in advertising literature, brochures, etc 3. Definition of Manufacturer 4. Revised specifications for eyewear
TEPRSSC gave tentative go-ahead on all but 3 rd 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)
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, Finland (Sharon Miller and Janusz Beer from FDA attended) June, 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)
October, 2002 IEC Meeting Items discussed: 1.Incorporation of the new CIE action spectrum for Non-melanoma skin cancer (NMSC). 2.Classification of sunlamp products according to NMSC-effective output. Additional class (Type 5) was added to include products that had been previously excluded. 3.Absolute cap on UV irradiance (1 W/cm 2 – NMSC- weighted) from sunlamp products accepted. 4.Decision to liaise with IEC TC 34 (lamp measurement committee) to develop acceptable replacement lamp coding scheme.
June, 2003 IEC Meeting Items discussed: 1. Detailed evaluation and modification of the Instructions for Use, including limiting the use of products by minors. 2. 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.
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. seeing increased use of sunlamp products over last few decades, especially among young women and even children. increased rates of skin cancer among Americans. 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.
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.
Proposed Revised Label: WARNING - Ultraviolet radiation may cause: injury to the eyes and skin skin aging skin 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 1010.3.
Proposed Amendment 2 Inclusion of warning label into catalogues, specification sheets and descriptive brochures Consistent with req. in the laser std
Proposed Amendment 3 Significant modification of a sunlamp product means recertification as a manufacturer Consistent with req. in the laser std.
The modification of a sunlamp product, previously certified under Sec. 1010.2, 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 provisions The modification of a sunlamp product, previously certified under Sec. 1010.2, 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 provisions of Secs. 1010.2. and 1010.3. of Secs. 1010.2. and 1010.3.
Examples of significant modification Replacing original lamps with lamps that are incompatible Increasing the maximum timer setting Removing required labeling or replacing original labeling with labeling that would render the product noncompliant
Proposed Amendment 4 Protective Eyewear Requirements: Current language in standard: the spectral transmittance shall not exceed a value of 0.001 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 the spectral transmittance shall not exceed a value of 0.001 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
Proposed Revised Requirements Same UV limits For 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 the luminous transmittance shall not be less than 1% over the 380 to 780 nm wavelength region
Where: Y( ) = Relative Luminous Efficiency Function of the Human Eye S( ) = Relative Spectral Emittance of Standard Illuminant A as defined by CIE
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 60335-2-27). (IEC 60335-2-27).
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.
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. This action spectrum has been extensively studied and confirmed as accurate in several laboratories worldwide. Used by FDA in Sunscreen Monograph Used by FDA in Sunscreen Monograph Used by meteorological groups and National Weather Service who define UV Index for solar irradiance Used by meteorological groups and National Weather Service who define UV Index for solar irradiance Harmonize with international standards for sunlamps Harmonize with international standards for sunlamps
Proposed Amendment 5 (b) Adopt internationally-accepted definition of Minimal Erythemal Dose (MED) MED = 200 J/m 2 (FDA currently uses 156 J/m 2 ) Maximum Timer Limit is currently 4 MEDs In 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)
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 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 Absolute system that involves lamp code is needed to solve problems associated w/ current system
Current Labeling SUNLAMP - DANGER- ULTRAVIOLET RADIATION. FOLLOW INSTRUCTIONS. USE ONLY IN FIXTURE EQUIPPED WITH A TIMER.
Proposed Labeling Scheme Wattage – Reflector code – UV code –Wattage = nominal lamp wattage, marked watts or W
Reflector code O for non-reflector lamps B for lamps with a broad reflector angle > 230° N for lamps with a narrow reflector angle < 200° R for lamps with a regular reflector 200° < < 230°
UV Code UV Code = X/Y X = total erythemal-effective irradiance (250 to 400 nm) (250 to 400 nm) Y = ratio of NMSC-effective irradiance (250 to 320 nm/320 to 400 nm) (250 to 320 nm/320 to 400 nm)
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 Tanning Irradiance from a single lamp shall be either measured at a distance of 25 cm or corrected to irradiance at 25 cm
Acceptable Ranges Lamps 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 – 47/3.2 –Suitable replacements: 100 W – R – (42 to 52)/(2.3 to 3.8) e.g. 100 W – R – 42/2.3 100 W– R – 52/3.8 100 W– R – 52/3.8
Future Proposals? Recommended Exposure Schedules (when FDA study complete) Additional changes instituted by International Committee during our standards promulgation process
Request for vote on proposals 1. 1. Warning Label – revised 2. 2. Require warning label be reproduced in catalogues, brochures, etc 3. 3. Clarify definition of manufacturer 4. 4. Revised protective eyewear specs 5. 5. Adopt CIE erythema a.s. and new MED 6. 6. Replacement Lamp coding scheme