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Amendments to the Sunlamp Perfomance Standard

CDRH Working Group on Sunlamps

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Review: Why did we publish the ANPRM

• Reports of a melanoma “epidemic” and a melanoma-sunlamp link

• Report of UVA - melanoma association

• AAD and citizen’s petitions

• Some salon owners - not attentive to regs.

• Specific amendment proposals from CDRH

• International harmonization, e.g., IEC

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What revisions were we considering in the ANPRM?

• Make exposure schedule part of the standard

• Lower cumulative doses

• Use cancer action spectrum, plus erythemal action spectrum

• Extend exposure schedule to different skin types

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What revisions were we considering in the ANPRM?

• Sunlamp product manufacturer = anyone who modifies the product

• Have a simpler warning label• Include a melanoma warning• Place warnings in catalogs, spec. sheets, and

brochures• Have a biological efficacy rating scale for

replacement lamps

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Response to the ANPRM

• 27 submissions– indoor tanning industry (4)– lamp and sunbed manufacturers (8)– dermatology organizations (2)– academia (3)– salon owners (4)– State and County regulatory agencies (5)– insurance company (1)

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No plans to ban sunlamps

• Individual choice - sun and/or salon

• Risks are fairly well understood by public

• Informed consent statements are being used

• Emphasis will be on cooperation, not banning

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Our approach to amendments

• Some issues are straightforward, easy to implement, and non-controversial

• Some issues will require more work, but are also non-controversial

• Some issues are complex and controversial

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Our approach to amendments

• Therefore, we will approach amendments to the Sunlamps Performance Standard in at least two stages

– the first stage will address easiest, non-controversial issues

– the second stage will require more research and evaluation on complex and controversial issues

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We will proceed ASAP with five amendments

• Amendment 1: Make exposure schedule a part of the standard

• Amendment 2: Use cancer action spectrum, plus erythemal action spectrum

• Amendment 3: Emphasize that a manufacturer = anyone who modifies product

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We will proceed ASAP with five amendments

• Amendment 4: Place warnings in catalogs, spec sheets, and brochures

• Amendment 5: Have a simpler warning label

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Amendment 1: Make exposure schedule a part of the standard

• Current recommended exposure schedule is is in a policy letter of August 21, 1986

• We will update current recommended exposure schedule for skin type II and make it a requirement in the Performance Standard

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Amendment 1: Make exposure schedule a part of the standard

• We will continue to evaluate other exposure schedules for other skin types for possible use at a later date

• Future exposure schedules should be – scientifically based, and – preferably part of a national/international

consensus

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Amendment 2: Use cancer and erythemal action spectrum

• IEC is adopting the action spectrum for squamous cell carcinoma to be used with the erythemal action spectrum

• New amendment - We propose to follow the lead of IEC and also use the SCC action spectrum

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Amemendment 3: Manufacturer = anyone who modifies product

• Anyone who replaces a lamp with an incompatible bulb or changes an intented performance feature becomes a manufacturer - must re-certify and re-identify product

• Many comments that this requirement be strong. Concerns about insurance coverage

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Amendment 4: Warnings in catal., spec. sheets and brochures

• We will proceed with an amendment to require warning labels in catalogs, specification sheets, and brochures

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Amendment 5: Simpler warning label

• Proceed with a simpler warning label

• Label will be identical or equivalent to the warning label of IEC

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Simpler warning label

• DANGER ULTRAVIOLET RADIATION• Follow instructions -Use protective eyewear• Over-exposure causes skin and eye burns• Long term use contribute to -

– Skin cancers (sometimes fatal)

– Wrinkling and sagging of skin

• Drugs and cosmetics may increase above effects

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Biological efficacy rating scale for UV lamps

• Future amendment - incorporate a new rating scale for replacement lamps

• More effort is needed to finalize such a rating scale

• Agreement that a rating system is needed

• Suggestion that the UV index be used as part of the rating system

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Other possible amendments

• Possible melanoma warning

• Lower cumulative doses

• Exposure schedules for different skin types

• The suggested amendments will be delayed because there is:– insufficient data to make a decision at this time– more research and evaluation is needed

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Work with Industry

• Discussion on industry proposals– consent forms

– exposure. Schedules

– skin types

– UV index

– “benefits”

• Workshop at Inter. Cong. of Photobiology

• FDA conferences (?)• Ongoing discussions

and evaluations

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Ongoing work in IEC

• Timers• Warning labels• Protective eyewear• “Panic” button• MED - 250 J/m2

• Exposure schedules for different skin types

• Lamp classification - use UV index

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Conclusions

• Proceed with a Proposed Rule with 5 amendments

• Continue to work on the other issues for possible future amendments