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US Sunscreen Regulations Update

California Chapter SCC April 24, 2012 David C. Steinberg, FRAPS. US Sunscreen Regulations Update. Uses of Sunscreens. Primary-the purpose is to prevent sunburn Secondary-the purpose is cosmetic-like moisturization, coloring the lips or makeup; that also protects against sun damage

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US Sunscreen Regulations Update

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  1. California Chapter SCC April 24, 2012 David C. Steinberg, FRAPS US Sunscreen Regulations Update

  2. Uses of Sunscreens • Primary-the purpose is to prevent sunburn • Secondary-the purpose is cosmetic-like moisturization, coloring the lips or makeup; that also protects against sun damage • The FDA does not differentiate, a drug is a drug whether it is primary or secondary.

  3. Types of Solar UV Radiation • UVA I (340-400 nm) • Can cause minor tanning but has minimal erythemal effect. Can cause long-term damage. Penetrates deeply. • UVA II (320-340 nm) • Slight erythemal contribution, mostly tanning • UVB (290-320 nm) • Causes sunburn and is a major contributor to skin cancer development. • UVC (200-290 nm) • Very energetic radiation. Absorbed by the ozone layer.

  4. Important Radiation • UVA 320-400 nm • Reality 320-380 nm • UVB 290-320 nm • Reality 300-320 nm

  5. History • 1978-ANPR (64 pages) • 1993-TFM (108 pages) • 1999-FM (27 pages) • 2007-PR for UVA ( 52 pages) • 2011-FM for UVA (45 pages)

  6. 1978 • SPF 15 • “Over exposure to the sun may lead to premature aging of the skin and skin cancer. The liberal and regular use over the years of this product may help reduce the chance of premature aging of the skin and skin cancer.”

  7. 1993 • SPF 30 • “SUN ALERT: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer and other harmful effects of the sun.”

  8. 1999 • SPF 30+ • “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.”

  9. 2007 • SPF 50+ • “UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damaging. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.”

  10. 2011 • SPF 50+ • “If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and other early skin aging caused by the sun” (only for Broad Spectrum and SPF 15 or higher products) • “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.” (other products)

  11. New Rules • Effective 6/18/2012 • Effects Labeling both front and back; SPF and UVA testing and claims

  12. Front Label • Required to identify the product as a sunscreen • If you pass the new critical wavelength test you must say Broad Spectrum SPF 30 (add the actual SPF) • Continuous text, no intervening text or graphics • Same font style, color, size on the same background • If you do not pass the test you can only say SPF 6 (add the actual SPF)

  13. Water Resistant Products Water resistant (40 minutes) or Water resistant (80 minutes)

  14. Drug Facts Labels • Required for all sunscreens • Exemption for products used only on specific small areas of the face (lips, nose, ears, etc.) is lifted. • Blister packs? • Ampersand labels? • Only exemption is the 60% rule

  15. Title • Drug Facts is bold and italics • 9 point minimum type • Headers have minimum 8 point and are bold italics • Text have 6 point and are plain type unless required by FDA in the Warnings section. • Fine lines separate with sections and do not touch bold lines • Bold lines separate sections and touch

  16. Actives/Purpose • Header is bold italics: Active ingredients • List in alphabetical order using USAN names only, followed by % • This must be actual % in product • Using Titanium dioxide and Zinc oxide you must subtract the coatings and stabilizers, etc. • Purpose is bold italics and the only permitted purpose is Sunscreen

  17. Uses • Helps prevent sunburn For Broad Spectrum SPF 15 and higher (optional) • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  18. WarningsBroad Spectrum Sunscreens • For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs • When using this product keep out of eyes. Rinse with water to remove. • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  19. WarningsOther Sunscreens Including Broad Spectrum with SPF below 15and Sunscreens which fail the Critical Wavelength test • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging • For external use only • Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs • When using this product keep out of eyes. Rinse with water to remove. • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  20. DirectionsNon-water Resistant Products • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor • Optional: apply to all skin exposed to the sun

  21. Directions Water Resistant Products • Apply liberally 15 minutes before sun exposure • Reapply: • After 40 [or 80] minutes of swimming or sweating • Immediately after towel drying • at least every 2 hours • Children under 6 months: Ask a doctor • Optional: apply to all skin exposed to the sun

  22. DirectionsBroad Spectrum Products • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses

  23. Other information • Protect the product in this container from excessive heat and direct sunlight This is also the preferred location of this: You may report a serious adverse reaction event from using this product to ……… More on this later

  24. Inactive ingredients • Inactive ingredients are listed alphabetically using USAN names if your product does not make any cosmetic claims • Inactive ingredients are listed in descending order down to 1% and any order below this, using INCI names, if the product makes any cosmetic claims

  25. Questions? • This is optional. If you list a phone number, unless times are listed, it is assumed it will be answered 24/7

  26. It Doesn’t Fit? • If the Drug Facts box takes up more than 60% of the room, you can use a modified format • But no optional text or restricted “advertising” text • The Box outline is not required • You may use less than 0.5 point leading • Drug Facts size is reduced to 7 point • Headers are 1 point less • Text is 1 point less • You can run on bullets

  27. Prohibited Claims • Sunblock • Sweatproof • Waterproof • All day protection or citing a specific number of hours of protection

  28. Tests • SPF-number of subjects required is reduced to 10. New SPF Standard. Maximum permitted claim is SPF 50+. Any number is permissible. • Issues with this new method • Broad Spectrum-Critical Wavelength of 370 nm. • Issues with this new method

  29. Combinations If 2 or more filters are used, the minimum SPF must be a multiple of twice the number of filters and each filter must contribute a minimum of 2 SPF to the final product. Hard to measure if you add a UVA only filter, as SPF measures UVB protection

  30. Future • Safety of UV filters • Raising limits on Avobenzone • Defining Zinc Oxide, USP • TEA’s • Expiration dating • Country of Origin • Non-compliant products on the market before 6/18/2012 are allowed

  31. Registrations • Sellers need labeler code • Manufacturers need labeler code • Manufactures need cite license • All drug formulations must be registered • All contract manufacturers have a special form to file • Foreign manufacturers or sellers must have a FDA registered liaison • All of the above must be done by FDA’s electronic system

  32. Unified Agenda February 13, 2012 • ANPRM- Sunscreen Safety 6/12 • NPRM -TEA UV filters-8/12 • NPRM Topical Antimicrobials 4/12

  33. FDA Requested • In 2007, the FDA requested methodologies for SPF (and in vivo UVA) testing procedures for these other types of sunscreens • Only a rinse-off method was submitted • Globally this issue is ignored

  34. Other Publications • Guidance on Enforcement Policy-draft • Comments on New Rules-accuracy of the cost burden, and other data. Due in 60 days • Limit SPF to 50+ unless clinical data shows additional benefit. Due in 90 days • Data on safety and effectiveness of sprays. Due in 90 days • Comments on draft guidance enforcement. Due 60 days.

  35. Comments • In 2007 the FDA received over 3300 comments • 5 Companies/Organizations accounted for over 2900 of these. • Over 1,000 almost identical comments where submitted in the first 4 hours! • In 2011 they received 35

  36. 2011 Comments • Request for extentions-3 • Dosage forms-5 • Labeling-1 • Effectives-4 • EWG-1

  37. OTC Labeling PL 109-462 • All OTC drugs sold under a monograph are required to have on the label a statement of how consumers can report a severe adverse reaction. • If the reaction meets the FDA’s definition, you must file certain forms with the FDA in a limited time period from the notification by the consumer. • Passed 12/22/2006

  38. Adverse Reaction Notification • In the Drug Facts box under “Other information” and state: you may report a serious adverse reaction to: • Outside the Drug Facts box but clearly visible: you may report a serious adverse reaction to: • Just having your name, address or toll free number or website , is not sufficient

  39. Options • Phone number • Must be answered 24/7 by a human being • US Address • Can be out sourced • See www.reportreaction.com

  40. Major Changes From 2007 • No more Sunburn Protection Factor • No more in vivo and in vitro UVA testing required • No more Stars for UVA protection • No more Product Designation Category required on labels • No more Water resistant or very water resistant

  41. Sidebar • The State of California has proposed listing Benzophenone on Prop. 65 • Many phone calls to me on this!

  42. Benzophenone • CAS: 119-61-9 

  43. Benzophone-3 (Oxybenzone) • CAS 131-57-7 

  44. Questions? David C. Steinberg, FRAPS Steinberg & Associates, Inc. Report Reaction, LLC 609-799-1575 phone 609-799-5271 fax davidpreserve@comcast.net

  45. Thank You!

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