Unlimited and Unrestricted access to Unlimited and Unrestricted access to ultraviolet radiation: A case for effective ultraviolet radiation: A case for effective state regulation over the indoor tanning state regulation over the indoor tanning

industryindustry

Meghana Desai Aruru, PhD (Candidate), MBA, B.S.PharmJ.Warren Salmon, PhD

Dept. Of Pharmacy AdministrationUniversity of Illinois at Chicago

maruru1@uic.edu

AgendaAgenda

• Introduction• Tanning practices• Epidemiology of UV radiation on skin• Fitzpatrick skin type classification• Indoor Tanning Industry• Policies pertaining to indoor tanning• Discussion & Questions

IntroductionIntroduction

• UV tanning – outdoors (sun) & indoors (tanning units)Prevalence of indoor tanning is defined variously as any use in the past 6 or 12 months or frequent use in the past 12 months

• NCI – Skin cancer most common form of cancer in U.S, diagnosed in more than 1.5 million Americans each year

• Increasing incidence of melanoma and non-melanoma skin cancers2005 : 59,580 melanoma cases, 7,770 deaths2006 : 62,190 melanoma cases, 7,910 deaths (estimated)

• SEER statistics - an average of 18.8 life-years lost per melanoma death. Melanomas addressed in Healthy People 2010, growing concern in AMA, WHO, AAD

UV Radiation UV Radiation

200 nm 280nm 320nm 400nm UVC UVB UVA

(absorbed by ozone) (highly carcinogenic) (weakly carcinogenic)

Acute & Chronic effects from UV radiation

Short term – itching, nausea, pruritis, xerosisLong term - polymorphous light eruption, disseminated

superficial actinic porokeratosis, mid-dermal electrolysis and actinic granulomas, melanomas, basal and squamous cell carcinomas

Pre-existing photosensitivity in Lupus Erythmatosus, Polymorphous Light Eruption, Porphyria, and Rosacea significantly exacerbated by exposure to indoor tanning

Emergence of tanningEmergence of tanning

1930’s & 40’s – Medical profession encouraged sun exposure as benefit to children

1948 – First reported studies of vitiligo with oral & topical psoralen

Development of ‘tan’ for cosmetic purposes – French designer Coco Chanel

1970’s – Development of UVA beds for medicinal purposes

Commercialization soon after with formation of the Indoor Tanning Association

Skin cancersSkin cancers

Melanoma in U.S –

Incidence rates rising by 4-8% each year Lifetime incidence is 1/71 3% of all cancers 1% of all cancer deaths Most common cause of death in women 30-39

years

Skin Cancers - MelanomasSkin Cancers - Melanomas

Melanoma in the U.S

0

10000

20000

30000

40000

50000

60000

70000

2000 2001 2002 2003 2004 2005 2006

Year

New

cas

es

7000

7200

7400

7600

7800

8000

Dea

ths

New cases Melanoma Deaths

Skin cancers - MelanomasSkin cancers - Melanomas

Risk factors:

Family history Red/Blond hair Ample UV exposure (freckling on upper back, history of 3

or more sunburns before age 20, 3 or more outdoor jobs before age 20)

Actinic keratosis Skin types I & II Advanced age Atypical or congenital nevi

Skin typesSkin types

Fitzpatrick’s classification – 1977

SED = sub erythemal dose

Skin type assessmentSkin type assessment

• Sun sensitivity or skin type remains constant during a lifetime

• Self assessment by individual tanners

• Assessment by low-wage, insufficiently trained tanning salon operators

Indoor Tanning AssociationIndoor Tanning Association

Total Number of Professional Indoor Tanning Facility Businesses: 25,000

Total Number of Professional Tanning Business Employees: 160,000

Total Professional Indoor Tanning Facility Customer Base: 30 million

Total Revenues Professional Indoor Tanning Facilities: $5 billion

Indoor Tanning IndustryIndoor Tanning Industry

Misleading advertisements &/or falsified messages:

Promoting UV protection through indoor tanning (lack of sufficient epidemiological evidence)

Promotion of health benefits through Vitamin D production

Promotion of trade-offs of certain internal cancers

Stand against sunscreens

Indoor Tanning IndustryIndoor Tanning Industry

Significant advertising & promotion to students

Formed a Political Action Committee (PAC) to prevent ban on under-18 tanning

Indoor Tanning IndustryIndoor Tanning Industry

Tanning salon operator education:

Through 2 private institutions – National tanning Training Institute (NTTI) and International Smart Tan Network (ISTN).

No training for skin typing

No training for radiation related burns and/or emergency procedures

No demonstration of equipment handling

Indoor TanningIndoor Tanning

Source: www.cartoonstock.com

Tanning Salon OperatorsTanning Salon Operators

Source: www.cartoonstock.com

Regulation & LegislationRegulation & Legislation

FDA – regulates equipment, adherence to performance standards, warning signs (FDA, 21 CFR Ch.1 § 1040.20)

Regulation since 1979 – Federal standards adopted to protect customers from eye and skin injuries

1985 – Amendments by allowing longer exposure times for UVA emitting lamps

1986 – Policy letter published on recommended exposure schedules

Currently – no regulation or monitoring of exposure times of patrons, no requirements for maintaining much information

Regulation & LegislationRegulation & Legislation

FTC – prohibits deceptive advertising

Individual states governance

ScreeningScreening

Differences of opinions:

AAD, ACPM – regular screeningIOM, NCI – insufficient evidence for screeningUSPSTF, CTF – screening at-risk population

Early detection of melanomas: High 5-year survival rate

External & visible cancer with known risk factors

DiscussionDiscussion

According to Sharon A. Miller at the FDA’s Center for Devices and radiological Health:

“FDA does not recommend the use of indoor tanning equipment”

Comments: - FDA does not regulate prevalence of indoor tanning - Currently no legislation protecting minors explicitly - No safeguards in place to protect the general tanning

population - No requirements for exposure schedules or monitoring

of UV radiation sessions in tanning salons

DiscussionDiscussion

Significant efforts by AAD, WHO, AMA to ban under-18 tanning

Involving health professionals to detect melanomas and other skin cancers

Regulation over exposure schedules with mandated record keeping

Risk communication to adolescents – immediate perceived benefits versus long term health issues

Development of melanomas at later ages – Medicare burden

ConclusionConclusion

UV exposure presents a significant and serious public health problem

State health departments should mandate cancer risk reduction

Need enforceable state regulatory safeguards in place

Consumer awareness alone does not change tanning behaviors

ConclusionConclusion

Under-18 adolescents typically do not understand risk-benefit tradeoffs

Concern about additive effects from both indoor & outdoor tanning from studies

Concern about proposed tanning addictions

Need for also stepping up oversight by FDA & FTC

All suggestions are reasonable and not overly burdensome

ConclusionConclusion

Increasing vigilance by state health departments over indoor tanning activities including monetary penalties

Monitoring tanning salon operator training to include in depth understanding of skin cancers in relation to UV radiation

Public Health commitment required for best course of action