O R I G I N A L A R T I C L E

Indoor tanning injuries: an evaluation of FDA adverse event reporting dataJohn C. Dowdy1, Robert M. Sayre1,2 & James G. Shepherd3

1Rapid Precision Testing Laboratory, Cordova, TN, USA, 2Division of Dermatology, Department of Medicine, University of TennesseeCenter for the Heath Sciences, Memphis, TN, USA, and 3KBD, Inc., Crescent Springs, KY, USA

Key words:consumer product safety commission;

CPSC; FDA; food and drug administration;

indoor tanning; injury

Correspondence:John C. Dowdy, Rapid Precision Testing Laboratory,

Cordova, TN 38016, USA.

e-mail: rptlDowdy@aol.com

Accepted for publication:4 March 2009

Conflicts of interest:None declared.

Summary

Background/Aims: In 1979 the Food and Drug Administration (FDA) designated indoor

tanning units would be regulated medical devices and that each must have an exposure timer.

In 1985 FDA added a scheduled series of doses designed to allow tanning with little risk of

concomitant sunburn. Subsequently FDA/CDRH maintained databases in which medical

device associated injuries were reported. The databases, MAUDE and its predecessor MDR,

are available online. While these records, in part, are not intended for evaluation of adverse

event rates, analysis provides insight into the etiology of UV-related tanning injuries.

Methods/Results: We compiled 142 records reported for 1985-2006 including 22%

noninjury malfunctions. Of the reported injuries �50% resulted from UV exposure, an

average of o 1/year resulted in hospitalization. At least 36% of the UV-related injuries were

attributable to various (user/operator) noncompliance with FDA sunlamp guidance policies.

During 1985–1995 there were six times more UV injuries than 1996–2006, presumably

reflecting cessation of much mandatory reporting in 1996. Injury reports declined steady

from 1997 to 2006.

Conclusions: FDA guidance appears most efficacious in injury prevention and we encourage

its incorporation into the enforceable performance standard. We also advise that tanning

industry professional training programs seek standardization/accreditation of their

personnel certifications through recognized accreditation bodies such as ANSI or ISO/IEC.

I n the US, Food and Drug Administration (FDA) specific

regulation of the indoor tanning industry officially began

with the publication, in 1979, of a performance standard for

sunlamps and sunlamp products (1). The current revision of this

standard was issued in September 1985 (2) supplemented by

several guidance documents (3–5) issued to the tanning industry

to assist in complying with the standard. Most notable among the

revisions to the 1979 standard was the revision of the

specification of the maximum exposure timer. The fixed 10 min

maximum exposure timer specified by the 1979 standard was

deemed inappropriate for many devices and was replaced by a

timer based on the effective spectral intensity of the particular

unit (5).

Classified as medical devices, initially Class 2 and later changed

to Class 1, sunlamps have been subject to premarket review of

information regarding the construction and compliance of each

model of sunlamp device and their manufacture under ‘good

manufacturing practices’. Consequently sunlamps have also been

subject to the ongoing reporting requirements of FDA’s medical

device adverse event reporting programs (6) in which problems

and injuries involving users of the new set of indoor tanning

devices were documented.

In early 1989 two reports were published (7, 8) documenting

injuries coincident with indoor tanning, collected by surveys of

dermatologists, ophthalmologists, and emergency room

personnel, conducted in Wisconsin, USA, during a 1-year

period (July 1, 1985–July 1, 1986). Afterwards a number of

papers cited this single example as if it were representative of

indoor tanning related injuries nation wide. This has continued

and a number of papers within the past several years still

reference these 1989 reports regarding the risk or incidence of

injury (9–12). Unfortunately, neither of the publications based

on the Wisconsin survey mention the revision of the sunlamp

performance standard or issuance of significant guidance to the

tanning industry which occurred during the time frame the

surveys were collected.

In this study we have endeavored to examine available online

information on tanning related injuries archived by FDA’s

medical device adverse event reporting programs as well as that

independently complied by the US Consumer Product Safety

Commission. Drawing on our experience in the photobiological

risk assessments, necessary for establishing appropriate sunlamp

exposure timer limits, and our ongoing involvement in tanning

standards development work we undertook to evaluate this data

r 2009 John Wiley & Sons A/S � Photodermatology, Photoimmunology & Photomedicine 25, 216–220216

for insight into the etiology of UV-related indoor tanning

injuries.

Methods

We examined the records available in two searchable online

databases, the MDR Data (Device Experience Network database)

and the MAUDE Data (Manufacturer and User Facility Device

Experience database) provided by the FDA’s Center for Devices

and Radiological Health (CDRH) (13).

We downloaded MDR data files (14), covering the years

1984–1997, extracted the files into spreadsheets and sorted the

records according to FDA product code. The FDA product codes

(15) listed on the date of download, July 17, 2007, included the

related codes: LEJ (Booth Sun Tan), RAB (Sunlamp Products (Pre-

Standard)), REF (Suntan Bed), REG (Suntan Lamp), REH

(Tabletop Sunlamp System). The more recent MAUDE database

(16) was queried for these product codes rather than

downloading the more numerous files. The only relevant

product code found in the MDR and MAUDE reports was LEJ.

Sometimes several injured individuals were reported in the

same record and in these instances we have replicated those

records so that each injured individual is counted. In order to

compare and combine the two sets of data we also had to

establish a set of parameters common to both data sets. These

were combined into a single set of data. Each record was

reviewed with respect to a semi-hierarchal set of yes/no

questions. The questions used were:

1. Was an injury reported?

2. Did injury result in hospitalization?

3. Did injury result in other medical attention?

4. Did injury result from UV exposure?

5. If UV injury, did exposure timer fail?

6. If UV injury, was exposure timer altered?

7. If UV injury, were incompatible lamps installed in unit?

8. Was information reported to establish adherence to

exposure guidance?

9. If reported, was exposure guidance followed?

10. Was UV protective eyewear used?

11. Was individual �19 years old?

12. Did report indicate equipment complaint?

13. Did report indicate lotion complaint?

14. Did report indicate staff complaint?

The answers to these questions were compiled into columns of

a spreadsheet and sorted according to common elements,

enabling the examination of circumstantial factors relating to

the reported UV related injuries.

Limitations

The FDA stresses that the reports contained in some of these

databases probably do not represent the total number of either

injuries or complaints as their submission is in part voluntary

and not a statistically sampled evaluation of adverse event rates

or comparison of event occurrences across device types. We

cannot find any information sent to physicians that such

compliance might be necessary and desirable especially to

insure necessary regulation. Additionally, such records possibly

over-represent more serious injuries as these complainants

may disproportionately seek documentation of incidents in

governmental records.

In addition to the FDA the Consumer Product Safety

Commission (CPSC) has collected hospital emergency room

reports of indoor UV device-related injuries for some years,

1972–1993 resuming in 1996 for ‘Sun lamps’ and 1980–1993

for ‘Suntan booths’ (17). In the late 1990s the FDA requested that

CPSC reinstate the suntan booths emergency reporting room

category for a one year period ending in June 2000 (17). The

FDA received that data but it is not included in this manuscript

because it has not, to our knowledge, been made publicly

available.

Results

The MDR database returned a set of 77 relevant reports

representing the larger set of injuries. The more recent MAUDE

database query returned 58 original reports. Expanding the

reports on multiple individuals for each injury resulted in there

being 142 total reports derived from the initial 135 extracted

from the two data sources. The incidents reported consist of

mechanical and electrical injury and acute UV overexposure and

do not include data on cumulative or chronic UV effects.

Figure 1 shows the major results of our analyses of the two

CDRH databases. From this we compiled documentation of

111 injured individuals with 56 reported injuries because of

UV exposure. Only 16 of all reported injuries required

hospitalization, seven of which were caused by UV exposure.

Injuries not involving UV represent close to 50% of all indoor

tanning injuries.

Of the 56 injuries reported involving UV overexposure, 36%

(Table 1) documented disregard of the mandatory warning

labeling on required eye protection and/or failure to follow

FDA guidance (3–5) on use of specific compatible lamps in units,

acclimatization schedule and maximum exposure time.

Regarding teenage tanning, in the data set there are seven

reports on individuals � 19 years old but only 4 of these

injuries are due to UV exposure. One teenager required

hospitalization due to UV exposure exacerbated by lack of

protective eyewear.

Among the total incidents we examined, two deaths were

reported. One appears to have been a heart attack before UV

exposure. The other was a dermatological patient, undergoing

photochemotherapy with oral psoralen, who suffered a fatal

phototoxic response following exposure.

There were considerably more reports of injuries involving

UV (48) to the FDA during the first 10 years of US indoor

tanning (1985–1995) when there were up to one million daily

tanners. In the period since (1996–2006) the number of indoor

217r 2009 John Wiley & Sons A/S � Photodermatology, Photoimmunology & Photomedicine 25, 216–220

Indoor tanning injuries

tanners has grown to approximately three million daily yet the

number of reported injuries involving UV for that period was

only eight.

Discussion

Statements by various investigators suggesting that there are

numerous injuries from indoor tanning seems to lack

supporting evidence in our examination of the available FDA

databases. The FDA emphasizes that the reports submitted to

them do not include the totality of injuries that probably

occurred. They suggest the likelihood that some injuries go

unreported, which is indisputable. However, anecdotal

comments from tanning industry sources claim that there have

been very few injury lawsuits, averaging less than one per year.

Few FDA reports made statements regarding litigation of injury

claims, consistent with this low rate of acknowledged law suits.

This, coupled with the low incidence of injury reporting, relative

to the estimated numbers of solaria patrons, suggests a relatively

low rates of serious acute injuries have actually occurred in

indoor tanning.

The FDA has provided the tanning industry with several

guidance documents (4, 5) regarding compatible lamps installed

in units, appropriate maximum exposure timers and an

acclimatization exposure schedule that should be followed. A

substantial number, 36%, of the injuries we reviewed seem to

have occurred as a result of failure, on the part of the tanner or the

solaria, to follow this guidance. Since the majority of UV injury

records were mute on the matter of guidance, we suspect a greater

percentage of these incidents were also preventable by simply

following FDA guidance policies. However, it should be noted that

FDA guidance policies are not enforceable and do not have the

same authority of law as do FDA performance standards (18).

0

5

10

15

20

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

Hospital Injury

UV Injuries

Injuries

# Reports

Num

ber

of R

epor

ts

Year Type of Report

Hospital Injuries

UV Injuries

All Injuries

Expanded Reports

Fig. 1. FDA MDR & Maude Indoor Tanning Reports (1985–2006). The reports seem to include complaints other than injuries. Injuries can be divided in

to UV induced injuries and mechanical and electrical injuries. Only 56 injuries involved over exposure to UV during this period. Sixteen injuries required

hospitalization but only half involved over exposure to UV.

Table 1. Injury from failure to follow FDA sunlamp guidance and

labeling

Wrong

LampInstalled

Did Not

Wear EyeProtection

Did Not

Follow

ExposureSchedule

TimerAltered

27% 11% 7% 2%

r 2009 John Wiley & Sons A/S � Photodermatology, Photoimmunology & Photomedicine 25, 216–220218

Dowdy et al.

Recently the issue of teenage indoor tanners has become a

focus of concern. Our analysis of these databases found seven

reports on individuals identifiable as belonging to this age group.

Only four seem to have received UV injuries, one of which

involved hospitalization due to lack of protective eyewear.

Another injury in this age group resulted from failure to follow

guidance using a coin operated unsupervised tanning unit. It is

our understanding that such self-service units are now less

common and in some jurisdictions no longer allowed.

Regarding two deaths that were reported, the fatal heart attack

was evidently only coincidental to the tanning salon location. The

only reported UV related fatality was a fatal phototoxic reaction

of a dermatological patient undergoing photochemotherapy with

oral psoralen. There is a warning label on tanning appliances

mandated by the FDA performance standard, which specifically

states:

‘Medications or cosmetics may increase your sensitivity to

the ultraviolet radiation. Consult physician before using

sunlamp if you are using medications or have a history of

skin problems or believe yourself especially sensitive to

sunlight.’ (2)

Given these precautions, this unfortunate incident may

reasonably be attributed to failure to heed the mandated

warning label.

Phototherapy drugs, psoralens in particular, are prominent

among the FDA’s list of drugs that increase sensitivity to light

(19). This list is widely used in the tanning industry to both

educate tanning salon staff and to inform prospective

tanners (20, 21). Unfortunately the list of photosensitizing

drugs, or its use in the solaria, is not formally part of the

sunlamp performance standard or FDA guidance to the tanning

industry.

We found 11% of the injuries were attributable to lack of

protective eyewear. The performance standard requires the

provision, by sunlamp manufactures, of protective eyewear with

devices sold. The admonition to wear eye protection is also

included on the warning label required by the performance

standard. This warning label displayed on a tanning machine,

also the topic of one of the guidance documents (3), is arguably

the only form of guidance the FDA provides the end user. This

warning label is currently under review for its effectiveness in

communicating these important messages to tanners (22).

There is a predominance of injury reports during the first ten

years of indoor tanning (1985–1995), with six times more UV

related injuries reported than for the 1996–2006 period. This is

probably a reflection of the cessation of much mandatory

reporting in 1996. However, in spite of the sizeable increases in

the number of tanners, now numbering some 3 million daily,

there have not been a concomitant increase in injury reports

during the past decade. This observation is paralleled by data

available from the CPSC through their online search portal, (23)

which also shows (Table 2) declining incidents with the three

year average decreasing from 32 (1991–1993) to 6.3

(1998–2000) to 1.0 (1905–1907).

Since the beginning of formalized indoor tanning, courses to

educate tanning salon operators have been developed by various

industry groups. Over the years the content of the courses have

improved and presumably so have tanning operators

understanding of how to adhere to FDA regulations and

guidance. The tanning salon industry has been diligent in

educating those managing and staffing these establishments to

reduce injuries by conforming to FDA guidance. It is certainly

reasonable to attribute some portion of the comparatively low

number of recent UV injury incident reports to these training

programs. A number of states now require operators to take

similar courses and accept only state approved certifications. We

propose that tanning industry educational programs seek formal

standardization and accreditation of these personnel certification

programs through a recognized accreditation body such as ANSI

or ISO/IEC.

Clearly the primary public health concerns about the practice

of indoor tanning are the long-term effects, in particular skin

cancers. In many epidemiological studies incidence of severe

sunburn is the primary correlate to increased skin cancer risk.

Consequently, the only information potentially relevant to

chronic ill effects discernable from examination of these

databases are the incidence of reported UV overexposure

injuries and the clear correlation of this type of injury with

failure to follow exposure schedules provided in FDA guidance

policies.

Current guidance, when followed, seems to have effectively

produced a minimum of acute UV exposure injuries. This is

seemingly supported by the observation that, FDA and CPSE no

longer require some types of reporting of injuries involving

indoor tanning, presumably because there were insufficient

incidents to warrant mandatory surveillance. We remain

concerned that some of the changes proposed by FDA/CDRH to

US sunlamp regulations may be problematic. In particular we are

Table 2. Results of CPSC NEISS online query, code: 1609 sun lamps

Year Sample Count

3 Year National Adjusted

Average Injury Estimate Estimate

1991 39 1945 18851992 34 1343 1294

1993 23 32.0 N/A� 1072

1994 Not collected

1995 Not collected1996 12 N/A� 388

1997 7 N/A� N/A�

1998 10 9.7 N/A� N/A�

1999 3 6.7 N/A� N/A�

2000 6 6.3 N/A� N/A�

2001 6 5.0 N/A� N/A�

2002 4 5.3 N/A� N/A�

2003 1 3.7 N/A� N/A�

2004 2 2.3 N/A� N/A�

2005 1 1.3 N/A� N/A�

2006 2 1.7 N/A� N/A�

2007 0 1.0 N/A� N/A�

�Not available (considered unstable).

219r 2009 John Wiley & Sons A/S � Photodermatology, Photoimmunology & Photomedicine 25, 216–220

Indoor tanning injuries

afraid that the proposed �50% increase to the maximum

exposure timer combined with limiting exposure schedules to

levels that may not maintain UV acclimatization will create

increased incidence of episodic overexposure (24, 25).

Accordingly, we urge that before promulgating new regulations

which may depart from current polices, FDA should, as they

proposed in 1999 (26), elevate their existing guidance to the

level of an enforceable standard.

Acknowledgement

This work was supported in part by the UV Foundation.

Disclaimers: The opinions and conclusions stated in this paper

are those of the authors and do not represent the official position

of any of the following organizations: RMS is a member of UL

Standards Technical Panel 482, and also of Commission

Internationale de L’Eclairage (CIE) Technical Committe 6–58.

JGS is the President of the UV-Foundation, a member of the

Board of Directors of the Indoor Tanning Association (ITA) and a

member of the International Electrotechinical Comission (IEC)

Technical Committee 61, Maintenance Team 16.

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