At the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee of the FDA on Indoor Tanning and Tanning Devices
March 25, 2010
I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families, and its Cancer Prevention and Treatment Fund. I have a Master’s in Public Health from Columbia University and am an Associate of the Johns Hopkins Bloomberg School of Public Health in the Department of Health, Behavior & Society.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies. We do not accept contributions from companies that make medical products.
One in ten Americans, including teenagers, visit indoor tanning facilities where they are exposed to UVA and sometimes UVB rays. Both types of UV exposure are known to increase the risk of various types of skin cancer, and last year the World Health Organization’s International Agency for Research on Cancer (IARC) declared tanning beds “carcinogenic to humans.”
Of the 30 million Americans who use tanning devices each year, approximately 2 million are adolescents between the ages of 11 and 18 (Cokkinides et al, Cancer 2009). Adolescent girls are particularly heavy users, with one study reporting that by age 17, as many as 35% of adolescent girls are tanning using FDA-cleared devices (AC Geller et al, Pediatrics, 2002). Research shows that almost all people who use tanning devices use them more often than the FDA’s recommended limits. So, it’s not surprising that 58% of the teenagers surveyed by Cokkinides et al. reported burns from indoor tanning. And we know that burns, especially when you are young, greatly increase the risk of skin cancer.
Although the FDA’s executive summary mentions how many people are employed in companies that make indoor tanning devices or sell them, those numbers should not influence this advisory committee. It is irrelevant to your job today, and should be irrelevant to the FDA’s decision.
Currently tanning devices that are not used for dermatologic disorders-the kind of devices used at the tanning salon in the mall-are considered Class I devices. These are devices classified as having the lowest risk to the consumer and include bandages and tongue depressors. Given that tanning devices emit UV radiation and have been labeled carcinogenic by IARC and other leading scientific bodies, it is time that the FDA re-classify these devices. The question you will need to answer today is: Should tanning devices be Class II or Class III? The Patient, Consumer, and Public Health Coalition, of which my organization is a member, recently wrote to Commissioner Hamburg recommending that tanning devices be considered Class III because a device that increases the likelihood of developing the most serious type of skin cancer and that has no real health benefits should be given the highest level of scrutiny by the FDA. I have brought a copy of that letter for this meeting record. Although UV radiation-regardless of the source-stimulates the skin to synthesize Vitamin D, there are far safer ways to increase your Vitamin D, such as through supplements.
We recommend that the FDA regulate indoor tanning devices as Class III devices and require that they go through the PMA process. Admittedly, it’s difficult to figure out how to conclude that these devices are safe and effective. They clearly aren’t safe…and what are they effective at? The U.S. does not need innovative new tanning devices unless they are safer than current devices. The only way to ensure that is through the PMA process. Clearing tanning devices through the 510(k) process as substantially equivalent to other, equally unsafe tanning devices is not in the interest of public health in the U.S.
Over 250,000 people are diagnosed with non-melanoma skin cancers in the U.S. every year and over 68,000 are diagnosed with melanoma, with 8,000 dying from it every year. The costs of these cancers to our health care system are enormous. I hope you will advise the FDA not to contribute to this epidemic of cancers by pretending that indoor tanning is risk-free.
In addition to reclassifying tanning devices, we ask that today’s panel consider the following:
1. While tanning facilities tend to rely heavily on UVA rays, many use varying proportions of UVB rays to speed the tanning process (93% to 99% UVA and 7% to 1% UVB). We recommend that a standard be set for the UVA/UVB mix that is the least dangerous, based on the science, while recognizing that NO mix is justifiably safe for a product that has no real benefits. This should apply to all such devices, whether for use by a dermatologist, or use by a tanning salon.
2. Tanning facilities should be required to screen people for skin type and people with a family history of skin cancer. Fair-skinned people with Skin Type I (unfortunately, these are the people most likely to use tanning beds) or people with a family history of skin cancer should be told that tanning devices are not approved by FDA for their use.
3. Tanning salons should be required to exclude anyone under 21, as recommended by the American Association of Pediatrics. If this is not done, we would agree with the American Academy of Dermatology recommendation banning tanning devices for minors. At the very least, parents should be required to sign an informed consent form in person at the time that the minor is using the tanning facility. Otherwise, these parental consent forms will be forged by the teenagers and will serve no function.
4. Indoor tanning facilities should be required to post prominently displayed, large “black box” warnings in waiting/reception areas and also on or next to the machine itself. These warnings would briefly describe risks and mandated limits on use (time per exposure, amount of UV radiation per exposure, and number of exposures per year). Customers should be limited to a certain number of visits per year to the same tanning facility or chain of tanning salons. (It would be preferable but clearly impossible to limit the total number of visits to all salons, since they are unlikely to share customer lists with one another.)
5. Patients should have to sign something indicating that they have read a patient disclosure or a “note of understanding.” This would include the number of tanning sessions per year that is the FDA approved limit, and patients should be able to take home with them an easy-to-understand brochure, written at the 6th grade reading level, that explains all the risks of indoor tanning as well as skin cancer warning signs.
More than half of all states have passed some type of restriction on the use of tanning beds, particularly when it comes to minors using them. It’s time for the FDA to take the lead and reclassify all tanning devices as Class III devices, requiring approval through the PMA process. It took our country until 1985 to get explicit warnings on cigarette packages about the risk of lung cancer and other diseases. Let’s put prominent warnings on tanning beds before we cost the U.S. more lives and healthcare dollars.