ASA Members and Supporters,
The U.S. Centers for Disease Control is collecting public input until Sept. 4 for a report intended to convince the U.S. Surgeon General to release a public statement on UV and skin cancer. It seems apparent this is part of the American Academy of Dermatology Association’s lobbying initiative to get surgeon general’s warnings put on sunbeds to continue their “sun scare” campaign to liken UV to smoking.
To help get CDC to meet with ASA scientists, we’d like you to send a united message that CDC needs to work with us before they proceed with any kind of report. ASA is submitting a scientific response to this. For our industry to succeed in this campaign, it is critical that we send as many letters as possible echoing this concern.
So we’ve made it easy for you to submit a response electronically.
1. Click here to go to the comment submission page
2. Type in your personal response or copy and paste the text below into the comment box
3. Fill out your information
4. Click “Continue” to review your submission
5. Check “I read and understand the statement above” and then click “Submit Comment”
Dear CDC –
A very brief 30-day public comment period (Aug. 5, 2013-Sept. 4, 2013) for a report which will have major public policy ramifications is incapable of producing material worthy of this broad-reaching topic for the following reasons:
(1) The main premise of your Notice — “preventing skin cancer through reduction of UV exposure” —and your broad statement that “A majority of skin cancers are caused by exposure to ultraviolet (UV) radiation from the sun or from indoor tanning devices” is very limited. It leads one to infer that you are already predisposed to a conclusion that most science suggests is not as black-and-white as your Notice infers and which is actually debated in the scientific community.
Melanoma skin cancer is more common in indoor workers than outdoor workers, who receive many times more UV exposure, and is most common on parts of the body that do not receive regular UV exposure. What’s more, melanoma mortality and incidence are increasing fastest in older men — the group least-likely to be addressed by this Notice’s stated areas of focus.
Further, your statement that “An estimated 3.7 million cases of basal and squamous cell carcinomas …are diagnosed in the U.S. annually” shows a lack of understanding of this issue. That figure refers to dermatology’s estimated number of procedures — not cases. One case is often represented by dozens of procedures, and there is no actual incidence registry of either of these cancers in the United States nor is there any government number showing an actual increase in these diseases.
(2) This document calls for policy about UV exposure to be based solely on the basis that any UV exposure leads to skin cancer (a conclusion that, again, is debated — a debate which is not reflected in your Notice) at a time when science is clearly starting to understand the broad-reaching benefits of regular UV exposure — benefits that are both vitamin D-related and which are now understood to be solely related to UV exposure itself. Acknowledgement of these fields of research is fully lacking in your Notice, nor is there any indication you have involved any of these disciplines in your process.
(3) Your announcement was buried in the Federal Register at the end of summer during a period when very few of the affected scientific fields or stakeholders would see this document, let alone have sufficient time in 30 days to respond.
This topic deserves a higher-level conversation before a CDC report or a Surgeon General recommendation about UV exposure should be drawn. I would like to join many Americans who insist that you conduct a more thorough, public and inclusive panel of experts and public participants to examine the broad-reaching affects of UV policy fully before proceeding. As it is, your Notice suggests your public understanding of this issue is based solely on the dermatology industry’s lobbying points.
ASA Members and Supporters,
It is critical that you take action today to stop the regulation changes proposed by the FDA. These changes would not only impact the manufacturers of suntanning equipment, but also the salons that currently own and purchase suntanning equipment. For our industry to succeed in this campaign, it is crucial that we send as many letters as possible.
We’ve made it easy for you to submit a response electronically.
1. Click here to go to the regulation proposal’s page
2. Once there, click on “Comment Now!”
3. Fill out your information (choose “Device Industry – C0012″ as the category)
4. Copy and paste this text into the comment box (feel free to customize):
As a sunbed salon owner, my business will be harmed by the unintended consequences of FDA’s proposed order to re-classify tanning equipment as Class 2 medical devices and amend warning labels to include a statement about minors.
(1) The proposed order provides that products already in the marketplace must cease being used if the manufacturer does not submit a 510(k) within one year of the order’s effective date. This is simply not possible, as many equipment manufacturers are no longer in business. (2) It will be cost-prohibitive for manufacturers still in business to retroactively file a 510(k), and many won’t. That will make it mandatory for sunbed salons to replace much or all of their equipment at elevated prices, forcing many to close.
Closing salons is the written lobbying goal of the AAD, which FDA partnered with to announce this order in its May 6 press conference. FDA’s 2010 Plastic Surgery Advisory Panel included 9 AAD members (6 dermatologists and 3 plastic surgeons) — a conflict of interest since dermatology stands to gain financially from measures that close or restrict tanning salons. Dermatology condones its own usage of sunbeds competitively to tanning salons and has lobbied to expand that “safe” service. No panel member declared that conflict, despite being asked.
That conflict of interest appears to have tainted analysis of the data supplied to FDA. Data in the WHO IARC report implicate dermatology sunbeds (96%) as the major source of risk increase for under-35 users, but showed that commercial salons did not increase risk significantly (6%).
Neither the science behind nor the effects of this order have been properly considered. FDA should revisit this issue in constructive cooperation with the sunbed market and qualified independent epidemiologists – using the working group stakeholder meeting format it convened Feb. 7-8, 2002 — before proceeding with any rule revision.
5. Click “Submit”
All comments must be submitted by August 1! Please take a couple minutes to submit your comments today.
Thank you for your help!
American Suntanning Association
The U.S. Food and Drug Administration on Monday announced a proposal to change pre-market manufacturing standards for sunbeds, including a suggestion that sunbed labels add a statement urging young people not to use sunbeds.
FDA’s proposal comes three years after a non-binding FDA advisory panel urged the agency to seek changes, including reclassifying sunlamp products as Class II medical device instead of a Class I device. The reclassification would require manufacturers to change the way they introduce new sunlamp products — a change that, by itself, does not change the end-consumer experience with sunbeds.
“If the order is finalized, manufacturers would have to submit a pre-market notification (510(k)) to the FDA for these devices, which are currently exempt from any pre-market review,” the FDA said in a statement. “Manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use. The order proposes to include a contraindication against use on people under 18 years old, and the labeling would have to include a warning that frequent users of sunlamp products should be regularly screened for skin cancer.”
Sunbeds already include clear warning labels — labels the sunbed market worked with FDA to create. In a 2002 meeting with FDA, the sunbed community and FDA constructively agreed on changes to that warning label spurred by a 1999 request that sunbed rules be reviewed.
FDA has not involved the American Suntanning Association in development of the current proposal.
“The professional sunbed community has not had any input in this preliminary proposal thus far. We remain dedicated to sunburn prevention and look forward to working with the FDA to improve consumer protection and to assure that all information regarding indoor tanning is in accordance with the science,” the ASA said in a statement released to the media 30 minutes after Monday’s press conference.
The ASA will work with other industry groups to participate in the process with the FDA constructively.
The FDA will take comments on the proposed order for 90 days.
To read the FDA’s press release click here.
To read the FDA’s proposal, click here.
To read current FDA regulations, click here.
MAY 4 — The American Suntanning Association (ASA) congratulates West Virginia lawmakers this week for enacting parental-consent legislation that ASA supported and that professional sunbed centers have used as a standard for years.
West Virginia Gov. Earl Ray Tomblin signed the law May 1, which will take effect in July. It formalizes the protocol professional salons have already had in place: Requiring parents to sign consent for teenagers to use sunbeds in a salon. This standard recognizes that many medical professionals believe sunburn prevention — not total sun avoidance — is what needs to be emphasized in public policy on this topic.
ASA this spring encouraged the West Virginia House of Representatives to enact the standard as a practical alternative to legislation in the West Virginia Senate that would have banned all teenagers from using sunbeds in a salon. Total bans would lead families who wish to tan to unregulated home sunbeds and more-frequent outdoor tanning — both of which are more likely to lead to sunburn and overexposure.
“Nationwide, ASA is working with state legislatures to support informed parental consent as the standard for sunbed usage by teenage clients,” ASA President Bart Bonn said. “We have always supported constructive legislation on this topic.”
The American Suntanning Association (ASA) is the largest network of professional businesses dedicated to providing responsible indoor tanning services while increasing public awareness about the facts associated with moderate UV and spray-on tanning. For more information about ASA visit www.AmericanSuntanning.org.
A recent episode of MTV’s “True Life” followed two young adults that were self-proclaimed “tanning addicts.” The episode was filled with misconceptions about tanning, including outdoor, indoor and spray tanning. As the leader in responsible tanning, the American Suntanning Association wants to clear up some of that misinformation.
Nobody should tan indoors or outdoors multiple times a day. Moderate indoor suntanning is all about looking good while reducing the risk of sunburn. Trained indoor suntanning operators, with the help of session management software, won’t allow customers to tan more than once in a 24-hour period. Operators also control all exposure times to minimize a client’s risk of overexposure and sunburn.
The “75% increased risk of melanoma” statistic is misleading. This statistic came from a World Health Organization study that combined the data from medical phototherapy equipment, unsupervised home units and commercial sunbeds. Results of the study showed medical equipment to increase risk 96%, unsupervised home units 40%, and commercial sunbeds only 6%, which is statistically insignificant. The statistics were combined for the 75% and incorrectly attributed to sunbeds.
Spray tanning is not just like applying makeup to your skin. The primary ingredient used in most spray-on tanning equipment today is called dihydroxyacetone (DHA). DHA, a colorless sugar, interacts with the outermost layer of the skin to darken skin color in a period of several hours. It takes about 12-24 hours for the DHA in your skin to reach its full tanning potential and a spray-on tan can last as long as 7-10 days. Some spray solution does include an instant bronzer to give instant results while the DHA darkens. Spray tanning does not offer any sunburn prevention.
The American Suntanning Association is a values-based coalition of suntan centers committed to teaching the vision of responsible and balanced sun care. For more information, visit TanResponsibly.com.