ASA Makes Industry’s Case to Food and Drug Administration at September Meeting

In September, American Suntanning Association Research Director Allen Miller led a scientific meeting with the U.S. Food and Drug Administration regarding their indoor tanning proposed rules. Miller and the ASA scientific team presented scientific evidence that shows how the proposed rule changes could have adverse affects on the consumers the FDA is trying to protect. ASA has invested considerable resources to constructively work with the FDA and support a better plan for consumers and our market.

Here is Miller’s summary of the meeting:

The FDA attendees were:

Richard P. Felten, Expert Reviewer, Division of Surgical, Orthopedic, and Restorative Devices, Office of Device Evaluation. CDRH
Steve Nager, a doctor
Sharon Miller, CDRH/OIR/Division of Radiological Health/Magnetic Resonance & Electronic Products Branch
Neil Ogden, CDRH/ODE/Division of Surgical Devices — Chief, General Surgery Devices Branch 1
Ian Ostermiller, CDRH Regulatory Counsel · Vasum Peiris, CDRH, pediatrics medical officer
The tanning industry group was myself, Dr. David Hoel, John Overstreet, Jim Shepherd and Ellen Flannery and Christopher Hanson of Covington and Burling, our FDA counsel.

Ellen Flannery began the meeting by stating that the FDA convened an Advisory Panel Meeting in March 2010 to consider scientific information about UV radiation and tanning. That was six years ago. Since that time, there have been significant changes in the understanding of the benefits and risks related to sunlamp products. The purpose of our meeting was to ask that the FDA undertake a thorough review of all the new science published since the 2010 meeting. The point being that without considering new developments, the FDA could be doing more harm than good with this approach.

In particular, more recent scientific articles do not support FDA’s assertion in the proposed rule that children and adolescents who are exposed to UV radiation (including from tanning salons) may be at higher risk of developing certain types of skin cancer than persons who begin exposure later in life as adults. We told the FDA that this ban could push teens to more risky behavior through unsupervised sun tanning either outside or at home.

Science related to mandating an under 18 ban – I began by talking about the infamous 2009 WHO/IARC fiasco. I explained Dr. Hoel’s role in that working group, how the “75% more likely to develop melanoma” statistic was actually generated by staff and had been originally published in 2006 and ignored. Dr. Hoel explained how the IARC working group really didn’t discuss sunbeds but simply reclassified UV light from a sunbed to human carcinogen, the same category as the sun. This is important because the FDA that in the preamble to the proposed rule, relies upon the 2006 International Agency for Research in Cancer (IARC) report and the follow-up 2012 Boniol study done by the same people as the 2006 IARC report (who by 2012 had left IARC and worked for the private organization, International Prevention Research Institute (IPRI).

Dr. Hoel and I told the FDA that these studies have been discredited and superseded by the 2014 Colantonio study which found that there is no statistically significant correlation between indoor tanning before age 25 versus after age 25 and increased risk of melanoma. In addition, I pointed out that the FDA fails to acknowledge that the 2010 Lazovich study published after the meeting of the March 2010 Panel, found that younger individuals are not at increased susceptibility to the effects of UV radiation. We concluded that a careful review of our previous scientific submission shows that the totality of the current scientific evidence does not support the restrictions on use of sunlamp products (including the under-18 ban) being proposed by FDA.

We also talked about how the studies often group home tanning with salon tanning and if you separate out the home tanning data, there is no increased risk for melanoma from tanning in a salon and a 50% increased risk of melanoma from home tanning. We gave them a copy of Dr. Hoel’s meta-analysis showing this.

Science relating to proposed limitations on tanning exposure – Dr. Hoel and I pointed out that FDA’s suggestions of limiting indoor tanning in a tanning salon to: (1) two times per week, (2) once every 48 hours and (3) 15 kJ/m2 per year, all appear to be based on a view that non-burning UV is somehow bad for a person’s risk of skin cancer or is otherwise unhealthy and should be limited.

We told the FDA that current science does not support any of these limitations, other than a separation of 48 hours between each of tanning session in the first two week of a tanning course. To the contrary, there is significant science indicating that insufficient UV exposure is one of the nation’s leading public health problems. The current state of the science shows that there is no harm in a person staying tan year-round by using a commercial tanning salon, assuming there is no UV burning, and lots of benefits (whether we can promote these potential benefits or not). FDA’s current exposure guidelines as set forth in the 1986 policy are designed to prevent burning.

The proposed twice-a-week spacing and 48-hour spacing (except as stated above) is contraindicated by science that has been established for 30 years that, for a given dose of UV, skin cancer risk is minimized by getting that dose as quickly as possible without burning. Dr. Hoel argued that melanoma risk is reduced by having chronic year-round UV exposure, so an annual limit is also contraindicated by science.

The notion of limiting persons with Skin Type III and Type IV to the UV doses appropriate for persons with Skin Type II also is a consequence of a view that less UV exposure is always better than more. This view is contraindicated by the science.

We also discussed the adoption of some of the Intermittent Exposure Chart (IEC) regulations. We understand that the FDA’s proposed recommendation of an annual limit is based on an assumption by the IEC many years ago that indoor tanning should not provide more UV exposure per year than a Dutch indoor worker receives annually from the sun. This arbitrary assumption of the IEC provides no scientific basis for the proposed rule. The Sharon Miller studies cited by FDA as supporting FDA’s notion that a tan can be maintained on a year-round basis with an annual dose of 15 kJ/m2 examined only colorization and made no investigation of epidermal thickening, an essential element of a tan, and thus also does not provide any scientific basis for the proposed rule. We pointed out that tanning equipment is approved by the FDA “for tanning purposes” and a tan includes colorization of existing melanin by UVA, production of melanin by UVB, and epidermal thickening, all of which contribute to protection against subsequent sunburn.

We also discussed efforts we have undertaken to get the CDC to back off its hard line on UV exposure using these same arguments.

If you have any questions about the FDA’s proposed indoor tanning rules, call 855-879-7678.

ASA APPLAUDS CONGRESSIONAL REPEAL OF “TAN TAX”

10% tax has devastated an industry dominated by women, resulting in  the closure of nearly 10,000 small businesses and loss of 100,000 jobs since 2010

WASHINGTON, DC (January 7, 2016) – The American Suntanning Association (ASA) today endorsed action taken by Congress to repeal the 10% federal excise tax on indoor tanning. The repeal was included in the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015, which passed in both the House and Senate and now goes to the President for action.

“We applaud Congress for taking action to repeal this onerous and unfair tax, which has crippled an industry and hurt small business owners across the country,” said ASA President Bart Bonn. “We urge President Obama to sign the bill into law.”

Since the tan tax went into effect in 2010, approximately 10,000 small business-owned salons – more than half of all tanning salons in the U.S. – have closed, resulting in the elimination of nearly 100,000 jobs in communities across the country, in an industry heavily dominated by women owners and employees.

“The tan tax is an example of a misguided policy, implemented with little forethought, which turned out to be the real ‘war on women’ over the past five years,” noted Bonn.

In addition, the tax has generated less than 1/3 of the revenue projected by the Congressional Budget Office, or an average of only $84 million per year. With the IRS allocating $11 million annually to collect and administer the tax, coupled with Small Business Administration loan defaults and the loss of income and payroll taxes from closed salons, the net impact of the tax has arguably been negative to the U.S. Treasury.

“The President committed that no family making less than $250,000 a year would see any form of tax increase on his watch,” noted Bonn. “Unfortunately, that has not been the case with the tan tax which impacts millions of Americans at all income levels who enjoy tanning.”

Repeal of the tan tax has gained momentum in Washington since the introduction in July 2015 of HR 2698, “The Tanning Tax Repeal Act of 2015.” During 2015, the repeal garnered bi-partisan support, with 79 members of Congress, both Republicans and Democrats, signing on as co-sponsors of the bill.

The American Suntanning Association is a Section 501(c)(6) nonprofit organization representing professional sunbed salon owners committed to responsible and balanced sun care. The ASA urges a facts-based discussion among the industry, medical community and government regarding the risks and benefits of UV exposure. For more information, visit www.americansuntanning.org

Nebraska Court Rules That Anti-Disparagement Lawsuit Filed by ASA-Member Tanning Salons May Proceed

Earlier this year, tanning salon operators in Nebraska, supported by the American Suntanning Association (ASA), filed a lawsuit in Nebraska state court against the Nebraska Cancer Coalition (NCC), and two of its officers, alleging defamation and violation of the Nebraska Deceptive Trade Practices Act. In response, the defendants filed a motion to dismiss the action, arguing that the plaintiff salon operators had failed to state a claim upon which relief could be granted.

In a decision entered November 24, 2015, the Nebraska District Court denied the defendants’ motion to dismiss the lawsuit. In ruling in favor of the plaintiff salon operators, the Court found that the complaint alleged facts sufficient to state a claim against both the NCC and the two individually named defendants, for both defamation and violations of the Nebraska Deceptive Trade Practices Act.

As part of its ruling, the Court found that the lawsuit sufficiently stated facts showing the alleged false and defamatory statements made by the defendants in their “The Bed Is Dead” campaign (www.thebedisdead.org), were made in the course of the defendants’ business, vocation, or occupation. In so ruling, the Court relied on plaintiffs’ allegations that the defendants’ anti-tanning campaign was:

“a coordinated scheme [that] is funded in part by individuals and commercial entities having a direct financial interest in generating negative publicity about indoor tanning salons, including the sunscreen and cosmetic industries and those providing UV light treatments in medical facilities,” and that

“Dr. Watts and other members of the NCC have a financial interest in destroying Plaintiffs’ businesses, as Dr. Watts and others in his industry seek to offer cosmetic dermatology services to Plaintiffs’ customers, in place of those services provided by Plaintiffs.”

The Court also noted in its ruling that “Defendants’ statements, as alleged by Plaintiffs, prejudice Plaintiffs in their profession, trade, and business” and that “Plaintiffs have sufficiently alleged that Defendants’ statements are defamatory per se.”

To review the ruling, and find out more information about the suit, please visit Nebraskatanfacts.com. To contribute to a dedicated fund to support this litigation (your contribution may be tax deductible as a business expense), please visit the ASA Legal Fund’s GoFundMe page.

Nebraska Tanning Salons File Lawsuit to End Unlawful Campaign of Misstatements and Disparagement

Suit filed by seven small business owners operating 68% of tanning salons in the Omaha and Lincoln markets

Omaha, Nebraska (July 22, 2015) – Today, seven small business owners operating 30 tanning salons in the Omaha and Lincoln markets filed a lawsuit in state court against the Nebraska Cancer Coalition (NCC) and two of its officers. The action states that the plaintiffs have been harmed as a result of false, misleading and defamatory statements made by the NCC about their businesses and the indoor tanning industry.

“Small businesses in Nebraska are suffering, and consumers are being misled, as a result of the misinformation being put out by the NCC,” said Bart Bonn, president of plaintiff Ashley Lynn’s, Inc., the Palm Beach Tan franchisee in Nebraska. “We advocate moderate and sensible UV exposure for Nebraska citizens who choose to tan, and pride ourselves in operating our businesses within both FDA guidelines and the law. It is both unfair and unlawful for the NCC to attack our businesses with a campaign full of deception and untruths.”

The complaint alleges that through an orchestrated campaign known as “The Bed is Dead,” the NCC committed defamation and violated the Nebraska Deceptive Trade Practices Act. The filing highlights the fact that the American Suntanning Association (ASA), an industry trade group in which the plaintiffs are members, contacted NCC on multiple occasions over an 11-month period, documenting the inaccuracies and misleading elements of its campaign and asking the NCC to make corrections.

“It is unfortunate that Nebraska tanning salon owners must seek relief in the legal system to preserve the right to operate our businesses free from misinformation and attacks,” said Curt Bowen, president of plaintiff JB & Associates, Inc., the Sun Tan City franchisee in Nebraska. “But in this case, our very livelihoods are on the line.”

The suit asks that the defendants correct their misstatements to the public and refrain from engaging in further deceptive trade practices and defamatory statements. The full lawsuit, including detailed scientific information supporting the plaintiffs’ claims, is available at www.Nebraskatanfacts.com.

 

Plaintiffs’ efforts are being supported by the American Suntanning Association (ASA), a Section 501(c)(6) nonprofit organization representing nearly 1,000 tanning salons throughout the United States. For more information, visit www.americansuntanning.org.