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Old 01-13-2016, 06:54 PM   #1 (permalink)
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Arrow ITA Update 1/12/16

Executive Directors Report
I want to update you on very important recent developments at the FDA that requires your attention. Three days before Christmas, the FDA published two proposed rules in the Federal Register that could have a significant impact on our industry for years to come. The first, a proposal that would make sunlamp products (which includes both sunbeds and sunlamps) restricted devices, is clearly aimed at implementing a ban on use for anyone under the age of 18.
The second proposal encompasses amendments to the performance standard which we have known the FDA has been considering for years. This is the far more complicated and far reaching of the two proposed rules. These amendments address a host of specific issues such as output of the equipment, replacement lamps, eyewear, the warning label, and recommended exposure schedules, among other things.
First it is important to understand the process. Unlike the last mandate from the FDA which was promulgated in 2014 and went into effect in last September where the FDA reclassified sunlamp products to class II medical devices, the procedures the FDA has to follow in a formal rulemaking are more drawn-out and complicated.
For both proposed rules, we have 90 days to provide the FDA with the industrys detailed responses called comments. At the close of the comment period, the FDA is required to weigh all comments and respond in writing to each one justifying everything they propose to do. There is no way to know how long this phase of the process will take but certainly months, possibly six months to a year or even longer.
After considering and responding to the arguments we and others submit, the FDA can publish a final rule. The final rule may be different from the original proposal or not. There is no set timeline for publication of a final rule. It could take months, it could be years, or it could be never. While never is unlikely, it will almost certainly be months or a year.
Finally there is an implementation period. For the restricted device proposal, there is a 90 day period; for the amendments to the performance standard, there is a one year phase in. The bottom line is that this will drag out over the next 12-18 months or even longer.
It is also important that everyone in the industry understands that this is very serious and we are approaching it that way. The process will not only be long but also costly. We have a law firm that is arguably the best FDA law firm in Washington advising us on the strategy and they will be drafting the industrys comments. We will challenge the FDA on the science they use to justify any restrictions they are proposing. The FDA will also have to justify the potential costs to the industry in implementing any new regulations.
Because of the potential impact these proposed rules will have on both the manufacturers and the salons, we are partnering with the American Suntanning Association to present a unified industry response.
It is a fact that the FDAs decisions on these two proposed rules will affect your business for years to come so please dont sit on the sidelines. Support this effort financially through membership or contributions. We are setting up a segregated fund which will only be used to pay for this fight. If you want more information, contact us at admin@theita.com.
Thank you again for your continued support for this association and all we do. I will regularly update the membership on all developments.
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Old 01-13-2016, 07:29 PM   #2 (permalink)
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Re: ITA Update 1/12/16

For everyone that doesn't like to read long posts.....you MUST read the one above. Or shut your doors now and save yourself the trouble.
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Old 01-14-2016, 10:37 AM   #3 (permalink)
 
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Re: ITA Update 1/12/16

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Originally Posted by sunsally View Post
For everyone that doesn't like to read long posts.....you MUST read the one above. Or shut your doors now and save yourself the trouble.
At what point will we publically challenge the FDA on the validity of the science they claim to be relying on? People's current anger and distrust of government and politicians makes this a prime opportunity to expose the FDA for what it is - the most corrupt government regulatory agency in the history of the US. Why do we just let them lie to the public without refuting the bought and paid for research they use to back up their actions? What am I missing?
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Old 01-14-2016, 01:09 PM   #4 (permalink)
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Re: ITA Update 1/12/16

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At what point will we publically challenge the FDA on the validity of the science they claim to be relying on?
The comment period is public. Comments from our industry will be challenges to the FDA's position, comments from derms & sunscare people will be supportive of it.

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People's current anger and distrust of government and politicians makes this a prime opportunity to expose the FDA for what it is - the most corrupt government regulatory agency in the history of the US. Why do we just let them lie to the public without refuting the bought and paid for research they use to back up their actions?
How would this "exposure" happen and what would "exposing" the FDA accomplish? Would U.S. voters suddenly demand that their Congressional Reps and Senators support legislation to abolish or reform the FDA? Would U.S. voters demand that their Presidential candidate pledge to abolish or reform the FDA? Not likely.

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What am I missing?
Only the chance to influence the FDA's process.
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Old 01-14-2016, 01:29 PM   #5 (permalink)
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Re: ITA Update 1/12/16

Ken is correct. We have about 70 days left in the comment period. The ITA/ASA are hard at work preparing our response. Please feel free to contact me for more details.
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Old 01-14-2016, 06:26 PM   #6 (permalink)
 
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Re: ITA Update 1/12/16

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Originally Posted by Ken View Post
The comment period is public. Comments from our industry will be challenges to the FDA's position, comments from derms & sunscare people will be supportive of it.



How would this "exposure" happen and what would "exposing" the FDA accomplish? Would U.S. voters suddenly demand that their Congressional Reps and Senators support legislation to abolish or reform the FDA? Would U.S. voters demand that their Presidential candidate pledge to abolish or reform the FDA? Not likely.



Only the chance to influence the FDA's process.
FDA's decision is already made up so the process isn't even relevant. My point is that it's all about the public's perception of what is said during the 'process' and the headlines created afterwards which will be 'FDA Bans Teens From Indoor Tanning'. Tanya Tanner isn't savvy enough to understand what actually happened so she just decides that if the FDA says my daughter can't tan, then I shouldn't be doing it either.

My point is that we need to create our own headline that says 'FDA Process Controlled By Big Money'.
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Old 01-14-2016, 07:17 PM   #7 (permalink)
 
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Re: ITA Update 1/12/16

prime opportunity to expose the FDA for what it is - the most corrupt government regulatory agency in the history of the US.

They are exposed on a very regular basis by the natural health community,every day they are exposed.But the mainstream media is what controls the minds of most people.

They are exposed based on all sorts of bias.It is so obvious and off the charts how they operate as policemen for the pharmaceutical industry that it is no laughing matter.

So don't even think about that route.

Not to sound like a pessimist,but their maids are made up on this.Only in an actual court of law will truth be upheld on occasion,not the fda kangaroo court.

I still maintain that this is in direct response to the court case going .The FDA may have written and talked about this a long time ago,but decided to pull out this weapon and use it now.Because they know what the truth is and it is going to be told in a court of law.

I also still maintain that in a court of law,under oath,they will not find a single dermatologist to testify.Attorney's ,armed with the truth are not going to be friendly when questioning them.

When being questioned by the FDA,FTC ,AMA ,these derms only get friendly questions and are not under oath.Then when questioned by the FDA they have no problem ,stretching and twisting the answers to suit the moment.

In court,it is different.The long term goal is to prevent this from ever going to court again and giving the green light to all of the tyrants who like to attack us for their own financial gain.
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Old 01-14-2016, 09:35 PM   #8 (permalink)
 
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Re: ITA Update 1/12/16

Wonder how many on FDA panel , smoke, drink and do drugs. and follow the perfect life style? They have all the answers, but we have no rights to choose what is good or bad for us. MODERATION, is the key to any and all things we do.
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Old 01-15-2016, 01:30 PM   #9 (permalink)
 
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Re: ITA Update 1/12/16

Folks, as you can see from this recent Forbes article, big pharma and the derms have completed half of their goal. Are you aware that over 50% of us have closed our doors in the last 5 years? Interesting how the dramatic lack of competition hasnt helped many of us increase our yearly revenue. We still insist on calling our industry The Tanning Industry with Tanning Beds, instead of what we really are, a Sun Industry, with Sun Beds. Yet we wonder why we keep getting hammered from all sides. Just my opinion, but tanning just for the sake of getting a tan is an outdated, frowned upon, dumb activity. However going into a sun bed for all the benefits the sun provides and, in addition, looking better from the resulting healthy glow seems to me to be a more intelligent approach. But that's just me.
What does remain clear though, is that if we continue our "business as usual" approach, another 50% of us will be gone in less than another 5 years.

The Tanning Tax By the Numbers

According to the American Suntanning Association, nearly 10,000 tanning salons have closed since the tax went into effect. This has resulted in the loss of nearly 81,000 jobs, according to industry estimates.

Prior to Obamacare, there were over 18,000 tanning salons in America–now there are just over 8500.

Prior to Obamacare, over 164,000 people worked for tanning salons, including the self-employed proprietors. Now that number is down to 83,000, almost exactly half of what was there before.
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Old 01-15-2016, 03:42 PM   #10 (permalink)
 
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Re: ITA Update 1/12/16

We are allowing a government to regulate us, when we should have self regulated ages ago. We need to have licensed operators, but we don't.

We allowed the under 18 ban to happen, when there is sufficient scientific evidence that the elderly or the younger population are the ones who would benefit most from controlled Sun exposure.

We almost never ever see any marketing material or anything educational from our industry that shows no matter your race; you need Sun exposure during the winter. Do you think that if we were recognized as a place where everyone visited; like a gym; do you think then we would see growth for us? The irony behind the fact that those who are darker skinned would need Sun the most and most have never even thought about how important it is for them, let alone actually walk in to one of our stores, is surreal and hard to fathom. How we have left the largest piece of the pie away from us this whole time is clear evidence that we do not have any vision.

Our legal and constitutional rights have been, are being and will continue to be violated and we seriously can't do anything about it? There should be no compromise. None whatsoever. The fact that we are compromising with these people is just another blemish on those who are fighting for us and it makes it hard to support anyone if you don't agree with how they fight a battle that we as salon owners will have to deal with repercussions.

It's just an all around miserable situation to be in. Unbelievable.
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