510(k) Requirements by the FDA

ITA’s Response to the FDA Administrative Order

            As everyone is certainly aware, in early May the FDA issued an Administrative Order reclassifying ultraviolet lamps for tanning to a class II medical device. If this order is approved, it could have a significant negative impact on your business.

            The ITA is planning a comprehensive response. We will address a number of major issues including the following.

The Economic Impact will be harmful to small business:

• The 510(k) requirement proposed by FDA would have a severe negative economic impact on thousands of small businesses nationwide. FDA is proposing to impose 510(k) notification requirements on sunlamp product manufacturers that are very detailed and would require a substantial amount of premarket testing.  It would be very expensive for manufacturers to comply with these testing and submission requirements, and these costs would also likely be passed onto the tanning salons that are small businesses located around the country.  In addition, the requirement for FDA review of a 510(k) would be especially burdensome for companies that have no experience with the medical device premarket review process, and would likely lead to substantial delays in introducing new products to the market.”
• FDA already faces a significant backlog of 510(k) applications.  The proposed order would require manufacturers to secure 510(k) premarket notifications for all products within one year of the proposed order’s effective date. The industry is very concerned about delays by the agency to clear 510(k) submissions and the impact this would have on the industry and small businesses nationwide.
• The FDA’s proposed order calls into question the viability of products already in the marketplace and the substantial investments in those products.  The proposed order provides that products already in the marketplace must cease being marketed if the manufacturer does not submit a 510(k) within one year of the effective date of the final order.  The industry is very concerned about the future status of products that are already in the market for which the manufacturer is no longer in business or for which it is not economically viable for the manufacturer to incur the costs associated with filing a 510(k) notice.

The Entire Industry has to Weigh In and oppose this order!

            We know from recent statements made by the FDA that the number of comments filed has an impact on the FDA’s final decision.  We also know that the American Academy of Dermatology and other anti-tanning lobbying groups are mounting an aggressive campaign to get their members to generate comments to the FDA in support of the order.  This is a link to the AAD campaign website: click here.

Please join us and contact the FDA to oppose the proposed order!

• Click here to access a template that you can use to customize your comments.
• Click here to access filing instructions.

            Please focus your remarks on the negative economic impact that reclassification would have on you personally and talk about how this change could affect your business and livelihood.  Please use the issues outlined above and apply them to your business.  For example:

• The order is vague regarding equipment already in the field, potentially making it illegal and requiring you to replace much or all of your equipment.
• The order adds great expense for companies bringing new products to market adding additional costs for you and your customers.
• The vagueness of the order related to lamp replacement could make lamp replacement cost prohibitive.
• The industry is already struggling in the recession and as a result of the 10% excise tax being imposed on tanning services.  This change will push many small businesses over the edge.

           Comments are due by August 7. Please don’t delay! Remember, FDA’s final decision likely will be influenced by the number of comments filed by members of our association and within our industry.

            Please send the ITA a copy of the comments you submit to the FDA. If you have any question or need assistance, please contact the ITA (admin@theita.com) or call (202) 367-1142.

List Your Salon with us Today!

We all know the importance of getting links built for our websites with others and that is why we give salons the chance to build through our online salon directory at www.SunlessTanMasters.com/tanning/directory

So we hope you will take a moment to feel out our form and submit your salon business today!

Spray Tanning in 2013. What New?

New for 2013! We are in March and even though we sale a lot of equipment this time of year, our tanning solutions and the stock items are still a big focus of ours. To get the perfect spray tan we depend just as much on them as we do our equipment’s. So our focus is being able to offer them at the best prices and the best value packages to make every purchase count.

Since this is the busiest time of year for us and you, we write this short article to update ourselves on new changes and remember where we were one year ago. If you would like to see the article from 2012 please check out our blog at Sprayontans.info or look at our post on Face Book, March 15^th 2012.

We have new specials on our tanning solutions. The new collection of 2012, the tan essentials was introduced to us and right now you can buy any one 32oz liter and get your chose of the 2^nd bottle half off.  Also in the Tampa Bay collection you can get any 128oz gallon and the second half off if you’re looking to stock heavy for your salons.

Our disposable wear packages have not changed much this year. We have lowered the price of them some but they are still the same package designs. Many of our customers have enjoyed them the last year and we saw no way to make them really better than they already are.

More popular options in colors have been produced and our sales of these items have moved up. We have introduced the new turquoise pop up tents and hope new color option will be available for them soon. Tan Essentials has them Glam Collection in the turbine machine in four colors and the Maxi Mist still has the Gemstone collection in five colors. Both have been reduced in price which may account for them becoming a little more popular.

Maxi –Mist spray tanning equipment has gone under a new upgrade. Their new designs are being released this month. Maxi-mist likes to update their equipment every year and they always do a really great job. Their spray guns are remaining the same, and their turbines are getting a new design. They are even updating the names of them to the Maxi-Mist Evolution.

The Tan Essential was introducing in the US in 2012. They have been a really great new brand and have an affordable price to go with it. There sales almost out did Maxi-Mist in 2012 but remained just a tad behind. Their company has been a pleasure working with us and our customers to help solve any problem that has arise. We look forward to helping them build more here in the United States.

Even though Turbine Machines are the most popular right now in the spray tanning industry, we would like to encourage our followers to take more consideration in an Airbrush System.  We have been working with Iwata, Paasche, and Badger companies for over 7 years now and we here know the values of having these types of equipment’s over turbines in our salons. These companies have done serious updates and are being overlooked on their high performance, over faster tanning with larger spray guns at lower prices. Airbrush offers so much more in services with nails, tattoo, and the growing popularity of airbrush makeup. These are manufacturers right here in the United States working hard for us and we should take more considerations on some of the great products they have available. Their equipment is some of the best and their systems have not changed much in the past few years, but why fix something that is not broken. If you’re looking to offer the ultimate spray tan services, then you should be considering Airbrush Equipment.

We have also lodged our third and final website Spray Tan Essentials at www.spraytanessentials.com Each of all our websites have different features and this one has all of our spray tanning products but also carries a full line of products available from private labeling in your salons. Bath and body supplies in lotions, scrubs, conditioners, and so much more can be purchased in bulk at wholesale prices. We are also about to launch where you can buy sunless tanning products in private labeling for your businesses. There are also Body wrap supplies and equipment for salons if interested in learning more on that, then please check the website out.

Another feature we have added is the financing options for purchases over ninety-nine dollars. The program is sponsored by Pay Pal’s bill me later services so you know it is a trusted merchant to work with. We hope this will be able to help many of the small businesses we work with in getting what they need when they need it.

To finish with, we look forward to another year of sunless tanning and teaching others the benefits of spray on tans. We have changed and so have you and we looked forward to another year of connecting, learning, and building within the tanning industry and to be able to do that with you.

Get your Salon Featured on our blog!

We are wanting to start featuring salons on our blog by writing a short article about them and how their businesses are special. Links will be provided to your websites and or face book pages so people may read more about your company.

We are hoping that this will be in some small way beneficial to your business and can also help us build more into our blogs information resources for the future.To see more information check out our page, " Tell us about Your Salon" in the right page list.

You can find the form to get started at our website Spray Tan Essentials. Here is the link.
http://www.spraytanessentials.com/aboutsalons

Please submit to some new Surveys

We have posted some new surveys for 2013, so we can better understand you as a customer.  Our goal is to learn more of what you like and be able to keep better track of it within our system.  So it is important to have you interact with us more and vote for what you like. All the surveys are set up to show you the results of others who have voted so you may see what others are doing also.

Hope you like them and can help us out.

New Specials on Spray Tanning Solutions

We try to bring you some great specials here and there throughout the year.  Since this is the time many of you like to stock up on supplies and solutions, we are running a special on some of popular brands in gallons.  Check them out under our Discounts & Specials Tab at the top of your screen.

We have also finally been abe to bring back our amazon checkout.  It was taken off at the end of last year due to our system was doing an upgrade and a feature within that program was not working correctly. NOW, everything is back and running and we know are glad to welcome back our amazon customers.

You may also be seeing better deals on our disposable items and larger packages. Our suppliers have really worked with us to be able to bring better pricing and a better product to all of you. Please contact us if you have any questions regarding these items.

And Finally, a new collection of tanning solutions have come our way this month. The Tanning Essentials Collection of spray tan solutions is a wonderful high quality product that gives excellent results. The brands covered are the ever popular organic blends of Celestial Tan, and Focus. And lets not leave out the LiquidSun and That's So blends that are also organic blends.

So much is going on and happening right now for many of our Salon owners across the nation. We are here to help by phone or email support whenever you may need. We may still be small but we are growing and it is because of great customers like you who make us a success. So please keep your feedbacks coming and we will keep on improving in our services to make things more easy for you all. With shout of Good Luck, we wish you all the best.

20 Years of Tanning Bed Use.

Patricia Krentcil, also known as the ''The Tanning Mom" has reformed and is no longer using the UV Light tanning beds to get her tan.  She has been seeking professional help to deal with her excessive tanning disorder also known as Tanerexcia, and we wish her well in her quest. Patricia Krentcil became famous in 2012 for the allegations (never proven) of letting her 5 year old tan within a tanning bed which ended up producing burns on the child.

This last year, many of us has looked to Patricia and judged her for what she has done to herself, but she is not alone with her disorder. Tanning salons all across the board have seen the effect 1st hand of over tanerexcia with UV lights. It has been happening for a long time now, and I feel that Patricia has brought this more into light for our industry. Many of you may have had the discussion with a client or two over excessive tanning and possible have recommend some safe alternatives or skin treatments for these clients. If you haven't before spoken up to them, please do mention some of your concerns to them and let them know you are thinking of there health. In the end it is the clients decision if they change there methods or not, but I do think you will get some brownie points for being concerned for them.

As many of you know, tanning effects our skin. The more we tan the more we harm ourselves in health and our skin as we grow older. It is important to remember the #1 rule in tanning and that is to moisturize, moisturize, moisturize. Hydrating our skin while tanning helps our body heal and except the tan more. It doesn't matter what type of tanning method you use, The sun, UV lights and even sunless tanning. Our skincare is #1 not the tan.  We encourage salons not to focus on just tanning products within there businesses but to look at skin care treatment and regiments that your clients may be interested in. Lotions, creams, mud mask, body wraps, mineral treatments, there are so many to choose from that can help keep our skin healthy while tanning. Offer them as retail items for purchase or start offering the services yourself and bring in extra income. Many larger salons already offer these types of treatments and even have the hydration booths.

Many women are taken more of a roll with their skin care regiments like Patricia Krentcil who is seeking new skin treatments and her skin is already starting to improve. It is never to late to start caring for your skin no matter what the damage may be. UV Tanning has come a long ways in the last 20 years and so have the people who have used these services.  We all have learned a lot and we still are learning new things to this day.

Tanerexcia is something we should all look into and learn more about. It is like most any other additions we have and we encourage you to learn more on the subject.  Included is a link to Wikipedia about tanning additions.

Let's Start Promoting our Business!

You are all keeping us busy here in Alabama working hard to get out your supplies, so we know you are all busy bees to! Our orders are going out faster than ever before and many of you getting your supplies within a weeks time. This is because we and our suppliers and manufacturers have all set new standards for our companies are working harder to achieve them. All the companies we deal with are long standing suppliers and WE understand the demand you have to get your supplies as needed. So rest assure you can count on us to not only help you find the right equipment and supplies, you will also be getting them faster than before.

As we have notice the last few weeks, many of you are stocking up on tanning solutions and retail products for your salon. This is why we have some special promotional items right now at great discounts. You must check them out at DISCOUNTS & SPECIALS on our website.

So now, let's talk about Promoting! You have it goin on right now and NOW is a perfect time to promote your services. A spray tan package always get a customers attention.  Something simple and easy to explain like "Special of the Month! Spray Tan a Week.''  Hang a sign out front of your salon to get their attention even more.

Which brings me to the second marketing tool you should consider. Signage and posters, flyers and any other type of print item you can think of. Put a small poster in rooms with tanning beds or around your salon or spa. As your customers come in daily and see these items, they become more curious and will more than likely ask about your spray tan services.

We have added items to our MARKETING MATERIALS with many free downloads you can print right from your home. Investing in marketing can get expensive at times and sometimes we might be running low on our supplies. These free downloads can help in a pinch so please download whatever you may like. Some can be edited and you can add your own business information with simple word programs. And other are in pdf documents that can be opened with simple Adobe readers.

I know this may seem shorter than my other blast outs, but I'm a little tired right now from working hard for all of you today. I'll be back tomorrow doing what I love and that is talking with all of you teaching, learning, and being a partner as well as a friend. So until we speak again, Good Luck!