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Old 03-01-2016, 04:42 PM   #1 (permalink)
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Arrow Help us with the FDA

March 1, 2016
Attention Indoor Tanning Industry ¿ Help Fight FDA¿s Proposed Additional Restrictions on Indoor Tanning
On December 22, 2015 the FDA issued two proposed rules both of which could have a significant impact on the indoor tanning industry for years to come.
The Indoor Tanning Association will submit extensive comments on behalf of the industry. Because this directly affects your business and your livelihood, the FDA needs to hear from you as well.

Proposed Rule: Restrictions on Sale, Distribution, and Use of Sunlamp Products
• Ban on use by anyone under the age of 18.
• Require customers to sign a consent (risk acknowledgement certification) form every 6 months acknowledging the risks.
• Additional warnings on all advertising (website, printed, in-store) including retail to customer which the FDA would have the authority to oversee.
Please follow the link to FDA website and use the following bullet points below to your voice your opposition to the proposed rule. Once you are on the FDA¿s page cut and paste the bullets or submit your individual comments.
http://www.regulations.gov/#!submitC...15-N-1765-0001

• My business already requires written parental consent for customers under age 18. This is a decision for parents, not government.
• Parents of teens already have adequate information about the risks of over-exposure.
• Requiring risk acknowledgement certification or signed consent every six months is unnecessary and a burden on the customer and business. There are already multiple warnings about the potential risks of over-exposure.
• There is no scientific justification for restricting suntanning. The risks have been exaggerated and the benefits ignored.
• This is another overreach of government that will do nothing to protect public health, in fact it may harm it. People are already afraid to go outside due to the constant harping about skin cancer.

Proposed Rule: Sunlamp Product Performance Standards
• New warning label
o Only two skin types -- I&II
o 20 minute timer max for all sunbeds
• Harmonizes US regulations with some IEC (international) standards including recommending 48 hours between tanning sessions
• Revised recommended exposure schedule
o Recommending limiting tanning to only twice a week.
o Recommending an annual exposure limit based on no more than six courses annually of eight sessions (maximum of 48 sessions annually)
Status of equipment already in the field ¿ the proposed rule does not address this question which could create an enormous problem. -- If the FDA does not grandfather existing equipment, all beds not certified under the new regulations could be illegal after the implementation date. Thus, businesses would be dependent on the manufacturer to recertify a bed line or the business would have to purchase new equipment.
Please use the following link to Federal Register and bullet points below to your voice your opposition to the proposed rule. Once you are on the FDA¿s page cut and paste the bullets or submit your individual comments.
https://www.federalregister.gov/arti...v#open-comment
• The FDA must make it clear that existing equipment is grandfathered.
• The industry is already heavily regulated at the Federal and State level.
• There is no scientific justification for restricting suntanning. The risks have been exaggerated and the benefits ignored.
• This is another overreach of government that will do nothing to protect public health, in fact it may harm it. People are already afraid to go outside due to the constant harping about skin cancer.
• Existing regulations have been more than adequate to protect the public.
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Last edited by Robert K; 03-02-2016 at 07:32 AM.
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Old 03-01-2016, 07:26 PM   #2 (permalink)
 
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Re: Help us with the FDA

Did tanning salons at one time not have the most enviable track record in respect to everything the FDA oversees?

How about pharmaceutical drugs?Is the FDA planning on having everyone who pics up a prescription sign an acknowledgement that over 100,000 people die every year in the USA from PROPERLY PRESCRIBED DRUGS?

I kinda doubt it.But they will go after the product with the most enviable track record they have ever seen


I believe it was less than one complaint per 1,000,000 sessions!
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Old 03-21-2016, 08:00 AM   #3 (permalink)
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Re: Help us with the FDA

Today is the final day to submit comments. Take 10 minutes out of your day and help your business and industry.
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