Thursday, June 12, 2025
  • Home
  • About
  • Contact
  • Advertising Information
  • Subscribe
  • ist Live
ist Magazine
  • Home
  • Columns
    • ASA News
    • Ask Wolff
    • Epic Sales
    • Ergoline Focus
    • Eye to Eye
    • Lamp Talk with Leif
    • Lync IT
    • Notes from the Road
    • Trending @DevotedCreations
    • UK View
    • Monthly Motivation
  • Features

    Letter From The Publisher – March 2025

    SunCatchers, Boutique – Sun – Spa | Phenix City, AL

    Shining a Light: My Experience at the Heartland Tanning VIBE Expo

    sunbed

    Compliance Reliance

    sunbed

    Peak Season 2025 Success: Proven Strategies to Boost Profits

  • Health
    • All
    • Health Newsletter
    • Nutrition Corner
    red light therapy

    The Science of Light: Why It’s the Next Big Thing in Wellness

    “Love The Skin You’re In”

    3 Ways to Keep Your Bones Healthy & Strong

    The Truth About Retinol Confirmed by a Dermatologist

  • News
    • All
    • In The News
    • Industry Happenings
    • News Extra
    • Special Interest
    linked in as a sales platform

    The Rise of Short-Form Content on LinkedIn: A Game Changer for Business Growth

    Dmitry Tsvetkov / stock.adobe.com

    Revolutionizing The Industry: Why Tanning Is The New Full-Body Skincare

    heartland tan

    Talking About Heartland Tan’s January 2025 VIBE Event 

    IST Industry Choice Awards Winners 2024

    IST Industry Choice Awards Winners 2024

  • Spotlight
    tanned smiling woman teeth

    PSA: Delivering Bronze Skin Is Not Enough Anymore

    April 6, 2025
    glo tanning arkansas paragould

    Glo Tanning: New Salon Opening Spotlight

    April 4, 2025
    When focus flows, energy goes

    “Where Focus Goes Energy Flows”

    April 1, 2025
    The Secrets of Visionary Thinkers: 10 Rules For Brainstorming Success

    Warren Buffett Hates EBITDA. Here’s Why You Should Too

    March 18, 2025
    salon of distinction

    Salon of Distinction: Bear Naked Tanning

    March 17, 2025
    jchizhe / stock.adobe.com

    Keep It Simple Sales – K.I.S.S.

    March 17, 2025
  • Resources
    • Industry Links
    • Sun is Life
  • Lamp Talk
  • Digital Edition
No Result
View All Result
ist Magazine
  • Home
  • Columns
    • ASA News
    • Ask Wolff
    • Epic Sales
    • Ergoline Focus
    • Eye to Eye
    • Lamp Talk with Leif
    • Lync IT
    • Notes from the Road
    • Trending @DevotedCreations
    • UK View
    • Monthly Motivation
  • Features

    Letter From The Publisher – March 2025

    SunCatchers, Boutique – Sun – Spa | Phenix City, AL

    Shining a Light: My Experience at the Heartland Tanning VIBE Expo

    sunbed

    Compliance Reliance

    sunbed

    Peak Season 2025 Success: Proven Strategies to Boost Profits

  • Health
    • All
    • Health Newsletter
    • Nutrition Corner
    red light therapy

    The Science of Light: Why It’s the Next Big Thing in Wellness

    “Love The Skin You’re In”

    3 Ways to Keep Your Bones Healthy & Strong

    The Truth About Retinol Confirmed by a Dermatologist

  • News
    • All
    • In The News
    • Industry Happenings
    • News Extra
    • Special Interest
    linked in as a sales platform

    The Rise of Short-Form Content on LinkedIn: A Game Changer for Business Growth

    Dmitry Tsvetkov / stock.adobe.com

    Revolutionizing The Industry: Why Tanning Is The New Full-Body Skincare

    heartland tan

    Talking About Heartland Tan’s January 2025 VIBE Event 

    IST Industry Choice Awards Winners 2024

    IST Industry Choice Awards Winners 2024

  • Spotlight
    tanned smiling woman teeth

    PSA: Delivering Bronze Skin Is Not Enough Anymore

    April 6, 2025
    glo tanning arkansas paragould

    Glo Tanning: New Salon Opening Spotlight

    April 4, 2025
    When focus flows, energy goes

    “Where Focus Goes Energy Flows”

    April 1, 2025
    The Secrets of Visionary Thinkers: 10 Rules For Brainstorming Success

    Warren Buffett Hates EBITDA. Here’s Why You Should Too

    March 18, 2025
    salon of distinction

    Salon of Distinction: Bear Naked Tanning

    March 17, 2025
    jchizhe / stock.adobe.com

    Keep It Simple Sales – K.I.S.S.

    March 17, 2025
  • Resources
    • Industry Links
    • Sun is Life
  • Lamp Talk
  • Digital Edition
No Result
View All Result
ist Magazine
No Result
View All Result
Home Columns ITA Update

Join the Cause! ITA Prepares Response to FDA

John P. Ribner by John P. Ribner
July 1, 2013
in ITA Update
Reading Time: 2 mins read
0
0
SHARES
0
VIEWS
Share on FacebookShare on Tweeter

The Indoor Tanning Association has a plan to fight the biggest battle this industry has ever faced. The only question is, are you ready to help?

The ITA is preparing its response to the Food and Drug Administration regarding proposed tanning equipment reclassification – 510(k) – announced May 6. If passed, this would have far-reaching impact upon the industry, which is why the ITA is urging everyone to get involved. “The FDA’s proposal is open for public comment for 90 days,” said John Overstreet, ITA Executive Director. “After that, the agency will review all comments before final recommendations are issued. We know that the number of comments matters because the FDA has said as much, so we encourage everyone to get involved. Business owners needing assistance are urged to contact us and we will walk them through the process.”

You might also like

ITA Update: A Fond Farewell

ITA Update
Obamacare Repeal and Replace In Stall Mode

Obamacare Repeal and Replace: Promising News for Salons

Among the concerns raised in the ITA’s response is the cost that 510(k) will pose to tanning equipment manufacturers. “The FDA would require a substantial amount of pre-market testing, and it would be very expensive for manufacturers to comply with the testing and submission requirements,” Overstreet said. “These costs would also likely be pushed down to the tanning salons, which are small businesses located throughout 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 pre-market review process, and would likely lead to substantial delays in introducing new products to the market.”

The ITA is concerned about the length of time for approval involved in the 510(k) process. “The proposed order gives manufacturers just one year to get products approved, and there is great concern that this is insufficient,” Overstreet said. “We’re also concerned about replacement lamps, as the proposed order is not clear regarding how sunlamps will be approved for replacement. Also, who is responsible for approval and labeling of equipment already in service, and discontinued equipment and sunlamps? These are questions that need to be addressed by the FDA.”

On May 6, the FDA announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices. If the order is finalized, manufacturers would have to submit to the FDA a pre-market notification (510(k)) for these products, which are currently exempt from any pre-market review. 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.

As the ITA continues to prepare its response to the FDA, the organization encourages members of every tanning industry sector to register their concerns to the FDA. To help prepare for the biggest battle this industry has ever faced, contact the organization – your industry organization – and ask how you can help.

Previous Post

The Salon Whisperer Knows What You Need… A LEGENDARY BASH!

Next Post

ITA Board Meeting Focuses on FDA Administrative Order

John P. Ribner

John P. Ribner

A 14-year industry veteran, John "Ribby" Ribner has written hundreds of articles for IST Magazine and, as Director of Editorial Content, has also helped guide the publication's evolution. Ribby is a graduate of Central Michigan University's journalism program and has brought many years of newspaper reporting experience to his position of Head Writer. He is also the author of three novels, "Legacy of the Bear," "Prophecy of the Bear" and "World So Dark."

Related Posts

FDA’s Proposed Rules for Indoor Tanning
ITA Update

ITA Update: A Fond Farewell

by John Overstreet
August 1, 2017
FDA’s Proposed Rules for Indoor Tanning
ITA Update

ITA Update
Obamacare Repeal and Replace In Stall Mode

by John Overstreet
July 1, 2017
FDA’s Proposed Rules for Indoor Tanning
ITA Update

Obamacare Repeal and Replace: Promising News for Salons

by John Overstreet
June 1, 2017
ITA Update
ITA Update

Executive Director’s Report: What is to Become of the Tan Tax?

by John Overstreet
May 1, 2017
ITA Update
ITA Update

Trump’s Regulatory Freeze and Sunlamp Products … continued

by John Overstreet
April 3, 2017
Next Post

ITA Board Meeting Focuses on FDA Administrative Order

Recommended

IST June 2025 Cover

June 2025 – IST Digital Edition

June 2, 2025
Ist-may-2025 cover

May 2025 – IST Digital Edition

May 5, 2025
credit cards stacked on each other

Planning For Trouble With Merchant Advances

April 7, 2025
IST april 2025 cover

April 2025 – IST Magazine Digital Edition

April 7, 2025

Popular Posts

  • The Heat Is On Sun Protection Lotions

    10 Tips To Abolish Raccoon Eyes

    0 shares
    Share 0 Tweet 0
  • Peak Season 2025 Success: Proven Strategies to Boost Profits

    0 shares
    Share 0 Tweet 0
  • A TOWEL IS NOT ENOUGH!

    0 shares
    Share 0 Tweet 0
  • Four Seasons National Tanning Expo
    A Sign of a Great 2024!

    0 shares
    Share 0 Tweet 0
  • Let’s Talk About Stripes, White Patches & White Spots.

    0 shares
    Share 0 Tweet 0

Don't Miss It

IST June 2025 Cover
Digital Edition

June 2025 – IST Digital Edition

June 2, 2025
Ist-may-2025 cover
Digital Edition

May 2025 – IST Digital Edition

May 5, 2025
credit cards stacked on each other
Epic Sales

Planning For Trouble With Merchant Advances

April 7, 2025
IST april 2025 cover
Digital Edition

April 2025 – IST Magazine Digital Edition

April 7, 2025

IST Magazine is the premiere, multi-award-winning business-to-business publication for the indoor tanning industry, providing valuable business articles and industry information in a fun, professional format.

Information

  • Advertising Information
  • Contact
  • Copyright Policy
  • Privacy Policy
  • Subscribe
  • Terms of Use

Categories

  • Columns
  • Features
  • Health
  • News
  • Spotlight
  • Digital Edition

© 2024 ist Magazine.

No Result
View All Result
  • Home
  • Columns
    • ASA News
    • Ask Wolff
    • Epic Sales
    • Ergoline Focus
    • Eye to Eye
    • Lamp Talk with Leif
    • Lync IT
    • Notes from the Road
    • Trending @DevotedCreations
    • UK View
    • Monthly Motivation
  • Features
  • Health
  • News
  • Spotlight
  • Resources
    • Industry Links
    • Sun is Life
  • Lamp Talk
  • Digital Edition

© 2024 ist Magazine.