Laws And Regulations News

FDA Regulations Are Out– Here’s What You Can Do

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On May 5th, 2016, the FDA announced their deeming rule on other tobacco products, including e-cigarettes, and the news for the vaping community has unfortunately not been good. Just as expected by many insiders, the FDA has introduced regulations that will greatly affect the industry and force several American e-cigarette and e-liquid companies to close their doors.

 

Main Points of the Deeming Affecting E-Cigarettes

  1. Restriction of Sale to Minors – E-cigarette and e-liquid sales will be prohibited to anyone under the age of 18 in any of the 50 United States.
  2. Premarket Authorization – There is more than one path to market authorization, however almost all e-cigarette devices will be forced to submit the PMTA to be in compliance, a lengthy piece of paperwork that requires extensive research and costs an estimated $330,000 to complete. The PMTA would need to be completed for each product sold, that includes both devices and e-liquids. The manufacturers have 24 months from the effective regulation date to submit their PMTA and have it approved to continue selling their products on the market.
  3. Modified Risk Claims – E-cigarette companies will not be able to claim any potential health benefits or consider e-cigarettes a cessation device. They will not be able to refer to a product as tobacco-free or smoke-free and cannot address how vapor is safer than smoking in any way.
  4. Potential Harmful Aerosol Constituents – Three years after the effective regulation date, companies will have to produce testing results for any even potentially harmful constituents in their vapor. The testing is costly and would need to be performed for each flavor and nicotine level combination, causing an expensive and time-consuming task for e-liquid companies especially.
  5. Warning Labels – E-cigarette and e-liquid manufacturers will be required to place FDA approved warning labels on all packaging.

 

What Does All This Mean for Vapers?

Right now, nothing. There is no reason to panic at this moment, nothing will be off the market today, tomorrow or next week. These are the deemings and the FDA expects for them to be effective in August—after that it is 2 years before products will have to submit their applications to be approved, it could be even another year after that before the FDA can approve or reject the application. During that time, your favorite products, as long as the manufacturers keep providing them, will be available.It’s also important to remember that this is affecting USA-based manufacturers, and while many of our favorite products are made in the US, there are several great companies and products based in the UK, in Canada, indeed all over the world, that will still have their products available, so your favorite e-juice or device could always easily be available to you online.  Some of your favorite companies that are USA based will also be working hard to be in compliance, so with hope and good luck, they will be available still too. The FDA has yet to announce, but they may also restrict certain flavors, which would greatly affect the selection of e-juices on the market even more.

The saddest thing is because of the intensity of premarket authorization, these deemings almost certainly mean that smaller companies will be forced out of business– if there are not changes made.

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What Do I Do?

Don’t panic, but don’t be idle, if you like a variety of devices and e-liquids contact your congressional representative now. The most specific way to help is to support the “Cole” Bill, HR 2058. Visit the CAASA Website for information on how to contact representatives and spread the word. Share this information on social media too—let it spread like wildfire.

Remember to stay informed, you can read the full deeming from the FDA here.

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