Articles & Discussions about the FDA ecig rules - The community needs to come together now more then ever

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badkolo

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JoanJ

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zoiDman

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The Full Regulations have Not been Finalized. What people are seeing Today is just an Opening Salvo.


“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for tobacco Products.

He said Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, adding, “It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”

http://www.washingtonpost.com/natio...7c8684-ca39-11e3-93eb-6c0037dde2ad_story.html
 

badkolo

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As stated previously, we understand that,
for some products, there may not be predicate products that were on the market as of February
15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes
and similar novel products. For this reason, we are proposing that these manufacturers who
cannot use the SE pathway submit PMTAs to FDA no later than 24 months following the
effective date of the final rule. We are also proposing a 24-month compliance period for the
submission of SE reports. Therefore, FDA does not intend to initiate enforcement action against
products on the market for failing to have made an appropriate submission until 24 months
following the effective date of the final rule. If a manufacturer submits a PMTA or SE
application for its affected products within the 24-month time frame, FDA does not intend to
initiate action against those products for failing to have a marketing authorization unless and
until such a time as we have responded to the application.


manufactureres have 2 years form ruling to register products form 2007 on, that wont happen for another year or 2 then they have 2 years to do so, so we are looking at 3 to 4 years before any impact will happen with devices. They need to register the product and they will not stop sales of those products until after the 24 month period if they havent registered it.
 

zoiDman

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I don't think the Battle is going to be Waged over the Hardware side of e-Cigarettes.

Put a 510 thread on an LED and Every Mod can be Sold as a "Flashlight". And who can say that an RBA or Clearo is not going to used to Vaporize 0mg.

Heck... There is a Huge Market for Vaporizers that are used to Inhale a Substance that is Illegal in Most States. But people don't have any Problems buying them. And e-Cigarettes are Not going to be Illegal.

Where the Regulations are going to Effect People is Liquid e-liquids purchased over the Internet. Doing DIY Only works if a person can buy Liquid Nicotine Base.
 
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