Thursday, April 24

BREAKING: FDA TO RELEASE THEIR REGULATIONS (UPDATED 2:55PM)






Greg  Conley announced that the FDA will formally announce their deeming regulations tomorrow (Thursday). They are setting the framework for future regulation.


Excerpt:

" WASHINGTON — The Food and Drug Administration plans to begin regulating electronic cigarettes for the first time, banning sales to minors and requiring manufacturers to put health warnings on the nicotine-delivering devices that have become a multibillion-dollar industry, according to officials who described the agency's proposal.

But the agency will stop short of steps that many public health advocates and some members of Congress have called for, including restrictions on television advertisements and flavorings, such as pumpkin spice or chocolate, that may target younger consumers, officials said. The agency plans to announce the new rule Thursday.

Regulators do not yet have scientific evidence for a rule on flavorings, but the subject is still being researched, Mitchell Zeller, director of the FDA's Center for Tobacco Products, told reporters.
"There are far more questions than answers," he said, adding that the new regulation would provide a "framework" for additional rules in the future.

Even without restrictions on advertising or flavorings, the new rule represents a "significant step in the agency's ability to regulate tobacco products," Zeller said. "I call the market for e-cigarettes the wild, wild West in the absence of regulations."


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UPDATE 5:01 AM

From Gregory Conley

This is NOT good news and vendors and vapers should vehemently OPPOSE these regulations, as they will work to the benefit of large tobacco and e-cigarette companies will Wall Street investors that don't make the products used by 98% of this subreddit's users, while potentially shutting down hundreds or thousands of small and medium-sized businesses thanks to an extremely expensive, resource-heavy, and arbitrary system setup by the Family Smoking Prevention & Tobacco Control Act.


This is actually worse than I expected.
Two years after the regulation is written, e-cigarette companies will have to put in 'new tobacco product' applications for any product released to the market after February 25, 2007.* This is not mere registration. This is a lengthy and expensive process. If you don't file an application, your product is banned. If you file an application and the FDA finds that your product shouldn't be on the market for one of a variety of reasons (including their favorite, 'You failed to submit adequate evidence of x, y, and z.'), it can be pulled from the market.
After that 2 year date, any new e-cigarette product must be approved by the FDA before it goes to market. If the FDA does not approve your product, it cannot be brought to market. This is not a fast process, as evidenced by a Government Accountability Office report that was highly critical of huge delays that were and still are happening at the FDA Center for Tobacco Products.
For just a sample of what a "new tobacco product" application is like, see here. This a document from when the FDA refused to even file (let alone approve) four "new tobacco product" applications : http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf


This is bad news for e-cigarette cosumers. The chance of a flavor ban or an online sales ban from the start was never really an option. This prospect was here all along and is not positive.
There is also something called "substantial equivalence" which is a smaller, but still expensive, loop to jump through. However, FDA guidance on substantial equivalence, and their past decisions on other applications, indicate that it would be a fruitless effort to prove substantial equivalence for a 2016 e-cig product vs. a 2007 product.



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UPDATE 5:20 AM

Former CASAA Lawyer Greg Conley will be coming on Mod Envy this Saturday to explain the FDA regulations.



UPDATE 10:00 PM

Complete Regulations can be found HERE



UPDATE 2:24 PM

 






UPDATE 2:50PM

So whats my take on all this?
 

Well it was coming and could have been a lot worse.  Right now we have about 2.5 years before the shit hits the fan.  About 3-5 months for implementation and 2 years for enforcement to take place. This without any challenges in court.  I have a lot of questions about what happens after the 2.5 year mark and my hope is Greg Conley will be able to shed some light on them - this Saturday on Mod Envy.


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