The U.S. Food and Drug Administration proposed asserting its authority over new tobacco products on Thursday, including e-cigarettes, flavored cigars and nicotine gels.
It’s a basic first step, extending the FDA’s regulatory power, but the rule would immediately make e-cigarettes off-limits to kids under 18 and would require makers to tell the agency what’s in their products.
“They would have to report to us the constituents of their products and also how they are making them,” said FDA commissioner Dr. Margaret Hamburg.
But the agency does not propose, for now, limiting Internet sales or television advertising.
Congress gave FDA the authority to regulate tobacco products in 2009, but the law didn’t include e-cigarettes and certain other products. The legislation also does not allow FDA to ban tobacco products outright, but it can limit sales and marketing and require warning labels.
Click the link above or below to read the full article on NBCNews.com. These are the first officially official FDA regulations regarding vaping and ecigs. They are really hanging in there with the “we don’t know how safe they are” I think were all sick of hearing that song. From the looks of it. The FDA can’t ban them outright, but can limit sales / marketing and require warning labels. Pretty sure I just predicted this in one of my latest VLOG videos. All the cool and fancy labels. Those WILL be going away. Honestly as long as we can continue to vape. I don’t care about fancy labels.
Flavors such as strawberry and “thin mint” make it clear the products are being aimed at children, teens and young adults, Hamburg said.
Same old lame duck arguments. This is official people. The FDA is beginning to flex their regulatory power over ecigs for as they say
“We don’t know as much about the safety and risks of e-cigarettes and that is why we want to be able to regulate them,” Hamburg told NBC News.
-Grimm
::EDIT:: A word from Mr Greg Conely Via REDDIT
Two years after these regulations go into effect, any e-cigarette product then on the market containing nicotine or any e-cigarette product marketed to be used with nicotine will be BANNED if the manufacturer does not submit a costly application to the FDA. New products will not be permitted to enter the market without FDA approval. FDA is woefully and inadequately prepared to handle this.
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 with 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. http://www.gao.gov/assets/660/657451.pdf
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
Also see this snippet from a Lancet article (behind a paywall) by Dr. Lawrence Deyton, the former Director of the Center for Tobacco Products, in which the burden that will be put on e-cigarette and e-liquid companies is outlined:http://pastebin.com/5nGxZYac
This is bad news for e-cigarette consumers. 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.
Vapers should not only oppose this deeming regulation, but also support vendors that stick up for their businesses and consumers.
(Going to edit this post a bit with some links as the night goes on)
~ Gregory J. Conley, JD, MBA Twitter: @GregTHR Bio: http://heartland.org/greg-conley