“According to this revised compliance policy, for newly deemed products that are on the
market on the effective date of this final rule and were not on the market on February 15, 2007,
FDA is providing a 12-month initial compliance period for manufacturers to submit (and FDA to
receive) an SE exemption request, an 18-month initial compliance period for manufacturers to
submit (and FDA to receive) SE applications, and a 24-month initial compliance period for
manufacturers to submit (and FDA to receive) a PMTA.”
“To facilitate the determination that a product is eligible to serve as a valid predicate, any
individual who has evidence that an e-cigarette or other ENDS was commercially marketed in
the United States on February 15, 2007, may submit a stand-alone grandfather submission to
FDA (See final guidance, “Establishing That a Tobacco Product Was Commercially Marketed in
the United States as of February 15, 2007” (79 FR 58358, September 29, 2014)).”
So, if you know something about a particular product, submit an application
ENDS = Electronic Nicotine Delivery System, or in other words, current generation mods, tanks, atomizers, etc.
“Vape Establishments Acting as Manufacturers–Several comments asked FDA to clarify
whether e-cigarette retail stores and vape establishments are considered “tobacco product
manufacturers” under the FD&C Act. In response, FDA has explained that establishments that
mix or prepare e-liquids or create or modify aerosolizing apparatus for direct sale to consumers
are tobacco product manufacturers under the definition set forth in the FD&C Act and,
accordingly, are subject to the same legal requirements that apply to other tobacco product
manufacturers.”
It’s crazy enough that they’re regulating e-liquid as a tobacco product; but they’re also regulating our HARDWARE as a tobacco product, which is ridiculous. It would be like the USDA regulating cereal bowls as a grain product.
So it begins.
It looks like BIG TOBACCO and BIG PHARMA win and convinced our elected officials to SUCK on something other than a cigarette or cigar… err…
Don’t be too put off, this will be creating a huge opportunity for ahem… “Free Enterprise”
“Smuggler’s Blues” playing in the background.
I hope everybody is well stocked in nicotine and gadgets to get them through. I know I am.
That’s the world we live in. Where Big tobacco and Big Pharma are allowed bully in completely illegal ‘legislation’ - they’ve pumped millions into anti-vape scare mongering over the past 3-4 years in preparation, so lot of people who were on the fence now see vaping = smoking. They are killing millions of people with these regulations but hey … let’s all just go along with it …
The regs need to be looked over. They were just released today. My guess is nothing since it is a FDA approved product. You better worry more about your equipment being you blend your own juice. Those who don’t blend just may be up shitz creek without a paddle. They still do not take effect yet so maybe something might happen between now and then. There’s still HR2058…
I’m not a lawyer, but I’m no dummy either. From what I’ve read so far, there is more than a good chance that our vaping “landscape” will look very different come this August. CASAA has a team reviewing the deeming rules, and its related laws and regulations. I’m anxious about what they’ll reveal to us.
Although I’m not panicking just yet, I am stocking up on 10% PG nic base (100mg/ml) in bulk. I’m going to keep it in the freezer, and only dole out in a 30ml bottle to use as necessary. I bought a gallon today, and I’ll likely buy more over the next several months. I’d rather be able to mix, and use my stash of hardware than be forced to use Blus or some such lame device. I’ll be stocking up on some coils too.
Good bye to all the small “gourmet” mixing shops…RIP
Also, your LVS that custom mixes, may no longer be able to do so.
"(Comment 25) One comment stated that e-cigarettes have two variables–the ratio of the
propylene glycol to vegetable glycerin and the level of nicotine in the product–which would
result in many combinations and, therefore, require submission of numerous, very costly PMTAs
for products that have very minor variations. In contrast, one comment noted that the lower
number of ingredients in e-cigarettes means that less information will be required in PMTAs for
e-cigarettes than for other products.
(Response) The requirements and costs of a PMTA may vary based on the type and
complexity of the product. Variations in the ratio of ingredients, such as propylene glycol and
glycerin, would indicate that products have different levels of each of these ingredients. As
stated in section 910(a)(1)(B) of the FD&C Act, any change in an ingredient level, as with
additions or removal of ingredients, yields a new tobacco product." pp.81-82