The FDA would say this is evidence of your having been exposed to nicotine in your teens, and the resulting brain damage.
Nicotine causes permanent damage in young brains
http://www.iamexpat.nl/read-and-discuss/lifestyle/news/nicotine-causes-permanent-brain-damage
I am aware there are scientific studies poses risks to fetal development and brain development in adolescents.
Thing begs the question why I am not aware of any reported case of fetal nicotine syndrome nor
nicotine addled juvenile disorder.( defense attournies take note of the latter,it might win you a
case or two)
serve dual-purpose as a vape and head shop.--------agree,, the head shop near me has more mods/atty's than the 3 b&m vape stores,,to the point i thought they must carry everything.....i was impressed.
The advertised use is a non-factor. Actual use determines the need of regulatory action per FDA determination.
#16 is the real killer, if accurate. Maybe they meant that until something's been denied, or some enforcement action's been taken, litigation is highly unlikely to suceed.
This is my understanding also. Until your product is off the market and or your going bankrupt
you have no damages ergo,no case.
Is anything that the FDA has released Final and Statutory without the Presidents Signature? As I understand it... No, it Isn't.
Can the President Sign the FDA's Rule Set before Congress (Both Houses) has Approved it... No He/She Can't.
With out intervention outside of the FDA the President and congress need do nothing and the regulations stands as is. I am not sure of the time frame involved but,this is my understanding.
Intervention is only required to change or rescind the regulation not, to allow it to stand as is.
There could be some pre-functionary nod of approval which would be next to doing nothing.
Hey, was doing some in depth late night reading. Digest this and tell me if you think this means what I think it might mean:
(Comment 26) Many comments stated that a requirement to prepare PMTAs for all of the many parts and components that go into some of the newly deemed tobacco products would create an effective ban of these products.
(Response) The definition of a tobacco product includes components and parts, and these products are subject to the automatic provisions of the FD&C Act, including premarket authorization requirements. However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further
manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against such eliquids or other components and parts of newly deemed products that are sold or distributed solely for further manufacturing without a marketing order.
I have read this and seen it posted many times. My best guess is if your making juice in bulk
and selling it wholesale in 55 gallon generically labeled drums to branders you're not under
any regulatory burden. Those that buy it and prepare it for individual sale would be saddled
with the regulatory burden and cost. Sounds good doesn't it but, wait there's more.
This gives the wholesaler 2 to 3 years free ride. By that time as those with the regulatory
burden drop by the wayside because the burdens cannot be met there becomes a point
in order to stay in business the wholesaler would have to brand and prepare the juice
for individual sale to the end users. Now the wholesaler becomes the manufacturer and
now has the regulatory burdens imposed by the regulations. At this juncture it is unclear to me
what the time frame to complete the market entry process will be. The juice was on the market but
the new manufacturer wasn't under the regulatory burdens. Again my best guess would be
an additional 2 years to prepare and apply with another year for approval. Could be a total
of 6 years of a free ride. I fully expect that during the later time frame considering 99.9%
of the competition has been eliminated the FDA will step in change a few word in the
regulations and divvy up the spoils with the real players or change nothing and everything
reverts back to the status quo because whats left of the market would be statistically
irrelevant.
@kbf101998
Ditto
Regards
Mike
