FDA deeming regs

[QuittingVegas]

I don't post much but this subject is something this community needs to be aware of. Most of the products we are using are advertised for tobacco use. This is definately going to hinder us.

Sorry mods if this is in the wrong area.


Below is the 500 page ruling. There is a lot of info. I am reading many ecig forums trying to decipher it all.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

 

[CarolKing]

I wonder how that would work if we ordered through Canada if it begins to be an issue for us in America? I saw that on the news today. It got me somewhat worried. Maybe we need to stock up?

 

[little maggie]

Could someone summarize? I tried reading it and see that vapes and vape related products are being controlled but that's as far as I could get. Is there a part where the actual herb is being controlled other than being controlled the way alcohol is?

 

[stickstones]

I dug deep enough to figure out what components and accessories are. The document is littered with tobacco references and this regulation is aimed at ecigs and hookahs. At this point it doesn't seem to be concerned with our vapes or purposes, and a distinction between use with herbs and not tobacco is probably the best thing we can do to separate ourselves from it.

However, I'm almost certain that the current pens used for wax, etc. will fall under it's umbrella.

 

[QuittingVegas]

To summarize everything tobacco and vape related is going to have to go thru an approval process with the FDA. Each item must have its own application and the estimated cost for preparation of this application is over a million dollars.

Added:
Yes this bill is focused on tobacco, ecigs, and hookah. How many of you accessories are listed?

This is copied from section X.
Currently, tobacco products unregulated by FDA are widely available and come in many
forms, including cigars, pipe tobacco, waterpipe tobacco, liquids (e-liquids) for ENDS (the most
popular of which are electronic cigarettes, but also include e-hookah, e-cigars, vape pens,
personal vaporizers, and electronic pipes), liquid nicotine that is made or derived from tobacco,
nicotine gels, and certain dissolvable tobacco products (i.e., dissolvable products that do not
currently meet the definition of "smokeless tobacco" in section 900(18) of the FD&C Act (21
U.S.C. 387(18)) because they do not contain cut, ground, powdered, or leaf tobacco and instead
contain nicotine extracted from tobacco). Upon implementation of this final rule, currently
unregulated tobacco products and future products meeting the definition of "tobacco product"
under section 201(rr) (except accessories of newly deemed tobacco products) will be subject to
chapter IX of the FD&C Act.
FDA issued a proposed deeming rule

 

[psychonaut]

Best advice I can give is get a couple of mods or learn to build your own box mod. Removable batteries, rba's. We have to learn to DIY all this stuff. That will sucks for the vast majority of users, but we have 2 years to learn.

 

[QuittingVegas]

Yes we do have 2 years and there still is some hope due to other bills trying to be passed (bill 2058 I believe) I just wanted this community to be aware. No sense being blindsided. There's a lot of info to comb thru but the more I read the bleeker it looks.

 

[Slow Draw McGraw]

I dug deep enough to figure out what components and accessories are. The document is littered with tobacco references and this regulation is aimed at ecigs and hookahs. At this point it doesn't seem to be concerned with our vapes or purposes, and a distinction between use with herbs and not tobacco is probably the best thing we can do to separate ourselves from it.

However, I'm almost certain that the current pens used for wax, etc. will fall under it's umbrella.

Hey Sticks,

You think we can ride on the 'aromatherapy' aspect. That can be separate from vaping?

 

[stickstones]

I think we have to given the verbiage. If they are going after tobacco products, then my stuff is for other herbs.

 

[Grow Goddess]

Best advice I can give is get a couple of mods or learn to build your own box mod. Removable batteries, rba's. We have to learn to DIY all this stuff. That will sucks for the vast majority of users, but we have 2 years to learn.

It could be less than 90 days. The 2-year extension has not been approved yet.

 

[xRUFUSx]

I'm most interested in discovering if the new legislation will make pure and/or 100mg nicotine solutions harder to obtain (for ejuice producers and DIY'ers). Will "ingredients" with nicotine also be regulated as tobacco products or just the end-consumer products?

Guess I better get to reading.
edit:

(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 83 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.

Looks like I'm in the clear for now (see bold)

 

[CarolKing]

The Solo is sold as an aromatherapy device. Other vaporizer are sold under those descriptions.

 

[shredder]

The Solo is sold as an aromatherapy device. Other vaporizer are sold under those descriptions.

I really really hope your right, and the Feds agree. My favorite vapes are just small companies that most likely would be run out of business.

Maybe someday we will be using vapes kept up like Cuban cars, lol. I'm pretty sure my volcano could survive for years.

 

[justvapin]

I just ordered some spare stems for my E-nano and will order some extra spare elbs and an extra dry stem for the EVO.......would suck to suddenly not be able to get any of that stuff. Rather be well stocked.

 

[Jethro]

I'll grab another Solo when I can. Thanks for the heads up. Damn government always messing things up.

 

[ghost]

If all the big players in the vape/ejuice game came together and each chipped in a few grand, they could form a decently powerful lobby and likely get this thrown out or at least heavily amended.

The only way to do anything in this country as far as laws/government is via lobbying, people and smaller companies need to wake up and realize this and join together and put some money up to form their own lobbies...

 

[TheDarkOne]

Im worried...and I guess sad. The cottage industry popping up around vape juice was really fun. I dont drink alcohol, just use marijuana, so for me it was what I imagine a microbrewery to be like. Im going to stock up on a few more Mods and Attys, and of course coils.
My whole life the Feds have been the constant antagonist. FFS now they are going after people who like to Vape? Out of all the things they have to worry about...Im just speechless.

 

[aesthyrian]

It would be nice if the FDA put more effort into regulating food, and drugs, and not the devices that are used to consume food and drugs. We all know that the nations food and drugs are severely under-regulated in many ways.

Does the FDA also regulate plates, microwaves and such?

I mean I get it, it's hysteria from all those "Exploding vape pen!" news stories which are most always a case of a shorted battery on something like a coin, because some idiot didn't spend .98 cents on a plastic case for his spare 18650.

This is just very unnecessary. We don't need GMO labels dammit, but ban those god damn e-cigs!

Big Tobacco is still just as big as ever I guess... and yes that's who I believe is behind this. Not "the government". It's always lobbying that controls whatever issue. The fact that cigs are still legal, yet this is even a discussion says it all. Big Tobacco would rather kill competition than evolve and adapt their business strategies.

Sort of how they treat Cannabis.

 

[psychonaut]

The industry is not going down without a fight. As it stands right now, big players in the industry are suing the FDA. There is more to come.

 

[Bad Ocelot]

There are a couple vape lobbying groups. Sam Bee had a good segment about the deeming regulations on her show & how big tobacco lobbied for them to try & push the small guys out so they could take their market share. Pretty fucked, but utterly predictable. I doubt the regs will take effect in their current form. Fingers crossed. As someone who vapes nicotine as well I think regulations are a good idea, I want the products properly labeled & safe, however you would have to try really hard to come up with a worse set of regulations, for both small businesses and end users. SMDH...

 

[grokit]

I think we have to given the verbiage. If they are going after tobacco products, then my stuff is for other herbs.

They'll use it to go after herbal medicine too,
as they are perennially attempting to do already.

Selective enforcement is the new corruption

I'm most interested in discovering if the new legislation will make pure and/or 100mg nicotine solutions harder to obtain (for ejuice producers and DIY'ers). Will "ingredients" with nicotine also be regulated as tobacco products or just the end-consumer products?

People be vaping their transdermal patches to get a quick nic fix?

 

[THC SCIENTIFIC]

One thing people don't understand is glass is marketed as "for tobacco use only" that's going to fall under FDA now, and if they do market it under for herbal use only, then their could be issue with interstate commerce.


Essentially this bill is trying to regulate our vaporizers in our industry as well.


Anything that has a coil, battery, cartridge and tank falls under FDA jurisdiction come August.

 

[Slow Draw McGraw]

Selective enforcement is the new corruption

This right fucking here.

 

[syrupy]

They'll use it to go after herbal medicine too,
as they are perennially attempting to do already.

What are these "herbs" people keep referring to? My nano is strictly for essential oils...

 

[QuittingVegas]

Gov't bullshit at its finest.

For those interested there's a film coming out later this summer called A Billion Lives. It dives into the deception and greed brought on by money and government.