FDA FDA deeming regulation proposals

[rolygate]

Today, the FDA published its proposals for a 'deeming regulation' that would apply tobacco law to ecigs and related products.

http://www.ofr.gov/OFRUpload/OFRData/2014-09491_PI.pdf
https://www.federalregister.gov/art...uired-warning-statements-for-tobacco-products
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-09491.pdf

 

[Gresh11]

Quick question. When will these regulations come into effect?

Where's the catch, without going through the whole document?



Edit: Nearly 12 hours later: Sorry for the daft questions. I've just put my seat-belt and crash helmet on. I predict turbulence. Onward and upward, I wish the flight crew all the best. I feel pretty helpless at the moment. I won't waste anymore of your time. Power to the PV!

 

[Coastal Cowboy]

My quick wash after reading the proposed new regulations:

• Bottom line, up front: We didn't get the whole loaf, but we got more than half of it.
• FDA did their homework on e-cigs
• The labeling and age restriction requirements are consistent with the e-cig community's opinions
• Some B&M and small boutique vendors will struggle to stay in business
• The tardiness of these new regs is telling us a lot about FDA's struggle to identify e-cigs as a legitimate threat to the public health
• There will most likely be no banning of flavored e-liquids
• Liquid nicotine (unflavored) will still be widely available

I have not read the proposed regs thoroughly. This just represents my early impressions of FDA's first draft. My recommendation is that everyone within earshot provide well written comments using Roly's link above.

Sorry I've been away so long, y'all. I'm self employed and my "boss" has been a hard drivin' sunnofa biscuit eater since October.

 

[Kryyptyk]

Quick question. When will these regulations come into effect?

For 75 days after the proposed rules are published in the Federal Register, they will be open to public comment, then revised and finalized, after which they should be in full effect up to 24 months later.

 

[KODIAK (TM)]

My 2 immediate concerns:

1.) On the topic of "age restriction". How does that work for online e-juice suppliers?
2.) Also, the FDA limiting nicotine content in said e-juice.

 

[OBF_Vapor]

My 2 immediate concerns:

1.) On the topic of "age restriction". How does that work for online e-juice suppliers?
2.) Also, the FDA limiting nicotine content in said e-juice.

This can be accomplished employing the same techniques used by beer/cigar of the month clubs. signature requirements for delivery

I didnt see anything about nic level restrictions

 

[Kryyptyk]

My 2 immediate concerns:

1.) On the topic of "age restriction". How does that work for online e-juice suppliers?
2.) Also, the FDA limiting nicotine content in said e-juice.

1.) The minimum age for U.S. purchases both online and in a B&M will be the legal smoking age, usually 18. It will be tough to enforce the online aspect, as minors have been purchasing prohibited items online since I was one, but it will be law nonetheless.
2.) As far as I can see, there haven't been any suggestions to limit nicotine content, so if it does happen it will be in a different set of deeming proposals.

 

[MissBoo]

The only rule I saw that didn't seem quite fair was the banning of advertising "harm reduction". I don't own a business, but as someone who smoked for 40 years and am now smoke-free, everything I have read says that vaping is less harmful than smoking. It will be interesting to see how the businesses who want to advertise feel about this.

The rule that requires a list of ingredients is a good one, IMHO.

 

[KODIAK (TM)]

2.) As far as I can see, there haven't been any suggestions to limit nicotine content, so if it does happen it will be in a different set of deeming proposals.

I learned of this nicotine level limitation from another dissertation/translation here "somewhere". Looks like I'll have to dive into the FDA Dead Sea Scrolls and see for myself. (If I'm not back by next Tuesday you'll know I'm blind and can't type any more).

Thanks Kryypt!

 

[hlk]

I think the glaring issue is the "FDA Approved" nonsense.
I hope they understand that by having to approve vape hardware it will be a nightmare for all of us including them. I understand on the liquid side people should know what they are inhaling but hopefully they will change their position on the hardware. If not then what will it take to get FDA approval?
This is the part we need sorted out so the industry can continue as it has.

The genie is already out, the FDA is late to the game and there will always be a way to sell them even with the regs.

Look at the headshops and what they sell... You just need a disclaimer stating your hardware is not for vaping anything but water right?

I see no way the industry will not get around anything they can throw at it..

 

[thanswr]

My quick wash after reading the proposed new regulations:

• Bottom line, up front: We didn't get the whole loaf, but we got more than half of it.
• FDA did their homework on e-cigs
• The labeling and age restriction requirements are consistent with the e-cig community's opinions
• Some B&M and small boutique vendors will struggle to stay in business
• The tardiness of these new regs is telling us a lot about FDA's struggle to identify e-cigs as a legitimate threat to the public health
• There will most likely be no banning of flavored e-liquids
• Liquid nicotine (unflavored) will still be widely available

I have not read the proposed regs thoroughly. This just represents my early impressions of FDA's first draft. My recommendation is that everyone within earshot provide well written comments using Roly's link above.

Sorry I've been away so long, y'all. I'm self employed and my "boss" has been a hard drivin' sunnofa biscuit eater since October.

My impression is the FDA was very conservative over these new regulations.

Regulations were coming because they were needed.

As far as I can see, the FDA wasn't proposing anything out of a need to protect public health. If the FDA had seen any evidence of a public health risk, the report would have been vastly different.

On a personal note, it's nice to see people discussing things calmly and not disintegrate into "Don't tread on me".

 

[Gresh11]

I feel privileged to have kicked this incredibly important thread off but do so only as a very concerned onlooker. I am not a regular ecf member, but a vaper of the world. Vaping in Australia is in its infancy, Europe is flailing at a Goliath, the USA seems to me the hope of the team. Power to the PV and I shall continue to follow this thread closely. Onward and upward. Good luck!!!

 

[OBF_Vapor]

The only rule I saw that didn't seem quite fair was the banning of advertising "harm reduction". I don't own a business, but as someone who smoked for 40 years and am now smoke-free, everything I have read says that vaping is less harmful than smoking. It will be interesting to see how the businesses who want to advertise feel about this.

The rule that requires a list of ingredients is a good one, IMHO.

If anyone wants to say that there product is healthy and have FDA approval they can get that done for the low low price of about 10 million bucks.

There are too many variables out there to prove harm reduction. Folks like everyone here feel that they are better than smoking but the fact of the matter is that there are no long term studies yet simply because vaping is relatively new. People have been smoking for 100+ years and we have decades and decades of studies showing what they do. I am willing to take the risk with vaping because I KNOW smoking will kill me, vaping should not.

 

[tommy2bad]

What struck me was the date for products to become subject to this regulation 15 feb 2007. I don't think any ecig was already on the market then so every vapor product will have to apply for aproval once this comes into effect. Their is mention of a long lead in for ecigs maybe longer than the two years prescribed but I wonder if this is because they realize the backlog all the applications will cause rather than any concession to vaping.
I don't like that they state that this deeming regulation is a starting point for further regulation such as removing flavors or certain products, slippery slope and all that regulation has become.
I am also concerned that this will mean a tax regime similar to other tobacco products, i.e. based on potential take up rather than health effects.
It's certainly a long document even allowing for the amount of repetition, strikes me that their hiding something in the verbiage. Looking forward to some of the experts take on this.
And talking of 'experts' Stan is disappointed with it, so that a good thing right?

 

[Coastal Cowboy]

I think the glaring issue is the "FDA Approved" nonsense.
I hope they understand that by having to approve vape hardware it will be a nightmare for all of us including them. I understand on the liquid side people should know what they are inhaling but hopefully they will change their position on the hardware. If not then what will it take to get FDA approval?
This is the part we need sorted out so the industry can continue as it has.

The genie is already out, the FDA is late to the game and there will always be a way to sell them even with the regs.

Look at the headshops and what they sell... You just need a disclaimer stating your hardware is not for vaping anything but water right?

I see no way the industry will not get around anything they can throw at it..

I am cautiously optimistic that devices not containing nicotine will not be regulated under the proposed language published today.

The language of the statute under which these proposed regs are promulgated is very clear. The Congress wanted to regulate tobacco products, and not devices that are capable of delivering nicotine. Someone correct me if I'm wrong, but the FDA does not regulate pipes. Or humidors.

Under the statute, FDA can only regulate tobacco products, and there are no tobacco products in your average, empty off-the-shelf Evod starter kit, ProVari or Vamo. If their intent is to regulate devices not containing nicotine, but that can be used to deliver a 0mg vapor, that provision wouldn't survive the first hearing by a US District Magistrate, much less a fully robed US District Court Judge.

And, let's not get out of breath or start panicking here. There is an unusually long 75-day comment period, after which the regulations (as revised following comments) would not go into effect until sometime in 2016. Who doesn't think entrepreneurs won't figure out a way to beat this thing to the finish line, with months to spare?

And who doesn't think a deep-pocketed e-cig device or liquid maker won't challenge the final proposed regs?

 

[MorpheusPA]

Don't Tread on Me!

Except in this case, they didn't, it seems. I was tremendously worried about the availability of unflavored nic concentrates, but they did nothing.

I was worried they'd simply ban flavors. Nope.

I was worried they'd ban advertising to adults. Nada.

I wasn't worried about devices as they clearly don't fall under the FDA's umbrella.

All in all, while this isn't 100%--the approval process' efficiency remains to be seen--I'd say the vaping community got a solid 80% of what it really wanted.

 

[stauglocal]

So what about buying devices/juices from other countries? Does the FDA have authority to stop importing of such items?

 

[Bob Chill]

An article on the US News website brought something to my attention. Online sales weren't addressed because the product doesn't fall under jurisdiction yet. It will likely be addressed once the rule is final.

I pondered the online sales part earlier and realized that even if the FDA doesn't address it the States surely will. I have a hunch that States will be rushing to tax nicotine juice ASAP. And as a part of the tax package they will ban online sales individually. My guess would be this happens inside of the 24 month window.

 

[klynnn]

That is what I'm interested in. Will they start confiscating orders from overseas that may include eliquid?

 

[StormFinch]

I am cautiously optimistic that devices not containing nicotine will not be regulated under the proposed language published today.

The language of the statute under which these proposed regs are promulgated is very clear. The Congress wanted to regulate tobacco products, and not devices that are capable of delivering nicotine. Someone correct me if I'm wrong, but the FDA does not regulate pipes. Or humidors.

Under the statute, FDA can only regulate tobacco products, and there are no tobacco products in your average, empty off-the-shelf Evod starter kit, ProVari or Vamo. If their intent is to regulate devices not containing nicotine, but that can be used to deliver a 0mg vapor, that provision wouldn't survive the first hearing by a US District Magistrate, much less a fully robed US District Court Judge.

And, let's not get out of breath or start panicking here. There is an unusually long 75-day comment period, after which the regulations (as revised following comments) would not go into effect until sometime in 2016. Who doesn't think entrepreneurs won't figure out a way to beat this thing to the finish line, with months to spare?

And who doesn't think a deep-pocketed e-cig device or liquid maker won't challenge the final proposed regs?

Looks like pipes will fall within the FDA's jurisdiction with this particular regulation. The text says: .

"Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes."

The way I understand it, they're not going to regulate humidors, or the case you store an eGo in, but they will regulate pipes and anything else a tobacco product goes into, like an e-cigarette cartridge (or in modern terms tank) and anything else used to heat said tobacco product. I know for a fact that they already regulate what advertising match books can have on them when sold as a smoking accessory.

As for zero nicotine juices, a vendor who sold no nicotine whatsoever along with vaping accessories just might be able to get around the regulations, but I'm not entirely sure.

What I'm wondering about now is the DIY flavoring industry.