FDA Was nic base available pre 2007?

[Culinarytracker]

I have searched all over about this and found nothing. Could you get 100mg nic base before the cutoff date in 2007?
If things go through as proposed I could see this having a big impact on whether or not a bottle of e-liquid will be able to get approved under the regs.

I can't help but think that they will push to make it impossible to come into contact with the liquid.

 

[scartn]

That's where they will get us. Nicotine will be the only thing, after this all said and done, that the FDA will be able to control. It's the only tobacco product really listed in what I've read. Everything else can be used for something else. That's what I'm seeing in this. We will get to keep our toys and flavors.

I think people are worrying about the wrong thing. Without nic. everything else is useless to most people.

To buy nic base you will have to get a license from the FDA, EPA and any other ABC agency that's required. That will stop the DIY and many small company's. Then they could regulate the nic so low (due to junk science) in premixed juice to make it useless.

I'm hoping this takes a few years to happen but I'm afraid it won't.

 

[Culinarytracker]

I found this article while looking into the "gel" idea that is in the proposed wording.

"Nicogel in the Hand a Surrogate for Tobacco in the Lungs"
http://www.medpagetoday.com/PrimaryCare/Smoking/4847
Published: Jan 12, 2007

At least this article makes mention of pharmaceutical grade nicotine's existence.

 

[Stosh]

That's where they will get us. Nicotine will be the only thing, after this all said and done, that the FDA will be able to control. It's the only tobacco product really listed in what I've read. Everything else can be used for something else. That's what I'm seeing in this. We will get to keep our toys and flavors.

I think people are worrying about the wrong thing. Without nic. everything else is useless to most people.

To buy nic base you will have to get a license from the FDA, EPA and any other ABC agency that's required. That will stop the DIY and many small company's. Then they could regulate the nic so low (due to junk science) in premixed juice to make it useless.

I'm hoping this takes a few years to happen but I'm afraid it won't.

Yup, the nicotine is the easiest choke point, easiest to control. But don't count on your toys too fast, they wrote the proposed regulations broad enough to include anything that would be "intended" to be used with a tobacco product".

They're the ones that get to determine what is intended for what.....

Read this over 3 or 4 times, and pay close attention to the "intended" parts....deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act

 

[Katya]

On the other hand, eliquids were readily available pre-Feb. 15, 2007, date, so wouldn't they have to be grandfathered in? This forum was founded by SJ in 2007 (later in the year), but he clearly talks about buying bottles of ejuice for his cartridges. Which makes perfect sense, because the very first e-cig was a three-piece--one needed a bottle of eliquid to fill it. I don't know what levels of nicotine concentration were available back then, but clearly flavors were. And even if one could only get 24 or 36 mg/ml, that's fine with me.

http://www.e-cigarette-forum.com/forum/standard-e-cigarette-reviews/532-e-cig-com.html#post11416

I also picked up three bottles of flavored nicotine liquid to try them out.

 

[Cloud Junky]

There will be some crazy vaping hardware available when that time comes and the way that people will get nic will be even more crazy.

This is something we will all get through, I am sure there will be a loophole somewhere.

 

[Stosh]

On the other hand, eliquids were readily available pre-Feb. 15, 2007, date, so wouldn't they have to be grandfathered in? This forum was founded by SJ in 2007 (later in the year), but he clearly talks about buying bottles of ejuice for his cartridges. Which makes perfect sense, because the very first e-cig was a three-piece--one needed a bottle of eliquid to fill it. I don't know what levels of nicotine concentration were available back then, but clearly flavors were. And even if one could only get 24 or 36 mg/ml, that's fine with me.

http://www.e-cigarette-forum.com/forum/standard-e-cigarette-reviews/532-e-cig-com.html#post11416

If the e-liquid being sold now is exactly the same as was sold in 2007, they could apply for the substantial equivalence exemption so long as the PG/VG ratios is the same, nicotine concentratiosn is the same and the FLAVORING is the same.....

a tobacco product is substantially equivalent within the meaning of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive,

from eCFR — Code of Federal Regulations

Definition of additive....

The term “additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.

....from....U.S.C. Title 21 - FOOD AND DRUGS

 

[Katya]

Well, the chemist who created Ruyan 4 recipe disappeared under suspicious circumstances so the RY4 makers may have to reapply, but other than that, Dekang and Janty should be fine...

 

[DC2]

Well, the chemist who created Ruyan 4 recipe disappeared under suspicious circumstances so the RY4 makers may have to reapply, but other than that, Dekang and Janty should be fine...

I'm glad I really like DK-TAB then, because it may be my only option.

 

[Jman8]

So they can control / choke nic base, rather easily, but cannot control other substances that are currently banned? Very hard to believe, but an interesting consideration.

 

[Uma]

Haha, I think we're on the same line of thought. I dug around last night about the history of the vaporizers. Between Eagle Bill and a few others, they apparently have been around for quite some time in various crazy ways. Good reading if anyone is interested in the history of vaporizers. (Open mind a must).

 

[KODIAK (TM)]

If nic base were available pre-2007 then we'd be home free. E-liquid makers would simply sell zero nic flavorings (in essence, candle juice) and we'd combine the two.

 

[Uma]

Check out smokey's thread.
http://www.e-cigarette-forum.com/forum/standard-e-cigarette-reviews/532-e-cig-com.html#post11416

 

[DC2]

If nic base were available pre-2007 then we'd be home free. E-liquid makers would simply sell zero nic flavorings (in essence, candle juice) and we'd combine the two.

Not really if it "were available" but more if it were being sold and marketed here in the United States prior to the grandfather date.

 

[tj99959]

Not really if it "were available" but more if it were being sold and marketed here in the United States prior to the grandfather date.

And I don't know of anyone that was making e-liquids in the US priror to 2008. However it's the same ncotine that has been used in NRT's for a very long time.

So they can't eliminate nicotine from the market, but they can control who can buy it.

 

[Stosh]

So they can control / choke nic base, rather easily, but cannot control other substances that are currently banned? Very hard to believe, but an interesting consideration.

They are working on ways of controlling the choke points for tobacco produce sales, along with many other substances and behaviors. All the FDA has to do is make vaping a "tobacco product" and the DOJ will take it from there, closing down payment options for "high risk transactions". Some of the included products...

Some merchant categories that have been associated with high-risk activity include, but are not limited to:

Ammunition Sales
Cable Box De-scramblers
Coin Dealers
Credit Card Schemes
Credit Repair Services
Dating Services
Debt Consolidation Scams
Drug Paraphernalia
Escort Services
Firearms Sales
Fireworks Sales
Get Rich Products
Government Grants
Home-Based Charities
Life-Time Guarantees
Life-Time Memberships
Lottery Sales
Mailing Lists/Personal Info
Money Transfer Networks
On-line Gambling
PayDay Loans
Pharmaceutical Sales
Ponzi Schemes
Pornography
Pyramid-Type Sales
Racist Materials
Surveillance Equipment
Telemarketing
Tobacco Sales
Travel Clubs

Managing Risks in Third-Party Payment Processor Relationships

 

[KODIAK (TM)]

Not really if it "were available" but more if it were being sold and marketed here in the United States prior to the grandfather date.

That's what I meant by "available"... meaning to the consuming public. The FDA SE hurdles aside, just not sure what pharmaceutical boundaries there would be.

Wouldn't bother me a bit to add "1" drop of a separate legal nicotine base to a tank of legal flavoring.

 

[Kent C]

If nic base were available pre-2007 then we'd be home free. E-liquid makers would simply sell zero nic flavorings (in essence, candle juice) and we'd combine the two.

I was hoping this to be the case, but I don't think it is. The purpose of the pre-2007 date is to establish a 'predicate product' that was already FDA approved, to which a 'new product' that is substantially equivalent. If one could show that a new product was SE to a formerly approved product, then the new product would be grandfathered in without the need for an 'application'. However, you would still have to show substantial equivalency to the predicate product.

I think the only way this could happen is if one attempted to show how ecigs are SE to cigarettes, nic gum, patches, etc.

edit: see:
http://www.e-cigarette-forum.com/fo...economic-impact-analysis-16.html#post13035445

 

[DC2]

And I don't know of anyone that was making e-liquids in the US priror to 2008. However it's the same ncotine that has been used in NRT's for a very long time.

Yes, but that was available for NRT manufacturers as a pharmaceutical product.
And I'm not sure if it was "sold and marketed" in the United States as I always heard it came from China.

These are two really big questions...

If there was nicotine base available (and there was for NRT products) how does that apply when someone wants to use them for "tobacco" products?
And if the nicotine base did in fact come from China, how would that factor in to this equation.

I have no idea on either count.

 

[aikanae1]

I think this is our one big hope and worth fully exploring.

Was nicotine available for retail sale in the US prior to 2007

And how was it sold? (Ordering from overseas is ok)

What was the quality/quanity available?
-would we need MSDS or how can we prove the equivilancy?

Obviously, my hope is to get ONE eliquid nic base passed, in any amount, in any strength, in any base to begin with. At least we would have that. I don't see a black market to be a viable option for most vapers and certainly not for new vapers. I dread the thought of people resorting to industrial nic, which isn't that widely available anyway - but ya' know someone will try ...