FDA Big news coming out of FDA

[Surf Monkey]

Did you read this yet SM? I scanned it and will read more later - But -
To me it looks like it's all about labeling and advertising claims -
Not banning or doing away with as they tried before - No?

Correct. It's about marketing and labeling. But those are easy to get around. Gorilla advertising, online advertising from domains hosted on foreign servers... not to mention the snail's pace that the government moves at by default. In other words, we don't want these kinds of regulations on the industry, but the industry itself has more and more power every day. In my estimation it's a foot race and the FDA is already several lengths behind.

 

[Surf Monkey]

I wonder if the way around this sort of regulation is to simply label everything novelty and sell components in separate store locations as they do e-liquid in much the same way that the adult toys and "water pipes" do in certain shops. Of course, you would still have to be VERY careful about your advertising but that's not too much of a surprise.

Agree. I have had to deal with SOPA and COPA when designing advertising targeted at children (Cap'n Crunch) and the regs are extremely tight. Arguably much tighter than anything the FDA is proposing in this case. Yet the children targeted advertising industry is alive and well. It would suck for these kinds of strictures to be imposed, but it wouldn't be the end of the game.

 

[Sirius]

Why do I always see fat cat politicians and back room deals with a bunch of money exchanging going on whenever I read any kind of government regulation policy?
Probably because it's true.

The buzzards are gathering for the feast.

 

[Bad Ninja]

There needs to be some type of basic guidelines for selling ejuice, IMHO.

I personally DIY because I do not trust these fly-by-night juice companies with their ingredients, or their cleanliness standards.

juice companies ran out of a kitchen, garage, or some dust filled room scares me, and can cause the industry a lot of problems down the road.

Who knows what they put in their product?

 

[DC2]

Things are not looking good. This is absurd: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery …

Essentially, claims that e-cigs can help people to stop smoking will render the products subject to medical regulation.

Claims that e-cigs are safer will render them subject to "modified risk tobacco" authorisation.

E-Cig companies will be limited to marketing their products as being "satisfying", essentially using the language of the tobacco industry prior to 2000 (due to a Brown & Williamson loophole).

This rule is proposed to "remove ambiguity for marketers", but at the expense of any consumer-facing clarity.

The future looks bleak.

Anybody that didn't see this coming exactly as stated was not paying any attention whatsoever.
It's exactly how the FSPTCA is written, and what they have been telling us all along.

 

[DC2]

When govt starts actively restricting/banning nicotine extract we are in serious trouble.

Quoted for truth, or because it is the most important point made so far in this thread.

 

[cooladdict]

I don't understand how any product that doesn't contain tobacco can be classified as a tobacco product. Why isn't the FDA focusing more on establishing what an unhealthy dose of nicotine is rather than trying to lump non-tobacco products into the same category as tobacco products? This whole thing doesn't make any sense to me.

 

[Bones]

Correct. It's about marketing and labeling. But those are easy to get around. Gorilla advertising, online advertising from domains hosted on foreign servers... not to mention the snail's pace that the government moves at by default. In other words, we don't want these kinds of regulations on the industry, but the industry itself has more and more power every day. In my estimation it's a foot race and the FDA is already several lengths behind.

Agree. It mostly looks like a Glossary of terms and explanation of conditions under which regulations would be drafted. It could be bad depending on how they apply the terms in the final regulations - But it could also be nothing more than defining terms that they use to craft regulations that are reasonable in the end. And it almost looks like they are admitting E-Cigs reduce harm. To me it seems like "Smokeless Tobacco" is mentioned far more than E-Cigs. At first I was very concerned, but the more I look at it, the less concerned I am. This is not in any way a conclusion, nor a regulation, but a glimpse into the legal thought process that may eventually lead to one. Worth keeping a close eye on, for sure, but not reason to think the sky is falling.

 

[DC2]

I don't understand how any product that doesn't contain tobacco can be classified as a tobacco product. Why isn't the FDA focusing more on establishing what an unhealthy dose of nicotine is rather than trying to lump non-tobacco products into the same category as tobacco products? This whole thing doesn't make any sense to me.

It makes even less sense when you consider that there may not BE any unhealthy dose of nicotine.
Other than that which kills you.

 

[folkphys]

"Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose."

Would someone please tell the FDA to quit conflating Smoking Cessation with the Treatment of Nicotine Addiction.....because I haven't SMOKED a cigarette in like three years, but I sure ain't been treating my nicotine addiction.....in point of fact i may actually be feeding it.

 

[DC2]

Agree. It mostly looks like a Glossary of terms and explanation of conditions under which regulations would be drafted. It could be bad depending on how they apply the terms in the final regulations - But it could also be nothing more than defining terms that they use to craft regulations that are reasonable in the end. And it almost looks like they are admitting E-Cigs reduce harm. To me it seems like "Smokeless Tobacco" is mentioned far more than E-Cigs. At first I was very concerned, but the more I look at it, the less concerned I am. This is not in any way a conclusion, nor a regulation, but a glimpse into the legal thought process that may eventually lead to one. Worth keeping a close eye on, for sure, but not reason to think the sky is falling.

The terms are all defined in the FSPTCA.
And the requirements to meet those terms are also defined.

Unless they drastically change the terms or requirements in their final regulations, there is nothing good here.
And certainly nothing reasonable.

It might be helpful for some to review the various FDA determinations made so far on...

--Substantial Equivalence
--Modified Risk Tobacco Products

Oh, wait, I'm not sure there is a way to review the FDA determinations on Modified Risk.
I think only one company (Swedish Match) has even tried that path.

And they were shot down hard.
After spending a ton of money and producing a library worth of data.

FDA protects cigarette from snus, instructs TPSAC to criticize/oppose Swedish Match's MRTP application

 

[VHRB2014]

There needs to be some type of basic guidelines for selling ejuice, IMHO.

I personally DIY because I do not trust these fly-by-night juice companies with their ingredients, or their cleanliness standards.

Juice companies ran out of a kitchen, garage, or some dust filled room scares me, and can cause the industry a lot of problems down the road.

Who knows what they put in their product?

We here at the kitchen table express can most surely guarantee there is zero cigarette ash in our custom juice!
.
.
.
.
.
.
.
. Cat hair on the other hand.........................Is easy to pick out, Ha, ha.
(We love our kitty's)

 

[cooladdict]

It makes even less sense when you consider that there may NOT be any unhealthy dose of nicotine.
Other than that which kills you.

True! I just don't see how nicotine is a tobacco product. Are they going to regulate tomatoes and peppers next? Lots of vegetables have nicotine in them. Not all vaping products contain tobacco, and even those that do do not contain the carcinogens cigarettes do. It's ridiculous to lump everything into the category of "tobacco."

 

[oplholik]

From what I get after skimming it is that this is just the proposal. So still wait and see, and some time to go.
There is a 60 day comment period.
Then:
B. Proposed Effective Date
The Agency proposes that any final rule based on this proposal will become effective 30
days after the date of publication of the final rule in the Federal Register. During the pendency
of this rulemaking, manufacturers will continue to be under an obligation to comply with all
applicable provisions of the FD&C Act and applicable regulations.

 

[VHRB2014]

When you try to talk sanity to a Politician, they give Iran the bomb.

 

[Bad Ninja]

True! I just don't see how nicotine is a tobacco product. Are they going to regulate tomatoes and peppers next? Lots of vegetables have nicotine in them. Not all vaping products contain tobacco, and even those that do do not contain the carcinogens cigarettes do. It's ridiculous to lump everything into the category of "tobacco."

Lol
All the nicotine we use in ejuice comes from tobacco.
Let's be honest with ourselves, if we expect honesty from the government

 

[footbag]

I'll bet they could synthesize nicotine. It would do two things... Give the vendors a workaround, and make vaping more dangerous. Funny how that works.

 

[Surf Monkey]

I'll bet they could synthesize nicotine. It would do two things... Give the vendors a workaround, and make vaping more dangerous. Funny how that works.

Doubtful. Easier to extract it from the plant. I mean, unless you relish the idea of waiting for someone to actually achieve the synthesis and you don't mind paying $50 for a 10ml bottle.

 

[retired1]

Synthetic nicotine already exists. And it's expensive, VERY expensive. You'd see costs quadruple for ejuice alone.

 

[DC2]

Doubtful. Easier to extract it from the plant. I mean, unless you relish the idea of waiting for someone to actually achieve the synthesis and you don't mind paying $50 for a 10ml bottle.

This is a good thread to look at regarding synthetic nicotine...
http://www.e-cigarette-forum.com/forum/threads/l-and-d-nicotine.92643/#post-1387008