Deeming Regulations have been released!!!!

[mikepetro]

The FDA certainly didn't coordinate with anyone, did they?

I wonder............. BT, BP?

 

[CMD-Ky]

The FDA certainly didn't coordinate with anyone, did they? I was happy to see them moving forward. I don't pretend to understand it all and get lost in the jargon, but more power to them! It could have a nationwide effect if successful.

FDA, "coordinate", a governmental agency? Perish the thought but, if the agency did coordinate then we all know that it is for our own good (even if we just don't see it).

 

[Rossum]

Has anybody followed the Hartland "Coordination" thing?
Coordination with the FDA: Hartland, Wisconsin Holds Public Hearings
Could this really do anything, or will it just be received as a lobbying effort for Johnson Creek?

Seems to me it would provide the perfect reason (excuse?) for new management at the FDA to say something to the effect of, "You're right, our predecessors didn't do this by the book, and therefore the Deeming is null and void." This would be by far the most straightforward way to kill the it, supposing of course, that they are so inclined.

I don't give the Coordination Challenge much of a chance in today's courts though, if the new management at the FDA decides to fight it there.

 

[mikepetro]

So where does the "Coordintion" objection head next? Was it just a brief filed with the FDA? Do they "have" to respond?

 

[TJVapes]

So where does the "Coordintion" objection head next? Was it just a brief filed with the FDA? Do they "have" to respond?

They with EVCA submitted it to FDA for response. If the response isn't favorable, then it goes to court. I don't know if they have to respond. It would be naive to think the FDA would just say, yeah we messed up, but wouldn't that be nice. I guess this will be another court case to go with the others buf it's a community affected rather than individuals, although I'm not sure who all the other entities are involved in other cases.

 

[mikepetro]

Rep. Duncan Hunter, a long-time vaping proponent, introduced a bill Thursday aimed at loosening regulations for e-cigarette products that were tightened under the Obama administration.

......

H.R.2194 - 115th Congress (2017-2018): To protect the public health by providing the Food and Drug Administration with certain authority to regulate e-liquids and personal electronic vaporizers, to reduce the morbidity and mortality resulting from cigarette smoking through the responsible regulation of e-liquids and personal electronic vaporizers as a tobacco harm reduction strategy, and for other purposes.

“SEC. 1003. Prohibited acts; penalties.

“(a) Prohibitions.—

“(1) IN GENERAL.—The following acts and the causing thereof are hereby prohibited:

“(A) The sale of an electronic vapor product or e-liquid to any person younger than 18 years of age.

“(B) The manufacture of an e-liquid or personal electronic vaporizer in noncompliance with the standards under section 1004(b) in violation of an order issued under section 1004(e).

So, how is "manufacture" defined? Does this just mean on a commercial level, or does it mean DIY and "Moding"?

“(2) RETAILERS.—Notwithstanding subparagraphs (A) and (E) of paragraph (1), a retailer may be found to be in violation of either such subparagraph (with respect to sale or introduction or delivery for introduction in interstate commerce at retail) only if the violation occurs knowingly.

“(b) Adulteration.—An e-liquid or personal electronic vaporizer shall be treated as adulterated if—

“(1) it was manufactured in noncompliance with the standards under section 1004(b) in violation of an order issued under section 1004(e); or

“(2) it was manufactured by an e-liquid or personal electronic vaporizer manufacturer that does not have a certification in effect as required by section 1004(c).

“(c) Misbranding.—An e-liquid or personal electronic vaporizer shall be treated as misbranded if its labeling (as such term is defined in section 201 with respect to drugs) is in noncompliance with the standards under section 1004(b) in violation of an order issued under section 1004(e).

“(d) Penalties.—Any person who violates a provision of subsection (a) shall be imprisoned not more than 3 years, fined not more than $10,000 (notwithstanding section 3571(e) of title 18, United States Code) for each day on which the violation continues, or both.

I get lost is all of the sections and paragraphs and subsections. Does this "penalty" only apply to "Retailers"?

Surely they cant be saying we could go to jail for mixing our own juice, or building our own Mods, can they?

 

[Burnie]

Surely they cant be saying we could go to jail for mixing our own juice, or building our own Mods, can they?

I think it only applies if you are selling it to someone else. I see No Way for them to enforce what we do in our own home for personal use of a legal product. JMHO

 

[DavidOck]

Other than making 100mg nic hard to get....

 

[Eskie]

As @Burnie said, it's at the retail level. What you do and how you do it are not issues as far as DIY or build your own. You just can't sell it to a third party in a retail setting. However, you can always give it as a gift. I can PM you my mailing address.

 

[Eskie]

Oh, FYI. Gottlieb just got confirmed by the Senate. That might liven things up a bit.

 

[Str8vision]

Oh, FYI. Gottlieb just got confirmed by the Senate. That might liven things up a bit.

In an article from the Hill;

"The Senate on Tuesday confirmed Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration (FDA).

Gottlieb, a former FDA director and deputy commissioner under former President George W. Bush, was confirmed in a 57-42 vote. He will replace Robert Califf, the acting FDA chief who was appointed last year by former President Barack Obama".........

...."Moving forward, the new FDA chief will be tasked with taking a look at Obama regulations for electronic cigarettes and requirements for calorie counts on restaurant menus, as well as approvals for genetically engineered animals.

During the Obama administration, the FDA exerted its authority granted by Congress to regulate all tobacco products, including cigars and e-cigarettes, but it is unclear if Gottlieb will bend to industry pressure and roll back the regulations.

Sen. Sherrod Brown (D-Ohio) raised concerns about investments Gottlieb has made in the e-cigarette industry.

“His job is to police big tobacco, to stand between these multi-million dollar marketing executives and the 15-year-olds who are attracted to these products,” Brown said Tuesday on the Senate floor. “And he’s invested in these companies in the past. So can we really trust him?” ".....

 

[Str8vision]

Gottlieb is a licensed, practicing physician who has invested in the e-cigarette industry? Interesting. Of course these "investments" may actually have been with BT (Blu - Vuse) if so this still might not bode well for us...

 

[HBcorpse]

Comey was just fired.

Looks like Trump has started draining that swamp...

Like him or not, at least he's doing a lot of the things he said he would...

 

[mikepetro]

Other than making 100mg nic hard to get....

They still arent "regulating" nicotine any more than it already is.
Which surprises me. Take away the nic and the rest of it fades into obscurity.

 

[WorksForMe]

Gottlieb is a licensed, practicing physician who has invested in the e-cigarette industry? Interesting. Of course these "investments" may actually have been with BT (Blu - Vuse) if so this still might not bode well for us...

Nope. I believe he was on the board of Kure Corp.

KŪRE Vaping Lounge Franchise - KURE

Kure Vaporium | Premium Vape Juice

Dr. Gottlieb testimony at Senate confirmation hearing 4/5/17

 

[zoiDman]

Oh, FYI. Gottlieb just got confirmed by the Senate. That might liven things up a bit.

Yeah... It was a Busy day in Washington.

 

[Buckeyevapen]

Yeah... It was a Busy day in Washington.

THATs an understatement.

 

[MacTechVpr]

They still arent "regulating" nicotine any more than it already is.
Which surprises me. Take away the nic and the rest of it fades into obscurity.

It is a false dilemma. FDA does not "regulate" nicotine where vaping is concerned; however, they may as a drug per Soetera (as I understand), an approach so far not undertaken.

Vaping IS NOT combustion of tobacco which is the function that is lawfully the object of tobacco law. Until we address this we will be forever mired in regulatory over-reach. Especially NOW that even our advocates seem in favor of memorializing FDA's presently ambiguous jurisdiction into law.

BEWARE!

Extract vaping from tobacco legislation.

Good luck.

 

[mattiem]

Vaping IS NOT combustion of tobacco which is the function that is lawfully the object of tobacco law. Until we address this we will be forever mired in regulatory over-reach. Especially NOW that even our advocates seem in favor of memorializing FDA's jurisdiction into law.

BEWARE!

Extract vaping from tobacco legislation.

Good luck.

^^^^^^^^This ^^^^^^^ a thousand times this....

 

[Rossum]

Vaping IS NOT combustion of tobacco which is the function that is lawfully the object of tobacco law.

Until we address this we will be forever mired in regulatory over-reach. Especially NOW that even our advocates seem in favor of memorializing FDA's presently ambiguous jurisdiction into law.

BEWARE!

Extract vaping from tobacco legislation.

What about the smokeless tobacco products? Chew, Dip, Snuff, Snus, etc? None of them involve combustion either.