OMB publishes the FDA's deeming regulation information on the December agenda

[AgentAnia]

Per Steve K's vaping World:

Is the FDA Plotting to Curb eCig Market? Regs Coming in December

View rule here: View Rule

 

[2coils]

We know this would be coming. I hope we can rally enough troops to fight this thing off!

EDIT: And to all the vendors and manufacturers who welcome regulation, be careful what you wish for! You welcome it now your getting it. I hope you all finally wake up and smell the coffee!!!

 

[AgentAnia]

We know this would be coming. I hope we can rally enough troops to fight this thing off!

EDIT: And to all the vendors and manufacturers who welcome regulation, be careful what you wish for! You welcome it now your getting it. I hope you all finally wake up and smell the coffee!!!

Since I'm feeling kind of bitter this morning about the whole regulation thing, I'll add to that: To all vapers who have not joined CASAA, who have not written to their representatives, who have not posted rebuttal comments to anti-ecig articles, who are content to sit back and let happen what may: We need your help. Without it, you are part of the problem.

:not promising to end ranting any time soon:

 

[drtwain5]

With the advent of EU regs and upcoming FDA regs on ecig under the hammer of tobacco products (and as medical devices in the EC downstream - not if but when), I wonder how manufacturers and vendors are currently approaching these regulatory adverse events? Everything in the vaping world is programmed to suffer death by a thousand cuts: nic, flavors, tanks, cartos, mods. Infuriating!

 

[AgentAnia]

1. I have been searching today and cannot find that the text of FDA's proposed rule has been published/made public anywhere, so with just the OMB's response, there's still not much data. However, I do not like the tone of this part of it:

Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as "novel tobacco products," have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additional restrictions that FDA seeks to promulgate for the proposed deemed products would reduce initiation and increase cessation (particularly among youth). This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary given that consumer use may be gravitating to the proposed deemed products.

If this is simply a summary of FDA's language, I'm not surprised. If this language originated with OMB, it makes me even more nervous.

 

[AgentAnia]

With the advent of EU regs and upcoming FDA regs on ecig under the hammer of tobacco products (and as medical devices in the EC downstream - not if but when), I wonder how manufacturers and vendors are currently approaching these regulatory adverse events? Everything in the vaping world is programmed to suffer death by a thousand cuts: nic, flavors, tanks, cartos, mods. Infuriating!

I am a fortunate vaper indeed! There's just one B&M in my town. It's just two blocks from me. It's for real; they even carry Provaris. And the owners are active members of SFATA, and were primed to fly to DC for the SFATA flyin before a family emergency prevented it. When I'm in the store, we spend more time discussing regs and vaping politics than we do equipment.

So yes, there are vendors out there who care and who are involved. Just not sure, at this point, if there are enough...

 

[Orb Skewer]

I think Uma encapsulates it here (from another thread)

"The FDA is passing the buck to individual towns. NYC, Boston, San Rapael, you name it, they're doing the devils dirty work for them.
It all began with a nice little meager statement consisting of "we have no power to ban eCigs or tobacco, but you towns, cities, and states do".


It's mission creep

 

[ennagizer]

I can't be the only one - I read the rule several times and as soon as I think I understand something the next sentence/section makes me question my understanding.

 

[NorthOfAtlanta]

I can't be the only one - I read the rule several times and as soon as I think I understand something the next sentence/section makes me question my understanding.

Bureaucratic thought speech, they don't understand it, how are we supposed to?

 

[drtwain5]

1. I have been searching today and cannot find that the text of FDA's proposed rule has been published/made public anywhere, so with just the OMB's response, there's still not much data. However, I do not like the tone of this part of it:

Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as "novel tobacco products," have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additional restrictions that FDA seeks to promulgate for the proposed deemed products would reduce initiation and increase cessation (particularly among youth). This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary given that consumer use may be gravitating to the proposed deemed products.

If this is simply a summary of FDA's language, I'm not surprised. If this language originated with OMB, it makes me even more nervous.

Ominous and perverse. This has little to do with actual health risks and evidence based epidemiology, but everything to do with taxation, FDA marketing approvals and control. While prohibitionists assert that vaping is a gateway to tobacco addiction for teenagers basedon findings from a single, unconfirmed CDC study¹, their own evidence may be interpreted to mean that vaping presents an off-ramp to tobacco use in adolescents.
¹Centers for Disease Control and Prevention. Notes from the field: electronic cigarette use among middle and high school students—United States, 2011-2012.

 

[WorksForMe]

If I read this rule correctly, it is only a notice that they are planning to issue an NPRM in December, along with their justification and authority to do that. Hopefully somebody with more legal/government knowledge will comment.

J.R.

 

[stevegmu]

If I read this rule correctly, it is only a notice that they are planning to issue an NPRM in December, along with their justification and authority to do that. Hopefully somebody with more legal/government knowledge will comment.

J.R.

Yes, that's correct. Nothing has been stated as of yet. My guess will be it will be pushed until next year. The government hardly gets anything done in December.

 

[Bill Godshall]

View Rule

The proposed rule has two parts: one part deems all tobacco products to be subject to the FD&C Act; the other part proposes additional provisions that would apply to newly-deemed products as well as to other covered tobacco products. The proposed deeming action differs from most public health regulations in that it is an enabling regulation.

Alternatives: This should describe, to the extent possible, the alternatives the agency has considered or will consider for analysis (section 4(c)(1)(B) of E.O. 12866). Special consideration should be given to flexible approaches that "reduce burdens" and maintain "freedom of choice for the public" (section 4 of E.O. 13563). In addition to the benefits and costs of the proposed rule, FDA has estimated the benefits and costs of several alternatives to the proposed rule: deeming only, but exempt newly-deemed products from certain requirements; exempt certain classes of products from certain requirements; deeming only, with no additional provisions; and changes to the compliance periods.

Risks: This should include, if applicable, a description of "how the magnitude of the risk addressed by the action relates to other risks within the jurisdiction of the agency" (section 4(c)(1)(D) of E.O. 12866). You should include a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction. Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as "novel tobacco products," have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additional restrictions that FDA seeks to promulgate for the proposed deemed products would reduce initiation and increase cessation (particularly among youth). This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary given that consumer use may be gravitating to the proposed deemed products.

 

[Dave_in_OK]

The way I read this is the deeming rule is to give them the power they need to do what they want. Meaning that they currently do not have that power. That in it's self scares the crap out of me! I don't feel that they need any more power; if anything I feel they should have less.

 

[stevegmu]

The way I read this is the deeming rule is to give them the power they need to do what they want. Meaning that they currently do not have that power. That in it's self scares the crap out of me! I don't feel that they need any more power; if anything I feel they should have less.

They already have it. The OMB just allows for funds to be used for regulations. They have been given the green light to use taxpayer money to issue proposed regulations, as long as they are in the scope of what is listed in the rules. As OMB is an arm of the Administration, the FDA now officially has the backing of the President to go forward.

 

[zacherychristopher]

Didn't Thomas Jefferson say that the constitution was written and in acted to protect us from the greatest form of tyranny which is too much government? I am very bad at politics and writing political letters...I have written my state senators and representatives at federal and state level and haven't gotten a response or even an indication they got my mail beyond the auto generated ones on the web pages...but that was during the government shut down so who knows? I just think it's funny that we can't even get enough money together to keep the government going but they can pull all this cash to regulate the things that help us...guess it's time to stock up

I read that link twice and I don't understand a word of it so maybe someone can right a "large print for G.E.D holders" edition of me please? I joined the CASAA, but i missed the last meeting do to work. If there is something else I can do to help or someone can explain to me how we can stop this from happening I am all ears...I am not off topic...I am honestly confused by the double speak college legal fine print mumbo jumbo in this and need someone to explain to me what we can do to fight back other than just hold our breath and wait for elected officials to read our pleas...is there someone else I can write? I rally? A fundraiser? how bout a bake sale? Seriously? How can the FDA in a day in age when we are supposed to be so inlightened and should have learned from the first tobacco prohibition and alcohol prohibition later on that taking things away doesn't solve the problem for anyone....it just makes things worse till the government figures out a tax schedule and gives it back highly controlled at a price hike to cover the "taxes", pats themselfs on the back and gives eachother a raise in pay it feels like...and this seems to be starting out no different. please tell me I am wrong? help me understand..

 

[CES]

This may be slightly off topic, but I had contacted my senators about the upcoming proposal of the deeming regs, and one of them suggested that i also contact May Nelson at the FDA directly, and provided contact information:

May Nelson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-32
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850

As the deeming process moves forward, Ms Nelson might also be a person to contact.

 

[chuckie]

Looks like the typical scare notices that the vendors post on this forum every few months.Find a place to buy glycerin and learn to wrap a coil and you'll be fine.

 

[stevegmu]

Looks like the typical scare notices that the vendors post on this forum every few months.Find a place to buy glycerin and learn to wrap a coil and you'll be fine.

I've thought this for a while. What better way to drum up business? Wonder how many would go out of business if/when the FDA issues their regulations and they turn out to be no big deal...

 

[Orb Skewer]

I've thought this for a while. What better way to drum up business? Wonder how many would go out of business if/when the FDA issues their regulations and they turn out to be no big deal...

So, as forums mainly get footfall from the 'niche' end of the market (not the mass market cig-a-likes), and those people on the forums then panic (because of this cunning master plan), start learning about DIY (e-liquid), buy a rebuildable or two, metres of wick, a couple of drums of kanthal, flavourings and base nic (enough to open a small shop), and start looking at Fast tech (other budget suppliers are available) and end up with enough 'stuff' to keep them from buying from vendors on a regular basis, and also stocked against the possible apocalypse for months on end ?

yeah, that makes sense