Skip to comments.FDA proposes first e-cigarette rules, including banning sales to minors
Posted on 04/24/2014 12:06:57 PM PDT by Tolerance Sucks Rocks
WASHINGTON The federal government wants to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration.
While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.
(Excerpt) Read more at foxnews.com ...
Nanny State PING!
Yup. Crack down on evil tobacco and those evil E-Cigs and loosen the reigns on wonderful pot. So, in 40 years or so, will “they” discover “they” made a huge mistake? Will pot companies be forced to stop advertising and marketing and have to pay for their “awful lies”?
Gonna go fire up a Marlboro now. While it’s still legal.
You think that’s bad, when I use to live in the totalitarian state of New York city, Despot Mike Bloomberg demanded a list from all landlords of the tenants who smoke in their apartments.
keeping drugs from kids?
such an outrage
This is only one small part of what Owebama’s plans were, the big item he announced was putting the full tobacco tax on pipe tobacco and cigars!
That roll your own ‘pipe tobacco’ is going to be taxed at the same rate as cigarette tobacco!
Hey! It was for your own good. He don’t care if you like it or not. :>}
The cool thing about these devices is you can make your own e-cig fluid at home. The ingredients are common to food production and insecticide.
Regardless what Constitution-ignoring socialist FDR's activist justices wanted everybody to think about the scope of Congress's Commerce Clause powers, and with the exception of federal entities under the exclusive legislative control of Congress evidenced by the Constitution's Clause 17 of Section 8 of Article I, the states have never delegated to the feds, via the Constitution, the specific power to regulate intrastate commerce. This is evidenced by the following excerpt.
State inspection laws, health laws, and laws for regulating the internal commerce of a State, and those which respect turnpike roads, ferries, &c. are not within the power granted to Congress. (emphases added) Gibbons v. Ogden, 1824.
So the idea of the federal government wanting to ban sales of electronic cigarettes to minors, while arguably a good thing, is nontheless outside the scope of Congress's Commerce Clause powers imo. The states need to legislate such bans under their 10th Amendment-protected powers until they choose to amend the Constitution with such a prohibition.
Unfortunately, many freepers don't care about constitutionality, if their ox isn't gored.
For over 100 years SCOTUS has held that they do have that authority.
How do you dry and cure your leaves?
Much of the progressive slide into the pit began about 100 years ago with unconstitutional rulings by the Supreme Court.
It will take vocal fighters to reverse that progressive crap.
It's a rather long process, but I'm happy with it. It took a few years of experimenting before I found a process that I was happy with.
“, Despot Mike Bloomberg demanded a list from all landlords of the tenants who smoke in their apartments.”
Is that even legal? You know,that silly old fashioned thing called privacy.
We must do something about this immediately!
It’s a DRUG DELIVERY DEVICE.
Nothing in the proposed regulations prevents an ADULT from feeding their addiction 24/7, 365 days a year.
More to the point, I am curious if you have a purpose-built structure where you dry and cure your leaves. Also, how long does it take for you to dry and cure your leaves?
Maybe I’m old fashioned but I thought it was the parents’ responsibility to keep drugs from kids.
If something is legal to sell it’s not the government’s business who buys it.
And God help you if you grow any in your backyard.
Feds can pound sand.
We have about a 60 day growing season here, and even in that it is likely to frost.
I don’t even know if it would grow here?
Tobacco can grow almost everywhere. It even grows well indoors.
Trees is about all I can grow here.
I’m in the middle of a woods, stuff don’t get enough sunlight.
As I've ranted in similar threads, the problem is that parents have not been making sure that their children are being taught the federal government's constitutionally limited powers.
On a related note, I think that even conservative legal professionals, including justices, got indoctrinated in college instead of being taught the federal governments limited powers as the Founding States had intended for those powers to be understood.
Not all of them contain any nicotine. Is Johnson & Johnson and the rest of big pharma (they are behind the push for all this regulation)required to put such a warning on their "nicotine delivery devices?"
How about caffeine, it's an addictive chemical, and one which is regularly sold to minors - should coffee and sodas have warning labels and age restrictions?
Comparing nicotine addiction to caffeine is a wining issue for vapids. I urge you to keep using it as they are very comparable and your argument resonates with the public.
I urge you to keep utilizing the words and arguments of the left, it works wonders on sites such as this. Keep up the good work.
Before the advent of the Ultra Nanny State tobacco was grown all around here in Wisconsin - I can assure you it is not bothered by short seasons or extreme cold. Now our corn goes into our gas tanks. Idiots rule!
Of course, they are safer, but we can't let them tell anyone that. Nicotine is addictive, yes, but only minimally harmful, akin to caffeine. It is the 3,000 other chemicals in tobacco cigarettes that give you lung cancer.
So the tobacco companies are behind this. $2 billion of e-cigarette sales are eating into coffin nail sales, so e-cigs must be held up while the tobacco industry re-gears to take over the budding e-cig industry ... using the heavy hand of the state get their way: registration of existing products, lawyers, paperwork, etc. K-Street is out in force for the tobacco industry on this.
Then, when RJR, Lorillard and B&W have an 80% market share, suddenly e-cigs will be safer and they will be called 'mild' and 'light'.
Not B&W anymore, but Altria.
Its a DRUG DELIVERY DEVICE.
Then a Keurig coffee maker is a drug delivery device also. And Starbucks is a pharmacy.
They deliver caffeine. A mild addictive stimulant.
I think this is great news and a win for people and public health. The FDA basically did nothing.
Much like the Keystone pipeline, they just punted.
This is a summary I trust.
Thursday, April 24, 2014
FDA’s Proposed Electronic Cigarette Deeming Regulations: The Good, the Bad, and the Ugly
This morning, the FDA finally released its draft deeming regulations for electronic cigarettes. Here is my initial take on these draft regulations from a public health perspective. I have divided my analysis of the 241 pages of provisions into three sections: the good, the bad, and they ugly.
1. The regulations ban the sale of electronic cigarettes to minors, both in person and via the internet.
The ban on the sale of electronic cigarettes to minors is a critical aspect of the proposed regulations. If properly enforced, it will help keep these products out of the hands of minors. An additional benefit of this provision is that it will obviate the need for every city and town council in the nation to enact its own e-cigarettes sales restrictions.
2. The regulations do not ban the sale of electronic cigarettes to adults via the internet.
A ban on the sale of electronic cigarettes to adults via the internet would have been devastating to the bulk of the electronic cigarette market and would have placed an immediate limit on the potential for growth in this market.
3. The regulations do not ban the use of flavorings in electronic cigarettes.
Many anti-smoking groups and advocates have been pushing for a ban on the use of flavorings in electronic cigarettes. Such a ban would have devastated the industry, as the flavors are a key aspect of what makes these products competitive with tobacco cigarettes. In addition, the flavors make e-cigarettes distinct from tobacco cigarettes and make it much less likely that people who switch to these products will return to regular cigarettes. In addition, youth who use flavored electronic cigarettes are most likely less inclined to initiate smoking because once they are accustomed to the flavors, cigarettes would seem extremely harsh.
4. The regulations do not ban or restrict e-cigarette advertising or marketing to adults.
Many anti-smoking groups and advocates have been calling for a ban on all e-cigarette advertising. This would of course have been devastating to the industry and would have given tobacco cigarettes an unfair advantage in the marketplace. The FDA decided to defer any decision on marketing restrictions at this time. It is likely that the agency will revisit this issue in the future, but with more time, the FDA can craft marketing restrictions that balance the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.
5. The regulations do not immediately pull any e-cigarette products from the market.
One of my fears in advance of the release of the regulations was that they would require substantial equivalence determinations for most products currently on the market an would pull some products from the market pending such determinations. Instead, the agency decided to allow all existing products to remain on the market, giving them two years to apply for FDA approval. In addition, new products can enter the market for the next two years without pre-approval from the agency.
If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.
1. The regulations do not limit the marketing of electronic cigarettes to youth.
There does need to be some restriction on the marketing of electronic cigarettes to youth. The FDA deferred a decision on marketing restrictions at this time. However, it is important that the agency does revisit this issue and that it craft restrictions that carefully balance the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.
2. The regulations require pre-approval (or substantial equivalence determinations) for all new electronic cigarette products.
This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market.
3. The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products.
This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail’s pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market.
1. The regulations apply section 911 (the modified risk product provisions) to electronic cigarettes.
This is a complete disaster and is not in the interest of protecting the public’s health. In fact, this provision is going to harm the public’s health. It is going to require manufacturers to implicitly lie about the intended purpose and relative safety of their products.
Sadly, the agency concluded that it is not sure that e-cigarettes are any safer than tobacco cigarettes. The FDA states: “Many consumers believe that e-cigarettes are “safe” tobacco products or are “safer” than cigarettes. FDA has not made such a determination and conclusive research is not available.”
That the FDA is not sure whether smoking is any more hazardous than vaping does not say a lot for the agency’s scientific standards.
This provision is going to undermine the public’s appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes.
In addition, this is going to force companies to rely on other methods to pitch their products, such as using sexy models, emphasizing that e-cigarettes can be used where tobacco cigarettes are allowed, and relying on celebrity endorsements. The FDA is literally forcing e-cigarette companies to lie about their products and instead of pitching them as safer alternatives to smoking, to pitch them with non-health-related benefits.
Under this provision, an electronic cigarette company cannot even inform consumers that the product does not produce smoke because such a claim would be considered a “reduced exposure” claim under the Tobacco Act.
All in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination (if not a new product approval), and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.
At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.
Thanks for the ping!
I saw your argument with Gabz a minute after I posted that.
As far as being a drug delivery device, you are 4 years behind the justice system.
The FDA already tried that stunt and lost in court.
Just an FYI.
Thank you. This is very useful.
Lorillard bought an e-cig company, blue ecigs, for $135 million in 2012. They will have a huge advantage in being able to fund the cost of the massive red tape associated with these regulations. The effect will be to reduce consumer choice and competition.
Despite how the big gubmint loving state run media proclaim this to be stone tablets from heaven, they are not.
These are “proposed” rules. There is a 75 day comment period. Then they won’t go into effect for 2 years.
A lot can change politically in 2 years. And will.
Yea, more Obama!