US Federal Appeals Court Panel upholds New York City's ordinance banning some flavored OTP

[Bill Godshall]

US Appeals Court panel upholds NYC ban on some flavored OTP
http://www.ca2.uscourts.gov/decisio...4c6f-953b-e7ff83d1e74a/1/doc/11-5167c_opn.pdf
Wednesday, February 27 | Talk Radio News ServiceTalk Radio News Service

The following excerpt (on pages 3-4) of this court ruling presents an excellent summary of the legal limitations and requirements for the FDA to propose/approve new regulations for tobacco products (under Chapter IX of the FSPTCA).

If/when the FDA proposes the "deeming" regulation (to regulate e-cigarettes, cigars and other products under Chapter IX provisions), the agency has stated that it also intends to propose additional regulations (presumably that would ban e-cigarette sales to minors, require warning labels, restrict nicotine levels, advertising, promotions, sponsorships, sales, and/or flavorings).

Seems like some/many of the requirements in the third paragraph (below) for FDA to consider when proposing/approving new regulations for e-cigarettes cannot be met unless the FDA grossly misrepresents the evidence on e-cigarettes.


The Family Smoking Prevention and tobacco Control Act


Congress enacted the FSPTCA in 2009 to grant the Food and Drug Administration
(“FDA”) authority to regulate tobacco products under the Food, Drug, and Cosmetic Act,
21 U.S.C. § 301 et seq. See 21 U.S.C. § 387a(a). Under the Act, the FDA’s authority
extends to the regulation of “all cigarettes, cigarette tobacco, roll-your-own tobacco, and
smokeless tobacco and to any other tobacco products that the [FDA] by regulation deems
to be subject to [the Act].” Id. § 387a(b).

Of particular relevance to the present action is § 907 of the FSPTCA. Entitled
“Tobacco Product Standards,” it sets out a “special rule for cigarettes,” which provides
that “a cigarette or any of its component parts . . . shall not contain, as a constituent . . . or
additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or
spice.” Id. § 387g(a)(1)(A). Section 907 further grants the FDA authority to revise the
special rule for cigarettes, id. § 387g(a)(2), and to adopt additional product standards if
“appropriate for the protection of the public health,” id. § 387g(a)(3)(A). Specifically,
the FDA is authorized to establish standards “respecting the construction, components,
ingredients, additives, constituents, including smoke constituents, and properties of . . .
tobacco product,” id. § 387g(a)(4)(B)(i), and to adopt provisions restricting their sale
3and distribution, id. § 387g(a)(4)(B)(v). The FDA may not, however, “ban[] all
cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little
cigars, all pipe tobacco, or all roll-your-own tobacco products,” or “requir[e] the
reduction of nicotine yields of a tobacco product to zero.” Id. § 387g(d)(3).

Before imposing “restrictions on the sale and distribution of a tobacco product,”
the FDA must determine “that such regulation would be appropriate for the protection of
the public health.” Id. § 387f(d)(1). In deciding whether a regulation is appropriate, the
FDA must consider “the risks and benefits to the population as a whole, including users
and nonusers of the tobacco product.” Id. Specifically, the FDA must take into account
“the increased or decreased likelihood that existing users of tobacco products will stop
using such products,” as well as “the increased or decreased likelihood that those who do
not use tobacco products will start using such products.” Id. § 387f(d)(1)(A), (B).
Finally, the FDA may not “prohibit the sale of any tobacco product in face-to-face
transactions by a specific category of retail outlets; or . . . establish a minimum age of sale
of tobacco products to any person older than 18 years of age.” Id. § 387f(d)(3)(A).

 

[FloridaNoob]

true, but I am thinking they will go after flavoring as a possible avenue based on the above. I mean nic content won't cause someone to start/stop vaping, so to speak. However, they could say that flavors would attract persons to vaping. I think there would be large grounds to fight against any nic reduction in E-liquids as the nic content level does not hep to either encourage someone to start, nor would it encourage someone to quit using them. That said, flavoring can be offered in non-nic concentrations to be added by the user to their nic liquids. Say at a 50/50 ratio. Buy 16 mg nic 80/20 pg/vg and mix with 80/20 pg/vg flavored in equal parts would end up with the right flavor concentrate at 8 mg nic strength. Problem solved.

 

[Lilkurty]

This is encouraging as before they impose restrictions they have to look at all of the impacts

Less smokers
Less butts
Less environmental smoke
Less fires and burn injuries
Less burdon on health care
Possible therapeutic uses in mental health and better delivery of oral antibiotics etc
NJOY recycles their packaging
Less cost means less underground (especially up here in Canada where it is significant)

I am sure that there are many more but the point is that this suit was hoping to not have to deal with that part of it because they know that they cannot possibly argue that benefits outweigh detriments of their product.

 

[Bill Godshall]

Since 2009, the FDA has falsely claimed that flavored e-cigarettes are target marketed to youth, and that there's no evidence e-cigarettes are less hazardous than cigarettes. But federal judges base their court rulings on actual evidence, not fear mongering propaganda.

But there's no evidence e-cigarettes have ever addicted any non tobacco user, there's no evidence that e-cigarettes have ever harmed anyone (except for a dozen exploding battery incidents more than a year ago), and there's no evidence that e-cigarettes are marketed to youth.

Virtually all e-cigarettes (>98%) are used by smokers or former smokers (who quit by switching), and surveys have found very little "ever use" or "past month" use of e-cigarettes by youth (far less than alcohol, pot, cigarettes and cigars and less than smokeless tobacco and hookah).

 

[Fiamma]

IMHO if the FDA decided to limit nic to 4mg period and to only allow non refillable sealed carts with flavors limited to tobacco and / or menthol, it would not only prevent people from being able to make the switch to e cigs, it would send some e cig users back to tobacco.

There are a lot of people who vape 24mg and some who vape 36mg to get over the hump when making the switch. They then may lower nic levels as they get adjusted to the lack of the MAOI's and other chemicals in cigarettes, or they may not. There are other things in cigs that create the smoking rush besides nicotine, but for most people I've known who made the switch they needed much more than 4mg of nic, and the flavors do help in making that switch.

I would never have considered even trying if I had to vape tobacco or menthol only. My success came from dessert flavors, primarily. I vape them and don't eat the sweets, no weight gain and no sense of deprivation. I am smoke free now for 2 years, at 4mg nic. I started with 16mg nic and pretty much the PV never left my hands. I smoked for 55 yrs.

The line in that law: "Finally, the FDA may not “prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets;" says they can't ban you from buying whatever they decide to allow us to have in a store, BUT it does not say we can still buy online. That alone would shut a lot of e cig vapers off without a source, except for Blu, Njoy and stick type stuff sold in convenience stores, gas stations, WalMart et al. Bothers me also that they mention "specific category of retail outlets". What does that mean in plain English?

As April gets closer a lot of places are rushing to ban e cigs in various situations, including in some localities vaping in a condo you OWN. Everyone is in a hurry to get laws and ordinances in place. WHY? Suddenly Calif is floating a bill to BAN e cigs everywhere smoking is now banned. They think the Gov this time out will sign it if enacted, where the prior one said adults can make their own decisions. I live in Calif and I am not happy about that.

I've been fighting this kind of action since long before I joined ECF. Letters, emails, phone calls. It's like butting your head against a stone wall, coming back bloody, and doing it again. The country has been sold a huge bill of goods by organizations they think they can trust to look out for their health. Those organizations are corrupt and have been lying through their teeth all along. Anything that 'looks like smoking' is anathema to them and they have grossly influenced the mass of our population. Zealotry and people who blindly accept the lies will do it to you every time. Smoking will kill you. Vaping will probably not. You roll the dice and you take your chances. It's called freedom of choice. They would erase that freedom to fit their world view and they have been working at it for years. These organizations ask for your donations, to work against you. The government takes your taxes and works against you. Where will it end? I fear we shall soon see.

FloridaNoob:

To make your suggested mix the flavored juice would have to have close to double flavor or you wouldn't get much of a taste. Not many people making the switch can do it on 8 mg nic juice. You also assume the FDA would allow 16mg non flavored juice.

 

[Petrodus]

Ya think the rush to ban e-smoking is bad now ...
Wait till the FDA announces the regulations it wishes to put in force.
Everyone opposed to e-smoking, as well as those wishing to get
a jump on banning e-smoking, will be dancing in the street using
the FDA's propaganda to push for bans everywhere.

 

[the_vape_nerd]

Who cares what they do to flavors?

It's the nicotine ban thats going to be problematic.

I can buy flavoring on Amazon right now and unless they decide to ban PG based food flavorings it's a non issue.

 

[Fiamma]

Who cares what they do to flavors?

It's the nicotine ban thats going to be problematic.

I can buy flavoring on Amazon right now and unless they decide to ban PG based food flavorings it's a non issue.

Well sure but you DIY and most smokers don't and most new vapers don't right away. What about them? Or do you live on an island...

 

[sonicdsl]

Who cares what they do to flavors?

It's the nicotine ban thats going to be problematic.

I can buy flavoring on Amazon right now and unless they decide to ban PG based food flavorings it's a non issue.

That may be true for many of us that have been vaping for awhile, but there are so many smokers who have yet to discover the joy of vaping. If they rule out flavors, that would probably turn many away, effectively condemning them to a potential death sentence.

 

[Lilkurty]

We have seen the excellent success rate of "the hardest core" smokers quit entirely because of the flavours. After you get over the hump and adjust your nic levels down, it's all about the enjoyment of vaping flavours. And my God 4 mg! That's nothing!,
I don't know how it can be so difficult for the FDA to realize that you don't try to fix something that is not broken. So I can see where they would want to know that the juice is manufactured with consistency and properly labelled, sealed and not accessible for children to buy. But I really hope that they realize that a market that is only e cigs will not be as successful.
The advantage we have IMO is that our product is so simple. I couldn't take a reg cig or little cigar and make it flavoured but I damn well can add flavouring to nic juice.

 

[Fiamma]

We have seen the excellent success rate of "the hardest core" smokers quit entirely because of the flavours. After you get over the hump and adjust your nic levels down, it's all about the enjoyment of vaping flavours. And my God 4 mg! That's nothing!,
I don't know how it can be so difficult for the FDA to realize that you don't try to fix something that is not broken. So I can see where they would want to know that the juice is manufactured with consistency and properly labelled, sealed and not accessible for children to buy. But I really hope that they realize that a market that is only e cigs will not be as successful.
The advantage we have IMO is that our product is so simple. I couldn't take a reg cig or little cigar and make it flavoured but I damn well can add flavouring to nic juice.

Plain fact is the FDA doesn't care what we want, they need to please their paymasters. We are not their customers, pharma is.

 

[Lilkurty]

Plain fact is the FDA doesn't care what we want, they need to please their paymasters. We are not their customers, pharma is.

And that is the saddest thing isn't it. It may not be scientific but we have proven by our numbers that our current system is successful and safe just as it is. This alone is obviously a huge step forward for public health that would have a tremendously positive influence on so many more. Yet the FDA is not motivated by improvements in public health.