Tennessee Senate Bill 910 - ban on e-cigs or sloppy language?

[sjrily]

OK - This came up on FB and I thought I'd see what was here. Searched the forums and couldn't find any threads (if there are some, I apologize for my sloppy searching).

But there's a petition out against Tennessee banning the actual sale or distribution of e-cigarettes http://www.capitol.tn.gov/Bills/107/Bill/SB0910.pdf. There's nothing reported on electroniccigaretteban.org, but then I looked up the Tennessee Code and started reading the actual code that would be changed and tried to decipher exactly what the new language means (the first and last paragraphs of the bill).

Basically - I'm not so sure Tennessee is pushing through a ban on all sales of e-cigs - and if they are, they are leaving all kinds of room for lawsuits. I'm going to be lazy and more or less restate/expand the last post I made on FB, so:

First look at the last paragraph of the bill which reads:

"It is an offense to distribute or sell any product or device containing or
delivering nicotine intended or expected for human consumption that is not a tobacco​

product, as defined in § 39-17-1503, unless such product or device has been approved...."


But the very first paragraph indicates the definition of e-cigarettes will be ADDED to §39-17-1503 as such:

"Electronic cigarette" or "E-cigarette" means a battery-operated device that contains
cartridges filled with nicotine, flavor and other chemicals that are turned into vapor which is inhaled by the user;"​

The problem here is that the language doesn't EXPLICITLY identify e-cigs as a tobacco product as it does bidis (see code) - so is it defined as a tobacco product by being in that section or not? Since the US Appeals ruled e-cigs could not be regulated as a drug, but instead as a tobacco product (which means they can restrict some things, but not the actual sale) does that make it a given? I would think so, but I've never known legal language to make assumptions of this sort.

But anyway, then you look at ALL the amendments where what originally read "tobacco products" now reads "tobacco products or electronic cigarettes" and you have to ask what the point of all that is if all sales and distributions are being banned.

For example: 39-17-1504 (a) will now read: "It is unlawful for any person to sell or distribute any tobacco products or electronic cigarette to another person who has not attained eighteen (18) years of age or to purchase a tobacco products or electronic cigarette on behalf of such person under eighteen (18) years of age."

39-17-1506 (a) will now read: "Every person who sells tobacco products or electronic cigarettes at retail shall post conspicuously and keep so posted at the place of business a sign, no smaller than ninety-three and one-half (93½) square inches, to ensure that it is likely to be read at each point of sale, stating the following..."

If the sale of e-cigs where to be "illegal," then all of these changes would be about as stupid as saying "It is unlawful for any person to sell or distribute any tobacco products or electronic cigarette, or weed to another person who has not attained eighteen (18) years of age."

See what I mean? I was thinking the last paragraph intended to address other products (perhaps not yet invented), and if the new definition of e-cigs added to 39-17-1503 was explicit about being a tobacco product, I would be certain of that, because it WOULD be a tobacco product as defined in section blah blah, and all the other amendments would make perfect sense as they related to sale and distribution to minors.

But if the last paragraph means truly that the sale of e-cigs will be forbidden, then the changes/additions in Part 1 and Part 15 are in complete conflict. The language in Part 1 addition bring to question a lot of other things (such as bottles of e-juice, since those are not e-cigarettes as e-cigarettes are defined, but they are products containing nicotine), but I want to figure out first if this really is a ban on all sales. (And if so, can a state overstep federal ruling? If they can do this could they also ban all sales of tobacco cigarettes?)

post thought - If in fact this is not a ban on all sales, then we might consider whether or not we are over-reacting whenever e-cigarettes are mentioned (I know I did). The state capital was bombarded with petition emails - and I almost sent one too, but something bugged me about the language and I wanted to understand it first. We need to be reasonable and rational ones and retain credibility - not be reactive like the antis. If we're reactive then that means we're operating on emotion too - which is what we're fighting.

I'm ready to mail a petition, I just want to make sure there's something to petition. So can anybody help me out here?

 

[Brutus Buckeye]

Here is what we have started in the TN Forum:

http://www.e-cigarette-forum.com/forum/tennessee-vapinteers/168631-call-action-tn-vapers.html

 

[sjrily]

Ah - Ok, didn't see that thread. But I still hope someone will discuss the actual language and the issues I pointed out. Is this really a ban on all e-cig sales or have we over-reacted without fully reading what was being changed and how? Is it more about regulating sales to minors and adding a provision for nicotine products NOT defined as tobacco products? I don't know, that's why I brought it up for discussion.

I really think it's important we understand - if we petition every time there's legislation involving e-cigs, we'll stop being heard. We do want there to be regulations regarding minors - if that's more what this is about, then we definitely DON'T want to petition that. And all amendments except the last one indicate this is about access to minors

 

[Brutus Buckeye]

sj I'm with you on the confusion of the way this was written, but it is the last paragraph to me that looks to be a straight out ban on e-cig sales. I also like the fact that this seemed to be hidden withing the Agriculture Sub-Committee and not in the Health Sub-Committee.

 

[sjrily]

Yeah! I still haven't figured what that's about (but I'm trying *lol*) But what do you think about the statement " as defined in 39-17-1503," and then the inclusion of e-cigs (defined) in same? They don't state e-cigs are banned - only that products not defined as tobacco products are banned. That to me seems a lawsuit waiting to happen (against the state, if they ban all sales - since it's been ruled they are tobacco products).

And what are your thoughts about all the changed language in Part 15 —Prevention of Youth Access to Tobacco? Why would regulation regarding youth access now include e-cigarettes if by the same pen stroke sales to all people are banned?

 

[Brutus Buckeye]

I agree, very confusing language. I plan to talk to my rep tomorrow and get some clarification.

 

[sjrily]

Great! Please post back what you hear. I can't call cause I'm the next state over.

I did find this on the legislative report 3/4/11 here:

SB 0910: Sale of electronic cigarettes to minors. Prohibits the sale of electronic cigarettes to minors. Prohibits distribution and sale of non-FDA approved nicotine delivery products or devices as tobacco use cessation products. Creates Class B misdemeanor for violations and authorizes the court to impose a civil penalty of no more than $10,000 for each violation. (S: Overbey; H: Armstrong)
House Co-Sponsors: Favors; Tindell
Senate Status: Referred to Senate Commerce, Labor & Agriculture.
House Status: Referred to House General Subcommittee of Agriculture.

It's looking more like the summaries all read that what they're making an offense is selling non-FDA approved, non-tobacco cessation devices/products (of which e-cigs are not, according to the court) but it's not quiet worded that way in the actual bill. It's nonsensical to require FDA approval on something the courts have stated is not under FDA jurisdiction.

I'm just really concerned we jumped the gun (though a petition that they clean up the language would be in order). The last thing we want to do is petition regulation of sales to minors. That kind of press could seriously hurt a cause for e-cigarettes. I wish more people would look into this.

(And on the Argi SC - tobacco is argi, of course, but it's probably theirs because they are also concerned with "human nutrition"

 

[kristin]

CASAA is working on letters and a Call to Action page.

YES, this would ban the sale of e-cigarettes and nicotine cartridges and nicotine liquid in bottles.

There is no federal court ruling that e-cigarettes are a tobacco product. No e-cigs have been approved or classified by the FDA in any way, shape or form. The FDA does have the authority to regulate them, as they contain nicotine - it's just a matter of HOW they can regulate them.

Judge Leon and the D.C. Appeallate court gave an opinion when they ruled on the injunction that the FDA did not prove its case that it had the right to detain e-cigarettes as drug delivery devices and had to stop holding shipments of Smoking Everywhere and Njoy ONLY, and gave the opinion that the FDA should regulate e-cigs (sold by those 2 companies) as tobacco products, but did not order the FDA to do so. So the states would not be overstepping anything. States often have the power to make federal laws more stringent, they just can't make them less so.

All of the language covering sales to minors is in there should the FDA eventually approve them as smoking cessation or tobacco products. Then they would still prohibit the sale to minors AND it covers the illegal sale to minors once it gets into the coes stage, where fines and penalties are decided. There will probably be harsher penalties for sales to minors.

Edited to add: Also, should the FDA approve one brand of e-cigs as a smoking cessation device (which most lobbyists are convincing legislators these should be regulated as) it does NOT automatically approve ALL e-cigs as smoking cessation devices. So, there could feasibly be both approved and unapproved e-cigarettes on the market in the future. (Some e-cig companies are still going that route.) Should e-cigarettes that don't claim to be smoking cessation devices be officially recognized as tobacco products, they should all fall under "tobacco products," which thanks to the FSPTCA the FDa now regualtes, as well. Some, many or all e-cigs looking to be classified as tobacco products may not meet the FDA deadline as a new tobacco product and may not get "approval" as a tobacco product, either. (I know - it's very confusing!)

 

[kristin]

Actually, I've amended my last post. This WOULD ban liquid refill bottles because they contain nicotine intended for consumption and are not FDA-approved as a smoking cessation product nor are they recognized as a tobacco product.

 

[sjrily]

Thank you Kristin! That helps - and yeah - it was an opinion - I should have recognized that. But I'm still confused - The court said they could regulate e-cig sales as tobacco products, but they could not regulate them as drugs. The FDA can only approve drugs - they can't by their nature and by law approve tobacco. And if the FDA DID ever approve them as drugs, then the language regarding sales, etc. for "tobacco products or electronic cigarettes" is moot. The definition of electronic cigarettes in section 39-17-1503 would also be moot. It doesn't include patches and gum, only tobacco products. If e-cig were ever approved as a cessation (drug) product, they would no longer be a tobacco product - so I don't understand what purpose the amendments serve. I hope I'm making sense...

 

[sjrily]

But the FDA can not approve tobacco products: the FDA itself has previously asserted that if tobacco products were within its jurisdiction, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use. It can only approve drugs.

And I wondered to where the e-juice fit in, it is a product that contains nicotine, but it is not included with the e-cig definition to be added in the section mentioned.

 

[GMoney]

Actually, I've amended my last post. This WOULD ban liquid refill bottles because they contain nicotine intended for consumption and are not FDA-approved as a smoking cessation product nor are they recognized as a tobacco product.

I agree. That is my reading also.

But the FDA can not approve tobacco products: the FDA itself has previously asserted that if tobacco products were within its jurisdiction, they would have to be removed from the market because it would be impossible to prove they were safe for their intended use. It can only approve drugs.

And I wondered to where the e-juice fit in, it is a product that contains nicotine, but it is not included with the e-cig definition to be added in the section mentioned.

Tobacco WAS not under the jurisdiction of the FDA. Congress passed a bill to give the FDA the power to regulate tobacco products but they cannot ban them.

 

[cheechwiz]

Why does the goverment have to always try to ruin good things

 

[kristin]

Sharon, the FDA doesn't have the power to ban tobacco products, but it does now have the power to approve NEW tobacco products and regulate ingredients and marketing. At this point the FDA is still insisting e-cigs are new, unapproved drug delivery devices, so all they have to do is require approval as drugs and that will effectively remove them from the market until they can get approved.

The court case ruling only applies to two companies - Njoy and Smoking Everywhere (which actually withdrew from the case) and it does NOT rule those products to be tobacco products, it just rules that they are NOT drug delivery devices.

 

[sjrily]

Tobacco WAS not under the jurisdiction of the FDA. Congress passed a bill to give the FDA the power to regulate tobacco products but they cannot ban them.

Which is why states can't (legally) turn around and ban them - Federal preempts State - even in the regulation of a federal agency. So the next question is whether e-cigs are tobacco products - yes, they are. Courts ruled that the FDA can only regulate as tobacco products and in that ruling define:

(rr) (1) The term “tobacco product” means any product
made or derived from tobacco that is intended for human
consumption, including any component, part, or
accessory of a tobacco product . . .

(2) The term “tobacco product” does not mean an article
that is a drug under [the FDCA’s drug provision], a
device under [the FDCA’s device provision], or a
combination product described in [the FDCA’s
combination product provision].

And congress had previously defined tobacco products as "any product made or derived from tobacco that is intended for human consumption," and the Tobacco Act prevents FDA jurisdiction "over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use."

So maybe states COULD ban them, but they would lose any challenge.

The key thing at this point is "customary recreational use vs. therapeutic use." That's why I believe that the bills (or at least the one I've been studying) are regulating sales to minors and making it an offense to sell any non-FDA, non-tobacco nicotine product as cessation/harm reduction. You take every amendment and addition in there and go to the actual code and read every line item as they will appear amended and you'll see what I'm saying.

There is one single phrase that would clarify this 100% - add "a tobacco product" to the subdivision being added to 39-17-1503 (which is definitions). Seventeen of the 18 sections treat the e-cig as a tobacco product. It does not make sense that section 18 bans them. So the last question is - does the bill consider e-cigs as tobacco products (it should since the federal government does)? If so, then what is needed is clarification. If not, then the bill needs top be stopped.

Why does the government have to always try to ruin good things

Because we let them.

kristin - I understand what the FDA is insisting, but two courts have ruled otherwise. I'm not sure what you mean about the FDA approving new tobacco products - they can only oversee production practices, marketing, etc. Tobacco products can not be FDA-Approved. They can not approve them as tobacco products. They can only approve new tobacco products making health claims. And since rulings help establish broader law - in reading the decision I linked above, I can not help but argue that e-cigarettes are considered a tobacco product - as long as they are sold as recreational products. If someone tries to sell them as cessation or harm reduction, only they would be called down and required to go through the motions of new drug approval - not all e-cig makers.

Maybe you can share some of the resources regarding FDA approval of recreational tobacco? Trying to sort this out has brought out the worst of my OCD *lol*

 

[kristin]

You really need to read the FSPTCA. Everything you cite changed with that Act. The FSPTCA allows the FDA to allow or approve new tobacco products for sale AS tobacco. The FDA previously tried to regulate tobacco products as drug delivery products and was shot down in Brown vs. Williamson. Please read my posts again - you are wrong that any courts RULED that any e-cigs are tobacco products. All they have ruled is that Njoy products cannot be treated as drug products and seized by the FDA during that lawsuit. The states can absolutely ban the sale of unapproved drugs or unregulated tobacco products. Your link is an Opinion and not a ruling.

 

[sjrily]

You really need to read the FSPTCA. Everything you cite changed with that Act. The FSPTCA allows the FDA to allow or approve new tobacco products for sale AS tobacco. The FDA previously tried to regulate tobacco products as drug delivery products and was shot down in Brown vs. Williamson. Please read my posts again - you are wrong that any courts RULED that any e-cigs are tobacco products. All they have ruled is that Njoy products cannot be treated as drug products and seized by the FDA during that lawsuit. The states can absolutely ban the sale of unapproved drugs or unregulated tobacco products. Your link is an Opinion and not a ruling.

OK - I will read more of the FSPTCA - but what I cite is what was used as a basis for the lower court's ruling, which the higher court then affirmed in December. And the link includes opinion, but it also includes the arguments made in the case.

I did find info on the FDA requiring "substantial equivalence" for new tobacco products. This is what you're talking about, right? I haven't read through it all, but I will.

 

[GMoney]

You really need to read the FSPTCA. Everything you cite changed with that Act. The FSPTCA allows the FDA to allow or approve new tobacco products for sale AS tobacco. The FDA previously tried to regulate tobacco products as drug delivery products and was shot down in Brown vs. Williamson. Please read my posts again - you are wrong that any courts RULED that any e-cigs are tobacco products. All they have ruled is that Njoy products cannot be treated as drug products and seized by the FDA during that lawsuit. The states can absolutely ban the sale of unapproved drugs or unregulated tobacco products. Your link is an Opinion and not a ruling.

Kristen, Thanks for all your hard work. I am going to read all the relevant statutes when I get a little spare time. Quick question - I seem to recall, although I could be mistaken, that the State Tobacco lawsuits Settlement precluded the States outright Banning tobacco products, am I recalling incorrectly? I do agree that otherwise the States absolutely have the right to ban tobacco products.

 

[sjrily]

Ok – just to clarify, I’m not saying the FDA can’t make things miserable, or that they can’t restrict flavors, etc., but they can’t ban them as they’re being marketed now. I dug through only parts of the TA about a year ago, so I am definitely revisiting that.
On the “substantially equivalent” terms, which the act allows for, I would raise the argument that e-cigarettes where on the market before Feb 15, 2007, so they would be exempt from that requirement. I might lose, but I’d still raise it.

I do still believe that for all practical purposes, e-cigs are considered to be tobacco products – if for no other reason than by proxy of how the courts handled them and what they told the FDA it could and could not do. I understand this may still be questionable, but rulings and opinions do mold the laws and set presidencies for how like issues are handled in the future – and in the case of e-cigs, that’s a good thing.

Please understand I'm not trying to argue with anybody, I'm just trying to get the facts straights to fully understand what's at play - which is probably impossible since the government is involved

 

[kristin]

Sharon, it's important to remember that the court ruling doesn't apply to ALL e-cigaretts, only Njoy products AND only pertains to the injunction. The ruling and opinion ONLY applies to Njoy. It sets precedence, which could help other companies, but without the FDA declaring all e-cigs tobacco products, each company will have to get it's own court ruling. But this was a ruling on the injunction and NOT on the actual case. The definition of tobacco product is actually what the FDA tried to use years ago to get control of tobacco. Now with FSPTCA the FDA has the power to decide how a nicotine product is regulated, but it's supposed to be based on intended use, which is what Njoy is going to argue in court now that they have the injunction. That is what this case boiled down to - intended use - otherwise you could argue that the nicotine patch was a tobacco product. Njoy agrees with you and that is why they are suing the FDA, but it hasn't been ruled yet that Njoy is right, just hinted that it's the way the judge will rule in the actual trial. So there is no law or ruling that makes e-cigs tobacco products and the states figurred out a way to ban those and even new flavored smokeless tobacco products.