FDA to regulate e-cig as tobacco

[yvilla]

Sjrily, the key to that prohibition against "marketing in combination" provision is the marketing part. As you see above in the part of the guidance you quoted, what a seller cannot do is to "market" the product "as containing both products". In other words, you could not market an e-cigarette with nicotine as also containing a substance to combat colds (even if you privately thought that pg just might do that).

For our purposes, pg is simply and solely an inactive ingredient, the base that makes our e-cigs vape. The same goes for vg. There IS no problem with the above quoted prohibition against "marketing in combination" with anything contained in eliquid that is just an inactive ingredient.

NOR are e-cigs marketed as a food or a candy that also contains nicotine as a stimulant - that would similarly be a no go under the statute.

 

[Secti0n31]

Ok, first of all I think this is actually kinda cool. It means the FDA is retreating, and anyone with tactical knowledge knows that if ya press the retreat, you can win the battle. Anyway, there are a few things that I'd like to add.

1. There are still quite a few tobacco products that actually contain tobacco, that can still be bought online. Cigars, Pipe tobacco, pipes, chew, RYO tobacco, etc etc.

2. There are absolutely flavored tobacco's still out there, namely pipe tobacco, but some RYO cig tobacco is available in cherry and vanilla as well. Don't forget Chewing tobacco.

3. Correct me if I'm wrong, but even tho these things emit vapor, the articles that I've read state that they intend to categorize these as smokeless tobacco products. The taxes on smokeless tobacco, pipe tobacco and cigars, are far less than those on cigarettes or RYO, so they may hike the price, but I suspect that it'll be no more than 5-10 cents on the dollar.

4. If they're worried about chocolate or strawberry appealing to kids.... um... the underage people that smoke smoke some pretty potent cigs. Marl reds, Newport kings & 100's, Camels, Serious stuff. Also, if kids can get their hands on weed, cigs, beer and porn, they'll be able to get their hands on e-cigs too, but it's a little more conspicuous when you're getting everything online, and you get packages every day. You'd think their parents would be more suspicious of that than they would be about the weekend party or perhaps even coming home smelling like smoke.

5. If we keep pushing, this may just go away. Nicotine is not a controlled substance. These products (so far) aren't dangerous, and so far one judge has already kicked the FDA's ... out of court so hard that they're running with their tails between their legs on their "rock solid stance" towards e-cigs. If we remain vigilant and CASAA continues to kick .... like we have been, we'll do well.

Keep on Vapin! I love the progress!!!

 

[trying]

One way to look at it is: If they do stop the flavored liquids and just limit them to regular and menthol tobacco flavors, then all we would have to do is buy our tobacco juice and mix our own flavors. Not something I realy want to do, but if it comes to that then so be it.

Nicotine does not taste like Tobacco so the "regular" flavor would be the taste of (Nicotine & PG). Therefore odd as it might sound is that in order for E-cigarettes to taste like tobacco it would require that tobacco flavor be added which is not likely to be something FDA would allow.

What would be needed would be a less pure tobacco extract that would retain the flavor of tobacco and that is a process that Ruyan is attempting to patent. ( more about that on another thread )

 

[AttyPops]

Re: Bans. They can't ban flavors folks. They're candy making flavors (mostly). If they try and put restrictions on flavored e-juice, the vendors will get sell separate "water" flavoring drops. If they try and ban nicotine sales... it would be rough.
Re: Taxes. My post in another thread on this very popular FDA topic:

All I know is:
1) I admit that I don't really know anything when it comes to all these regulations/taxes etc.
2) It makes my head hurt just thinking about it.
3) They shouldn't be taxed, or they should be taxed at a rate even lower than snus and snuff. Zero is best. They haven't proven any harm yet. Unless you tax nicotine. Then you tax gum, lozenges, patches, inhalers, potatoes, tomatoes.....

 

[GregH]

Nicotine does not taste like Tobacco so the "regular" flavor would be the taste of (Nicotine & PG). Therefore odd as it might sound is that in order for E-cigarettes to taste like tobacco it would require that tobacco flavor be added which is not likely to be something FDA would allow.

I just need to point out that regular cigarettes also have added flavors. The particular flavorings would most likely vary for each brand's own recipe. It's one of the main ways the brands can differentiate themselves from each other. For example, it's why a Marlboro tastes different from a Camel.

Here is an excerpt from the ingredient list for one company's cigarettes:

Along with blended tobacco and water, the 26-item L&M list includes high fructose corn syrup, sugar, natural and artificial licorice flavor, menthol, artificial milk chocolate and natural chocolate flavor, valerian root extract, molasses and vanilla extracts, and cedarwood oil

So when the government banned flavored cigarettes, they didn't intend on banning all flavors used in the making of regular cigarettes. Their intention was to eliminate candy- and fruit-flavored cigarettes (peach, strawberry, vanilla, clove) that they claimed would appeal to children.

Please note that I am in way condoning or apologizing for the fact that flavored cigarettes have been banned, nor am I hoping the same for our liquids. I think most of us here agree that the original arguments that led to the ban hold no water. But we need to stop promulgating the idea that we'll be left with nothing but flavorless liquid to vape.

 

[yvilla]

Thanks for that GregH.

I cannot count how many times, since the Tobacco Act was passed in 2009, that I've pointed out that the flavoring ban, as to conventional cigarettes, is a ban on "characterizing flavors" only. As you point out, that means cigarettes specifically marketed as a "cherry" cigarette, or a "blueberry" or "clove" cigarette. It does NOT mean a ban on unheralded and unmarketed flavor ingredients, that are simply added to make the product more palatable. These flavoring ingredients are indeed still allowed and allowable in the cigarettes being sold today and tomorrow and next year!

So even IF at some point down the road the FDA manages to institute a so-called "flavor" ban on smokeless tobacco products such as e-cigs (and dissolvables and the like), it will also almost assuredly be solely a ban on "characterizing flavors", consistent with the existing regs as to cigarettes.

 

[Bill Godshall]

I sent this press release out earlier today, and spoke to one reporter.

For immediate release:
contact: Bill Godshall 412-351-5880

E-cigarettes, e-liquid and other nicotine containing products are now tobacco products

Today's annoucement by the FDA Regulation of E-Cigarettes and Other Tobacco Products to not appeal Judge Richard Leon's ruling in NJOY v FDA https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 to the US Supreme Court means that e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams and nasal sprays are now unregulate tobacco products according to federal law (as long as no therapeutic claim is made by the manufacturer/importer).

These nicotine products now join cigars and pipe tobacco as unregulated tobacco products under the Family Smoking Prevention Tobacco Control Act. Currently regulated tobacco products include cigarettes, roll-your-own and smokeless tobacco.

Bill Godshall, executive director of Smokefree Pennsylvania, welcomes this sea change in the federal legal definintion and regulation of tobacco/nicotine products, stating: "Smokers will have greater access to many different less expensive smokefree alternatives, and manufacturers can now truthfully market these new smokefree tobacco products to smokers as far less hazardous alternatives to cigarettes."

Sales of e-clgarettes are likely to continue skyrocketing with this decision, and many more stores will begin selling them.
There is no evidence that e-cigarettes have harmed any of the estimated million smokers who have switched in the past several years. "This decision will boost e-cigarette sales at the expense of tobacco cigarettes, and many more smokers will switch," said Godshall.

The change is also likely to decimate drug industry sales of nicotine gums, lozenges and patches. "Not many smokers will pay $.75 for a nicotine lozenge if they can buy a virtually identical tobacco lozenge for $.20," added Godshall.

The FDA has indicated that it plans to propose regulations for these smokefree nicotine alternatives as tobacco products.

 

[kritter]

So here is question. The states that have ecigs banned, will they lift the ban when the fda regulates as tobacco product? Seems they would have to ban cigarettes and other tobacco products in that case

 

[ccclady]

I don't understand all the legal and technical language in these reports, but the one thing that stands out to me is that "the FDA is now classifying e-cigarettes as tobacco products". If this is the case,why is it being seen as a victory for us and a step-forward?? The two main things I've come to understand since switching from regular cigarettes to vaping are...(1) it's NOT tobacco with it's associated 4,000+ chemicals in analog form; and (2) if it's now going to be considered as a tobacco product, wouldn't that make it subject to the same bans as well as exorbitant tobacco taxes that we've seen nationwide?? Can someone please explain it to me so that I can understand how this is a "good" thing?

 

[Secti0n31]

So here is question. The states that have ecigs banned, will they lift the ban when the fda regulates as tobacco product? Seems they would have to ban cigarettes and other tobacco products in that case

Individual states can have any laws that they'd like, but I don't know of any states that have banned the sale of ecigs. I know in CA people use e-cigs quite a bit because of the smoking bans. I know NY has tried, and some CITIES have banned their SALE. I also know that e-cigs are actually included in the "indoor smoking ban" of NJ, however I don't think any US states have actually banned e-cigs alltogether. I think the current rulings in the US towards e-cigs will stand until overturned by the individual municipalities that have those laws.

 

[GMoney]

I think it is a little early to break out the champagne. As I've said before, it was extremely unlikely that SCOTUS was going to grant cert if the FDA petitioned. This is just the next step. Although, FDA could have tried to get Congress to classify e-cigs as drug delivery devices - they most likely determined that was a lost cause. We need to see what regulations FDA proposes - whether they are fair or meant to destroy the serious viability of e-cigs. I seriously doubt they have any intention of allowing e-cigs to become a popular cigarette replacement.

 

[sjrily]

Sjrily, the key to that prohibition against "marketing in combination" provision is the marketing part. As you see above in the part of the guidance you quoted, what a seller cannot do is to "market" the product "as containing both products". In other words, you could not market an e-cigarette with nicotine as also containing a substance to combat colds (even if you privately thought that pg just might do that).

For our purposes, pg is simply and solely an inactive ingredient, the base that makes our e-cigs vape. The same goes for vg. There IS no problem with the above quoted prohibition against "marketing in combination" with anything contained in eliquid that is just an inactive ingredient.

NOR are e-cigs marketed as a food or a candy that also contains nicotine as a stimulant - that would similarly be a no go under the statute.

Oh, I would agree with you, yvilla, and would argue that, definitely - but I wouldn't be at all surprised if the FDA tries to split hairs by claiming that the marketing of say - Watermelon eJuice - violates this section because watermelon flavoring is a food product under FDCA, and nicotine has been added to it - So the flavoring is identified as containing a tobacco product.

This is all way ahead of anything of course, it just caught my eye as a possible loop hole related to one of the things the antis have been screaming about - flavors.

 

[MoonRose]

I don't understand all the legal and technical language in these reports, but the one thing that stands out to me is that "the FDA is now classifying e-cigarettes as tobacco products". If this is the case,why is it being seen as a victory for us and a step-forward?? The two main things I've come to understand since switching from regular cigarettes to vaping are...(1) it's NOT tobacco with it's associated 4,000+ chemicals in analog form; and (2) if it's now going to be considered as a tobacco product, wouldn't that make it subject to the same bans as well as exorbitant tobacco taxes that we've seen nationwide?? Can someone please explain it to me so that I can understand how this is a "good" thing?

The reason we wanted e-cigs to be classified as a tobacco product is that they will not have to go through the extreme trials and tests that would be required if they were classified as drug delivery devices. Had they been classified as drug delivery devices they would have immediately been pulled from all markets until such time as all appropriate tests and trials had been completed (which could take up to 8 years) and then those who wished to do so and could afford the extremely high fee that the FDA charges to approve new drugs, then they could have been returned to the market.

By classifying them as tobacco products, they remain on the market and the FDA will work towards appropriate regulations that will apply to them. This is one of the roles that CASAA will play in attempting to insure that the FDA regulates them appropriately. CASAA will also be important in the contacting of all parties who will eventually be involved in determining how and how much taxation will be placed on e-cigs and e-juice. There are no 100% guarantees that the powers that be will play fair, but CASAA will be on the front lines fighting for the rights of all users of smoke-free alternatives.

 

[capnbang]

It doesn't matter how much you protest nor how many protest.You can have 200 clinical studies showing ecigs are better than traditional cigs and it wont matter one bit.THE FDA WILL GET THEIR WAY!I think it was 06 or 07 the FDA came out on April the 20th thats 4/20 national smoke a joint day and said ......... has absolutly no medicinal value whatsoever.Thats in your face LOL giving you the finger kinda stuff.I'm sure if someone started digging there would be countless other examples of the FDA practices.I think its pretty well proven that ......... has medical benefits.I also know that ecigs are far better on your health than analogs but the FDA doesn't care.

 

[OwnedByAGrey]

*grumble grumble* I am NOT smoking tobacco! *grumble grumble*

 

[vpgtd]

so does this mean that the fda will have to regulate all nicotine containing items as a tobacco products. I mean we can get nicotine from other plants to.

Edible Nightshades
Tomatoes, potatoes, eggplants, tomatillos and both sweet and hot peppers contain small amounts of nicotine. Eggplant contains the largest amount, though it is quite low compared with tobacco. Tomatoes have decreasing quantities of nicotine as they ripen, but both green skin and sprouted areas on potatoes have more than the usual amount. Cooking reduces the amount of nicotine by approximately half.

Other Nightshades
Leaves, flowers and stalks of the pituri bush (Duboisia hopwoodii) were used by Australian Aborigines as chewing tobacco; it's very high in nicotine content. Datura, also known as jimson weed, is high in nicotine as well as other toxic alkaloids.

Other Plants Containing Nicotine
Milkweed, papayas, zinnias, coca, club moss, horsetails and ......... are among the plants that produce nicotine in small quantities.

 

[Grimloki]

What does this bit of the FDA press release mean?

“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

link - Regulation of E-Cigarettes and Other Tobacco Products

 

[Nicko]

How will this news affect the proposed state sales bans, in NY for example? Ms Rosenthall stated that sales should be banned until the FDA approved them as drug delivery devices. There's no way this will happen now. Maybe they could still ban internet sales and interstate sales. How about old-fashioned mail-order? That might work.

 

[yvilla]

ut I wouldn't be at all surprised if the FDA tries to split hairs by claiming that the marketing of say - Watermelon eJuice - violates this section because watermelon flavoring is a food product under FDCA, and nicotine has been added to it - So the flavoring is identified as containing a tobacco product.

If you were selling ("marketing") a watermelon juice, "as" juice (as a food product), that also had nicotine added to it, promoted as a stimulant juice, for example - that would violate the "marketed in combination" prohibition.

Watermelon flavored nicotine eliquid, however, is just that, a flavored alternative tobacco product. Is is not sold as a juice for drinking, but rather is marketed as nothing but an alternative tobacco product. Do you see the difference?

That is not to say the FDA may not try prohibit "characterizing flavors" in smokeless products in the future, as the FSPTCA now prohibits them for cigarettes only - but that's a different issue altogether, not the "marketing in combination" issue at all.

Another example of something that would indeed likely violate the "marketing in combination" prohibition is any nicotine eliquid that also has any other drug added to it, and sold expressly for its having the other drug mixed within - like that infamous ...... infused eliquid that the FDA already challenged back in September.

 

[trying]

What does this bit of the FDA press release mean?

“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

link - Regulation of E-Cigarettes and Other Tobacco Products

The most critical issue now is how does the FDA define "tobacco product" ?
As in substantially equivalent to a tobacco product prior to Feb. 15, 2007.
If FDA defines "tobacco product" as one already recognised in 2007 as a tobacco product and taxed as such then then E-cigarettes are not included and therefore are subject to testing prior to approval.

If it is enough that they only need be marketed (not test marketing) to the public, then the outcome is more promising.