Regulation Of E-Cigarettes

[Christopher]

Regulation of E-Cigarettes and Other Tobacco Products

This is directly from the FDA.

April 25, 2011

Dear Stakeholder:

The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.

The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.

Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.

Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.

The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.

The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.

Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.

Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”

FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.

Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.

“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.”

We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.

Sincerely,

Lawrence R. Deyton, M.S.P.H., M.D.

Director

Center for Tobacco Products

Janet Woodcock, M.D.

Director

Center for Drug Evaluation and Research

[Brian]

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.

What's your interpretation of that?

[Christopher]

I can't say publicly one way or another. We just sent it over to our lawyer. I'm confused on whether or not it considers a model a new product or the overall processes itself.

[turtle11c]

They keep referring to electronic cigarettes as a tobacco product but the only part of tobacco is the nicotine. I wonder what they would say if people quit buying eliquid with nicotine in it. What would they call it then?

[TroopX]

So what's the oldest nic juice you've vaped? (after expiration)

[cheryli]

"The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Have they determined any guidelines for this yet? How soon will they 'enforce' the 'general controls?"

[DerStadtschutz]

"user fees?" What the crap? What exactly does that mean? Are they seriously gonna try to charge us for how much we use our e-cigs? How would they possibly even monitor or enforce that? I find that particular part of this very interesting... And stupid.

"We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health." LOL, sure they do. That's why aspartame, chantix, and a crapload of other things that are bad for you are FDA approved, right? Also, that's why cigarettes are okay, but they wanted to pretty much shut down the e-cig industry. The FDA wants to protect and promote public health? That's the funniest thing I've heard in a while. Well, at least they're not going for the drug device thing anymore...

Edited April 26, 2011 by DerStadtschutz

[Christopher]

It's likely these fees will be charged to the suppliers. Though I'm not 100% sure yet what exactly for.

And aspartame....*shudders* that's some nasty stuff right there.

[DerStadtschutz]

They'll probably charge vendors some ridiculous amount of money to try and drive them out of business then.

[Basilray]

I see a lot of nicotine coming from China or foreign sources in the future...

[Natas]

i just hope they dont try to jack up the prices on everything like juices and different mods i think thats why vaping is such a great thing because of the variety

[ripple]

I would think, based on where they have gone with tobacco, you will see restrictions and rule regarding flavors for sure.

It might be time to begin working on development of those DIY skills in creating favors and other things many of us currently enjoy!

[Elayna]

I think a lot of the small suppliers are gonna get shafted. The FDA will end up stopping all shipments from other countries to do "quality" control, on devices and juices, so don't get too comfy with the idea that you can just get it from out of country. Then the tobacco co's here might try to start making juice so that they can recoup some of the billions they have lost in lawsuits etc. and loss of sales because of the Stop Smoking crud. Then we get to see about the taxes and other idiocies. Get the idea.... they want us to smoke so that they can move the $$ around and someone will keep getting rich while the small folk get shafted - again. E smokes threaten that, and until they can figure out how to make it make money for them, they will make it very difficult for anyone to make a living doing something good, and afterward, no one will be able to because they will have the monopoly. So, think about making yer own absolute, and then go from there. They can't ban flavor vendors... there's too much of a cooking industry that uses the flavors we do too. But staight nic juices .... those will become hard to get and flavored nic juice will have trouble coming in too, those that are currently in country or made here will ok for a short while, until the FDA finds the directest supplier, and makes it impossible for our vendors to get supplies. my 2 cents.

[Cheriepye]

They keep referring to electronic cigarettes as a tobacco product but the only part of tobacco is the nicotine. I wonder what they would say if people quit buying eliquid with nicotine in it. What would they call it then?

That's exactly what I was thinking, turtle.

The device says right on it's web page that

It's not to be used for medical uses.

The tobacco part has me saying hmmmm too.

Cherie

[Elayna]

folks.. no nic juice is either a combo of pg/vg or pg and/or vg with distilled water. You could add any flavor you like...... I see any e-cig device becoming like a corn cob pipe..... It's the NICOTINE. China grows close to 90 percent of the tobbaco used in the nic juices. After all the bad press about Chinese products, do you really think the FDA is gonna let them get away with truly sending "good" juice here? I personally don't think so, but I am a cynic.

[gmf1]

Would like to congratulate you guys on a win Have had no such win here in Aus but a win there might give my government a nudge.