Docket Update June 29, 2009

**TropicalBob** · 06-27-2009, 07:55 PM

I think it's time to trot the FDA email to suppliers one more time, for those who missed it (and it was weeks ago). It defines the device, the liquid and the intended use, citing applicable laws. It's worth a read and ponder. This is not what I'd like to read, but it's the FDA speaking, so we best listen:

Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.

In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body.

The "electronic cigarettes" that we have reviewed are designed with a re-chargeable battery-operated heating element that volatilizes the chemical constituents contained within replaceable cartridges. These cartridges may or may not include nicotine. Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

Furthermore, the "electronic cigarettes" that we have reviewed are not subject to the Federal Cigarette Labeling and Advertising Act (FCLAA), Pub. L. No. 89-92, (15 U.S.C. §§ 1331 et seq), nor are they subject to the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), Pub. L. No. 98-474 (1986), (15 U.S.C. §§ 4401 et seq). Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.

This email was repeatedly sent, so it constitutes de facto policy. Not a nice thing to read, but it's what we have to live with until a court rules against this policy. No one here is making up the FDA's position. To that agency, we use unapproved medical devices that deliver an unapproved drug cocktail to treat a medical condition called nicotine addiction.

Nit-pick it if you want, but to me the intent of these words is quite clear on the legality of our product. And that will guide their future action.

**yvilla** · 06-27-2009, 09:02 PM

I'm glad you reposted that letter TBob, because reading again it illustrates the beauty of SE's current argument (in their Supplemental Brief posted by Sun) that the new tobacco legislation actually supports their position.

Take a look at this excerpt from the FDA letter:

"Please be aware that electronic cigarettes that we have reviewed are drug-device combinations under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 353(g)(1)) with their "drug" uses, as defined by section 201(g) of the Act (21 U.S.C. § 321(g)), as the primary mode of action.

In this regard, these products contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional cigarettes. And, like conventional cigarettes, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body."

Okay, so we see the FDA regards ecigs as very like conventional cigarettes. And indeed, in FDA V. BROWN & WILLIAMSON TOBACCO CORP., the FDA argued that cigarettes were a combination drug-device under section 503(g)(1) of the FD&C Act (21 U.S.C. 353(g)(1)), precisely the same provision they cite in their letter now as to ecigs. They would have regulated cigarettes as such had the Supreme Court not decided cigarettes were simply wholly exempt from FDA regulation.

So now fast forward to the new tobacco legislation. Recognizing the unalterable fact that all tobacco products are nicotine delivery devices and could easily fit the drug and drug-device definitions already found in Chapter V of the Food and Drug Act, the new legislation specifically covers this by providing that tobacco products will be regulated by the new provisions only, and not by the drug provisions in Chapter V of the exisiting law. So as SE writes in its brief:

"The Act explicitly provides that "tobacco products" will be regulated by the FDA under the new Chapter IX of the Food, Drug, and Cosmetic Act, and "shall not be subject to the provisions of" Chapter V ("Drugs and Devices"). Id. at § 101(a) (adding a new Section 901 to the Food, Drug, and Cosmetic Act)."

So, if the FDA regards ecigs as so much "like conventional cigarettes" as they say in their letter, then the new legislation certainly does support SE's arguments that they should not be considered a drug-device combination subject to Chapter V of the FD&C Act, but rather a "tobacco product" under the newly passed Chapter IX.

**Sun Vaporer** · 06-29-2009, 08:55 PM

Today there was no movement on the Docket Sheet. We are still waiting for the FDA to submit their Reply Brief to SE's Supplemental Brief. The FDA's Brief is due by July 6, 2009.-------Sun

**Sun Vaporer** · 06-30-2009, 09:09 PM

This thread wll be updated every business day to report any movment on the Docket. As requested by Smokey, only discussion about the case should be posted here to keep the thread on point about the case as was requested by members who want to read about the evolution of this case. --Thanks, Sun

**Sun Vaporer** · 06-30-2009, 09:12 PM

Today there was no movement on the Docket Sheet again. We are still waiting for a the FDA to respond to the SE's Sup. Brief which is due by July 6, 2009

**LuckyCharm** · 07-01-2009, 04:12 AM

Just posting a reply so I get notified of updates. If someone knows of a better way to do this, please PM me.

~~Cheryl

**Sun Vaporer** · 07-01-2009, 04:16 AM

Cherly--all update will be right here posted as usual for everyone.

Sun

**LuckyCharm** · 07-01-2009, 05:23 AM

Thanks Sun, but sometimes I forget to check, so an email update is helpful in that regard. You rock!

~~Cheryl

**Sun Vaporer** · 07-01-2009, 08:54 PM

As expected, today NJOY (Sottera, Inc. As Invervenor) also filed a Supplemental Brief again arguing that this is a case of the FDA overstepping its jurisdiction even with the passage of the new legislation of the the Family Smoking Prevention and Tobacco Control Act of 2009
It will be very interesting to see the FDA's response that is due by July 6, 2009.

------------Sun