Smoking Everywhere V. FDA Daily Docket Sheet Update

[Sun Vaporer]

Today, SE filed a supplemental brief in support of not rendering their case moot due to the newly signed legislation. They argue that:
　
"While SE recognizes that the FDA now has the appropriate statutory authority to establish a regulatory scheme for E-cigarettes, the FDA's import ban was not consistent with the former Food, Drug, and Cosmetic Act, and is not consistent with the FDCA as newly amended. By the passage of the Act, Congress did not authorize the FDA to treat tobacco as a drug and it did not authorize the FDA's actions in the instant case; rather, it conferred limited jurisdiction on the FDA to regulate tobacco products in a manner consistent with the Act and with the Administrative Procedures Act ("APA"), 5 U.S.C. §§ 551, et seq.

The FDA's future regulation of E-cigarettes will have to be established by properly promulgated rules, subject to public notice and comment.
The narrow question before the Court on SE's motion for preliminary injunction is whether the FDA is authorized to treat the E-cigarette as a drug-device combination product, thus allowing the product's detention as a new and unapproved drug. As demonstrated by the Act, SE has correctly maintained that the E-cigarette is not a drug-device product, and that the FDA's decision to treat it as such, without notice and opportunity for comment, is an unlawful and improper exercise of authority under the FDCA and the APA.


The enactment of the Family Smoking and Prevention Control Act affirms, with Congress's imprimatur, SE's argument that E-cigarettes do not constitute a drug, device, or combination product under the FDCA. Because the stated grounds for the FDA's detention of SE's product is exactly that E-cigarettes constitute such a combination product, the Court should grant SE's motion for preliminary injunction and enter an order declaring that the FDA lacks statutory authority to regulate SE's E-cigarettes as a drug, device, or combination product."
　
We will now await a reply from the FDA-------------Sun

[Sun Vaporer]

Today, Judge Leon granted SE's Request to file their Supplemental Motion and Brief in Support thereof and further ordered the FDA to file any Reply by July 6, 2009.

06/24/2009 MINUTE ORDER granting. MOTION for Leave to File Instanter a Brief of Supplemental Authority in Support of its Motion for Preliminary Injunction by SMOKING EVERYWHERE, INC. It is hereby ORDERED that the motion for leave to file is GRANTED. It is further ORDERED that defendants shall file their response, if any, no later than 7/6/2009. Signed by Judge Richard J. Leon on 6/24/2009. (lcrjl1) (Entered: 06/24/2009)06/24/2009 Set/Reset Deadlines/Hearings: Response due by 7/6/2009. (kc) (Entered: 06/24/2009)
Here is the complete Motion and Memeorandum in Support as filed:

PLAINTIFF SMOKING EVERYWHERE, INC.'S MOTION FOR LEAVE TO FILE INSTANTER A BRIEF OF SUPPLEMENTAL AUTHORITY IN SUPPORT OF ITS
MOTION FOR PRELIMINARY INJUNCTION
　
Plaintiff, Smoking Everywhere, Inc. ("SE"), , hereby moves the Court for leave to file instanter a Brief of Supplemental Authority in support of SE's Motion for Preliminary Injunction. SE respectfully submits that, since SE's preliminary injunction motion was fully briefed and argued in May 2009, significant legislative developments have occurred which, inter alia, grant the FDA jurisdiction over tobacco products for the first time and which require supplemental briefing to explain. See Truckers United for Safety v. Mead, 86 F. Supp. 2d 1, 3 (D.D.C. 2000), rev'd on other grounds, 329 F.3d 891 (D.C. Cir. 2003) (accepting supplemental briefs filed in response to recent legislation bearing on the issues before the court). Because, as explained in greater detail in the accompanying Brief of Supplemental Authority, the enactment of the Family Smoking Prevention and Tobacco Control Act affects the legal arguments posited by both SE and the Food and Drug Administration
("FDA") with respect to the FDA's regulatory authority over electronic cigarettes, SE respectfully requests that the Court grant SE leave to file instanter the accompanying Brief of Supplemental Authority.
SE's Brief of Supplemental Authority is enclosed herewith.
　
PLAINTIFF SMOKING EVERYWHERE, INC.'S BRIEF OF
SUPPLEMENTAL AUTHORITY IN SUPPORT OF ITS
MOTION FOR PRELIMINARY INJUNCTION

Plaintiff, Smoking Everywhere, Inc. ("SE"), submits this Brief of Supplemental Authority to advise the Court of recent developments regarding legislation relevant to the issues presented by Plaintiff's Motion for Preliminary Injunction that have occurred since the Court heard oral argument on the motion on May 15, 2009. Although the passage of the Family Smoking Prevention and Tobacco Control Act ("Act") gives the Food and Drug Administration ("FDA") newfound authority to regulate tobacco products, this does not moot the issue currently pending before the Court. The FDA has wrongfully attempted to assert jurisdiction over electronic cigarettes as a drug-device combination product, and this wrongful assertion of authority is well beyond even the FDA's expanded jurisdiction, as the Act specifically prohibits the FDA from treating tobacco products as "drugs" or "devices." Therefore, despite the passage of the Act, the FDA's attempted regulation of the E-cigarette as an unapproved drug-device combination product remains unlawful, and, accordingly, this Court should grant SE's motion for a preliminary injunction.

STATEMENT OF FACTS
On June 11, 2009, the United States Senate, by a vote of 70 to 17, passed the Family Smoking Prevention and Tobacco Control Act as part of an amended version of H.R. 1256. 155 Cong. Rec. S6497-6523 (daily ed. June 11, 2009). The following day, June 12, 2009, the United States House of Representatives also passed the Act in the same form as the Senate by a vote of 307 to 97. 155 Cong. Rec. H6630-6660 (daily ed. June 12, 2009). The Act was signed into law by the President on June 22, 2009.
As an earlier version of H.R. 1256 and the proposed Family Smoking Prevention and Tobacco Control Act figured prominently in the arguments posited by SE in its Reply Brief in Support of its Motion for a Preliminary Injunction, and as the proposed legislation was repeatedly referenced by both SE and the Court at the oral argument on the motion, SE submits this short supplemental brief to highlight several relevant provisions of the Act and to address the effect of the Act on the arguments forwarded by SE in support of its Motion for a Preliminary Injunction.
Overview of Relevant Sections of the
Family Smoking Prevention and Tobacco Control Act
The Act amends the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301, et seq., to explicitly grant the Food and Drug Administration statutory authority to regulate "tobacco products" and the advertising and promotion of such products.
As SE originally noted in its Reply Brief, the Act defines "tobacco product" in relevant part as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." H.R. 1256 at § 101(a)
(amending 21 U.S.C. §§ 321 to add subsection (rr)). The term "tobacco product" explicitly excludes "an article that is a drug under [21 U.S.C. § 321(g)(1)], a device under [21 U.S.C. § 321(h)] or a combination product described in [21 U.S.C. § 353(g)]." Id.
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). However, the FDA is explicitly prohibited from "banning 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" and from "requiring the reduction of nicotine yields of a tobacco product to zero" under the Act. Id. at § 101(a) (adding a new Section 907(d)(3) to the Food, Drug and Cosmetic Act).
Consistent with the provision clarifying that tobacco products are not subject to the provisions of Chapter V of the Food, Drug and Cosmetic Act, the Act makes new provision for "modified risk tobacco products." These products are defined as "any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Id. at § 101(a) (adding a new Section 911(b) to the Food, Drug, and Cosmetic Act). Finally, the distinction between tobacco products and "drugs" and "devices" under the Food, Drug, and Cosmetic Act's enforcement provisions is further reinforced by the Act's conforming amendments, which repeatedly require the addition of the term "tobacco product" in addition to "drug" and "device" in the provisions governing the FDA's enforcement authority. See id. at § 103 (amending, inter alia, sections 301 (21 U.S.C. § 331—prohibited acts), 304 (21 U.S.C. § 334—injunction proceedings), 703 (21 U.S.C. § 373—access
to records), 704 (21 U.S.C. § 374—inspection), and 801 (21 U.S.C. § 381—imports and exports) of the Food, Drug, and Cosmetic Act).

LAW AND ARGUMENT
The heart of the issue in this case is whether the FDA exceeded its authority by declaring, without opportunity for public notice and comment, that E-cigarettes were drug-device combination products that could not enter the country unless approved by the FDA. Plaintiff argues that the Supreme Court has already declared that the FDA lacks jurisdiction over tobacco and tobacco-related products.1 The passage of the Act did not give the FDA carte blanche to regulate tobacco products and has not mooted Plaintiff's position in this case. The FDA has consistently asserted that SE's product—the electronic cigarette ("E-cigarette")—constitutes a combination drug and device product and will remain so regardless of its labeling or any changes thereto. (See, e.g., Defs' Opp. to Pl's Prel. Inj. Mtn. at 16-17 (arguing that detention of E-cigarettes is appropriate because they constitute a "combination drug and device within the meaning of the FDCA"); see also AR DET at 82 (Email from Jim Shen, FDA Compliance Officer, to Benjamin England, Esq. dated Feb. 11, 2009, stating that "I have consulted with CDER/OC [the FDA's Center for Drug Evaluation and Research and the Office of Compliance]. We do not believe that this product can be relabeled to make it anything other than an article which . . . appears to be a drug-device combination product under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act.").) This position not only exceeds the scope of the FDA's prior authority, but also exceeds its grant of new authority.
1 As acts of Congress are not subject to interpretations that would render them a nullity, the passage of the Act serves only to confirm the FDA's prior lack of authority to regulate tobacco products in any manner. See TRW Inc. v. Andrews, 534 U.S. 19, 31 (2001) ("It is a cardinal principle of statutory construction that a statute ought, upon the whole, to be so construed that, if it can be prevented, no clause, sentence, or word shall be superfluous, void, or insignificant" (internal quotation marks omitted).).
As detailed in SE's Reply Brief in Support of its Motion for a Preliminary Injunction, the legality of the FDA's attempt to classify the E-cigarette as a drug-device combination product is a simple question of the scope of the FDA's statutory authority under the FDCA. The passage of the Act, while expanding the FDA's jurisdiction, makes the FDA's continued defense of its stated position untenable. This is particularly true where, as here, the FDA's position is not owed full deference by this Court. Ass'n of Am. Physicians & Surgeons, Inc. v. Food & Drug Admin., 226 F. Supp. 2d 204, 211 n.11, 212 (D.D.C. 2002); see also Fed. Election Comm'n v. Nat'l Rifle Ass'n of Am., 254 F.3d 173, 184-85 (D.C. Cir. 2001) (holding that informal interpretations are not entitled to full Chevron deference).
The Act underscores that E-cigarettes are not a drug-device combination product and that the FDA lacks any statutory authority to regulate E-cigarettes as a combination product, as the FDA has attempted to do here. While the electronic cigarette falls within the definition of a "tobacco product" under the new authority provided by 21 U.S.C. § 321(rr) and the new Section 901, as noted above, the Act explicitly specifies that a "tobacco product," such as the electronic cigarette, cannot be treated by the FDA as a drug, a device, or a combination product. Accordingly, the FDA's decision to classify E-cigarettes as a drug-device combination—a decision made without public notice or opportunity for comment—and to ban the importation of E-cigarettes as an unapproved drug simply lacks any prior statutory basis and directly contradicts the plain language of the new Act.
While SE recognizes that the FDA now has the appropriate statutory authority to establish a regulatory scheme for E-cigarettes, the FDA's import ban was not consistent with the former Food, Drug, and Cosmetic Act, and is not consistent with the FDCA as newly amended. By the passage of the Act, Congress did not authorize the FDA to treat tobacco as a drug and it did not authorize the FDA's actions in the instant case; rather, it conferred limited jurisdiction on the FDA to regulate tobacco products in a manner consistent with the Act and with the Administrative Procedures Act ("APA"), 5 U.S.C. §§ 551, et seq. The FDA's future regulation of E-cigarettes will have to be established by properly promulgated rules, subject to public notice and comment.
The narrow question before the Court on SE's motion for preliminary injunction is whether the FDA is authorized to treat the E-cigarette as a drug-device combination product, thus allowing the product's detention as a new and unapproved drug. As demonstrated by the Act, SE has correctly maintained that the E-cigarette is not a drug-device product, and that the FDA's decision to treat it as such, without notice and opportunity for comment, is an unlawful and improper exercise of authority under the FDCA and the APA.

CONCLUSION
The enactment of the Family Smoking and Prevention Control Act affirms, with Congress's imprimatur, SE's argument that E-cigarettes do not constitute a drug, device, or combination product under the FDCA. Because the stated grounds for the FDA's detention of SE's product is exactly that E-cigarettes constitute such a combination product, the Court should
grant SE's motion for preliminary injunction and enter an order declaring that the FDA lacks statutory authority to regulate SE's E-cigarettes as a drug, device, or combination product.
Dated: June 23, 2009

---------Sun

[Bones]

Originally Posted by Sun Vaporer

Anytime new legislation is passed or new case law comes down during the pendency of a case, the parties are mandated to apprise the Court. This new legistlation was brought up repeatedly during the May 15th hearing and I am sure Judge Leon expected a Supplemental filing by the parties if the legislation passed----so it really is just the case taking its normal path and can not be viewed as any reflection of how the Court will ultimately rule------------Sun

OK well in honor of my 200th post - I'll just be mostly optimistic - I see a lot of wording that I really like in there -

I'll just go happily work in my garden for a while now and let the dark clouds roll in and rain on me later -
At which time I'll just dust off my trusty umbrella

[Vicks Vap-oh-Yeah]

Originally Posted by Sun Vaporer

Anytime new legislation is passed or new case law comes down during the pendency of a case, the parties are mandated to apprise the Court. This new legistlation was brought up repeatedly during the May 15th hearing and I am sure Judge Leon expected a Supplemental filing by the parties if the legislation passed----so it really is just the case taking its normal path and can not be viewed as any reflection of how the Court will ultimately rule------------Sun

What I think you're saying, here, Sun - is this is simply a rehash of what the court case is about, given additional thought to how the new legislation affects this particular case.

This is not a ruling... the case goes on...new deadlines have been established.

We wait longer.

[webtaxman]

Originally Posted by Surf Monkey

go look at section 9.11 of the act, which addresses "reduced risk" products. The regulatory authority granted in this area is far more lax than even the soft authority granted to the FDA in the case of traditional tobacco products.

Thanks SM--that is the section I was trying to remember whereby e-cigs could continue to still be manufactured, but studies must begin on the safety of the product--BUT while still allowing manufacturing of the product. Thus, no outright ban. SE's law firm did address this issue, but it clearly is not their main argument. The FDA are attacking e-cigs as a drug, a new drug, a new nicotine delivery device. SE's attorneys say "Can't do that." And that makes the assertion even stronger with their interpretation of the new Act- as they just argued.

I agree Sun as this was really a formality. SE's "Instanter" brief (never even heard of "instanter" before now) was well drafted, but it was generally not very persuasive--more like playing the name game which we all know as semantics.

Sun: Do you mind telling us your legal background? You seem to have a firm grasp of all things legal including proper interpretations.

I merely went through a paralegal program offered by the community college several years ago. I never practiced law--except my own filings pertaining to only me. In CA, paralegals must be supervised by an attorney to even call oneself a paralegal. And even then, offering legal advise is considered Unlawful Practice of Law (UPL). Paralegals were taking business away from CA attorneys. CA attorneys said no more legal advice for paralegals. Same thing is going on in Florida right now. Paralegal shops at every corner.

For yvilla: Me thinks I was wrong! As I said, happens a lot.

[yvilla]

Originally Posted by webtaxman

For yvilla: Me thinks I was wrong! As I said, happens a lot.

Mike, we can all be wrong at times - no worries there.

But yes, now that we see the whole of SE's supplemental brief, it is crystal clear that they are explicitly claiming "tobacco product" status for ecigs as I thought, and claiming that the new legislation supports their original argument that ecigs should not be regulated as "drug-devices" or as a "drug". The heart of that argument is this paragraph from their brief:

"While the electronic cigarette falls within the definition of a "tobacco product" under the new authority provided by 21 U.S.C. § 321(rr) and the new Section 901, as noted above, the Act explicitly specifies that a "tobacco product," such as the electronic cigarette, cannot be treated by the FDA as a drug, a device, or a combination product. Accordingly, the FDA's decision to classify E-cigarettes as a drug-device combination—a decision made without public notice or opportunity for comment—and to ban the importation of E-cigarettes as an unapproved drug simply lacks any prior statutory basis and directly contradicts the plain language of the new Act."

It will certainly be interesting to see if Judge Leon agrees with them or not. And of course, even if he does and they win this skirmish with the FDA, the battle would be far from over. Next up would be the proper interpretation of the new Act, and how ecigs get treated under that.

[brandeeashlynn]

Well now we have to wait for the FDA response. The FDA I am sure has their best lawyers working on this just as hard as SE does. They will take the SE statements and twist them around to the FDA s benefit. Hopefully the judge will not fall for it but with they way politics are these days I can see him ruling for the FDA. The FDA has alot of influence whether SE likes it or not so we have to play the wait and see game. I hope it goes in SE favor but only time will tell.

[Sun Vaporer]

Today, SE filed it Brief supplementing the legal authority it cited in its original pleadings to the Court in light of the passage of the new Tobacco Control Act:



............The Act amends the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301, et seq., to explicitly grant the Food and Drug Administration statutory authority to regulate "tobacco products" and the advertising and promotion of such products.
As SE originally noted in its Reply Brief, the Act defines "tobacco product" in relevant part as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." H.R. 1256 at § 101(a)
(amending 21 U.S.C. §§ 321 to add subsection (rr)). The term "tobacco product" explicitly excludes "an article that is a drug under [21 U.S.C. § 321(g)(1)], a device under [21 U.S.C. § 321(h)] or a combination product described in [21 U.S.C. § 353(g)]." Id.
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). However, the FDA is explicitly prohibited from "banning 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" and from "requiring the reduction of nicotine yields of a tobacco product to zero" under the Act. Id. at § 101(a) (adding a new Section 907(d)(3) to the Food, Drug and Cosmetic Act).
Consistent with the provision clarifying that tobacco products are not subject to the provisions of Chapter V of the Food, Drug and Cosmetic Act, the Act makes new provision for "modified risk tobacco products." These products are defined as "any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Id. at § 101(a) (adding a new Section 911(b) to the Food, Drug, and Cosmetic Act). Finally, the distinction between tobacco products and "drugs" and "devices" under the Food, Drug, and Cosmetic Act's enforcement provisions is further reinforced by the Act's conforming amendments, which repeatedly require the addition of the term "tobacco product" in addition to "drug" and "device" in the provisions governing the FDA's enforcement authority. See id. at § 103 ..........................



While SE recognizes that the FDA now has the appropriate statutory authority to establish a regulatory scheme for E-cigarettes, the FDA's import ban was not consistent with the former Food, Drug, and Cosmetic Act, and is not consistent with the FDCA as newly amended. By the passage of the Act, Congress did not authorize the FDA to treat tobacco as a drug and it did not authorize the FDA's actions in the instant case; rather, it conferred limited jurisdiction on the FDA to regulate tobacco products in a manner consistent with the Act and with the Administrative Procedures Act ("APA"), 5 U.S.C. §§ 551, et seq. The FDA's future regulation of E-cigarettes will have to be established by properly promulgated rules, subject to public notice and comment..."

The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.


Sun

[TropicalBob]

I agree that it belongs in a new category -- not drug, not tobacco. It's a novelty. A toy. The problem for us is that too many sellers advertised false claims for too long, drawing regulatory attention and initiating that letter from Sen. Lautenberg to the FDA demanding a full ban. It is probably too late now to change the stripes on this skunk.

The only real issue I think this suit contains is whether the FDA followed protocol before and at seizure of shipments. And it's hard to think they'd make a mistake. This was not a precipitous action, after all. It had been considered for many months; emails were carefully worded after the law was studied, etc. The FDA knew exactly what it was doing.

I believe Sun has hinted that the lack of a quick decision for injunctive relief means the judge knows his ruling will have a major impact on this new industry. His judgment will become e-smoking law. I'm glad he's taking his time. I hope he offers clear guidelines on what is and is not allowed into the country.

[yvilla]

Originally Posted by TropicalBob

Basically, they seem to be arguing that no matter the new law, e-cigs are still a tobacco product. Because they use a constituent of tobacco. Nicotine.

That also makes the lozenge, gum, nasal spray, et all, tobacco products, too, by the same logic. And they aren't. They are drugs, because nicotine is a drug being used to treat the medical condition known as nicotine dependence.

How is the e-cig different in the abstract from NRT drug products? It delivers the same drug, by use of a device. Keep in mind that lawyers can, and will, argue anything. Anything! But surely it's evident here that e-cig=tobacco cig is stretching reality a bit. And do we really want all the restrictions and taxes we'd get from such a decision?

Eagerly awaiting the verdict here so we can move on -- one direction or the other. After losing in Congress, this the bottom of the ninth for us.

TBob, you ask how is the ecig different from NRT drug products. The answer to that is their intended use. The pharmaceutical nicotine lozenge, gum, nasal spray products are all specifically designed, formulated and intended for use solely for smoking cessation purposes. They are all packaged with instructions to that effect, and are recommended only for short term use.

Of course someone could and people do use them for longer than intended, but that is not the issue. It is the intended use that makes them drug products, not the unintended uses.

The ecig, on the other hand, is intended to be used as a smoking alternative - for long term use and enjoyment. Harm reduction, yes for sure, but smoking cessation no. Again, some people may decide to use them only as a short term aid to total smoking cessation, but that is not their primary intended use.

This is in fact the same difference between your Stonewall dissolvables and the pharmaceutical lozenge - the Stonewall is a tobacco product, intended as a smoking alternative, and the lozenge is an NRT drug product, intended for smoking cessation.

As for the fact that there is no actual tobacco in ecigs, and they use only the liquid nicotine extracted form tobacco, how is that any different from the fact that there is no coffee bean or plant material in a cup of coffee, which uses solely the liquid extracted from the bean? Liquid coffee is most definitely still a "coffee product".

And those who have experimented with making their own eliquid from rolling tobacco, or from cigars or snus, you included, are they not using a "tobacco product" with their ecigs? The majority using commericially extracted nicotine liquid are not automagically using a "drug" just because they buy it already extracted rather than going DIY.