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Proposed Intervenor-Plaintiff,
Civil Action No. 1:09-cv-00771 (RJL)
and
Plaintiff,
vs.
and
Defendants.
__________________________________/
undersigned counsel, for its Complaint against the U. S. Food and Drug Administration
(“FDA”), Margaret Hamburg, Commissioner, and the U.S. Department of Health and
Human Services, and Kathleen N. Sebelius, Secretary of the U.S. Department of Health
§ 2201 and 5 U.S.C. § § 702-706. to enjoin FDA from improperly exceeding its statutory
and their accessories as drug, devices or drug device combination products under the
Federal Food Drug and Cosmetic Act, 21 U.S.C. § § 301-399a (“FDCA”). Furthermore,
this is an action to enjoin the FDA from banning the importation of E-cigarettes into the
United States, where such E-cigarettes and their accessories do not contain or otherwise
Parties
of business located at 3101 Hallandale Beach Boulevard, Suite 100, Hallandale, Florida
Defendant U.S. Department of Health and Human Services. FDA has responsibility,
among other things, for ensuring that certain drugs and medical devices sold within the
United States are safe and effective. The headquarters and principal place of business of
the defendant FDA is 10903 New Hampshire Avenue, Silver Spring, Maryland 20903.
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The headquarters and principal place of business of Defendant DHHS is at 200
4. This Court has subject matter jurisdiction over Plaintiff’s claims pursuant
5. This court has personal jurisdiction over Defendants FDA, DHHS, and
Factual Allegations
Smoke Anywhere’s Products
electronic smoking devices. It distributes and imports E-cigarettes under the trademark
“Fifty-One”.
inhalation of many of the cancerous byproducts that results from smoking traditional
cigarettes. E-cigarettes function by vaporizing a liquid nicotine mixture that, in the case
of Smoking Anywhere's product, is naturally derived from tobacco plants. Once the
nicotine mixture is vaporized, the user may inhale the nicotine vapor in a manner similar
to that of inhaling actual tobacco smoke, but without the fire, flame, tar, carbon
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9. E-cigarettes are made up of three basic parts: nicotine cartridge, the
heating element or atomizer, and the battery and electronics. The cartridge is a
disposable plastic container that serves as the mouthpiece of the E-cigarette and contains
four major ingredients: water, propylene glycol, nicotine and glycerol,. The heating
element vaporizes naturally-derived nicotine mixture to form the vapor that is inhaled by
the user. Finally, the battery and electronics power the heating element and monitor air
flow. Each of the parts of an E-cigarette is designed to look like an actual cigarette; the
10. When a user inhales on an E-cigarette, the air flow is detected by the
device’s electronics and activates the heating element within the E-cigarette. When the
heating element is activated, the natural liquid nicotine mixture is vaporized, and the user
inhales the nicotine vapor. The vapor contains a flavoring designed to simulate the flavor
and feel of tobacco smoke, but no flame, combustion, smoke, or ash is produced by the
use of an E-cigarette.
11. Smoke Anywhere does not market its E-cigarettes for any therapeutic
purpose (e.g., as a smoking cessation aid) or otherwise in a manner that could invoke
FDA jurisdiction.
E-cigarettes from overseas manufactures, and is not aware of any domestic manufacturer
are derived from the importation and distribution of E-cigarettes in the United States, and
if Smoke Anywhere could not obtain a reliable supply of E-cigarettes – its only product
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13. As part of its distribution network, Smoke Anywhere has binding
14. Throughout most of FDA’s history and until 1995, the Agency has
explicitly and repeatedly disclaimed the authority and jurisdiction to regulate tobacco
several occasions whether to extend FDA’s jurisdiction to include such products. Each
time, however, Congress determined that FDA should not have jurisdiction over tobacco
products.
15. In or around 1995, FDA reversed its long-standing policy and asserted that
it had jurisdiction to regulate cigarettes and tobacco products as nicotine delivery devices.
At that time, FDA proposed and adopted binding regulations relating to the marketing
16. In 2000, the Supreme Court of the United States, in Food & Drug
Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), held that
Congress did not intend the FDCA to grant the FDA jurisdiction to regulate cigarettes or
17. While thwarted by the Supreme Court in its initial attempts to regulate
cigarettes and tobacco products, beginning in approximately 2008 and continuing through
the present, FDA nevertheless has attempted to regulate the importation, distribution, and
sale of E-cigarettes in the United States. The electronic cigarette industry remains in its
infancy, as the creation of E-cigarettes was only recently made possibly by advances in
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micro-atomizer technology. Indeed, the FDA's regulatory interest in E-cigarettes has
coincided with a period of exponential growth in the electronic cigarette industry in the
United States.
internal FDA policy that includes the classification of E-cigarettes and accessories as
unapproved new drugs, devices, and/or drug-device combination products based on the
inherent characteristics of E-cigarettes and their accessories. In 2009 and 2010, the FDA
combination products that fell within the FDA's regulatory purview under Chapter V of
the FDCA.
19. Upon information and belief, in early 2009, the FDA added E-cigarettes to
Import Alert 66-41 and thereby directed U.S. Customs and Border Protection to reject the
entry of E-cigarettes and their accessories into the United States. An import alert advises
FDA field offices of potential issues relating to particular products. Specifically, Import
Alert 66-41 stated that E-cigarettes were unapproved drugs and/or misbranded drugs.
20. Upon information and belief, at no time before the FDA added E-
cigarettes and accessories to Import Alert 66-41 was the proposed action published in the
Federal Register. Neither was Smoke Anywhere or any other manufacturer, importer, or
submitting its written views or being allowed to make oral arguments before the FDA.
With the exception of this litigation, no such opportunity has ever formally been afforded
any such entity since the addition of E-cigarettes to the FDA's import alerts.
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21. Following several seizures of its products on grounds that they constituted
unapproved new drugs and/or devices, on April 28, 2009, Smoking Everywhere, Inc.,
another importer and distributor of E-cigarettes, filed this lawsuit, and sought declaratory
relief and permanent injunction against FDA's misclassification and repeated seizures of
its products.
the FDA was pending in this Court, on June 22, 2009, the Family Smoking Prevention
and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 ("Tobacco Act"), was
enacted. The Tobacco Act amended the FDCA to explicitly grant to the FDA, for the first
time, statutory authority to regulate "tobacco products" and the advertising and promotion
of such products. The Tobacco Act defines "tobacco product" in relevant part as "any
product made or derived from tobacco that is intended for human consumption, including
term "tobacco product" thus encompasses E-cigarettes, such as those imported and
distributed by Smoke Anywhere, that contain nicotine naturally derived from tobacco
leaves. The term "tobacco product" explicitly excludes "an article that is a drug under [21
23. The Tobacco Act also provides that tobacco products are to be regulated
by the FDA under the new Chapter IX of the FDCA and "shall not be subject to the
provisions" of Chapter V ("Drugs and Devices"). 21 U.S.C. § 387a(a). Further, the FDA
is expressly 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
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tobacco products" and from "requiring the reduction of nicotine yields of a tobacco
24. Following the enactment of the Tobacco Act, this Court granted a
preliminary injunction in this action. In its opinion, the Court is observed as follows:
FDA says that the electronic cigarettes marketed by plaintiffs are a drug-
device combination and should therefore be excluded from the Tobacco Act's
definition of "tobacco product" because the labeling and promotional materials
"represent and suggest that the product will provide the same drug effects as
cigarettes."…Because plaintiffs' electronic cigarettes are to be used, like
conventional cigarettes, as a means for delivering nicotine and because
consumers and scientists widely believe that nicotine has drug-like effects…,
FDA contends that plaintiffs' electronic cigarettes are intended to affect the
structure or function of the body…As a result, they qualify as a drug-device
combination, not as a tobacco product. Put simply, this argument is
bootstrapping run amuck.
That electronic cigarettes are devices for delivering nicotine and are
intended to have the same effect on the structure and function of the body as
cigarettes is hardly a basis for classifying electronic cigarettes as a drug-device
combination, thereby excluding them from the definition of "tobacco product."
If it were, then traditional cigarettes would be excluded as well. Indeed, any
tobacco product containing nicotine and claiming to have some pharmacological
effect would be excluded. Because this result would effectively dismantle the
existing regulatory wall Congress erected between tobacco products and drug
device combinations, I can easily infer that Congress did not intend tobacco
products to be drugs merely because they deliver nicotine,
….
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25. This Court went on to note:
the FDA appealed. The United States Court of Appeals for the District of Columbia
Circuit affirmed this Court's decision on December 7, 2010, holding that, "[t]ogether,
Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate
Sottera, Inc. v. FDA, 627 F.3d 891, 2010 U.S. App. LEXIS 24883, at *18 (D.C. Cir.
2010).
27. On July 17, 2009, the FDA formally detained a shipment of 5,990 pieces
See Notice of FDA Action attached as Exhibit “A”. Subsequently, on October 22, 2009,
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the FDA formally refused entry of Smoke Anywhere’s shipment into the United States.
See Notice of FDA Action and Refusal, attached as Exhibit “B”. The Notice of Action
from the FDA states that the shipment was refused entry because it was an “unapproved
new drug” and “appears to be a new drug without an approved new drug application”.
28. Upon information and belief, FDA will continue to order that all import
shipments of E-cigarettes be denied entry into the United States until such time that
E-cigarettes have been approved by FDA as a new drug within the meaning of section
201 of the FDCA, or to the extent that E-cigarettes are imported by companies or persons
Smoke Anywhere, which receives virtually all of its revenue from the distribution and
harm not only to Smoke Anywhere’s business, but also its contracts with its suppliers and
distributors. Without the ability to import E-cigarettes, Smoke Anywhere cannot sell or
distribute any of its products in the United States, thereby causing a massive loss in
30. Other than review in this Court, no sufficient avenue for redress exists for
Smoke Anywhere to prevent the imminent irreparable harm resulting from the Import
Alert. Without judicial intervention, FDA will apparently continue to assert unauthorized
control over Smoke Anywhere and, perhaps the entire E-cigarette industry, by improperly
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31. Smoke Anywhere seeks both a preliminary and permanent injunction
prohibiting FDA from enforcing Import Alert 66-41 with respect to Smoke Anywhere
E-cigarettes and from taking any other action to regulate Smoke Anywhere E-cigarettes.
Smoke Anywhere also requests the issuance of a declaratory judgment that FDA’s
COUNT I
(The FDA Assertion of Jurisdiction Over E-cigarettes is Ultra Vires)
33. FDA has no authority under the FDCA or any other relevant statute or
regulation to assert jurisdiction over E-cigarettes because Congress and the United States
Supreme Court have expressly prohibited the Agency from regulating tobacco products
marketed for smoking pleasure without therapeutic claims. The Supreme Court
determined that the delivery and use of nicotine through tobacco products is beyond the
34. FDA has no authority under the FDCA or any other relevant statute or
regulation with respect to E-cigarettes because E-cigarettes are not “drugs,” “drug
35. Indeed, Smoke Anywhere’s products are not labeled or marketed for any
therapeutic purpose or to provide any other medical benefit. Rather, they are marketed as
an alternative to traditional cigarettes to provide the user the same pleasures of smoking.
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contrary to the public interest. 5 U.S.C. § 706(2) (C). FDA’s assertion of authority is
unlawful, and any regulations or policies stemming from its unlawful conduct must be set
aside in accordance with Section 706(2) of the Administrative Procedures Act (“APA”).
5 U.S.C. § 706(2).
preliminarily enjoined pending judicial review of such actions pursuant to Section 705 of
the APA.
Anywhere has been seriously injured and faces irreparable harm as alleged in this
Complaint, in that its shipments of E-cigarettes were detained in July of 2009 and refused
in October 2009. Smoke Anywhere has a real and palpable fear that the FDA will
continue detentions and refusals of its products at ports of entry. FDA’s improperly
COUNT II
(Failure to Comply with the Administrative Procedures Act)
40. As a federal agency, FDA is required to follow and apply all laws, rules,
and regulations in a uniform manner and in such a way as to provide for due process for
41. FDA is charged by Congress with enforcing the FDCA and several other
public health laws. Congress has permitted FDA to implement and apply the FDCA
through the lawfully promulgated regulations of the Code Federal Regulations. Any final
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rule or regulation issued by an administrative agency that affects a substantive change in
the law must be adopted pursuant to the required notice and comment procedures of the
42. Import Alert 66-41, which inter alia, directed the CBP to reject the entry
drug delivery devices is effectively a binding, substantive rule that imposes obligations
on other parties and significantly affects the interests of Smoke Anywhere and others in
43. FDA did not provide opportunity for notice and comment pursuant to the
APA before classifying E-cigarettes as a new drug, a drug delivery devise, or a drug-
device combination. FDA neither published notice of the new rule in the Federal register
nor served personal notice on the parties affected by the un-promulgated rule.
44. FDA’s failure to comply with the procedures required by law is a violation
of Section 706 of the APA and thus renders its actions unlawful.
45. In addition, FDA has not established a rational nexus between the addition
of E-cigarettes to Import Alert 66-41 and the Congressional mandate empowering the
FDA to ensure the medical devices and medical products sold within the United States
46. FDA has had a custom and practice of not interfering with the importation
of E-cigarettes and other tobacco products that are outside of FDA’s jurisdiction. With
its addition of E-cigarettes to Import Alert 66-41, FDA has departed from precedent
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47. FDA’s addition of E-cigarettes to Import Alert 66-41 is an “arbitrary” and
“capricious” agency action because it departs from precedent without benefit of notice,
“capricious” agency action because it seeks to treat the non-therapeutic use of nicotine in
ongoing conduct of FDA, Smoke Anywhere has been harmed and is being harmed in
that: (a) Smoke Anywhere receives virtually all of its revenue from imported
E-cigarettes, and Smoke Anywhere has no available domestic manufacturers; (b) Smoke
Anywhere will lose the ability to fulfill its outstanding obligations and contracts with its
suppliers and distributors; (c) Import Alert 66-41 threatens the ongoing viability of
Smoke Anywhere; and (d) the inability to import E-cigarettes will lead to Smoke
Anywhere having to terminate its distributors and/or dismiss employees whose work
Anywhere has been seriously injured and faces irreparable harm as alleged in this
Complaint.
COUNT III
(Declaratory Judgment)
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53. Defendants’ actions are in violation of federal statute and regulations, and
are contrary to this Court’s preliminary injunction, to the extent the Court finds it
ongoing conduct of FDA, Smoke Anywhere has been harmed and is being harmed in
that: (a) Smoke Anywhere receives virtually all of its revenue from imported
E-cigarettes, and Smoke Anywhere has no available domestic manufacturers; (b) Smoke
Anywhere will lose the ability to fulfill its outstanding obligations and contracts with its
suppliers and distributors; (c) Import Alert 66-41 threatens the ongoing viability of
Smoke Anywhere; and (d) the inability to import E-cigarettes will lead to Smoke
Anywhere having to terminate its distributors and/or dismiss employees whose work
56. Smoke Anywhere requests the Court to: (1) declare that the actions of
FDA as set forth in this Complaint are contrary to the language of the law, are contrary to
binding precedent of the Supreme Court of the United States, are arbitrary and capricious
in their application, and are ultra vires; (2) enter judgment in favor of Smoke Anywhere;
and (3) enjoin and prohibit FDA from enforcing Import alert 66-41 with respect to
the United States and from taking any other action to regulate E-cigarettes as unapproved
drugs, devices or drug device combinations under the FDA that make no therapeutic
claims.
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PRAYER FOR RELIEF
enjoins Defendants from detaining Smoke Anywhere’s E-cigarettes, and from enforcing
Import Alert 66-41 with respect to E-cigarettes and E-cigarette component parts;
B. Upon hearing the merits, enter a declaratory judgment that Defendants are
combinations thereof under the FDCA if no therapeutic claims are made and that the
addition of E-cigarettes to Import Alert 66-41 is invalid, unlawful, and ultra vires of
from regulating E-cigarettes or E-cigarette component parts, or, in the alternative, enter a
permanent injunction that prohibits Defendants from regulating E-cigarettes unless and
until such time that Defendants undergo the required procedures pursuant to the APA;
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Mitchell S. Fuerst, Esq.
Pro hac vice Motion Pending
Robert J. Becerra, Esq.
Pro hac vice Motion Pending
Fuerst Ittleman, PL
1001 Brickell Bay Drive, Suite 2002
Miami, Florida 33131
305-350-5690 (o)
305-371-8989 (f)
mfuest@fuerstlaw.com
rbecerra@fuerstlaw.com
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EXHIBIT A
EXHIBIT B
CERTIFICATE OF SERVICE
I hereby certify that on this 18th day of March, 2011, I caused a true and correct copy of
the foregoing Verified Intervenor Complaint for Declaratory and Injunctive Relief to be served
Phillip J. Perry
LATHAM & WATKINS, LLP
555 11th Street, NW
Suite 1000
Washington, DC 20004
Drake S. Cutini
DEPARTMENT OF JUSTICE
Office of Consumer Litigation
P.O. Box 386
Washington, DC 20044