Case 1:09-cv-00771-RJL Document 80 Filed 05/04/11 Page 1 of 3

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA
____________________________________
SOTTERA, INC., d/b/a NJOY, )
)
Intervenor-Plaintiff, )
)
v. ) Civ. No. 09-cv-0771 (RJL)
)
U.S. FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants. )
____________________________________)

STIPULATION AND ORDER OF FINAL JUDGMENT

It is hereby stipulated and agreed among the parties, plaintiff-intervenor Sottera, Inc., and

defendants Kathleen Sebelius, Secretary of Health and Human Services, the Department of

Health and Human Services, Dr. Margaret Hamburg, Commissioner of Food and Drugs, and the

U.S. Food and Drug Administration, that this case is resolved as follows:

1. On January 14, 2010, this Court issued a Memorandum Opinion and Order granting a

preliminary injunction to prohibit FDA’s detention and refusal of electronic cigarettes (“e-

cigarettes”) imported by plaintiff-intervenor Sottera, Inc. d/b/a/ NJOY (“Sottera”), on the ground

that the electronic cigarettes were unapproved drugs or devices, unless the products were

intended to have a therapeutic effect. Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62

(D.D.C. 2010).

2. On December 7, 2010, the D.C. Circuit affirmed the judgment of the Court, and held

that FDA can regulate nicotine-containing products marketed for therapeutic purposes as “drugs”

and “devices” under the Federal Food, Drug, and Cosmetic Act (“FDCA”), but that other

“customarily marketed” nicotine-containing products can be regulated only as “tobacco products”

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under the Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Control

Act”), Pub. L. No. 111-31, 123 Stat. 1776, which amended the FDCA. Sottera, Inc. v FDA, 627

F.3d 891, 898-99 (D.C. Cir. 2010).

3. After the D.C. Circuit issued its decision, FDA directed its field operations not to

detain or refuse any shipments of e-cigarettes without therapeutic claims. Declaration of

Domenic J. Veneziano, Director, Division of Import Operations and Policy (April 4, 2011) ¶ 5

(Docket # 77, Attachment 1).

4. On April 25, 2011, FDA announced that the government would not file a petition for a

writ of certiorari in the United States Supreme Court in this case, and FDA would continue to

comply with the jurisdictional lines established by Sottera. Letter to Stakeholders (available at

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm).

5. FDA will continue to comply with the jurisdictional lines established by Sottera.

6. The motion of Smoke Anywhere USA, Inc., to intervene in this action is denied as

moot.

It is so ORDERED.

_________________________________
RICHARD J. LEON
United States District Judge

Entered this _____ day of _______, 2011

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FOR INTERVENOR-PLAINTIFF SOTTERA:

/s/
Philip J. Perry (D.C. Bar No. 434278)
LATHAM & WATKINS LLP
555 11th Street, NW, Suite 1000
Washington, DC 20004
Telephone: (202) 637-2200
Facsimile: (202) 637-2201
Phil.Perry@lw.com

FOR DEFENDANTS:

Of counsel:
DAVID J. HOROWITZ TONY WEST
Deputy General Counsel Assistant Attorney General

RALPH S. TYLER MAAME EWUSI-MENSAH FRIMPONG

Associate General Counsel Acting Deputy Assistant Attorney General
Food and Drug Division
KENNETH L. JOST
ERIC M. BLUMBERG Acting Director
Deputy Chief Counsel, Litigation

KAREN E. SCHIFTER
Senior Counsel /s/
U.S. Dept. of Health & Human Services DRAKE CUTINI
Office of the General Counsel Attorney
10903 New Hampshire Ave, Rm 31-4408 Office of Consumer Protection Litigation
Silver Spring, MD 20933 U.S. Department of Justice
301-796-8590 P.O. Box 386
Washington, D.C. 20044
May 4, 2011 202-307-0044
drake.cutini@usdoj.gov