IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
RIGHT TO BE SMOKE-FREE COALITION )
4049 E. Presidio Street )
Mesa, AZ 85215 )
)
AMERICAN E-LIQUID MANUFACTURING )
STANDARDS ASSOCIATION )
P.O. Box 184 )
Englewood, OH 45322 )
)
AMERICAN VAPING ASSOCIATION )
736 Washington Street )
Hoboken, NJ 07030 )
)
ELECTRONIC VAPING COALITION )
OF AMERICA )
P.O. Box 510403 )
New Berlin, WI 53151 )
)
GEORGIA SMOKE FREE ASSOCIATION ) Civil Action No. _______________
3212 Westside Country Drive )
Fort Oglethorpe, GA 30742 )
)
KENTUCKY VAPING RETAILERS )
ASSOCIATION, INC., d/b/a KENTUCKY )
SMOKE FREE ASSOCIATION )
9909 Taylorsville Road )
Louisville, KY 40299 )
)
LOUISIANA VAPING ASSOCIATION )
135 W. Genie Street )
Chalmette, LA 70043 )
)
MARYLAND VAPE PROFESSIONALS, LLC )
211 Saint Paul Street )
Baltimore, MD 21202 )
)
NEW JERSEY VAPOR RETAILERS )
COALITION )
3 Becker Farm Road, Suite 105 )
Roseland, NJ 07068 )
Case 1:16-cv-01210 Document 1 Filed 06/20/16 Page 1 of 37
2
OHIO VAPOR TRADE ASSOCIATION )
4251 Lyons Road )
Miamisburg, OH 45342 )
)
and )
)
TENNESSEE SMOKE FREE ASSOCIATION )
7203 Bonny Oaks Drive )
Chattanooga, TN 37421, )
)
Plaintiffs, )
v. )
)
FOOD AND DRUG ADMINISTRATION )
10903 New Hampshire Ave. )
Silver Spring, MD 20993 )
)
ROBERT CALIFF, M.D. )
Commissioner of Food and Drugs )
10903 New Hampshire Ave. )
Silver Spring, MD 20993 )
)
and )
)
SYLVIA MATHEWS BURWELL )
Secretary of Health and Human Services )
200 Independence Ave., SW )
Washington, DC, 20201, )
)
Defendants. )
)
COMPLAINT
The United States Food and Drug Administration (“FDA” or the “Agency”) recently promulgated a final rule that, inter alia, comprehensively regulates for the first time at the federal level electronic nicotine delivery systems (“ENDS”), commonly known as electronic cigarettes. The regulation was adopted pursuant to the Food, Drug and Cosmetic Act (“FDCA”), as amended by the Family Smoking Prevention and Tobacco Control Act (“TCA”). See 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule” or “final rule”). The Plaintiffs, consisting of national and state-wide trade associations representing the entire ENDS industry (i.e.,
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