US District of Columbia Federal Judge hearing case No. 09-cv-0771, SMOKING EVERYWHERE, INC. and SOTTERA, INC., d/b/a NJOY v. U.S. FOOD AND DRUG ADMINISTRATION, et al.

Judge Leon will have to decide if the FDA has regulatory authority over Electronic Cigarettes.

Biography

Judge Leon was appointed to the United States District Court in February 2002.

He received his A.B. from Holy Cross College in 1971, his J.D. cum laude from Suffolk Law School in 1974, and his LL.M. from Harvard Law School in 1981. Immediately prior to his appointment to the bench, Judge Leon was engaged in private practice in Washington, D.C., as a partner in the Washington office of Baker & Hostetler (1989-1999), and Vorys, Sater, Seymour and Pease (1999-2002).

Over at the Electronic Cigarette Forum's Smoking Everywhere V. FDA Daily Docket Sheet Update there has been great debate this week about how the vaping community should respond and proceed after the U.S. Court of Appeals sided with the FDA in the Smoking Everywhere vs FDA case resulting in a stay of Judge Leon's previous ruling denying their jurisdiction over ecigs until at least September when the court will hear arguments and make a final ruling.

Needless to say most people are outraged, some are confused and sadly many of those the vaping community looks up to as leaders have been arguing with each other instead of taking action while some vendors seem to be finally ready to challenge the FDA themselves.  

As usual in matters this important regarding things I've taken hours to consider and write my thoughts about, I figured I'd share here as well.

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
SMOKING EVERYWHERE, INC.,
)
Plaintiff,
)
and
)
SOTTERA, INC., d/b/a NJOY,
)
Intervenor-Plaintiff,
)
v.
)
Civil Case No. 09-771 (RJL)
)
U.S. FOOD AND DRUG
)
ADMINISTRA TION, et aI.,
)
Defendants.
)

MEMORANDUM OPINION (January H,2010) [# 2 and 24]

Plaintiff, Smoking Everywhere, Inc. (“Smoking Everywhere”), and intervenor-plaintiff, Sottera, Inc., which does business as “NJOY” (“NJOY”) (collectively, “plaintiffs”), are distributors of a product known as “electronic cigarettes” or “E­cigarettes.” They claim that inbound shipments of their products from overseas manufacturers have been denied entry into the United States, or have otherwise been detained, by order of the Food and Drug Administration (“FDA”) on the ground that

electronic cigarettes are an unapproved drug-device combination under the Food, Drug,

and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq. Plaintiffs seek a preliminary

Department of Health and Human Services and Secretary Kathleen Sebelius (collectively,

“FDA”),¹ enjoining FDA from regulating electronic cigarettes as a drug-device

combination and from denying entry of those products into the United States. As such,

In a 32 page ruling released today for the Smoking Everywhere vs FDA lawsuit, US Federal Judge Richard Leon has said the FDA has no jurisdiction over electronic cigarettes, at least in so far as regulating them as drug delivery devices. The FDA's efforts to regulate ecigarettes as a drug has taken a severe blow and ecig makers, sellers and users around the globe are rejoicing.

In his ruling Judge Leon had scathing words for the FDA:

This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices, Unfortunately it's tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."

Ray Story, CEO of Smoking Everywhere said ""big big big victory for us." and ecigarette forums around the Internet lit up tonight with rejoicing and celebration at the good news.

What effect with this ruling have as the electronic cigarette industry faces challenges from attorney generals from California and other states as well as stiff opposition from anti smoking groups has yet to be seen.

Court Documents and other resource materials related to the Smoking Everywhere, Inc. v. FDA lawsuit.