NICOPURE LABS v. FDA: UNOPPOSED MOTION OF THE CAMPAIGN FOR TOBACCO-FREE KIDS FOR LEAVE TO FILE AMICUS CURIAE BRIEF IN SUPPORT OF THE DEFENDANTS, July 27, 2016

July 27, 2016 5:02 pm by Gene Borio

The PDF is Here

EXCERPT:

The Campaign has a strong interest in how the courts construe FDA’s authority to advance the public health in connection with these products, given their rapidly increasing use among the nation’s youth, their conceded addictiveness, the wide variations in product types available in the current unregulated market, the detection of hazardous constituents in some e-cigarette products, the reports of adverse events relating to these products, and the continuing uncertainty over whether e-cigarettes contribute to smoking cessation or abstinence, or instead encourage “dual use” of e-cigarettes and traditional, deadly tobacco products..

We believe the Campaign’s perspective on these issues as a non-governmental public health advocacy group is distinct from that provided by the government Defendants, and that the Court will benefit from this additional perspective. We also anticipate that several other public health groups will join the Campaign as signatories to this brief, such that the Court will not be burdened by multiple amicus briefs from similar public health advocacy orientations.

END EXCERPT

FULL TEXT:

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

NICOPURE LABS, LLC, et al.

Plaintiffs,

v.

FOOD AND DRUG ADMINISTRATION,

et al.

Defendants.

Civ. No. 1:16-cv-0878-ABJ

UNOPPOSED MOTION OF THE CAMPAIGN FOR TOBACCO-FREE KIDS FOR LEAVE TO FILE AMICUS CURIAE BRIEF IN SUPPORT OF THE DEFENDANTS

Pursuant to D.C. District Court Rule 7(o), the Campaign for Tobacco-Free Kids (“the Campaign”) hereby moves this Court for leave to file an amicus curiae brief in support of the motion for summary judgment to be filed by the Defendants in this case, and in opposition to (1) the motion for summary judgment filed by the Plaintiff Nicopure Labs on July 8, 2016 and (2) the summary judgment motion filed by the Plaintiff Right to be Smoke-Free Coalition and other trade associations on July 25, 2016. By agreement with the Plaintiffs, this amicus brief would be filed on August 19, 2016, so as to provide the Plaintiffs with sufficient time to address the brief in their pleadings due August 26, 2016. Accordingly, we believe this timeframe is consistent with and would not disrupt the schedule set forth in this Court’s June 28, 2016 scheduling order.

The Campaign is a leading public health organization that has been a longtime force in the fight to arrest the devastating impacts of tobacco product use in the United States and worldwide. In this capacity, the Campaign has an acute interest in the Food and Drug Administration’s (“FDA”) regulation of products under the Tobacco Control Act through the so-called “Deeming Rule” (81 Fed. Reg. 28983 (May 10, 2016)), which regulation has been challenged in this case. The Campaign has been involved for years in efforts to understand and evaluate the public health impacts of e-cigarettes, the products at issue in this case. The Campaign made a substantial contribution to the administrative record in the Deeming Rule proceedings, filing extensive comments on the proposed rule that were joined by other public health and medical organizations. The Campaign has a strong interest in how the courts construe FDA’s authority to advance the public health in connection with these products, given their rapidly increasing use among the nation’s youth, their conceded addictiveness, the wide variations in product types available in the current unregulated market, the detection of hazardous constituents in some e-cigarette products, the reports of adverse events relating to these products, and the continuing uncertainty over whether e-cigarettes contribute to smoking cessation or abstinence, or instead encourage “dual use” of e-cigarettes and traditional, deadly tobacco products..

We believe the Campaign’s perspective on these issues as a non-governmental public health advocacy group is distinct from that provided by the government Defendants, and that the Court will benefit from this additional perspective. We also anticipate that several other public health groups will join the Campaign as signatories to this brief, such that the Court will not be burdened by multiple amicus briefs from similar public health advocacy orientations.

Counsel for the Campaign has contacted counsel for the parties in this case requesting their consent to file this amicus brief. Counsel for the Plaintiffs have notified us that their clients consent to this motion and to the filing of the proposed amicus brief under the conditions set forth above. Counsel for the Defendants have advised that their clients, consistent with the government’s practice, take no position on the motion.

A proposed order accompanies this motion.

Respectfully submitted,

Of Counsel: /s/ Carlos T. Angulo

Carlos T. Angulo (D.C. Bar No. 466257)

Mark Greenwold Andrew N. Goldfarb (D.C. Bar No. 455751)

Dennis Henigan ZUCKERMAN SPAEDER LLP

Campaign for Tobacco-Free Kids 1800 M Street, NW, Suite 1000

1400 Eye Street, NW Washington, DC 20036

Washington, DC 20005 Tel: (202) 778-1800

Facsimile: (202) 822-8106

cangulo@zuckerman.com

agoldfarb@zuckerman.com

July 27, 2016

CERTIFICATE OF SERVICE

Pursuant to Local Civil Rule 5.4, I hereby certify that on this 27th day of July, 2016, I electronically filed the foregoing UNOPPOSED MOTION OF THE CAMPAIGN FOR TOBACCO-FREE KIDS FOR LEAVE TO FILE AMICUS CURIAE BRIEF IN SUPPORT OF THE DEFENDANTS with the Court by using the CM/ECF system. All parties to the case have been served through the CM/ECF system.

/s/ Carlos T. Angulo

Carlos T. Angulo

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