RIGHT TO BE SMOKE-FREE COALITION, et al. v. FDA: PLAINTIFF TRADE ASSOCIATIONS’ MOTION FOR SUMMARY JUDGMENT, July 25, 2016

July 26, 2016 11:23 pm by Gene Borio

The PDF is Here

EXCERPT:

The Court should enter summary judgment in favor of Plaintiffs by declaring that: (i) FDA has violated the APA by applying the February 15, 2007 grandfather date and must, therefore, establish a new grandfather date for all vaping products; (ii) FDA failed to comply with the RFA and must therefore, in the absence of a new grandfather date, consider significant regulatory alternatives, including the extension of the two year compliance period for all vaping products regarding the filing of pre-market applications; and/or (iii) the TCA is unconstitutional to the extent that it requires application of the February 15, 2007 date to vaping products.

END EXCERPT

FULL TEXT:

Case 1:16-cv-00878-ABJ Document 21 Filed 07/25/16 Page 1 of 3

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

RIGHT TO BE SMOKE-FREE COALITION,

et al.

Plaintiffs,

v.

FOOD AND DRUG ADMINISTRATION, et al.

Defendants.

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

PLAINTIFF TRADE ASSOCIATIONS’ MOTION FOR SUMMARY JUDGMENT

Plaintiff trade associations, pursuant to Fed. R. Civ. P. 56, hereby move for summary judgment against Defendants Food and Drug Administration; Robert Califf, M.D., Commissioner of Food and Drugs; and Sylvia Mathews Burwell, Secretary of Health and Human Services (collectively the “FDA”). Plaintiffs’ suit challenges the Family Smoking Prevention and Tobacco Control Act (“TCA”), 21 U.S.C. §§ 387a, et seq. (2009), and a final rule recently promulgated by FDA that regulates vaping products, including e-liquids and vaping devices, under the TCA, 81 Fed. Reg. 28,973 (May 10, 2016) (“Deeming Rule”).

Count One of Plaintiffs’ Complaint alleges that the Deeming Rule violates the Administrative Procedure Act (“APA”) because FDA applied a statutory February 15, 2007 grandfather date to vaping products, thereby forcing all vaping manufacturers to comply with a pre-market authorization process that is intended for more risky tobacco products. Under the APA, it was unlawful and otherwise arbitrary and capricious to do so, particularly given the fact that the Deeming Rule will ban or virtually eliminate the vaping market in contravention of the TCA’s goals and objectives. FDA had the authority and the statutory duty to establish a new

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Case 1:16-cv-00878-ABJ Document 21 Filed 07/25/16 Page 2 of 3

grandfather date for such products so that vaping product manufacturers may avail themselves of another pre-market authorization process intended for less risky tobacco products.

Count Seven of Plaintiffs’ Complaint alleges that FDA violated the Regulatory Flexibility Act, 5 U.S.C. §§ 601, et seq. (the “RFA”). Specifically, the RFA requires agencies to consider the adverse economic impacts on small businesses, including the consideration of significant regulatory alternatives that could alleviate such adverse effects. Given that the Deeming Rule will ban or virtually eliminate the vaping market, the vast majority of which consists of small businesses, FDA was required to evaluate, in the absence of establishing a new grandfather date, significant regulatory alternatives that would aid small entities in complying with the pre-market authorization process, including the extension of the Deeming Rule’s two year compliance period for filing pre-market applications.

Count Three of Plaintiffs’ Complaint alleges that the TCA violates the Due Process Clause of the Fifth Amendment and is unconstitutional to the extent that it does not permit FDA to establish a new grandfather date for vaping products, as application of the February 15, 2007 grandfather date will effectively ban or virtually eliminate the vaping market in contravention of the TCA’s underlying goals and objectives.

The Court should enter summary judgment in favor of Plaintiffs by declaring that: (i) FDA has violated the APA by applying the February 15, 2007 grandfather date and must, therefore, establish a new grandfather date for all vaping products; (ii) FDA failed to comply with the RFA and must therefore, in the absence of a new grandfather date, consider significant regulatory alternatives, including the extension of the two year compliance period for all vaping products regarding the filing of pre-market applications; and/or (iii) the TCA is unconstitutional to the extent that it requires application of the February 15, 2007 date to vaping products.

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Case 1:16-cv-00878-ABJ Document 21 Filed 07/25/16 Page 3 of 3

In support of this motion, Plaintiff trade associations rely on the Administrative Record certified by FDA and the accompanying Memorandum of Points and Authorities. With regard to Plaintiffs’ remaining Counts (Two, Four, Five, Six, and Eight), and pursuant to this Court’s Order dated June 28, 2016 (Dkt. No. 19), Plaintiffs incorporate by reference Plaintiff Nicopure’s Motion for Summary Judgment and supporting memorandum. A proposed order is attached.

Respectfully submitted,

/s/ Eric P. Gotting

Eric P. Gotting (Bar No. 456406)

Azim Chowdhury (Bar No. 986331)

KELLER AND HECKMAN LLP

1001 G Street, N.W., Suite 500 West

Washington, D.C. 20001

Telephone (202) 434-4100

Facsimile (202) 434-4646

gotting@khlaw.com

chowdhury@khlaw.com

July 25, 2016

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