Rozema v. U.S. Department of Health & Human Services

167 F. Supp. 3d 324, 2016 U.S. Dist. LEXIS 26044, 2016 WL 865300
District Court, N.D. New York·Decided March 2, 2016·No. 5:14-CV-0495 (GTS/DEP)·Published

Opinion

DECISION and ORDER

GLENN T. SUDDABY, Chief United States District Judge

Currently before the Court, in this action pursuant to the Freedom of Information Act (“FOIA”), 5 U.S.C. § 552, et. seq., filed by Kyle Thomas Rozema (“Plaintiff’) against the United States Department of Health and Human Services (“HHS”) and the United States Food and Drug Administration (“FDA”), are the following motions: (1) a motion for summary judgment filed by Defendants HHS and FDA (Dkt. No. 40); (2) a motion for summary judgment filed jointly by three of four Interve-nor-Defendants, Philip Morris USA Inc. (“Philip Morris”), R.J. Reynolds Tobacco Company (“Reynolds”), and Santa Fe Natural Tobacco Company, Inc. (“Santa Fe”) (Dkt. No. 41); (3) a motion for summary judgment filed by the fourth Intevenor-Defendant, Lorillard Tobacco Company (“Lorillard”) (Dkt. No. 42); and (4) Plaintiffs cross-motion for summary judgment (Dkt. No. 45). For the reasons set forth below, Defendants’ motions are granted, and Plaintiffs cross-motion is denied.

I. RELEVANT BACKGROUND

A. Introduction

This action arises from Plaintiffs challenge to the administrative denial of his FOIA request dated September 19, 2013, directed to the FDA, for information regarding the quantities of menthol contained in cigarettes “by brand and by quantity in each brand and subbrand from 2000 to 2010.” (Dkt. No. 1, ¶ 6 [Plf.’s [328] Compl.].) Generally, Plaintiffs Complaint alleges that HHS and FDA (collectively, “the Agency Defendants”) improperly withheld the requested records and that Plaintiff has exhausted his administrative remedies. (Id., ¶¶ 7-15.) On that basis, Plaintiff seeks an Order directing the Agency Defendants to disclose the requested records and an award of costs and attorney’s fees regarding his request. (Id.)

After Plaintiff filed his Complaint in this action, Philip Morris, Reynolds, Santa Fe, and Lorillard moved (collectively, “Inter-venors”)1 moved to intervene for the purpose of defending against the disclosure of the information Plaintiff seeks, which includes menthol quantities contained in products manufactured by those entities. (Dkt. Nos. 14, 23, 27.) Those motions were granted without opposition by Plaintiff or the Agency Defendants. (Dkt. Nos. 22, 28, 34.)2

B. Statutory Framework

Congress enacted the Family Smoking Prevention and Tobacco Control Act (“the Act”), 21 U.S.C. § 387 et seq., to grant FDA the authority to regulate, among other things, “all cigarettes [and] cigarette tobacco[.]” 21 U.S.C. § 387a(b); U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York, 708 F.3d 428, 430 (2d Cir.2013).3 As part of the Act, Congress also directed FDA to establish a twelve-mem■ber Tobacco Products Scientific Advisory Committee (“TPSAC”), the duties of which include providing advice, information, and recommendations to FDA on safety issues related to menthol cigarettes. 21 U.S.C. §§ 387g(e), 387q(c). While the Act grants a broad scope of authority to FDA, Plaintiffs FOIA request implicates that portion of the Act’s statutory and regulatory framework governing the submission of health-related information to FDA by tobacco product manufacturers (“TPMs”). •

More specifically, section 904 of the Act, 21 U.S.C. § 387d, requires TPMs to submit to FDA certain information concerning, among other things, the cigarettes that they manufacture. As is relevant here, first, TPMs are required to submit “a listing of all ingredients, including tobacco, substances, compounds, and additives that are ... added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.” 21 U.S.C. § 387d(a)(1) (“Ingredient Listings”). Second, TPMs must submit, at FDA’s request, documents and information related to research activities and scientific findings pertaining to, among other things, the health effects of tobacco products and their constituents. 21 U.S.C. § 387d(b)(1) — (3) (“Research Documents”). Third, and perhaps most importantly here, TPMs must submit listings of all constituents identified by [329] FDA as harmful or potentially harmful (“HPHCs”) in each tobacco product, “by brand and by quantity in each brand and subbrand.” 21 U.S.C. § 387d(a)(3). FDA published a list of 93 HPHCs (“HPHC List”) in 2012, and menthol was not listed. 77 Fed. Reg. 20034, 20036-37 (Apr. 3, 2012).4 FDA is required to “place on public display” the HPHC quantities reported by TPMs in a format that is “not misleading to a lay person” and “in a manner determined by” FDA. 21 § U.S.C. 387d(d)(1).5 With limited exceptions not applicable here, any information that TPMs report to FDA pursuant to 21 U.S.C. § 387d, which also constitutes trade secret and/or commercial or financial information under FOIA Exemption 4, 5 U.S.C. § 552(b)(4), “shall be considered confidential and shall not be disclosed[.]” 21 U.S.C. 387f(c); see also 21 C.F.R. § 20.61(c) (“Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.'”).

C. Procedural History and Undisputed Material Facts

1. Plaintiffs Failure to File a Statement of Material , Facts

Free access — add to your briefcase to read the full text and ask questions with AI

Rozema v. U.S. Department of Health & Human Services, 167 F. Supp. 3d 324, 2016 U.S. Dist. LEXIS 26044, 2016 WL 865300 (N.D.N.Y. 2016).

167 F. Supp. 3d 324 (Rozema v. U.S. Department of Health & Human Services) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Related

Central Intelligence Agency v. Sims
471 U.S. 159 (Supreme Court, 1985)
Anderson v. Liberty Lobby, Inc.
477 U.S. 242 (Supreme Court, 1986)
Larson v. Department of State
565 F.3d 857 (D.C. Circuit, 2009)
Schwarz v. Department of Justice
417 F. App'x 102 (Second Circuit, 2011)
Anderson v. Department Of Health And Human Services
907 F.2d 936 (Tenth Circuit, 1990)
David Carney v. United States Department of Justice
19 F.3d 807 (Second Circuit, 1994)