Fleminger, Inc. v. U.S. Dep't of Health & Human Servs.

• Decision Date: 23 February 2012
• Docket Number: Civil Action No. 3:10cv855 (VLB).
• Citation: 854 F.Supp.2d 192
• Court: U.S. District Court — District of Connecticut
• Parties: FLEMINGER, INC., Plaintiff, v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.

854 F.Supp.2d 192

FLEMINGER, INC., Plaintiff,

v.U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.

Civil Action No. 3:10cv855 (VLB).

United States District Court,

D. Connecticut.

Feb. 23, 2012.

Anthony J. Musto, Law Office of Anthony J. Musto, Fairfield, CT, for Plaintiff.

Ndidi N. Moses, U.S. Attorney's Office, New Haven, CT, for Defendants.

MEMORANDUM OF DECISION GRANTING IN PART AND DENYING IN PART PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT AND GRANTING IN PART AND DENYING IN PART DEFENDANTS' CROSS MOTION FOR SUMMARY JUDGMENT [Dkt. 36, 37]

VANESSA L. BRYANT, District Judge.

Plaintiff, Fleminger, Inc. (“Fleminger”), a manufacturer and retailer of green tea brings this action against the U.S. Department of Health and Human Services (“DHHS”), Kathleen Sebelius in her officialcapacity as Secretary of DHHS, the U.S. Food and Drug Administration (“FDA”), and Margaret Hamburg, M.D., in her official capacity as Commissioner of the FDA. Fleminger filed a petition with the FDA for authorization of certain qualified health claims regarding green tea on its products labeling. The FDA exercised its enforcement discretion requiring Fleminger to include a modified disclaimer to its qualified health claim that drinking green tea “may reduce the risk of breast or prostate cancer.” Fleminger alleges that Defendants violated its commercial speech rights under the First Amendment by requiring Fleminger to include the modified disclaimer to its health claim. Both Fleminger and Defendants have moved for summary judgment. For the foregoing reasons, Plaintiff's motion for summary judgment is granted in part and denied in part and Defendants' cross motion for summary judgment is granted in part and denied in part.

I. Background

The current case challenging the FDA's regulation of marketing claims regarding the health benefits for food under the First Amendment is closely related to a progression of similar cases challenging the FDA's regulation of health claims for dietary supplements under the First Amendment in the District of Columbia. In response to these cases, the FDA has developed a system for considering so called “qualified health claims” which it applies to both food products and dietary supplements. [Dkt. # 37, Def. Mem. at 6].

This is a case of first impression in this Circuit as neither party cites and this Court has not found any Second Circuit authority on point analyzing the FDA's qualified health claim process under the First Amendment. The D.C. Circuit and district court cases provide the most pertinent analysis and guidance on this rather unique issue. Before turning the particular facts and issues in dispute in the present case, it is necessary to first review these prior D.C. Circuit and district court cases as well as the statutory and regulatory framework underlying the FDA's power to regulate such health claims.

i. Legal Standard for Evaluating Commercial Speech Claims

Since health claims regarding both food products and dietary supplements are commercial speech, the FDA's regulation of such claims is evaluated under the multi-step framework established in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of New York, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980) and as later elaborated in Thompson v. Western States Medical Center, 535 U.S. 357, 122 S.Ct. 1497, 152 L.Ed.2d 563 (2002). As a “threshold matter,” the Court must determine “whether the commercial speech concerns unlawful activity or is misleading. If so, then the speech is not protected by the First Amendment.” Western States, 535 U.S. at 367, 122 S.Ct. 1497.

However, if the speech is lawful and not misleading or is only potentially misleading, the Court must ask “whether the asserted governmental interest in regulating the speech is substantial.” Id. (quoting Central Hudson, 447 U.S. at 566, 100 S.Ct. 2343). If the government interest is substantial, then the Court must determine “whether the regulation directly advances the governmental interest asserted” and finally “whether [the regulation] is not more extensive than is necessary to serve that interest.” Id. (quoting Central Hudson, 447 U.S. at 566, 100 S.Ct. 2343). The last step requires an evaluation of “whether the fit between the government's end and the means chosen to accomplish those ends is not necessarily perfect, but reasonable.” Pearson I, 164 F.3d at 656 (internal quotation marks and citation omitted). A “reasonable fit” is not a “least restrictive means” test, Clear Channel Outdoor, Inc. v. City of New York, 594 F.3d 94, 104 (2d Cir.2010), and thus courts do not ask where there is “no conceivable alternative” but instead require that the “regulation not burden substantially more speech than is necessary to further the government's interests.” Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 478, 109 S.Ct. 3028, 106 L.Ed.2d 388 (1989). “[I]f the Government c[an] achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so.” Western States, 535 U.S. at 371, 122 S.Ct. 1497. The “government has the burden of showing that the regulations on speech that it seeks to impose are ‘not more extensive than is necessary to serve’ the interests it attempts to advance.” Alliance II, 786 F.Supp.2d at 13 (quoting Western States, 535 U.S. at 371, 122 S.Ct. 1497).

Plaintiff argues that the Supreme Court's recent decision in Sorrell v. IMS Health Inc., ––– U.S. ––––, 131 S.Ct. 2653, 180 L.Ed.2d 544 (2011) altered or modified the traditional framework for evaluating commercial speech. See [Dkt. # 41, Pl. Opposition Mem. at 9, 9 n. 5]. Plaintiff argues that under Sorrell the government must demonstrate more than just a reasonable fit between the government's ends and the means chosen to accomplish those ends and suggests that Sorrell overturned the Supreme Court's prior holding in Fox. In Fox, the Supreme Court expressly rejected the proposition that government restrictions on commercial speech need to be the absolute least restrictive means to achieve the desired end and instead held that such restrictions require only a reasonable fit. Fox, 492 U.S. at 477–78, 109 S.Ct. 3028. Plaintiff bases its argument solely on the fact that the majority in Sorrell never used the word “reasonable” in connection with its analysis of the fit between the government's means and ends and at one point noted that the statute at issue “at least” must directly advance the substantial government interest. [Dkt. # 41, Pl. Opposition Mem. at 0, 9 n. 5].

The Court is not persuaded that the Supreme Court's decision in Sorrell altered the traditional scrutiny applied under the Central Hudson framework and overturned Fox's holding. The majority's opinion in Sorrell expressly relied on the Supreme Court's prior articulation of the standard for evaluating commercial speech claims in Central Hudson,Western States and Fox. See Sorrell, 131 S.Ct. at 2667–68 (“To sustain the targeted, content-based burden § 4631(d) imposes on protected expression, the State must show at least that the statute directly advances a substantial government interest and that the measure is drawn to achieve that interest. There must be a ‘fit between the legislature's ends and the means chosen to accomplish those ends.’ ”) (quoting Fox, 492 U.S. at 480, 109 S.Ct. 3028). The majority in Sorrell cited to Fox for the proposition that “there must be a fit between the legislature's end and the means chosen to accomplish those ends.” Sorrell, 131 S.Ct. at 2667–68. The fact that the majority did not use the word “reasonable” when it cited to Fox for the proposition that there must be a fit between the government's means and ends does not indicate that the Supreme Court mutely overturned well-established and long standing precedent. Moreover, the Sorrell court's focus was on the subject restrictions lack of neutrality and lack of any fit reasonable or otherwise with its stated purpose.

Further, under the traditional framework as articulated in Central Hudson,Western States and Fox, the government's restriction on speech must directly advance the governmental interest asserted. The use of the words “at least” by the majority in Sorrell does not alter or change any part of the traditional commercial speech analysis under this long standing precedent. See Fox, 492 U.S. at 474, 109 S.Ct. 3028 (noting that under Central Hudson, the Court “must determine whether the regulation directly advances the governmental interest asserted”). Moreover, it is unlikely that the Supreme Court would directly overturn a prior holding and drastically alter the level of scrutiny afforded under a foundational constitutional analysis without a thorough and comprehensive discussion heralding such an elemental change to the long standing and well-established constitutional framework. The decision in Sorrell did not impact the traditional framework for evaluating commercial speech under the First Amendment and accordingly the government must demonstrate a reasonable fit between its ends and the means chosen to accomplish those ends. The government is therefore not obligated to demonstrate that its restriction is the least restrictive means to achieve its ends.

ii. Statutory and Regulatory Framework

To determine the disputed issues, the Court must consider the statutory and jurisprudential context in which they arise. In 1990, Congress enacted the Nutrition Labeling and Education Act of 1990 (“NLEA”) Pub.L. No. 101–535, 104 Stat. 2353 (1990) (codified as amended at 21 U.S.C. §§ 301, 321, 337, 343, 34–1, 345, 371) which amended the Food, Drug and Cosmetic Act (“FDCA”) to provide the FDA with authority to regulate health claims on food including dietary supplements. Before NLEA was enacted, a food intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease would fall within the FDCA's definition of a drug and become subject to the FDA's requirements for...