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Posts Tagged ‘CTP’

R.J. Reynolds Tobacco Co. v. Food & Drug Admin., NO. 11-5332

Monday, July 8th, 2013

In August, 2011, five tobacco companies[1] filed a complaint[2] against the FDA in the United States District Court for the District of Columbia alleging that certain provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) violated their First Amendment right to free speech.[3] The tobacco companies challenged the graphic warning requirements which mandated that new graphic warning labels must comprise the top 50% of the front and back panels of cigarette packages, and 20% of each cigarette advertisement. The labels include textual warnings, graphic warnings, and a “1-800-QUIT-NOW” hotline.

Any attempts by the government to infringe on free speech must meet “strict scrutiny,” meaning that the government must assert a compelling interest for subsidizing the speech and must use narrowly tailored means to do so. There are two exceptions to the strict scrutiny rule when the government is dealing with commercial speech.[4] The first, known as the Zauderer test, is that factual and uncontroversial disclosures of information are considered permissible under the First Amendment if they are reasonably related to the government’s interest in preventing consumer deception and are not overly burdensome.[5] The other, the Central Hudson test, allows restrictions on commercial speech if the government can prove their interest is substantial, the restriction materially advances that interest, and the restriction is narrowly tailored.[6]

The District Court granted a preliminary injunction on the graphic warning requirements and granted summary judgment for the tobacco industry. The District Court held that the graphic warnings were not factual and uncontroversial disclosures of information that would fit into the Zauderer test. Using strict scrutiny, the District Court held that the FDA failed to show that the warnings were narrowly tailored to achieve a compelling government interest.[7]

A three-judge panel for the U.S. Court of Appeals for the D.C. Circuit affirmed, 2-1, that the graphic warning requirements are an unconstitutional violation of the tobacco industry’s first amendment protections, but held so under different reasoning. Similar to the District Court, The Court of Appeals held that the graphic warnings could not be analyzed under the Zauderer standard.[8] The court stated that Zauderer only applies to avoid misleading or incomplete commercial advertisements. With the additional advertising regulations put in place by the Tobacco Act, such as a ban on labeling cigarettes as “light” or “mild”, the court held that there is no evidence that the graphic warnings are in place to combat deceptive claims.[9] Rather, the court viewed them as impermissible attempts by the FDA to discourage people from smoking.[10]

Alternatively, the Court of Appeals applied the Central Hudson standard, rather than the strict scrutiny test used by the District Court, to hold the graphic warning requirements unconstitutional.[11] While the Appellate Court acknowledged that the FDA’s interest in reducing smoking rates could qualify as a substantial interest, the Court ruled that the FDA failed to prove that the graphic warnings would reduce smoking rates.[12] The Court stated that the FDA did not provide “a shred of evidence” that these graphic warnings would actually lead to a reduction in smoking rates. [13] Thus, the graphic warning requirements failed to materially advance the government’s interest and are an unconstitutional limit on commercial speech.

The dissenting appellate judge would have upheld the graphic warning requirements, except for the “1-800-QUIT-NOW” hotline, under both the Zauderer and Central Hudson standards.[14] The judge wrote that Zauderer is the correct standard of review as the warning labels convey factually accurate information and prevent misleading commercial speech, noting the tobacco industry’s history of deceptive claims regarding the adverse health effects of smoking.[15]

The FDA’s petition for a rehearing of the case before all of the judges on the D.C. Court of Appeals was denied on December 5, 2012. On March 15, 2013, the Attorney General announced that the FDA would not petition for the Supreme Court to review the decision.

Summary by Katelyn Blaney


[1] R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.

[2] Online Copy of Initial Complaint: http://www.hpm.com/pdf/blog/TobCompl-8-2011.pdf

[3] RJ Reynolds Tobacco Co. v. Food and Drug Administration, 696 F.3d 1205, 1208 (D.C. Cir, 2012).

[4] RJ Reynolds, 696 F.3d at 1212.

[5] Id.

[6] Id.

[7] Id. at 1212-13.

[8] Id. at 1214-15.

[9] Id. at 1215.

[10] Id. at 1216.

[11] Id. at 1217.

[12] Id. at 1218-19.

[13] Id. at 1219.

[14] Id. at 1223.

[15] Id. at 1222.



Disc. Tobacco City & Lottery, Inc. v. United States

Monday, July 8th, 2013

In August, 2009,  tobacco manufacturers and sellers[1]  brought suit[2] in the United States District Court for the Western District of Kentucky against the FDA, challenging provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”). In a case previously known as Commonwealth Brands, Inc v. United States, plaintiffs challenged the following requirements as violations of their First Amendment free speech protections, and sought a preliminary injunction barring the FDA from enforcing them, as well as a judgment declaring the provisions unconstitutional:

Graphic Warning Requirement: Tobacco manufacturers must reserve a portion of tobacco packaging for health warnings and graphic images

In Commonwealth Brands,[3] the District Court granted partial summary judgment in favor of the tobacco industry, holding both the color restrictions on their advertisements and the ban on safer product claims due to FDA regulation to be unconstitutional violations of the First Amendment. The District Court granted summary judgment in favor of the United States for every other challenged provision holding them to be constitutional. Both parties appealed this judgment to the Sixth Circuit Court of Appeals.

On March 29, 2012 a three-judge panel for the Sixth Circuit Court of Appeals upheld every contested provision of the Tobacco Act as constitutional, except for the restriction on the colors used in tobacco advertisements and the ban on continuity programs.[4]

Graphic Warning Requirement: In a 2-1 decision, the Court of Appeals held the graphic warning requirement to be constitutional. Arriving at this decision, the court distinguished between the Zauderer and Central Hudson standards of review for infringements on commercial speech, asserting that the former is reserved for disclosure requirements and the latter for prohibitions on speech.[5] The court viewed the graphic warnings as disclosures of factual information about the health risks of tobacco and, as such, evaluated them against Zauderer.[6] The Zauderer standard permits disclosure requirements as an infringement on commercial speech if they are reasonably related to the government’s interest in preventing consumer deception.[7] The court held that the graphic warning requirement was reasonably related to the FDA’s interest in preventing consumers from being mislead about the health risks of tobacco. The court noted the tobacco industry’s history of deceiving consumers about the health risks and addictiveness of tobacco, as well as the ineffectiveness of the current warnings on cigarette packaging, to hold that the graphic warnings are reasonably related to preventing consumer deception.[8]

The Court viewed the remaining provisions of the Act as prohibitions on speech and measured them against the Central Hudson standard. In order for restrictions on commercial speech to pass Central Hudson and be deemed permissible under the First Amendment, the government must assert a substantial interest in limiting the speech and the means by which they limit it must be narrowly tailored, meaning the government must use the least restrictive methods to further their interest.[9]

Restrictions on marketing “modified risk” tobacco products and the ban on implying tobacco product safety due to FDA regulation: Similar to the graphic warning requirement, the Court of Appeals found the government’s interest in preventing the tobacco industry from making fraudulent claims about the health effects of cigarettes to be substantial enough to satisfy the first prong of Central Hudson.[10] Under the Tobacco Act, in order for tobacco companies to market a product as “modified risk,” the FDA must first determine that the product will actually reduce the harm and risk of tobacco-related disease, taking into account first and second-hand smoke.[11] The court found the pre-approval of “modified risk” health claims to be sufficiently narrowly tailored to further the government’s interest in preventing consumer deception.[12] The Court of Appeals also held that the prohibition of claims that a tobacco product is safer, or less harmful, due to FDA regulation is narrowly tailored to prevent consumer deception. The Appellate Court, reversing the District Court on this count, saw this as a narrow infringement on the tobacco industry’s commercial speech that would otherwise mislead consumers into thinking the FDA endorses cigarettes and tobacco related products.[13]

 Ban on free samples of tobacco products and the ban on brand-name sponsorship and merchandising for non-tobacco related products: For these provisions of the Tobacco Act, the Court of Appeals found the government’s interest in curbing juvenile tobacco use to be substantial enough to limit the commercial speech of the tobacco industry.[14] The FDA produced considerable evidence showing that these specific marketing techniques reached an overwhelming number of juveniles. Based on this evidence, the Court found the ban on free samples of tobacco products, as well as the ban on any brand-name tobacco sponsorship of anything non-tobacco related, to be narrowly tailored to prevent juvenile tobacco use.[15]

Color restrictions in tobacco advertisements and the ban on continuity programs: Although the court decided that the government’s interest in protecting consumer deception was substantial, the court held that color restrictions of tobacco advertisements were too overbroad to further that interest.[16] The court stated that the government could have chosen less restrictive means to limit deceptive advertising, such as prohibiting specific images or phrases, rather than limiting them to black text on a white background.[17]

Furthermore, the court held that the tobacco industry’s continuity programs, in which companies offer benefits to existing customers, did not narrowly fit the government’s substantial interest of limiting juvenile tobacco use. The Appellate Court, reversing the District Court, relied on evidence which showed that most existing tobacco users are adults, thus, limiting the continuity programs would not have a material effect on curbing juvenile tobacco use.[18]

After the ruling in this case the tobacco industry petitioned for a Writ of Certiorari asking the Supreme Court to review the ruling (American Snuff Co v. United States). The Plaintiff’s Writ of Certiorari was denied on April 22, 2013.

Summary by Katelyn Blaney


[1] Discount Tobacco City & Lottery, Inc., Lorillard Tobacco Company, National Tobacco Company, L.P., R.J. Reynolds Tobacco Company, Commonwealth Brands, Inc., & American Snuff Company, LLC.

[2] Copy of Initial Complaint: http://www.fdalawblog.net/files/tobacco-lawsuit-v-fda-august-2009.pdf.

[3] District Court Decision: http://www.fdalawblog.net/files/commonwealth—dist-ct-sj-decision.pdf.

[4] Disc. Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 518 (6th Cir. 2012).

[5] Id. at 552.

[6] Id. at 558.

[7] Id. at 555.

[8] Id. at 562-63.

[9] Id. at 534.

[10] Id. 534-36.

[11] Id. at 531.

[12] Id. at 536-37.

[13] Id. at 551.

[14] Id. at 541.

[15] Id. at 541-43.

[16] Id. at 548.

[17] Id.

[18] Id. at 544.



Sottera, Inc. v. Food & Drug Admin.

Monday, July 8th, 2013

In April of 2009, Sottera, Inc., an importer and distributor of electronic cigarettes (“e-cigarettes”), sought a preliminary injunction barring the FDA from denying their products entry into the United States. E-cigarettes are “battery powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide.”[1] The nicotine in each e-cigarette is derived from tobacco plants. The FDA denied Sottera’s e-cigarette shipments entry into the U.S., asserting that e-cigarettes were unapproved drug-device combinations subject to their authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”).[2] The FDCA gives the FDA authority to regulate drugs, devices, or drug/device combinations.

In 2000, the Supreme Court decided in FDA v. Brown & Williamson, that the FDA did not have the FDCA authority to regulate tobacco products as customarily marketed, meaning tobacco products marketed without claims of therapeutic effect.[3] In 2009, the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) finally gave the FDA the authority to regulate customarily marketed tobacco products. The Tobacco Act defines tobacco products to include “all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combinations under the FDCA.”[4]

Sottera relied on Brown & Williamson to argue that e-cigarettes should be considered customarily marketed tobacco products such that the FDA has no authority under the FDCA to deny their products entry into the United States.[5] The FDA asserts that Brown & Williamson barred the FDA from regulating only those tobacco products that existed at the time the case was decided, and that e-cigarettes are properly regulated by the FDCA as a drug/device combination.[6]

The United States District Court for the District of Columbia granted a preliminary injunction barring the FDA from regulating e-cigarettes as drug/device products.[7] The Court held that Brown & Williamson precluded the FDA from treating e-cigarettes as a drug/device combination because e-cigarettes were customarily marketed tobacco products.

The D.C. Court of Appeals affirmed the District Court’s injunction barring the FDA from regulating e-cigarettes under the FDCA. The court held that e-cigarettes should be regulated as tobacco products under the Tobacco Act. The Court of Appeals stated that the holding in Brown & Williamson extended to all customarily marketed tobacco products.[8] Additionally, the court noted that the Tobacco Act specifically states that it does not “affect, expand, or limit” the FDA’s jurisdiction under the FDCA.[9] The Court of Appeals stated that,

 Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act.[10]

 Thus, the Court of Appeals sided with Sottera, holding that e-cigarettes are customarily marketed tobacco products subject to FDA authority under the Tobacco Act, not the FDCA.

The FDA indicated it will not appeal the decision and will move forward with e-cigarette regulation through the Center for Tobacco Products.

Summary by Katelyn Blaney


[1] Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010).

[2] Id.

[3] Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 126 (2000).

[4] Sottera, 627 F.3d at 894.

[5] Id. at 893.

[6] Id. at 895.

[7] Online Link to District Court Decision: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54.

[8] Id. at 895.

[9] Id. at 894.

[10] Id. at 898.




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