Law Suits: USA Legal Challenge to FDA


This action is designed to protect the plaintiffs’ First Amendment right to free speech.

Tobacco Company Lawsuit Against FDA Highlights Absurdity of FDA Tobacco Law
September 3, 2009
By Michael Siegel
…? Note that this is precisely the argument I made repeatedly prior to the law’s enactment. I argued that: “Supporters of the FDA legislation are trying to have it both ways. On the one hand, they’re trying to argue that cigarettes are going to be made safer by virtue of FDA regulation, thus reducing health risk and saving millions of lives. On the other hand, they don’t want cigarette companies to tell the public that the FDA regulates cigarettes because they are afraid that the public might wrongly infer that cigarettes are going to be made safer by virtue of FD
A regulation, thus reducing health risk and saving millions of lives.”

Commonwealth Brands, Inc. Issues Legal Challenge to FDA
Aug. 31, 2009
Commonwealth Brands, Inc. has today joined with a number of other companies including the R.J.Reynolds Tobacco Company, Lorillard, Inc. and Conwood Company in filing an action in Federal Court against the U.S. Food and Drug Administration regarding the recently enacted Family Smoking Prevention and Tobacco Control Act. This action is designed to protect the plaintiffs’ First Amendment right to free speech.
Commonwealth Brands believes that the legislation, as passed on 22 June 2009, imposes unprecedented and impermissible restrictions on its commercial free speech rights as guaranteed by the U S Constitution. If allowed, the Act will virtually eliminate the few remaining avenues that the Company has to communicate with its adult consumers.
Commonwealth Brands also believes that the Act directly violates its Constitutional rights by suppressing its lawful ability to participate in the scientific and political debate surrounding its products and unduly restricts its right to engage in commercial speech.
Jonathan Cox, CEO and President of Commonwealth Brands, Inc. said:
“Commonwealth Brands supports the Act’s aim of preventing youth access to tobacco products and actively participates in youth access prevention initiatives.
“However, the Act fails to respect the legitimacy of our commercial freedoms and our right to communicate with our adult smokers. We believe that many of the provisions within the Act violate our constitutional rights and are not reasonably related to the goal of reducing youth access to tobacco products.
“This action seeks to protect our legitimate business interests and ensure that we can continue to participate in dialogue about our products and contribute to the development of reasonable and proportionate regulation.”
Beyond these key Constitutional infringements, Commonwealth Brands, Inc. looks forward to partnering with the FDA to develop an effective regulatory framework for tobacco products.
Commonwealth Brands, Inc. is the fourth largest tobacco manufacturer in the United States. Its cigarettes include Davidoff, Sonoma, Montclair and USA Gold, one of the nation’s best selling brands*. Its portfolio of fine tobaccos consists of the Premier, McClintock, Rave and Bali Shag brands. The Company also manufactures a range of tobacco related products, which include Premier, Rizla, and El Rey cigarette tubes and E-Z Wider and Joker cigarette papers. Commonwealth Brands, Inc. is based in Bowling Green, Kentucky, and employs over 900 people across 50 States. The Company is committed to its employees, its brands and its consumers.


R.J. Reynolds and Lorillard File Suit Over Advertising Restrictions in FDA Tobacco Legislation; Decimation of Anti-Smoking Groups’ Claims Begins

September 01, 2009
By Michael Siegel

Yesterday, R.J. Reynolds and Lorillard filed suit against the federal government, challenging the constitutionality of the advertising restrictions in the recently enacted FDA tobacco legislation. The tobacco companies claim that the advertising restrictions violate their First Amendment free speech rights by unduly interfering with their ability to communicate with adult consumers.

A statement released by R.J. Reynolds stated that: “the law contains provisions that severely restrict the few remaining channels we have to communicate with adult tobacco consumers and, in our opinion, cannot be justified on any basis consistent with the demands of the First Amendment.”

Being challenged are not only the advertising restrictions in the law, but also the law’s requirement for larger, graphic warning labels on cigarette packages, the law’s restriction of tobacco companies’ ability to make truthful statements about the relative risks of various tobacco products, and a provision that bars sponsors of events from mentioning a sponsoring company’s cigarette products (only the corporate name can be mentioned).

One tobacco control expert, despite being a strong opponent of the tobacco industry in the courtroom, argued that the cigarette companies have a legitimate case based on Supreme Court precedent. According to a Reuters article: “Even one opponent of the tobacco industry said the companies could have a good case. ‘The tobacco companies have a very legitimate claim based on the Supreme Court’s own rulings,’ said Michael Siegel, professor of community health sciences at Boston University’s School of Public Health. ‘I question why the crafters of the legislation did not deal with the First Amendment issue appropriately,’ he added. ‘A ruling for the companies would negate a good portion of this legislation.'”

The Rest of the Story

As I predicted back in June, the tobacco companies are challenging the FDA legislation’s advertising and communication restrictions:

“There are two aspects of the legislation that are likely to be challenged on First Amendment grounds. First is the bill’s advertising restrictions. Second is the bill’s restrictions on truthful information that the tobacco companies are permitted to communicate to their customers.

The bill’s advertising restrictions are unlikely to be upheld by the Supreme Court because the Court has already struck down very similar regulations that were issued in Massachusetts. Here, the state imposed a ban on smokeless tobacco advertising within 1000-feet of schools and playgrounds, which is identical to one of the major advertising restrictions in the FDA legislation. The Supreme Court struck down those restrictions, ruling that they violate the First Amendment’s protection of free speech rights of the tobacco companies.

As a Congressional Research Service analysis explains the decision: “The Court determined that the regulations restricted speech more than was reasonable to advance the state’s interest in reducing underage (i.e., illegal) use of tobacco products and, thus, failed to meet the fourth part of the Central Hudson test. Banning all outdoor tobacco advertisements within 1,000 feet of a school or playground, in conjunction with other zoning restrictions, argued the Court, “would constitute a nearly complete ban on the communication of truthful information about smokeless tobacco and cigars to adult consumers.” The Court found that the restrictions on outdoor advertising of cigars and smokeless tobacco were overbroad in that they prohibited advertising “in a substantial portion of the major metropolitan areas of Massachusetts,” included oral communications, and imposed burdens on retailers with limited advertising budgets. The Court also upheld challenges by smokeless tobacco and cigar companies to the outdoor advertising restrictions on the grounds that adults have a right to information and the tobacco industry has a right to communicate truthful speech on legal products.”

The Campaign for Tobacco-Free Kids and other health groups have been misleading their constituents and the public about the likely effect of the legislation on cigarette advertising, because these groups have not been honest with us about the fact that the bill’s advertising restrictions are almost certainly going to be challenged in court and the fact that very similar restrictions were overturned by the Supreme Court in 2001.

When all is said and done, the effect of the legislation’s remaining advertising restrictions is likely to be quite minor.

The second aspect of the legislation which will almost certainly be challenged in court is the bill’s prohibition on cigarette companies making truthful statements about FDA regulation of tobacco products. The House version of the bill prevents companies from even stating that FDA regulation of tobacco products exists, while the Senate version prevents companies from making any statement that could be implied as suggesting that the FDA approves cigarettes for sale and consumption. In both cases, the constitutionality of the legislation is doubtful because it prevents companies from making truthful statements and therefore is likely in violation of their First Amendment free speech rights.

Jonathan Adler points out the absurdity of this aspect of the legislation: “One fear of tobacco-control activists is that cigarette companies would trumpet FDA approval, giving consumers the impression that cigarettes and other tobacco products are safe — or at least “safer” — now that the FDA is involved. To address this concern, the bill prohibits “any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that the product is approved by the Food and Drug Administration,” or was somehow deemed “safe” by the federal government. So while the FDA will now have the final say over what tobacco products may be on the market, federal law will purport to prohibit companies from saying so, lest consumers be “misled” into believing FDA regulation of tobacco is for their benefit.”

Supporters of the FDA legislation are trying to have it both ways. On the one hand, they’re trying to argue that cigarettes are going to be made safer by virtue of FDA regulation, thus reducing health risk and saving millions of lives. On the other hand, they don’t want cigarette companies to tell the public that the FDA regulates cigarettes because they are afraid that the public might wrongly infer that cigarettes are going to be made safer by virtue of FDA regulation, thus reducing health risk and saving millions of lives.

Now you can see why I call this a scam.”

While I do not believe that all of the provisions of the legislation being challenged will be overturned, I do think that some of them will, especially the restriction on advertising within 1000 feet of schools and playgrounds, since a similar regulation in Massachusetts has already been struck down by the Supreme Court. I also think that the restriction on cigarette companies’ truthfully telling their customers that the FDA now approves cigarettes will also be struck down.

The net effect of this lawsuit – even if only partially successful – will be the near decimation of the FDA tobacco legislation. There were only two provisions of the legislation that did anything to protect the public’s health to being with: (1) the warning labels [and the effects will be modest and short-lived]; and (2) the advertising restrictions. If the most stringent advertising restrictions are struck down, there will be little, if any, substance left to the legislation.

The claims of anti-smoking groups – like the Campaign for Tobacco-Free Kids – that this law will save lives by decreasing cigarette smoking due to the curtailing of the marketing of cigarettes to youths are soon to go up in smoke.

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