As I reported yesterday, R.J. Reynolds, Lorillard, and two smaller tobacco companies have filed a lawsuit against the federal government challenging the advertising and other speech restrictions of the FDA tobacco law. An examination of the actual complaint not only confirms that there is legitimacy to several aspects of the constitutionality claims being made, but also highlights the absurdity of the law itself.
In this post, I highlight two of the specific claims being made by the tobacco plaintiffs and show how these claims reveal and/or underscore the absurdity of the FDA tobacco law.
Claim #1: Restriction Against Telling the Truth About FDA's Regulatory Approval of Tobacco Products
One claim being made by R.J. Reynolds and Lorillard is the unconstitutionality of the law's prohibition of tobacco companies making any statement which could imply that the FDA approves of tobacco products or that these products are safer due to the FDA's regulatory oversight. The plaintiffs argue as follows:
"The Act prohibits Plaintiffs from making “any express or implied statement or representation directed to consumers” “through the media or advertising” that “conveys, or misleads or would mislead consumers into believing, that – (1) the product is approved by the [FDA]; (2) the [FDA] deems the product to be safe for use by consumers; (3) the product is endorsed by the [FDA] for use by consumers; or (4) the product is safe or less harmful by virtue of [either] (A) its regulation or inspection by the [FDA]; or (B) its compliance with regulatory requirements set by the [FDA].” ... The ban is also extremely vague. It thus arguably prohibits plaintiffs from making any reference “through the media” to the truthful fact that the FDA regulates tobacco products, because such reference could be construed as an “implied . . . representation” that the product is “approved,” “deem[ed] . . . safe,” or “endorsed” by the FDA, or “less harmful by virtue of” regulation by the FDA. At a minimum, the Act chills Plaintiffs from engaging in such truthful speech, including truthful non-commercial speech. The irrationality of this provision is underscored by the Tobacco Product Standards provision of the Act, which, as noted, authorizes the FDA to “require the reduction or elimination of an additive, constituent (including a smoke constituent), or other component of a tobacco product” if it determines that such reduction or elimination “is appropriate for the protection of public health.” ... Thus, the Act explicitly authorizes the FDA to decide what products lawfully may be sold, but prohibits anyone from truthfully describing the consequences of the FDA’s regulations."
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 FDA regulation, thus reducing health risk and saving millions of lives."
In other words, the FDA tobacco legislation, is in the very eyes of its crafters and supporters, such a scam that telling the public the truth about the law will essentially result in the defrauding of the American public by making us think that cigarettes are truly going to be made safer. Apparently, even the crafters of the bill know that this is not the case, and so they don't even want the public to find out that the FDA is regulating cigarettes in the first place.
The bill itself notes that the public may be easily misled into believing that cigarettes are safer merely by the mention of the fact that the FDA regulates tobacco products. The crafters of the bill were so worried about this that they wrote it right into the preamble to the law: "If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Depending upon the particular language used and its context, such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."
In other words, the clearly stated opinion of the crafters of this legislation is that if a cigarette company merely tells its customers, truthfully, that its products comply with FDA standards, consumers are likely to be misled into thinking the product is safer. Thus, the clear intent of the bill's crafters is that cigarette companies not be allowed to make any statement which even refers to the fact that the FDA regulates cigarettes and that the Agency sets standards to which companies must adhere.
So as the plaintiffs correctly point out, the bill has the effect of prohibiting truthful speech on the part of tobacco companies. They cannot even mention that the FDA regulates cigarettes, sets product standards, or that their company complies with such standards. Even if they were to inform consumers about changes they have made in their products to comply with FDA standards, that might give consumers the false impression that somehow their products have been made safer.
The first important implication of this is that the bill is blatantly in violation of the free speech rights of the tobacco companies. Courts have, in the past, had a difficult time allowing the government to infringe upon truthful communication of facts to consumers. The FDA legislation is so overly broad in the scope of its speech restriction in this area that a tobacco company executive could not even give a speech at a shareholder meeting in which he reports that the company in the past year has complied with all FDA tobacco product regulations. A company annual report would risk a violation of the law by stating that the company's products comply with FDA standards.
The second important implication of this is that the law is absurd on its face. On the one hand, the law admits that FDA regulation will not mean a safer cigarette. On the other hand, the law's entire premise is that FDA product standards will create a safer cigarette.
The truth is that the law is a scam, designed to make the public think that the FDA is making cigarettes safer, when in reality, there is no way that the FDA could make cigarettes safer.
Claim #2: Restriction Against Telling the Truth About the Concentration of Chemicals in Tobacco Products
A second claim by R.J. Reynolds and Lorillard is the unconstitutionality of the law's prohibition against tobacco companies making truthful statements about the concentration of chemicals in their products. For example, if R.J. Reynolds discovered a way to lower the nitrosamine content of its cigarettes and implemented it, so that they now contained half the level of nitrosamines, Reynolds could not tell that fact to consumers or it would be in violation of the law.
Once again, the constitutionality of this provision is questionable since it sweeps so broadly and prevents the company from even reporting in an annual report that it has lowered the level of nitrosamines or some other chemical in a particular product. The law seemingly also prevents the companies from mentioning a lowering of exposure to certain chemicals that have been mandated by FDA product standards.
The plaintiffs argue: "Under this vague and sweeping provision, if a particular type of tobacco product reduces risk “to individual tobacco users,” the FDA can ban Plaintiffs from disseminating truthful information about the health risks of those products, if, in the FDA’s view, dissemination of that truthful information may offer a level of reassurance that may encourage some tobacco users to consume those tobacco products rather than quitting altogether. “[T]he Constitution,” however, “is most skeptical of supposed state interests that seek to keep the people in the dark for what the government believes to be their own good.” Rubin v. Coors Brewing Co., 514 U.S. 476, 497 (1995) (Stevens, J., concurring) (citation omitted). The irrationality of this provision is underscored by the Tobacco Product Standards provision of the Act. ... Under this provision, the FDA is authorized to restrict the “nicotine yields” or otherwise require “the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product,” if the Secretary finds “that it is appropriate for the protection of public health to require the reduction or elimination of an additive, constituent (including a smoke constituent), or other component of a tobacco product because the Secretary has found that the additive, constituent, or other component is or may be harmful.” Id. Under the Modified Risk Tobacco Products provision, Plaintiffs may not accurately describe the FDA’s product standards without risking criminal punishment."
In addition to exposing the seeming infringement on the free speech rights of the tobacco companies, this claim also exposes the absurdity of the entire approach of the FDA tobacco law. On the one hand, the crafters of the law make it clear that reductions in levels of various smoke constituents do not necessarily translate into a safer product. On the other hand, the entire premise of the law is that by requiring reductions in levels of certain smoke constituents, the FDA will be mandating a safer product.
Once again, the law is basically a scam. It acknowledges that lower levels of smoke constituents does not mean a safer product, yet it leads the public to believe that by lowering the levels of certain smoke constituents, the FDA will be creating a safer product.
The Rest of the Story
The rest of the story is that this lawsuit exposes not only several constitutionally problematic provisions of the FDA law, but that it also exposes the absurdity of the very premise of the entire law.