Keeping FDA Regulation of Cigarettes a Secret


Yesterday, as expected, the House of Representatives approved a bill that would authorize the Food and Drug Administration to regulate tobacco products. One of the concerns raised by the bill's critics  is that FDA regulation of cigarettes will be interpreted as an official stamp of approval, signaling that cigarettes are safe to consume, or at least safer than they used to be. In response to this complaint, tobacco policy blogger Michael Siegel notes, the bill's authors added a provision that prohibits manufacturers from making "any statement directed to consumers through the media or through the label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration, including a statement or implication in the label, labeling, or advertising of such product, and that could result in consumers believing that the product is endorsed for use by the Food and Drug Administration or in consumers being misled about the harmfulness of the product because of such regulation, inspection, or compliance."

So the FDA will be regulating cigarettes, but manufacturers won't be allowed to say the FDA is regulating cigarettes, because (as the bill says elsewhere) "consumers are likely to be confused and misled" if they know the FDA is regulating cigarettes. Good thing that consumers don't read newspapers, watch TV, or look at Google News. Speaking of which, note that the gag order applies not just to labels and ads but to "any statement directed to consumers through the media." If an R.J. Reynolds executive mentioned FDA regulation during an appearance on CNBC, would he thereby commit a "prohibited act" under the Food, Drug, and Cosmetic Act, an offense punishable by up to a year in jail?

As Siegel notes, it's hard to see how such censorship of completely truthful speech could survive First Amendment scrutiny. As Siegel also notes, supporters of this bill were driven to such blatantly unconstitutional lengths precisely because they know that FDA regulation will be seen as a sign that cigarettes are safer but will not actually make them safer. In fact, if the FDA uses its authority to order a reduction in nicotine content, regulation will increase exposure to toxins and carcinogens for smokers accustomed to a particular dose, thereby making cigarettes more dangerous. As I discussed yesterday, it also could stifle the market for safer products that compete with cigarettes.

The tobacco regulation bill is here (PDF). The part dealing with statements about FDA regulation (Section 103, Paragraph tt) is on page 155.