Journal of Free Speech Law: "Speech Regulation and Tobacco Harm Reduction," by Jonathan H. Adler & Jacob James Rich

Here is the Introduction; the full article is here:

Regulatory constraints on the provision of truthful information to consumers about tobacco products may be having deadly consequences. Different types of tobacco products present different degrees of risk, yet a substantial proportion of consumers are unaware of these differences. Existing regulations governing tobacco products limit the ability of manufacturers to address these misperceptions. As a consequence, well-intentioned public health regulations may be undermining the protection of public health.

Regulation of commercial speech is a major component of federal regulation of tobacco products. Even before the enactment of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), Congress authorized cigarette warning labels and the regulation of cigarette advertisements. In 2009, this legislation expanded the regulation of speech, imposed a permitting regime for comparative health claims of alternative tobacco products and subjected cigarette alternatives, such as electronic nicotine delivery systems (ENDS) and other vaping products, to the same regulatory regime as cigarettes.

Federal regulation of tobacco company speech was adopted to counteract tobacco industry misinformation and manipulation of consumers. Controlling the advertisement, promotion, and labeling of tobacco products was embraced as a central element of reducing smoking rates and youth initiation in particular. While the regulation of tobacco advertising and labeling was considered an important public health measure, it was nonetheless subject to First Amendment scrutiny.

Since the adoption of federal tobacco legislation, the Food and Drug Administration (FDA) has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as cigarettes and other traditional forms of tobacco products. This includes labeling requirements and regulations governing tobacco product advertising. It also includes restrictions on providing consumers with truthful, and potentially life-saving, information about the relative risks of competing products.

While ENDS are now subject to the same federal regulatory regime as cigarettes, they do not pose the same risks. ENDS and other vaping products pose far less danger to users than combustible tobacco products, such as cigarettes. Yet recent polling shows that most consumers have a poor understanding of the relative risks of tobacco products, and that this public misunderstanding is getting worse. Barring producers from informing consumers about the relative risks of vaping products and their potential to help smokers quit smoking eliminates a potentially powerful tool for consumer education. Measures to prevent fraudulent or misleading marketing claims may be necessary, but current restrictions go so far as to outlaw the promotion of information acknowledged by the regulators themselves. Current restraints on truthful health information that could help or encourage smokers to quit are not only constitutionally dubious, they may undermine the protection of public health as well.

Part I of this essay describes what is currently understood about the relative health risks of ENDS and other vaping products, particularly as compared to combustible cigarettes. While uncertainties remain about the long-term risks posed by ENDS, the weight of existing scientific and medical evidence suggests that such products pose less risks to consumers and bystanders than cigarettes. The FDA concurs in this assessment. There is also strong evidence that such products can help smokers reduce their cigarette consumption and are more effective aids to smoking cessation than available FDA-approved alternatives.

Part II of this essay describes the current regulatory regime governing tobacco products and how this regime has been applied to ENDS and other vaping products. Under the Tobacco Control Act and the FDA’s subsequent decision to deem ENDS as tobacco products, such products require FDA approval before they may be sold, much like drugs and medical devices. They are also subject to specific regulation under statutory provisions governing “modified risk tobacco products” if any relative risk claims are made about such products, and, in some cases, even being treated as drugs or devices under the Federal Food, Drug and Cosmetic Act (FDCA).

Part III of this essay explains how the FDA’s regulatory regime hampers the ability of ENDS manufacturers to inform consumers about the relative risks of their products and the potential use of ENDS as smoking cessation aids. Under current law, ENDS producers must also obtain FDA approval before making any comparative risk claims, such as claiming that such products are less dangerous than cigarettes. Further, if ENDS manufacturers wish to inform smokers that ENDS may assist in smoking cessation, they must seek FDA approval for their products as drugs or devices. Even though such claims are accepted as true by the FDA, such speech is prohibited without prior FDA approval. In practice, this means that ENDS producers face greater restrictions on speech about their products than do other regulated entities, such as makers of nutritional supplements. These regulatory constraints hamper public health efforts and are constitutionally dubious.

Part IV explains why this regulation of health claims may be having serious negative consequences for public health. A majority of consumers, including current cigarette smokers, are misinformed about the relative risks posed by various nicotine products. Such public misunderstanding appears to be getting worse.

Part V explains why the current regulation of speech about the relative risks of ENDS and other vaping products is highly questionable under current commercial speech jurisprudence insofar as the FDA is prohibiting the communication of truthful information about such products. Even though product claims are subject to less demanding constitutional scrutiny than restrictions on political speech, existing restrictions are not sufficiently tailored to fit the government’s interest in promoting health. Greater recognition and protection of the speech rights of ENDS producers is not only required under existing First Amendment jurisprudence, it would also likely benefit public health.

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