Law Commons^™

Speech Regulation And Tobacco Harm Reduction, Jonathan Adler, Jacob James Rich

Faculty Publications

Regulation of commercial speech is a major component of federal regulation of tobacco products. Since adoption of federal tobacco legislation, the Food and Drug Administration has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as traditional tobacco products even though such projects appear to pose less of a threat to public health. Such regulation, and the restriction on truthful speech in particular, may be having negative consequences for public health. Barring producers from informing consumers about the relative risks of vaping products and their potential to reduce smoking eliminates …

Cheers To Central Hudson: How Traditional Intermediate Scrutiny Helps Keep Independent Craft Beer Viable, Daniel J. Croxall

NULR Online

Independent craft breweries contributed approximately $68 billion to the national economy last year. However, an arcane regulatory scheme governs the alcohol industry in general and the craft beer industry specifically, posing both obstacles and benefits to independent craft brewers. This Essay examines regulations that arguably infringe on free speech: namely, commercial speech regulations that prohibit alcohol manufacturers from purchasing advertising space from retailers. Such regulations were enacted to prohibit undue influence and anticompetitive behavior stemming from vertical and horizontal integration in the alcohol market. Although these regulations are necessary to prevent global corporate brewers from dominating the craft beer market …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher

O'Neill Institute Papers

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Effectively Regulating E-Cigarettes And Their Advertising—And The First Amendment, Eric N. Lindblom

O'Neill Institute Papers

If tobacco smoking did not exist in the United States, there would be no reason, from a public health perspective, to allow addictive, nicotine-containing e-cigarettes to be marketed and sold. Because e-cigarette use, by itself, is neither beneficial nor benign to users and nonusers, the only public health justification for allowing e-cigarettes in the existing U.S. market would be if doing so would not sustain or increase existing smoking levels but would help smokers quit completely or provide addicted smokers a less harmful way to obtain the nicotine they crave. Yet e-cigarettes are now pervasive in the U.S. market, being …

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …