In an article titled “Snake Oil Salesmen or Purveyors of Knowledge: Off-Label
Promotions and the Commercial Speech Doctrine,” Yale Law School Senior
Research Scholar Constance Bagley and her co-authors critique the Second
Circuit’s December 2012 determination in United States v. Caronia that Food
and Drug Administration rules prohibiting prescription drug makers from
promoting their products for off-label uses are unconstitutional under the First
Amendment.

According to the article, which will appear in a forthcoming issue of the Cornell Journal of Law and Public Policy, “this undue expansion of the Free Speech rights of commercial actors, if left unchecked” has the “potential to undermine the constitutionality of numerous areas of federal regulation,” including mandatory labels on food under the Nutritional Labeling and Education Act of 1990 and Food Allergen Labeling and Consumer Protection Act of 2004.

The authors call for anchoring regulatory regimes in promoting the public
good rather than individual paternalism and subjecting restraints on truthful
speech to intermediate scrutiny under Central Hudson as a way to comport
with the First Amendment’s purpose of facilitating “political liberty and
individual autonomy” and to avoid “a laissez-faire false utopia of unrestricted
commercial promotion,” which they suggest is the outcome of Caronia.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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