By Joel Kurtzberg, a Partner, Adam Mintz, Counsel, and John MacGregor, an Associate, in the New York, NY office of Cahill Gordon & Reindel LLP.

Executive Summary

The Food and Drug Administration has a complicated relationship with the First Amendment. The agency consistently chafes against arguments that the Constitution limits its regulation of promotional and other types of speech. Over the past three decades, regulated entities have been increasingly successfully challenging FDA actions that prohibit, limit, or compel speech about their products or services. Despite those defeats, FDA has continued its confrontational approach.

One example of that approach is the agency’s overzealous implementation of a 2009 tobacco control law’s section on modified-risk tobacco products. Two courts have rejected facial First Amendment challenges to the law’s limits on risk-related speech. FDA has set an extremely high approval bar, under which it has granted only two applications for reduced-risk promotion. And the agency has taken informal action against purported “switch claims” made about specific e-cigarettes as well as one company’s support of a ballot proposition to reverse a city’s ban on some tobacco alternatives.

This Working Paper explains that modified-risk tobacco manufacturers could successfully bring as-applied First Amendment challenges against FDA actions under the tobacco control law. FDA’s chilling of speech on the benefits of switching to tobacco alternatives not only singles out speech based on its content, but it also undermines Congress’s goal of improving public health. The agency’s inquiry on financial support for ballot proposition impermissibly targets the company’s fully protected right to participate in public debates.

The Working Paper also notes that the two court decisions upholding the tobacco control law’s provision on modified-risk communication leave open one form of promotion. The law curbs messages “directed to consumers . . . respecting the product.” That language, as one court specifically acknowledged, does not limit manufacturers’ ability to engage in generic advertising about tobacco alternative products in general.