Nicopure Labs, LLC v. FDA

The First Amendment free speech rights of e-cigarette manufacturers are not violated by a requirement that claims of reduced harm must be proven before they are advertised to the public, nor by a ban on free samples.

 The Issue: The FDA deemed that e-cigarettes are subject to laws governing sales and advertising for conventional cigarettes and certain other tobacco products. Those laws include a requirement that, before making claims of reduced harm to health (compared to use of conventional tobacco products), manufacturers must demonstrate to the FDA that their claims are substantiated by evidence. Applicable laws also include a prohibition on distribution of free samples. E-cigarette manufacturers argued that both provisions would violate their First Amendment free speech rights, and that the FDA acted “arbitrarily,” in violation of the Administrative Procedures Act

 Why It Matters: The case is important both for the specific threat to public health at issue and for its broader First Amendment implications. Besides posing serious health risks of their own, especially to youth, the demographic with the highest level of e-cigarette use, e-cigarettes are getting a new generation of youth addicted to nicotine, often resulting in long-term tobacco use (including smoking cigarettes), leading to serious illness and premature death for many.

More generally, a decision that pre-market review is unconstitutional would have hamstrung the ability to regulate deceptive advertising and promotions of any sort, no matter how harmful the deception. And a decision striking down the sampling ban would have threatened the constitutionality of any regulation of product sales and distribution.

Public Good’s Contribution: Public Good represented a leading public health legal advocacy organization appearing as an amicus in the United States Court of Appeals for the D.C. Circuit. Public Good’s brief explained in detail that the pre-approval requirement for health claims was far from unique, and was necessitated by the sordid history of deceptive claims by the tobacco industry for a long succession of allegedly safer tobacco products. And, contrary to the e-cigarette manufacturers’ claims that they represented a new and different industry not tainted by that history, Public Good demonstrated the intertwined ownership and personnel of the vaping companies and the traditional tobacco companies, and showed the continuity of strategies of deception over time. Public Good also argued that sampling clearly failed to meet applicable standards for when conduct is sufficiently communicative to receive First Amendment protection, and indeed that the vaping companies’ arguments would rule out any regulation of product sales or distribution. Public Good also clarified the correct standard of review if the First Amendment were found to apply.

Amicus represented by Public Good: Public Good’s brief in the D.C. Circuit was filed on behalf of the Public Health Law Center.

Outcome: The D.C. Circuit panel unanimously upheld all the regulations of e-cigarette promotion against all industry objections. In upholding the pre-clearance requirement for reduced harm claims, the Court attached substantial weight to the long history of tobacco industry deception, as explicated in Public Good’s brief. And the Court disposed of the challenge to the free sampling ban essentially along the reasoning of Public Good, which had filed the only amicus brief to address that issue.

266 F. Supp. 3d 360 (D.D.C. 2017), and affirmed, 944 F.3d 267 (D.C. Cir. Dec. 10, 2019).

Download our brief filed in Nicopure v. FDA.