In August, the US District Court for the District of Columbia issued its final decision in Bellion Spirits, LLC v. United States, Civ. No. 17-2538 (JEB). The Bellion case was brought by spirits company Bellion Spirits after the Alcohol and Tobacco Tax and Trade Bureau (TTB) refused to approve a series of health claims advanced by Bellion in connection with its vodka products. According to Bellion, the infusion of its vodka with a compound called NTX will mitigate the damage alcohol inflicts on human DNA.
In 2016, Bellion petitioned TTB to approve eight specific claims related to the NTX-infused vodka. After consulting with the federal Food & Drug Administration (FDA), in 2017 TTB rejected all eight claims. Bellion then brought suit, arguing that TTB's actions with respect to two of its claims were illegal and unconstitutional. Bellion's complaint advanced four counts alleging that:
TTB impermissibly delegated authority to FDA by consulting with FDA during the petition process; TTB's rejection amounted to the suppression of "commercial speech" in violation of the First Amendment; TTB's process amounted to an unconstitutional prior restraint on speech in violation of the First Amendment; and TTB's health claims regulation was impermissibly vague in violation of the Due Process requirement of the Fifth Amendment. The District Court's August 2019 opinion granted summary judgement in favor of TTB. The lengthy and entertaining opinion makes a number of important points, summarized below:
On the all-important issue of the standard of review, the court acknowledged that while it reviews questions of law de novo, it would review TTB's factual determinations under the deferential "substantial-evidence" standard. Under this standard, the court does not re-weigh the evidence but upholds an agency's factual determination if substantial evidence supports that determination. TTB's relative lack of expertise on public health issueslike the health effects of alcoholand its decision to seek assistance from FDA do not alter the deferential review given to TTB's factual determinations. The court rejected Bellion's claim that TTB impermissibly delegated its authority under the Federal Alcohol Administration Act to FDA by consulting with and relying on FDA's evaluation of Bellion's scientific evidence. It explained that although TTB cannot delegate its decision-making to FDA, it did not do so here. TTB merely consulted with a fellow agency to obtain more...