Thursday, December 12, 2019
The D.C. Circuit this week rejected First Amendment challenges by the vaping industry to two key provisions of the Tobacco Control Act. The ruling affirms the FDA's authority to require premarket review of vaping products and to ban the distribution of free samples of vaping products.
The case tests two provisions of the TCA. The first provision requires FDA premarket review of all new tobacco products, including e-cigarettes. The Act has three pathways for premarket review, depending on the type of tobacco product. Products designed for recreational use (like traditional cigarettes) get the easiest path of review; products marketed as safer than existing tobacco products ("modified risk" products) get a mid-level path; and products marketed as smoking cessation products get the most demanding path for review. The second provision bans the distribution of free samples.
Plaintiffs, a vaping manufacturer and a vaping industry group, argued that the two provisions violated the First Amendment. In particular, they claimed that the FDA uses a manufacturer's own claims about its product to designate an appropriate premarket review pathway (the modified risk pathway in this case), in violation of free speech. They contend that the ban on free samples impermissibly restricts their free expression. The D.C. Circuit flatly rejected the claims.
As to the premarket review requirement, the court cited circuit precedent that "explicitly approves the use of a product's marketing and labeling to discern to which regulatory regime a product is subject, and to treat it as unlawful insofar as it is marketed under a different guise." But in any event, the court also held that the requirement met Central Hudson's commercial speech test: "[E]ven if we were to scrutinize the FDA's reliance on new tobacco product descriptors as a burden on the Industry's commercial speech, the modified risk product pathway clears First Amendment scrutiny because it is reasonably tailored to advance the substantial government interest in protecting the public health and preventing youth addiction."
As to the ban on free samples, the court explained that this provision regulates conduct, not speech, and that the conduct has no obvious expressive value. The court rejected the plaintiffs' argument that free samples are "the most effective and efficient means of obtaining product-specific information when trying to switch away from deadly cigarettes":
The Industry thus appears to be urging us to afford constitutional protection to the informational value of customers' experience trying out vaping, including the experience of sampling the available flavors and sensations.
This extraordinary argument, if accepted, would extent First Amendment protection to every commercial transaction on the ground that it "communicates" to the customer "information" about a product or service. Even if we could bridge the gap between the opportunity to use a product and the expression of an "idea," the Supreme Court has long rejected the "view that an apparently limitless variety of conduct can be labeled 'speech' whenever the person engaging in the conduct intends thereby to express an idea."
But even if the free-sample ban imposed an incidental burden on speech, the court held that "the restriction itself applies to conduct and is imposed 'for reasons unrelated to the communication of ideas.'"