Avail Vapor, LLC v. FDA, No. 21-2077 (4th Cir. 2022)Annotate this Case
The Family Smoking Prevention and Tobacco Control Act requires manufacturers of new tobacco products to obtain authorization from the United States Food & Drug Administration (FDA) prior to marketing their products. In reviewing a manufacturer’s Premarket Tobacco Product Application, FDA must determine that the marketing of the product is “appropriate for the protection of the public health.” Section 910(c)(4), 123 Stat. at 1810. The agency denied Avail Vapor LLC’s application for its flavored electronic cigarettes, chiefly on the grounds that its products posed a serious risk to youth without enough offsetting benefits to adults.
The Fourth Circuit upheld the FDA’s decision denying Avail’s application. The court explained that under the Tobacco Control Act (TCA) the FDA has the daunting task of ensuring that another generation of Americans does not become addicted to nicotine and tobacco products. The TCA gives FDA the flexibility to determine whether marketing of a new tobacco product is appropriate for the protection of public health, taking into account evolving science and an everchanging market. FDA made the determination that Avail’s flavored ENDS products, seeking in all respects to mimic those sweet treats to which youth are particularly attracted, pose a substantial risk of youth addiction without enough offsetting benefits to adult smokers. FDA could not allow young adults to perceive e-cigarettes as another Baby Ruth or Milky Way, only to find themselves in the grip of a surreptitious nicotine addiction. Substantial evidence supports the assertion that “[t]here is an epidemic of youth use of e-cigarette products, and flavored products like petitioners’ are at the center of that problem.”