US Supreme Court Overturns Precedent, Impacting E-Cigarette Industry and FDA

According to VAPING360, the US Supreme Court has overturned a decades-old precedent that nearly gave federal agencies an insurmountable advantage in defending their regulations against legal challenges. The court's decision in Loper Bright Enterprises v. Raimondo (and a related case, Relentless v. Department of Commerce) could impact pending challenges in the e-cigarette industry against FDA regulations, potentially leading to changes in how the FDA regulates e-cigarette products.

The Supreme Court's decision overturned the Chevron doctrine based on the 1984 case of Chevron v. Natural Resources Defense Council. The Chevron doctrine held that as long as an agency's interpretation is reasonable, the court should defer to the "expertise" of federal agencies in interpreting ambiguous laws that the agency needs to implement.

This decision could potentially impact legal challenges to the FDA's interpretation of the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which grants the agency broad authority to regulate nicotine and tobacco products. The TCA does not specifically mention e-cigarette products, which were not on the market in the United States when the law was passed.

However, the FDA used a provision in the Tobacco Control Act to issue the 2016 "Deeming Rule," granting the agency regulatory authority over e-cigarettes, nicotine pouches, and other products not described in the 2009 legislation. The "Deeming Rule" establishes a system for manufacturers to submit market applications for e-cigarettes and other nicotine products.

When the FDA received a large number of pre-market tobacco applications (PMTAs) from small e-cigarette manufacturers and realized it was unable to individually consider them as required by the Tobacco Control Act (TCA), the agency created the so-called "deadly defects" system, allowing it to issue millions of marketing denial orders (MDOs) for flavored e-cigarette products without conducting actual scientific review.

In a friend-of-the-court brief submitted to the Supreme Court last year by a group of e-cigarette companies and trade organizations, industry lawyers explained how the FDA has used Chevron deference to create a maze of an elusive (essentially undefined) standard.

They wrote that the FDA "has taken a one-size-fits-all approach, which has dramatically tipped the scales in one direction, effectively banning all non-tobacco flavors (such as mint and fruit) of ENDS products, and in the process, focusing primarily on underage use, at the expense of adult smokers. The FDA implemented this de facto ban not by requiring Congress to amend the TCA or by establishing tobacco product standards through public notice and comment rulemaking procedures as required by the APA, but by issuing a regulation that is not based on the text, structure, and context of the TCA.

Due to the courts' tendency to view most challenges to federal agency power through the lens of Chevron deference, federal district and appellate courts have granted the FDA broad latitude to effectively ban all flavors of e-cigarettes, even when applications have been submitted, by improvising standards.

The decision of the Supreme Court in "Loper Bright" will impact how Congress writes laws, how federal agencies enforce laws, and how courts interpret laws. It could result in future court decisions partially limiting the FDA's Tobacco Products Center, forcing tobacco regulatory agencies to carefully consider the interests of adult consumers when reviewing market applications.