Closing the Regulatory Gap for Synthetic Nicotine

Abstract

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new "comprehensive plan for tobacco and nicotine regulation." This plan is focused on making cigarettes less addictive while facilitating the development of alternative nicotine-containing products that are far less harmful. This approach holds promise, and the public health stakes could not be higher-smoking is the leading cause of preventable death in the United States, causing roughly 480,000 deaths per year.But a new product is emerging that could upset the FDA's plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act's (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA's plan for tobacco and nicotine regulation.This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA's past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine satisfies the FDCA's definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine as a drug.

Analytical Method for Measurement of Tobacco-Specific Nitrosamines in E-Cigarette Liquid and Aerosol

“…In commercial EC solutions, various kinds of nicotine, such as synthetic nicotine, natural nicotine, and nicotine extracted from the stem are used [39]. The experiment that was performed in this study assumed that the target compounds in synthetic nicotine are same as nicotine in tobacco.…”

Synthetic nicotine has arrived

“…43 With multiple synthetic nicotine-containing product lines rapidly emerging, a case-by-case review strategy will likely be ineffective. If not regulated as a tobacco product, FDA could regulate synthetic nicotine as a drug, as proposed in a legal analysis by Zettler et al 4 FDA attempted to regulate combustible and smokeless tobacco products as drugs in the 1990s, but lost this ability following the Supreme Court Ruling in FDA vs Brown & Williams in which the court raised concerns that tobacco products marketed in the USA at the time could never meet the safety standards required for drugs and had no therapeutic benefits as required for drugs. 44 However, FDA has always regulated nicotine replacement therapy products as drugs, including nicotine gum, lozenges and patches, a status that did not change with the enactment of the FSPTCA in 2009.…”

“…2 3 The tobacco regulatory science community has occasionally discussed a hypothetical scenario in which a company would market a product containing synthetic nicotine. 4 Would FDA have regulatory authority over such a product ? Such scenario has ceased to be hypothetical.…”

Key Lessons for the Design of Consumer Protection Legislation

“…This allowed a firm to present chocolate milk powder as a healthy product under 58. Zettler, Hemmerich, Berman (2018), p. 1947-51. 59.…”