Determining Synthetic Nicotine’s Place in the Tobacco and Nicotine Regulation Landscape
Synthetic Nicotine, sometimes referred to as “tobacco-free nicotine,” is a man-made chemical version of nicotine that is not derived from tobacco. Recently, several Synthetic Nicotine products have entered the market and, with them, questions on how they will be regulated. The U.S. Food and Drug Administration (FDA) regulates all products that are “made or derived from tobacco,” but this leaves a potential federal regulatory gap for Synthetic Nicotine not made or derived from tobacco.1 Until the FDA makes an official decision on how treat Synthetic Nicotine, the products remain on the market.
The Family Smoking Prevention and Tobacco Control Act of 2009, which amended the federal Food, Drug and Cosmetic Act, gave the FDA the authority to regulate the manufacturing, sale, and marketing of cigarettes, roll-your-own tobacco, and smokeless tobacco, and created FDA’s Center for Tobacco Products (CTP). Through issuance of the so-called “deeming rule” in August 2016, the FDA extended its jurisdiction to additional tobacco products, including e-cigarettes, pipe tobacco, cigars, and hookah. The FDA has broad regulatory authority over all products made or derived from tobacco and intended for human consumption. This authority covers areas such as modified risk claims, sale and marketing restrictions, and product standards.
The FDA has made limited public statements on synthetic nicotine. According to its website, “E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.” The FDA will make determinations whether to regulate particular Synthetic Nicotine products on a “case-by-case basis.”
As the Synthetic Nicotine market grows, public health groups are urging the FDA to act either through CTP or FDA’s Center for Drug Evaluation and Research (CDER), which regulates drugs. The definition of a drug under 21 U.S.C. § 321(g) includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Researchers at the Public Health Law Center argue that since Synthetic Nicotine affects the structure of the brain, regulating synthetic nicotine as a drug would be the logical approach and would avoid allowing those products to fall into a regulatory gap. If the FDA regulates Synthetic Nicotine as a drug, Synthetic Nicotine manufacturers would likely have to take their products off the market and submit a new drug application.
One Synthetic Nicotine product that is currently causing controversy is Puff Bar, an electronic cigarette. Puff Bar was originally sold as a disposable tobacco-nicotine based E-cigarette when the FDA ordered its removal in July 2020 due to various violations of the Food, Drug and Cosmetic Act, including lack of FDA authorization to market the product.
This was an important step for curbing youth use of nicotine products. Based on the 2020 National Youth Tobacco Survey, use of disposable e-cigarettes increased 1000% from 2019 among high school students, with Puff Bar being the most popular product. However, in early 2021 the makers of Puff Bar announced they were returning to the market, claiming that their “nicotine-based products are crafted from a patented manufacturing process, not from tobacco,” and thus implicitly claiming the products are not subject to FDA jurisdiction. Puff Bar also claims that their nicotine is “purer than tobacco-containing or -derived nicotine” and “without the residual impurities of tobacco-derived nicotine.”6 These claims have not been evaluated, and little to nothing is known about their nicotine manufacturing process. Puff Bar has used the potential regulatory gap of Synthetic Nicotine to side-step the FDA’s processes and advertising restrictions. Several public health groups have written to the FDA urging it to remove Puff Bar from the market and to clarify the status of all Synthetic Nicotine products.
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