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.2
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.3
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.4 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.5 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.7
Congress could ensure that the FDA has jurisdiction over synthetic nicotine products like Puff Bar by amending the definition of “tobacco product” in the Food, Drug and Cosmetic Act to include products containing nicotine, regardless of the source of the nicotine. Moreover Section 916 of that Act, titled “Preservation of State and Local Authority,” now provides that states and localities may enact and enforce measures relating to the sale or distribution of tobacco products.8 Accordingly, if the definition of “tobacco product” were thus amended, states or localities could enact and enforce laws to prohibit or restrict the sale of synthetic nicotine products or certain categories of those products, such as those with flavors. Such measures would be likely to survive judicial challenge, as courts have consistently upheld local laws banning the sale of flavored tobacco products against claims that such laws are preempted by the Act as regulations of product standards.9
- 21 USC § 321(rr)(1) provides: “The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).’ [↩]
- Pub. L. No. 111-31, 123 Stat. 1776 (2009). [↩]
- Zettler PJ, Hemmerich N, Berman ML. Closing the Regulatory Gap for Synthetic Nicotine Products. Boston Coll Law Rev. 2018;59(6):1933-1982. [↩]
- U.S. Food and Drug Administration. 2020. FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization. [↩]
- Wang, T., Gentzke, A., Neff, L., Glidden, E., Jamal, A., Park-Lee, E., Ren, C., Cullen, K., King, B. and Hacker, K., 2021. Disposable E-Cigarette Use among U.S. Youth — An Emerging Public Health Challenge. New England Journal of Medicine, 384(16), pp.1573-1576.
- Truth Initiative. 2021. What you need to know about new synthetic nicotine products. [online] Available at: <https://truthinitiative.org/research-resources/harmful-effects-tobacco/what-you-need-know-about-new-synthetic-nicotine-products> [↩]
- see footnote 3 [↩]
- Food, Drug and Cosmetic Act, Section 916(a)(1), 21 U.S.C. § 387p(a)(1). Certain other state or local measures are preempted under the Act, such as those relating to product standards, misbranding, and adulteration, that are different from or in addition to those contained in the Act. Id., Section 916(a)(2)(A), 21 U.S.C. § 387p(a)(2)(A). [↩]
- See, e.g., Nat’l Ass’n of Tobacco Outlets, Inc. v. City of Providence, 731 F.3d 71 (1st Cir. 2013); U.S. Smokeless Tobacco Mfg. Co. LLC v. City of New York, 708 F.3d 428 (2d Cir. 2013). [↩]