Policy Change Redefines Tobacco Products
The US Food and Drug Administration (FDA) can now regulate the sale of synthetic Nicotine, a decision that could potentially wipe thousands of electronic cigarette, or e-cigarette, products off the market. In March, President Joe Biden signed a $1.5 trillion omnibus, or multi-topic, bill that expands the definition of a “tobacco product” to include lab-made synthetic Nicotine and traditional tobacco-derived Nicotine. The Federal Food, Drug, and Cosmetic Act (FDCA) now defines tobacco products as “any product made or derived from tobacco, or containing Nicotine from any source, that is intended for human consumption.”
This redistricting of what constitutes a tobacco product targets the regulatory loophole that some producers of e-cigarettes exploited to keep their products on the market. Over time, the FDA has refused or denied to review the applications of over 5 million vaping products. Instead of taking their products off the shelves, e-cigarette companies switched to synthetic Nicotine, thus avoiding the previous definition of tobacco products. Since their products were no longer under the umbrella of tobacco products, they could continue to sell their products without FDA regulation.
Another driving force that pushed some e-cigarette companies to turn to synthetic Nicotine products involved a requirement by the FDA in 2016 for companies to prove that their tobacco products caused more good than harm. This notion of good versus harm was often measured in the benefit to individuals trying to stop smoking versus the potential dangers of youth vaping. Again, to avoid this regulation, synthetic Nicotine products were manufactured instead of products containing traditionally derived Nicotine from tobacco.
What Are E-Cigarettes And Synthetic Nicotine?
E-cigarettes are battery-operated devices that heat a liquid into an aerosol, or vapor, that is then inhaled by the user. Commonly referred to as vape pens, e-cigs, tank systems, or mods, individuals can also use these devices to administer Cannabinoids like Marijuana and other substances. Inside a vape pen, a cartridge stores the e-liquid or “e-juice.” Besides Nicotine, e-juice can contain artificial flavorings, volatile organic compounds (acrylamide, benzene, and propylene oxide), micro-fine particles that get inhaled into the lungs, and trace amounts of heavy metals like lead, nickel, and tin. The flavorings of e-liquid pods, including bubblegum, strawberry, and many others, have long been criticized for potentially luring adolescents to try vaping and to continue use. Additionally, some flavorings contain diacetyl, a chemical linked to a severe lung disease known as “popcorn lung.” Some companies, including e-cigarette giant Juul, stopped selling fruit-flavored vaping pods altogether after pressure from the FDA to curb youth vaping.
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Synthetic Nicotine, or lab-made Nicotine, is created in a laboratory and is not derived from tobacco like traditional Nicotine. This form of Nicotine is often marketed as “tobacco-free” as it does not contain any tobacco leaf, but under new regulations, synthetic Nicotine can no longer be marketed as such.
How Does This New Law Change E-Cigarette Production?
This change in regulatory law ensures that synthetic Nicotine and tobacco-derived Nicotine products are all regulated under the FDA’s Center for Tobacco Products using the same benchmarks. This law will not ban vaping products and the production of vape pens, but it will have definite consequences for producers and consumers as popular products are potentially withdrawn from sale. For instance, back in 2020, the popular disposable e-cigarette company Puff Bar switched to a synthetic Nicotine formula after the FDA ordered the company to stop selling vapes as it had not followed the agency’s application process. This application process is often lengthy, as multiple big-name brands, including Juul, are still waiting to hear from the agency. The fate of companies like Puff Bar is unclear. To date, the FDA has only approved one vaping product, R.J. Reynolds’ Vuse Solo, and its corresponding tobacco-flavored e-liquid cartridges.
If Puff Bar, and similar companies, want to keep their synthetic Nicotine products on the shelf, they have until May 14 to make a premarket tobacco product application (PMTA) to the FDA. Once the PMTA is submitted, said products may remain on the market until July 13. Any synthetic Nicotine product that has not received FDA authorization by July 13 will be withdrawn from sale.
Criticisms Of The Bill
The response to the FDA’s new classification of tobacco products was split among 2 groups: those opposed to the shrinking number of cigarette alternatives and those in favor of further regulation of synthetic Nicotine products. Amanda Wheeler, president of the American Vapor Manufacturers Association, told Filter, “This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from Nicotine vaping and back into combustible smoking.” For adults trying to quit smoking cigarettes, e-cigarettes are often used to manage Nicotine cravings, but vaping is not without its dangers.
In contrast, some e-cigarette companies, including Juul, support the new regulatory law that will impact some of their largest synthetic Nicotine e-cigarette competitors. A Juul spokesperson previously stated that “illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.” By this sentiment, vaping companies and public health groups are in a tentative agreement.