Policy change redefines tobacco products
The US Food and Drug Administration (FDA) can now regulate the sale of synthetics Nicotine, a move that could potentially eliminate thousands of electronic cigarette, or e-cigarette, products from 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 synthetic nicotine made in a lab and traditional nicotine derived from it. tobacco. The Federal Food, Drug, and Cosmetic Act (FDCA) now defines tobacco products as “any product manufactured or derived from tobacco, or containing nicotine from any source, intended for human consumption.”
This redrawing of what constitutes a tobacco product targets the regulatory loophole that some e-cigarette producers have exploited to keep their products on the market. Over time, the FDA has denied or refused to review applications for over 5 million vaping products. Instead of pulling their products off the shelves, e-cigarette manufacturers have switched to synthetic nicotine, thereby avoiding the previous definition of tobacco products. Since their products were no longer under the tobacco products umbrella, they could continue to sell their products without FDA regulation.
Another driving force that caused some e-cigarette companies to turn to synthetic nicotine products involved an FDA requirement in 2016 for companies to prove that their tobacco products caused more good than harm. This notion of good versus bad was often measured in terms of the benefit to people trying to quit smoking versus the potential dangers of youth vaping. Again, to avoid this regulation, synthetic nicotine products were made instead of the traditional tobacco-derived nicotine products.
What are electronic cigarettes and synthetic nicotine?
Electronic cigarettes are battery-powered devices that heat a liquid into an aerosol, or vapor, which 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 to like Marijuana and other substances. Inside a vape pen, a cartridge stores e-liquid or “e-juice”. Besides nicotine, e-juice can contain artificial flavors, volatile organic compounds (acrylamide, benzene, and propylene oxide), microfine particles that are inhaled into the lungs, and trace amounts of heavy metals like lead, nickel, and lead. ‘tin. E-liquid pod flavors, including bubblegum, strawberry, and more, have long been criticized for potentially enticing teens to try vaping and keep using them. Additionally, some flavors contain diacetyl, a chemical linked to a serious lung condition known as “popcorn lung.” Some companies, including e-cigarette giant Juul, have stopped selling fruit-flavored vaping pods altogether after pressure from the FDA to curb youth vaping.
Synthetic nicotine, or lab-grown nicotine, is created in the lab and is not derived from tobacco like traditional nicotine. This form of nicotine is often marketed as “tobacco-free” because it contains no tobacco leaf, but under new regulations synthetic nicotine can no longer be marketed as such.
How does this new law change the production of electronic cigarettes?
This change in regulatory legislation ensures that synthetic nicotine and tobacco-derived nicotine products are all regulated by 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 certain consequences for producers and consumers as popular products will potentially be withdrawn from sale. For example, in 2020 popular disposable e-cigarette company Puff Bar switched to a synthetic nicotine formula after the FDA ordered the company to stop selling vapes because it failed to go through the application process. the agency. This application process is often long, as several major 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, Vuse Solo by RJ Reynolds, and its corresponding tobacco flavored e-liquid cartridges.
If Puff Bar and similar companies want to keep their synthetic nicotine products on the shelves, they have until May 14 to file a premarket tobacco product application (PMTA) with the FDA. Once the PMTA has been submitted, these products will be able to remain on the market until July 13. Any synthetic nicotine product that does not receive FDA clearance by July 13 will be withdrawn from sale.
Criticisms of the bill
The response to the FDA’s new classification of tobacco products has been divided into 2 groups: those who oppose fewer alternatives to cigarettes and those who favor more regulation of tobacco products. synthetic nicotine base. Amanda Wheeler, president of the American Vapor Manufacturers Association, told Filter, “This bill should be called the Cigarette Protection Act, because the indisputable result will be countless more Americans away from nicotine vaping. and reverting to combustible smoking”. For adults trying to quit smoking, e-cigarettes are often used to manage Nicotine cravingsbut vaping is not without danger.
In contrast, some e-cigarette companies, including Juul, support the new regulatory law that will impact some of their biggest synthetic nicotine e-cigarette competitors. A Juul spokesperson has 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.” With that sentiment, vaping companies and public health groups are in tentative agreement.