We’re in trouble when Big Tobacco is writing to the FDA, complaining that the government must do something about a vape product coming from China, Metatine or 6-methyl nicotine.
Let me back up a little bit. On April 14, 2022, the FDA was authorized to regulate tobacco products containing nicotine from any source, including synthetic nicotine. Some companies had begun producing vaping products with synthetic nicotine stating they didn’t have “tobacco” in them, so the FDA had no authority to regulate them. Congress corrected that. Around October 2023, vape stores in the U.S. started selling a product named Spree Bar. Spree Bar was sold claiming it was FDA premarket tobacco product application (PMTA) exempt. This product, and now others coming from China are marketed as containing “Metatine”, a trademarked name for 6-methyl nicotine, a synthetic nicotine analog. So again, manufacturers have, for the time being, found a way to work around the system until the FDA can decide whether 6-methyl nicotine can be regulated as a drug under the Federal Food Drug and Cosmetic Act (FDCA).
As of now, there is at least one vaping product on the U.S. market as well as several oral nicotine products that are using some derivative of 6-methyl nicotine. There are projections that this will be a billion-dollar market. Others are skeptical. Metatine is said to give users the same satisfaction a nicotine product does, and it comes with a lower price point, but the critical point is, for the time being, it isn’t hindered by the FDA’s authority over nicotine products.
Let me return to the letter Altia Group, the maker of Marlboro cigarettes, wrote to the FDA. In speaking of the warning vaping products that had 6-methyl nicotine in them, warning they posed a “new threat”. “The introduction and growth of chemicals intended to imitate the effects of nicotine, if left unchecked, could present unknown risks to U.S. consumers and undermine FDA’s authority,” the letter said.
Who loses in this story? Our kids do.
