On December 17th, 2019, the Food and Drug Administration (FDA) permitted two new "low nicotine" cigarettes to be sold to the public. These cigarettes are being manufactured by 22nd Century Group Inc.
Let's talk about 22nd Century Group Inc. first. They are organized around other operations, including Goodrich Tobacco, Botanical Genetics and Heracles Pharmaceuticals. Goodrich Tobacco creates commercial tobacco products and "potentially" less harmful cigarettes. Botanical Genetics works with "natural, safe and effective cannabis/hemp products for human health and industrial products." Heracles Pharmaceuticals is working on "X-22" which is a prescription smoking cessation aid. This information was collected at: https://www.xxiicentury.com/
22nd Century Group Inc. has created "Moonlight and Moonlight Menthol" cigarettes. These cigarettes contain 0.2-0.7 mg of nicotine per cigarette in comparison to 10-14 mg of nicotine in conventional cigarettes. The FDA believes that this product is appropriate for the sake of public health due to the potential to reduce nicotine dependency. The FDA feels that non-smokers would not use these products and youth wouldn't want to try these products. They also feel that if someone were to use these products as a non-smoker, there is a lesser chance of the individual to become addicted to nicotine.
Moonlight and Moonlight Menthol cigarettes do fall under the Food, Drug and Cosmetic Act as cigarettes, and therefore are required to adhere to federal law when it comes to advertising products. They are not allowed to have television or radio commercials, and the FDA put restrictions on how the cigarettes are advertised on websites and social media. These restrictions were put into place in an attempt to not appeal to the youth of America.
My thoughts on this.
1. If you are a current smoker of normal cigarettes, you wouldn't switch to a "less nicotine" cigarette. If you're used to getting 10-14 mg of nicotine per cigarettes, you would experience withdraw symptoms still due to a significant decrease in nicotine. To reach 10mg of nicotine, a person would have to smoke fifty Moonlight cigarettes to equate to one conventional cigarette.
2. The FDA obviously has the power to restrict advertisement to children. Instead of putting advertisement restrictions on vaping products, they attempt to ban flavoring. I believe this is ridiculous and overkill of the situation at hand.
3. The PMTA filing can cost anywhere from $28,000-$2,595,224. Sure, a large company that has their hands in various companies can afford these costs for two cigarettes, but what about the thousands of e-liquid companies?
As always, if you have questions, comments and/or concerns, please feel free to email me!
I hope you all have a wonderful holiday season in whatever you decided to celebrate! Well wishes from yours truly.