To all our customers, distributors, wholesalers and retailers, please note that the FDA has sent us a PMTA Acceptance Letter (dated February 5, 2021) for our nicotine toothpick PMTA submissions that were due on September 9, 2020 for new nicotine/tobacco products that were on the market on August 8, 2016 or earlier. Now we await the review phase.
Please note that any new nicotine or tobacco product that was not on the market by August 8, 2016, is not substantially equivalent to a grandfathered tobacco/nicotine product, or does not have FDA "Approval" as a pharmaceutical nicotine product for smoking cessation is required to have a PMTA to be submitted, reviewed and positive marketing order granted by the FDA in order to sell their products.
There are many products currently being sold online or even in stores that have not submitted PMTAs or received positive marketing orders by the FDA and these products are being sold illegally. Pixotine's Products are currently the only nicotine toothpicks brand that has publicly shared a PMTA Acceptance Letter.
Thank you to all who helped make this possible!
-Evan Grossman, CEO and Founder