8OHM1 d/b/a Digital Smoke Warning Letter Details

Summary

8OHM1 d/b/a Digital Smoke manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, which fall under FDA jurisdiction as tobacco products under the expanded definition that includes any nicotine source (effective March 2022), were being marketed commercially in the United States without compliance with applicable regulatory requirements. The Center for Tobacco Products determined the products were adulterated and/or misbranded due to the absence of required premarket authorization for these new tobacco products.