Loading…
Alohma LLC d/b/a Kure Vaporium manufactured and distributed e-liquid tobacco products containing nicotine that lacked required premarket authorization orders under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, whether containing tobacco-derived or non-tobacco-derived nicotine, were deemed new tobacco products subject to FDA jurisdiction but were marketed without obtaining the legally required premarket approval before commercial distribution in the United States.