Loading…
YCE DREAM LLC, operating as Space Vapor, manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders from the FDA. The company's products fell under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act, as they contained nicotine from any source and were intended for human consumption. The products were deemed adulterated and misbranded for failing to comply with applicable FDA regulations and marketing requirements for new tobacco products under section 910 of the FD&C Act.