FDA WARNING_LETTER - Soniceast LLC - March 31, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Aysegul Bidav on January 14, 2020, regarding disposable cigarette filters (NicStop and TarTrap) sold on https://www.nicstopfilters.com and https://www.tartrapfilters.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are adulterated under section 902(8) of the FD&C Act. This is because they are marketed as "modified risk tobacco products" (MRTPs) without an FDA order in effect, as required by section 911(a) of the FD&C Act. The websites and product labels make various claims, such as actively removing tar and nicotine, reducing health hazards, and improving breathing, which classify them as MRTPs under section 911(b)(2)(A)(i). The letter demands immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act. A written response detailing corrective actions, including discontinuing violative activities and a compliance plan, is required within 15 working days. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction.