Flame On, Inc. d/b/a USA Less – FDA Warning Letter, Jun 2, 2020

On April 22, 2020, the FDA issued a Warning Letter to Michael Sirota regarding the sale of tobacco products on the website https://www.usaless.com. The Center for Tobacco Products determined that cigar wrap products, specifically "Zig Zag Wraps Orange," were offered for sale or distribution to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of "Zig Zag Wraps Orange" to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products to minors. "Covered tobacco products" include cigar wraps as defined by 21 C.F.R. § 1140.3 and 21 C.F.R. § 1100.2.

The FDA requires immediate corrective action for this and similar violations. The company must ensure all tobacco products, labeling, and advertising on their website and other media comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money