Sugoi LLC – FDA Warning Letter

The FDA and FTC issued a Warning Letter to Albert Shu regarding Pink Sticks e-liquid products sold on sugoivapor.com. The FDA determined these are tobacco products under the FD&C Act.

Two FD&C Act violations were identified: 1. **False or Misleading Labeling/Advertising:** Pink Sticks e-liquid is misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. Its labeling and advertising imitate Pocky Strawberry biscuit sticks, a product appealing to children, through similar packaging, imagery, color scheme, and description ("a delicious flavor of ripe strawberries blended into a sweet pink cream that covers a crispy cookie biscuit"). The product also has a strong, detectable scent similar to the biscuit sticks. This imitation is misleading and poses a risk of accidental ingestion by children, with potential for acute nicotine toxicity, seizures, coma, respiratory arrest, and death. 2. **Sales to Minors:** Pink Sticks e-liquid is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b).

The FTC also reviewed the marketing under Section 5 of the FTC Act, stating that packaging Pink Sticks e-liquid in