FDA WARNING_LETTER - 13th Floor Elevapors, LLC

The FDA issued a Warning Letter to Breanne Warkenton regarding e-liquid products sold on http://www.13thfloorelevapors.com. The FDA determined that the Frank 'N Vape e-liquid is a tobacco product under the FD&C Act and is misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act.

The misbranding violation stems from the product's labeling and/or advertising, which is deemed false or misleading because it imitates food products, specifically Franken Berry cereal, which is marketed toward children. The labeling includes phrases like "Spooky marshmallows in scary berry cereal drenched in milk," features a cartoon character resembling a strawberry and Frankenstein's monster, and the product has a strong scent similar to the cereal. This imitation is considered misleading and increases the appeal to children, raising concerns about accidental ingestion and nicotine toxicity. The letter highlights the severe risks of liquid nicotine ingestion for children, including death, seizures, and respiratory arrest, noting that a small amount of Frank 'N Vape e-liquid (6mg/mL nicotine, 60mL volume) could be fatal or cause acute toxicity in a two-year-old.

The FDA requires immediate corrective action to address this violation and similar issues across all products and advertising platforms. Failure to comply may result in civil money penalties, criminal prosecution, seizure, and/or injunction.