FDA WARNING_LETTER - Brew Dr. Kombucha LLC

The FDA issued a Warning Letter to Ms. Hyung of Dr. K E-Liquid after reviewing her website, http://www.drkeliquid.com, which sells nicotine-containing e-liquids (e.g., 0.8%, 1.6%, 2.4%). These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation is under section 301(tt) of the FD&C Act, which prohibits misleading statements implying FDA approval, safety, or endorsement. The website displayed "FDA Registered Lab" and "Formulas FDA Registered" for products like Apple, Banana, and Blueberry e-liquids. Additionally, a retail display case for Dr. K E-Liquid products was found with the claim "FDA approved." These statements are deemed misleading to consumers, suggesting FDA endorsement or that the products are safer due to FDA regulation.

The letter requires immediate correction of these and similar violations across all promotional materials, websites, and retail establishments. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, or injunction. A written response detailing corrective actions, including discontinuation dates of violative promotions, and a plan for ongoing compliance, is required within 15 working days.