FDA WARNING_LETTER - Fox Pharma LLC - March 03, 2025

The FDA issued a Warning Letter to Fox Pharma LLC on March 3, 2025, following a January 2025 review of their website (https://foxpharma.us) and social media (Facebook, Instagram). The FDA observed that Fox Pharma LLC offers various injectable lipolytic products, including “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol,” for sale in the United States.

These products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The FDA cited claims on the company's websites establishing the products' intended use as drugs, such as "fat decomposition," "metabolic activation," "destroys and transports unnecessary fat cells," "removes cellulite," and "non-surgical face contouring." The FDA emphasizes the public health risk associated with injectable products bypassing the body's defenses.

Since no approved applications are in effect for these "new drugs," their introduction into interstate commerce violates federal law. Fox Pharma LLC must respond in writing within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to