FDA WARNING_LETTER - Julian Naya Beauty LLC - March 03, 2025

On March 3, 2025, the FDA issued a Warning Letter to Julie Ellis regarding products offered for sale on https://juliannayabeauty.com/ and associated social media. The FDA's January 2025 review identified injectable lipolytic products, including “Kabelline,” “Lipo Lab PPC Solution,” “Lipo Lab V-Line,” “LemonBottle Ampoule Solution,” “Lipo Vela,” and “Neobella,” as unapproved new drugs.

These products are deemed drugs under section 201(g)(1) of the FD&C Act due to claims on the website and social media indicating intent to prevent, treat, or cure disease, or affect body structure/function. Examples of claims include "fat dissolver," "eliminates fat deposits and cellulite," "redefine facial contours by breaking down fat cells," and "permanent fat removal."

The FDA states these products are not generally recognized as safe and effective for their intended uses, classifying them as "new drugs" under section 201(p) of the FD&C Act. Their introduction into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the FD&C Act. The letter emphasizes the public health risk posed by injectable products.

The recipient must respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address the