FDA WARNING_LETTER - Vivid-Scientific LLC - March 03, 2025

On March 3, 2025, the FDA issued a Warning Letter to Lisa Currin regarding products offered on vividscientific.com. An FDA review in January 2025 found the website selling unapproved injectable lipolytic products: "LemonBottle Ampoule Solution," "Lipo Lab PPC Solution," "Neobella Extreme," and "Deoxycholic Acid Booster."

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), because they are intended to affect body structure/function and treat/prevent disease. Claims like "FAT DISSOLVER," "Permanently dissolve fat and cellulite," and "PERMANENT FAT REMOVAL + SKIN TIGHTENING" establish their drug intent. Injectable products pose serious public health risks by bypassing natural defenses.

The products are not generally recognized as safe and effective, making them "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved applications exist for these products, violating sections 301(d) and 505(a).

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting