Filler Lux dba Filler Lux USA – FDA Warning Letter, Mar 11, 2025

The FDA issued a Warning Letter to Boris Kalashnikov regarding the sale of unapproved injectable lipolytic products on fillerx.com and instagram.com/fillerlux_usa/. An FDA review in December 2024 found products like “LemonBottle Ampoule Solution,” “Dr. Lipo+,” “Lipo Lab PPC Solution,” “DermaHeal LL,” and “Wonderfit” offered for sale in the U.S.

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 classifies them as drugs per section 201(g)(1) (21 U.S.C. 321(g)(1)) due to claims indicating intent to prevent, treat, or cure disease, or affect body structure/function. Examples of drug claims were observed on the websites.

The products are not generally recognized as safe and effective, making them "new drugs" under section 201(p) (21 U.S.C. 321(p)). No FDA-approved applications exist for these products. Injectable products pose significant public health risks, bypassing natural defenses and potentially leading to serious conditions.

The letter requires a written response within fifteen working days detailing corrective actions,