FDA warning letter · Drugs

Filler Lux dba Filler Lux USA

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your “LemonBottle Ampoule Solution,” “Dr. Lipo+,” “Lipo Lab PPC Solution,” “DermaHeal LL,” and “Wonderfit” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Passage 2

“Lipolysis Solution”

Passage 3

“Even without Lipase (Hyaluronidase), the lipolytic effect of Lemon Bottle is already excellent.”

Passage 4

“KEY INGREDIENTS 1. Riboflavin, Vitamin B2 induces activation of fat metabolism 2. Bromelain, Bromelain helps to break down fat and Remove inflammation 3. Lecithin, Lecithin destroys and transports unnecessary fat cells.”

Passage 5

Before and after FACE and BODY photographs depicting visible fat reduction in the chin, jaw, abdomen, and flank.

Passage 6

"Result After 24hours [sic] o Powerful Fat-dissolving Solution”

Passage 7

“When the part you want to lose weight is holding you back, Lemonbottle comes to the rescue!”

Passage 8

“Dr.LIPO+ PPC solution is developed for reducing body fat and tightening skin.”

Passage 9

“Dr.Lipo + New generation lipolytic”

Passage 10

“Dr.Lipo + is a direct lipolytic and acts on the adipocyte cell by destroying it.”

Passage 11

“Mechanism of action After the injection of the solution, the adipocyte cell (fat cell) dissolves and turns into a liquid emulsion.”

Passage 12

“Doctor Lipo+ - Direct Lipolytic”

Passage 13

“Composition: Phosphatidylcholine: Ensures fat absorption and transportation.”

Passage 14

"Try this efficacious PPC solution for fitter body. . .. This combined substance safely dissolves fat cells through interaction and consequently results in destruction of fat cells or minimizes the size of fat cells.”