Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your website offers various injectable lipolytic products, such as “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution,” “Neobella Extreme,” and “Deoxycholic Acid Booster,” for sale in the United States.
Passage 2No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products.