Fox Pharma LLC

Selected passages from the FDA letter

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

Passage 1

your injectable lipolytic products including “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol” 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

Your “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).