ABCO Laboratories, Inc. – FDA Warning Letter, Sep 9, 2011

The FDA conducted an inspection of ABCO Laboratories, Inc. from August 26 to September 9, 2011, identifying significant violations.

"IBU-RELIEF 12" was found to be an unapproved new drug under Sections 201(g)(1)(C) and 201(P) of the Act [21 U.S.C. §§ 321(g)(1)(C), 321(P)], violating Sections 301(d) and 505(a) [21 U.S.C. §§ 331(d), 355(a)]. Despite being labeled homeopathic, it contains ibuprofen, which is not a recognized homeopathic ingredient, thus not qualifying for CPG 7132.15 enforcement policies.

"Sexual Virility Max" was also deemed an unapproved new drug under Sections 201(g)(1)(C) and 201(P) [21 U.S.C. §§ 321(g)(1)(C), 321(P)], violating Sections 301(d) and 505(a) [21 U.S.C. §§ 331(d), 355(a)]. Laboratory analysis confirmed undeclared sulfoaildenafil and sulfosildenafil,