Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1This product is an unapproved new drug 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 2The labeling for your “ADVANCE KING” product does not declare that the product contains dexamethasone, diclofenac, and methocarbamol.
Passage 3Given that diclofenac and dexamethasone were not marketed as dietary supplements or as food before Voltaren and Hexadrol were approved, “ADVANCE KING,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).
Passage 4it is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for, among other things, use as an arthritis treatment.
Passage 5Your “ADVANCE KING” product is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 6The failure to disclose these ingredients in the product labeling renders your “ADVANCE KING” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).