West Coast Laboratories Inc – FDA Warning Letter, Feb 18, 2014

On February 4-18, 2014, the FDA inspected West Coast Laboratories, Inc. and found serious violations. The company's products, "Super ArthGold" and "Pro ArthMax," marketed as dietary supplements, were found to contain undeclared active pharmaceutical ingredients (APIs) including chlorzoxazone, indomethacin, piroxicam, diclofenac, ibuprofen, naproxen, and nefopam. These APIs are found in FDA-approved prescription drugs, and nefopam is not approved for use in the U.S. This renders the products unapproved new drugs under sections 201(p), 301(d), and 505(a) of the Act, as they are not generally recognized as safe and effective and lack FDA approval.

Furthermore, these products are misbranded under sections 502(f)(1), 502(a), and 502(f)(2) of the Act because they are prescription drugs lacking adequate directions for lay use, their labeling is false or misleading by failing to disclose material facts about potential serious health risks (e.g., cardiovascular events, gastrointestinal damage, drowsiness, dizziness, rapid heart rate, seizures), and they lack adequate warnings for users.

The inspection also revealed numerous Current Good Manufacturing Practice (CGMP) violations for dietary supplements, including "Nano Cal/Mag," "Lipozene,"