FDA WARNING_LETTER - CJ Labs, Inc. - June 24, 2011

On May 25 - June 24, 2011, the FDA inspected CJ Labs, Inc. in Miami, Florida, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). This caused dietary supplements like Milk Thistle and L-Carnitine to be adulterated.

Additionally, product labels for Nutra Stress Tablets, Tri-flex Capsules, Noni Juice, Arthritis Formula Capsules, and Prostaguard Capsules contained therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B) of the Act, and misbranded under section 502(f)(1) due to inadequate directions for use.

Cosmetic products, Cardispan Levocarnitina and Collagen Cream With Dribble of the Snail, were found to be misbranded under section 602(a) because ingredient lists did not comply with 21 CFR 701.3, including incorrect naming conventions and failure to list all constituents of trade name mixtures.

Key CGMP violations for dietary supplements included: * Failure to verify finished product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). * Failure to confirm identity and specifications of other components, or qualify supplier Certificates of Analysis (21 CFR 111.75(a)(