FDA WARNING_LETTER - Klein Laboratories, Inc. - November 12, 2013

On July 17, 2014, the FDA issued a Warning Letter to Klein Laboratories, Inc. following an inspection from August 22, 2013, to November 12, 2013. The inspection and review of the Osteojuv product label revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that Osteojuv is an unapproved new drug because its labeling claims, such as "Aggressively Target: ... Pain" and "Aggressively Target: ... Inflammation," indicate it is intended for disease treatment, mitigation, or prevention. As it is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act, requiring prior FDA approval for interstate commerce.

Even if not an unapproved new drug, Osteojuv is an adulterated dietary supplement due to numerous Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Key deficiencies include: 1. Failure to conduct identity testing for dietary ingredients (e.g., Glucosamine Sulfate, Chondroitin Sulfate, Hyaluronic Acid) and relying inadequately on supplier Certificates of Analysis. The firm's proposed methods (color, mesh, pH) were deemed insufficient for identity verification. 2. Failure to establish identity specifications for components. 3. Failure to establish product specifications