Biomedic Labs, LLC – FDA Warning Letter

On October 28, 2015, the FDA issued a Warning Letter to Biomedic Labs, LLC, following a July 2015 review of their websites, www.biomediclabs.com and www.biomediclabsrx.com. The FDA determined that Biomedic Labs was promoting products (Serracor-NK, Serra Rx80, Serra Rx 260, N-Acetyl Rx, and Vitamin D3 Rx) for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the websites, including testimonials, indicated the products were intended for the cure, mitigation, treatment, or prevention of diseases such as pulmonary fibrosis, COPD, cystic fibrosis, multiple sclerosis, fibromyalgia, arthritis, and various other conditions. Examples of claims included dissolving scar tissue, improving breathing, reducing coughing, preventing chronic lung diseases, and treating inflammation and pain.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a) and 301(d) of the Act. Furthermore, the products are misbranded under section 502(f)(1) of the Act because they are offered for conditions