FDA WARNING_LETTER - Medinatura Inc - June 16, 2020

The FDA issued a Warning Letter to Medinatura regarding its injectable products: "Zeel Injection Solution," "Traumeel Injection Solution," "Engystol Injection Solution," "Neuralgo Rheum Injection Solution," "Lymphomyosot X Injection Solution," and "Spascupreel Injection Solution." The FDA reviewed the product labeling and the company's website, http://hcp.medinatura.com/, from which orders are taken.

The FDA determined these injectable products are unapproved new drugs under section 505 of the FD&C Act, 21 U.S.C. 355, and their introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331. The FDA expressed particular concern due to the inherent risks of injectable products, which bypass the body's defenses, and the presence of potentially toxic ingredients like "mercurius solubilis" (mercury) and "embryo totalis suis."

The letter details numerous intended uses and claims from product inserts and the company's website, establishing the products as drugs intended to cure, mitigate, treat, or prevent disease, or affect body structure/function. As "new drugs," they are not generally recognized as safe and effective. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products.

Medinatura is required to