FDA WARNING_LETTER - Origin BioMed Inc.

The FDA issued a Warning Letter to Origin BioMed Inc. following a review of their website, social media accounts (Facebook, Twitter), and product labels for "Neuragen PN" and "Neuragen Cream." The FDA determined that these products are misbranded drugs under sections 503(b) and 301 of the FD&C Act.

The misbranding stems from numerous labeling claims establishing the products' intended use for treating severe, disabling nerve pain, including conditions like diabetic neuropathy, shingles, and fibromyalgia. Examples of claims include "topical treatment for severe, disabling nerve pain," "effective in relieving pain in a variety of nerve related conditions," and "clinically shown to reduce neuropathic (nerve) pains quickly." The products' name, "neuragen," also implies an association with nerve pain.

These claims classify "Neuragen PN" and "Neuragen Cream" as drugs intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the body's structure/function. The FDA asserts they are prescription drugs under section 503(b)(1) because they treat conditions requiring physician diagnosis and treatment. Consequently, they are misbranded under section 503(b)(4) for failing to bear the "Rx only" symbol.

While recognized as homeopathic drugs, the FDA states that homeopathic products are subject to the same regulatory requirements as other drugs and are not exempt from misbranding rules.