FDA WARNING_LETTER - NeumaLife

The FDA issued a Warning Letter to NeumaLife regarding their product, Qina, marketed on www.neumalife.com. The FDA determined Qina is an unapproved new drug, not a dietary supplement, due to promotional claims indicating it prevents, treats, or cures diseases like cancer and HIV/AIDS, and affects body structure/function.

Specific violations include: - **Unapproved New Drug:** Qina is promoted for treating conditions such as chronic illnesses, cancer, HIV/AIDS, tuberculosis, herpes, pneumonia, and asthma, and claims to reduce viral loads, increase CD4/CD8 counts, and improve quality of life. These claims classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). As it's not generally recognized as safe and effective, it's a new drug (section 201(p)) requiring FDA approval before interstate commerce (sections 301(d) and 505(a)). - **Misbranding (Lack of Adequate Directions):** Qina's intended uses (e.g., HIV, cancer) are not amenable to self-diagnosis and treatment by laypersons, thus adequate directions for safe use cannot be provided, rendering it misbranded under section 502(f)(1). - **Misbranding (False and Misleading Statements):** The website falsely claims Qina is "