2005 - IMPORT ALERT IA6641 by FDA
Background/Reason for Alert: Black salve, also known by the names cited above, has been advertised for use in the cure, mitigation, treatment or prevention of cancer. In addition, various websites promote black salve products for use in the treatment and cure of cancer, tumors, herpes, venereal diseases, diabetes, lupus, and internal malignancies. Based on its intended uses, this product is a drug. Further, CDER is not aware of any substantial scientific evidence that demonstrates that this product is generally recognized as safe and effective for its labeled uses. Districts may detain without physical examination any product named above, and refuse entry to any black salve product that is labeled or is accompanied by labeling, with claims that it is intended to diagnose, cure, mitigate, treat or prevent a disease.