FDA Calls Out ‘Black Salves’ As Dangerous

The US Food and Drug Administration (FDA) has issued message regarding websites selling certain salves or creams, commonly known as “black salve” that claim to treat or cure cancer, boils, moles and skin tags. These claims are false, the agency stated.

Salve products containing corrosive ingredients, including black salve, are dangerous and are not approved by the FDA to treat or cure any skin condition, particularly not skin cancer. Specifically, the FDA is warning consumers not to use any salves or other topically applied products that list any of the following potentially dangerous ingredients: sanguinarine, Sanguinaria canadensis, or bloodroot, alone or in combination with zinc chloride.

Although not all salves are dangerous, topically applied products with the above ingredients can destroy the skin and result in permanent disfigurement, tissue necrosis (death of cells in living tissue), and can result in infection, said FDA. Furthermore, using salve products such as black salve for serious conditions like skin cancer can result in delayed cancer diagnosis and cancer progression.

Some salve products contain corrosive ingredients that injure living tissue. They act either directly, by chemically destroying the tissue (oxidation), or indirectly by causing inflammation. 

Many salve products that contain corrosive ingredients claim to draw out only the cancer, leaving healthy skin untouched. This is false, asserted FDA. The ingredients in these products destroy cancerous and healthy skin equally. Using these products can result in permanent scarring and may even result in the need for reconstructive (plastic) surgery. In addition, these salves can destroy the top layer of skin while leaving cancer behind in the deeper layers, where the cancer may continue to grow.

It is also sold under such names as Skinprov, drawing salve, red salve, Cansema, bloodroot, Indian Herb, Hawk Dok Natural Salve, Black Drawing Ointment, and many others. The products come in many forms including salve, paste, cream and poultice (soft, moist material applied to wound). In some cases, corrosive salves may be marketed as natural or homeopathic products. In some instances, the corrosive ingredients are listed as “inactive” ingredients, said FDA.

The FDA has identified 24 cases of adverse events associated with black salve. Fifteen of these cases were reported within the past five years.

The agency also continues to send warning letters and take enforcement action against companies making false claims about these products. Two warning letters were recently sent to Haloderm, Inc., Carlsbad, CA and Oneness Labs, Irvine, CA.

According to Cynthia Ng in the FDA’s Center for Drug Evaluation and Research, “Consumers need to know that ‘black salve’ is an informal term and not the only name used for this product.”