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FDA WARNS CONSUMERS NOT TO USE DANGEROUS BLACK SALVE OR SIMILAR PRODUCTS



October 15, 2020

Here’s an important alert for consumers who may have purchased certain salves or similar skin products commonly known as “black salve” that are sold on websites with claims that they treat or cure cancer, boils, moles and skin tags (benign, or noncancerous, skin growths).

On Oct. 13, 2020, the Food and Drug Administration (FDA) issued a warning on its website urging consumers not to use black salve and similar products sold under several other names because they...

October 15, 2020

Here’s an important alert for consumers who may have purchased certain salves or similar skin products commonly known as “black salve” that are sold on websites with claims that they treat or cure cancer, boils, moles and skin tags (benign, or noncancerous, skin growths).

On Oct. 13, 2020, the Food and Drug Administration (FDA) issued a warning on its website urging consumers not to use black salve and similar products sold under several other names because they contain corrosive ingredients that are dangerous and can cause life-threatening injuries.[1] Additional names for such products include the following, among others:

  • Skinprov
  • drawing salve
  • red salve
  • Cansema
  • bloodroot
  • Indian herb
  • Hawk Dok Natural Salve
  • Black Drawing Ointment

In addition to salves, these products also come in many other forms including pastes, creams and poultices (soft, moist material applied to wounds). In some cases, such products have been marketed as “natural” or “homeopathic.”

The FDA noted that claims that black salve and similar products treat or cure skin conditions are false. The agency emphasized that salve products containing corrosive ingredients, including black salve, are not approved by the FDA to treat or cure any skin condition, especially not skin cancer.

The FDA specifically warned consumers not to use any salves or other products applied to the skin that contain any of the following potentially dangerous ingredients: sanguinarine, Sanguinaria canadensis or bloodroot, alone or in combination with zinc chloride. Disturbingly, the agency noted that in some cases, these corrosive ingredients are listed as “inactive” ingredients.

Salves and other topical products with these ingredients can kill skin tissue, resulting in pain, permanent scarring, disfigurement and infection. Skin damage from these products may require plastic surgery. In addition, using black salve and similar products to treat lesions due to skin cancer can lead to delayed cancer diagnosis and cancer progression. They may destroy the top layer of skin but leave behind cancer in deeper skin tissue, where the cancer can continue to grow.

The FDA has received reports of 24 cases of adverse events — including disfigurement and cancer progression — related to use of black salve. Fifteen cases were reported to the agency in the past five years. Death occurred in at least one person who used a corrosive salve to treat skin cancer instead of receiving proven cancer treatments.

What You Can Do

You should contact your doctor or a dermatologist if you have any concerns about skin cancer or other skin problems. Be sure to tell them about any products, including herbal or other “natural” products, that you may be using for any skin-related condition.

Do not use black salve or any other topical skin products that contain sanguinarine, Sanguinaria canadensis or bloodroot, alone or in combination with zinc chloride, as an alternative to proven medical therapies. These harmful products can result in permanent disfigurement and in the worst case, death.

To see the FDA’s consumer warming, visit the following link: https://www.fda.gov//consumers/consumer-updates/do-not-use-black-salve-dangerous-and-called-many-names.
 



References

[1] Food and Drug Administration. Do not use: Black salve is dangerous and called by many names. October 13, 2020. https://www.fda.gov//consumers/consumer-updates/do-not-use-black-salve-dangerous-and-called-many-names. Accessed October 15, 2020.