The warning letter was issued to a company called McDaniel Water LLC of Amistad, NM. The company has been selling a product it called ‘Black Indian Salve,’ which it also referred to as ‘Black Salve’ and ‘Indian Herb.’
Long history use doesn't imply safety
Black salve has a long history of use, which is not to say that it has ever been considered benign by health authorities. The basic ingredients typically are bloodroot (Sanguinaria canadensis) and zinc chloride. The McDaniel Water formula is advertised to contain Bloodroot, yellow dock, licorice root and galangal.
Bloodroot, an herbaceous plant native to eastern North America, has a history of use in Native American traditional medicine for treatment of warts and other skin issues. It is a known corrosive agent, as is zinc chloride.
Modern promoters have hawked this product for its purported effects to remove skin cancer tumors. One site that still openly sells the product, Alpha Omega Labs, a company reportedly operating out of Guayaquil, Ecuador, claims “Cansema (its brand name for its Black Salve product) is empirically a proven cure for skin cancer for the majority of those who use the product according to our instructions.”
The warning letter to McDaniel Water said the claims the company allegedly was making on the product caused it to be an unapproved new drug. This is in addition to the known dangers of the product.
“The combination of bloodroot and zinc chloride results in a corrosive topical agent capable of indiscriminately damaging healthy and diseased tissue alike and forming eschar (sloughed dead tissue). The tissue necrosis caused by topical application of products containing such ingredients (often referred to as "black salves") is well-documented,” the warning letter said.
The FDA consumer warning on Black salve has this to say:
“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. Furthermore, using salve products such as black salve for serious conditions like skin cancer can result in delayed cancer diagnosis and cancer progression,” the warning states.
The warning goes on to state that there have been 24 recent cases of serious adverse events connected to use of the salves, with 15 of those occurring within in the past 5 years.
Concerns in Australia
In addition to the concerns of US regulators, Austrialia’s Therapeutic Goods has seen an increase on the market of illegal Black Salve Products. Black Salve topical an ingestible products were seized in 2019 as part of a crackdown on illegal herbal health products entering the country.