McDaniel Water, LLC
FDA issued a warning letter to McDaniel Water, LLC (directors Gary McDaniel and Ruth Shields) regarding their product 'Black Indian Salve,' also marketed as 'Indian Herb,' 'X,' and 'Black Salve.' The product, which contains bloodroot and zinc chloride — known corrosive agents capable of causing tissue necrosis — was found to be an unapproved new drug marketed with disease-treatment and anti-cancer claims in violation of FD&C Act sections 505(a) and 301(d). FDA noted a prior 2019 warning letter to a related entity and a voluntary recall of a similar product, and warned that failure to address violations may result in seizure and injunction.
Flagged claims (7)
Licorice Root has been known to enhance immunity by boosting the level of interferon.
The Indian Herb is a 100-year-old folk remedy used to attack disease and aid in the healing process. It is also often referred to as 'X' or 'Black Salve'. Indian Herb may be taken internally or applied externally to abnormal skin growths.
The following guidelines are offered for the application of 'The Black Indian Salve' in treating various types of abnormal growths both external and internal.
Galangal . . . In recent studies, it was also found to have anti-cancer activities. It acts as an anti-oxidant and suppresses the genotoxicity of chemicals. Genotoxic substances are known to be potentially mutagenic or potentially cancerous.
Yellow Dock contains iron and can improve the function of the liver, kidneys, lymph glands and intestines. It has been used for the treatment of jaundice . . ..
Blood Root is considered highly effective for skin conditions . . . Its primary alkaloid, sanguinarine, has been found to be a potent anti-cancer agent. It is prized for its ability to heal infections & stimulate healthy tissue growth.
There will be no need for surgery.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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