FDA WARNING_LETTER - McDaniel Water, LLC - July 31, 2021

The FDA issued a Warning Letter to McDaniel Water LLC on September 7, 2021, following a July 2021 review of their product labeling and website (www.mcdanielwater.com). The letter addresses the unapproved new drug "Black Indian Salve," also referred to as "Indian Herb," "X," and "Black Salve," which is sold on their website.

The FDA states that "Black Indian Salve" is a public health concern due to its ingredients, bloodroot (Sanguinaria canadensis) and zinc chloride, both known corrosive agents. Their combination can indiscriminately damage healthy and diseased tissue, forming eschar. The letter references a May 16, 2019, Warning Letter to McDaniel Life-Line LLC for a similar product, "Indian Herb," which was subject to a voluntary worldwide recall on February 8, 2019, and an FDA safety alert on February 12, 2019.

The FDA determined that "Black Indian Salve" is not a dietary supplement because it is marketed for both topical application and ingestion, violating section 201(ff) of the FD&C Act. Instead, claims on its labeling and website establish it as a drug under section 201(g)(1) of the FD&C Act, intended for disease treatment or to affect body structure/function. Examples of drug claims include treating "