WARNING LETTER
McDaniel Water, LLC
MARCS-CMS 616186 —
September 07, 2021
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Gary McDaniel/Ruth Shields
Recipient Title
Directors
McDaniel Water, LLC
23711 Hix Drive
Canyon
,
TX
79015
United States
mcdanielwater@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
September 7, 2021
Ruth Shields, Director
McDaniel Water LLC
363 Ricketson Road
Amistad, NM 88410
RE: 616186
Dear Mr. McDaniel and Ms. Shields:
This letter is to advise you that in July 2021 the U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.mcdanielwater.com and has observed that you take orders there for the product “Black Indian Salve,” which you also refer to on your website as “Indian Herb,” “X,” and “Black Salve.” As explained further below, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 301(d). You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Your “Black Indian Salve” is concerning from a public health perspective because it is labeled to contain the ingredients bloodroot (Sanguinaria canadensis) and zinc chloride. Both substances are known corrosive agents. 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.
On May 16, 2019, the FDA issued a warning letter to McDaniel Life-Line LLC which offered a similar product, “Indian Herb,” for sale directly to consumers. The agency advises you that on February 8, 2019, “Indian Herb” was the subject of a voluntary worldwide recall of all lots of the product that were within expiration. In addition, the FDA Center for Drug Evaluation and Research (CDER) issued a safety alert on February 12, 2019 concerning the potential safety hazard associated with “Indian Herb” (see Indian Herb FDA Alert).
Unapproved New Drug Violations
You market “Black Indian Salve” as a dietary supplement with directions for both topical application and for ingestion. However, “Black Indian Salve” does not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act. Only products that are intended solely for ingestion may be lawfully marketed as dietary supplements. See section 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(2)(A)(i). Topical products and products intended to enter the body through the skin or mucosal tissues are not dietary supplements. Therefore, your “Black Indian Salve” is not a dietary supplement.
Rather, claims on your product labeling and your website establish that “Black Indian Salve” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or to affect the structure or function of the body. Examples of claims on your product label and website that establish the intended use of your “Black Indian Salve” product as a drug include, but may not be limited to, the following:
Black Indian Salve
From the package insert accompanying the product:
• “The following guidelines are offered for the application of ‘The Black Indian Salve’ in treating various types of abnormal growths both external and internal. . . . This is how people have used the ‘Black Indian Salve’ on external growths . . . The ‘Black Indian Salve’ is tracing out the infected area and drawing the poison back into the nucleus. It will make a hard core, similar to the core of a boil – hard and rubbery. The redness will diminish and a white ring will begin to appear around the nucleus. . . . Between the fifth and seventh day, a white ring will start to separate from the healthy tissue and become very loose. . . . Usually after the second application the growth itself is dead. The growth will become more painful as the body begins to eject its dying tissue. Swelling often occurs. . . . The core will not come out unless the whole growth is dead and detached from the healthy tissue. Then and only then will it come out intact. There will be no need for surgery. . . . For most people, in about 10 days the body completely pushes out the dead growth and the fever disappears. . . During the next 10 days, or as long as it takes, the body will fill in the cavity with either healthy tissue or scar tissue, depending on the individual’s body chemistry and health. . . . In many cases of removing external growths, people report that even though large masses of tissue was ejected from the body, even to the point of revealing the muscle structure below, bleeding did not occur and the body completely filled in the area where the growth had been.”
From the website http://mcdanielwater.com/page12.html:
• “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.”
• “
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.”
• “
Licorice Root
has been known to enhance immunity by boosting the level of interferon.”
• “
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.”
Your “Black Indian Salve” product is also a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under section 505(a) of the FD&C Act, a new drug may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. There is no FDA-approved application in effect for your “Black Indian Salve.” Thus, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
09/14/2021
Regulated Product(s)
Drugs