- Delivery Method:
- VIA UPS
Recipient NameBruce R. McDaniel
- McDaniel Life-Line LLC
HC 1, Box 2B
Felt, OK 73937
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3128
May 16, 2019
CMS Case # 571303
VIA UPS EXPRESS
Bruce R. McDaniel, President
McDaniel Life-Line LLC
HC 1, Box 2B
Felt, Oklahoma 73937
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, McDaniel Life-Line LLC located at HC 1, Box 2B, Felt, Oklahoma 73937 from November 6 – 16, 2018. We also reviewed your firm’s websites, www.mcdanielwater.com and www.lifelinewater.com, where you take orders for the product “Indian Herb.”
During the inspection, our investigators collected labeling for “Indian Herb,” a salve product manufactured and distributed by your firm. According to your website, www.mcdanielwater.com, “Indian Herb” is also referred to as “X” or “Black Salve.” Based on our inspection and review of your product labeling, including your firm’s websites, FDA has determined that your “Indian Herb” is an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). This product is also a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352.
This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, your drug products are adulterated within the meaning of section 501(a)(2)(A) of the FD&C Act, 21 U.S.C. 351(a)(2)(A).
Additionally, because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are also adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your December 3, 2018 response in detail, and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
Unapproved New Drug Violations
You market “Indian Herb” as a dietary supplement with directions for both topical application and for ingestion. However, “Indian Herb” does not meet the definition of a dietary supplement under section 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(2)(A)(i). Only products that are intended solely for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body through the skin or mucosal tissues are not dietary supplements. Therefore, your “Indian Herb” is not a dietary supplement under section 201(ff) of the FD&C Act.
Rather, claims on your product label and your websites establish that “Indian Herb” 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 websites, www.mcdanielwater.com and www.lifelinewater.com, establishing the intended use of your product include, but may not be limited to, the following:
Indian Herb package insert:
• “The ‘Indian Herb’ . . . balances the metabolism and any blood disorders.”
• “Treating Internal Abnormal Growths”
• “While the Herb has been relentlessly killing abnormal tissue in the body, or killing viruses, it has also been saturating the body with zinc.”
• “If you think the illness or abnormal growth may still be somewhat present, you may take the Herb for a second 21 days period.”
Your website www.mcdanielwater.com states:
• “Indian Herb Ancient herbs compounded to balance your metabolism and aid in healing the body.”
• “The Indian Herb is a 100-year-old folk remedy used to attack disease and aid in the healing process . . . 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, gingivitis and plaque. 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 appears to enhance immunity by boosting the level of interferon. It also contains powerful antioxidants and phytoestrogens. It has been historically used for treatment for chronic fatigue, viral infections, menopause, ulcers, fungal infections and arthritis.”
• “Galangal has powerful antibacterial properties. 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.”
In December 2018, your website www.lifelinewater.com stated:
• The Indian Herb is a perfectly balanced vitamin and mineral substance which balances the body’s metabolism and any blood disorders . . . The herbal paste may be taken orally or applied directly to abnormal growths or used as a ‘preventative/maintenance’ health aid.”
Your “Indian Herb” 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 “Indian Herb.” 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).
Misbranded Drug Violations
A drug is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your “Indian Herb” product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, the labeling for “Indian Herb Salve” fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1).
The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Insanitary Conditions Violations
You manufacture Indian Herb, a drug product intended to orally and topically treat internal and external abnormal growths, respectively. During the inspection, our investigator observed filthy conditions in your facility.
Your water system is not adequate for its intended use. The water from your water system is a drug component used in the manufacture of Indian Herb. The water system is a (b)(4) system, with no filters. You purposely (b)(4) your water system and (b)(4). Many objectionable microorganisms can reside in (b)(4) (e.g., pathogenic gram-negative and spore-formers) making the water produced by the water system highly susceptible to microbial contamination.
Your water system also has uncovered in-process storage tanks that are accessible to pests and the environment. Furthermore, your in-process storage tanks are corroded and coated with an unknown residue. You also do not monitor the water for microbiological growth.
FDA collected and tested water samples from your water system. Our test results show high levels of microbiological growth as well as the presence of objectionable microorganisms such as Pseudomonas aeruginosa.
In your response, you stated that, “The tanks have a continuing purifying process,” but you did not provide any scientific data to support your claim. Your response is inadequate because it does not address the violation.
1. Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups. Your firm also failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.42(c) and 211.113(a)).
You manufacture Indian Herb in your residential kitchen and store manufacturing equipment in your residential garage. In addition, you measure components using household utensils and mix components using a (b)(4) blender stored in a trash bag, in your residential garage, when not in use.
You also have no procedures in place to prevent contamination. These conditions and practices increase the risk of contamination of your drug products.
Your response is inadequate because you did not address these CGMP violations.
2. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company (21 CFR 211.22(a)).
You manufacture Indian Herb, a corrosive substance, using insanitary component water. Oversight is key to ensure drug product safety. You lack quality oversight for the manufacture of your finished drug product and you released drug product without an established Quality Unit (QU).
You confirmed the lack of a QU and acknowledged that you lack written procedures, including, but not limited to, those procedures governing the responsibilities and functions of the QU, product specifications, establishment of lot/batch numbers, batch release, stability studies, raw materials testing, and methods to risk mitigate distributed lots on the market. Without an adequate QU, you lack the ability to ensure the safety, identity, strength, quality, and purity of your drug product.
In response, you stated that, “The quality control is in the formulation of Indian Herb.” Your response is inadequate because it does not address the violation.
3. Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192 (21 CFR 211.198(a)).
You failed to investigate a serious customer complaint regarding the product Indian Herb. One of your customers reported that the product caused necrosis and erosion of the tip of her nose. You were made aware of this complaint by the customer in July 2018, but did not record any of the information.
In your response, you stated that you will establish procedures for receipt and handling of complaints. Your response is inadequate because you did not provide any details on these procedures.
4. Your firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)).
You did not perform any release testing for the chemical or microbiological attributes of your drug products. Without this basic testing, you cannot determine whether each drug product batch meets specifications and is suitable for release. In addition, you do not have established specifications for your drug products.
In your response, you stated that the “active strength of finished product is done by precise measurement of active ingredients.” Your response is inadequate because “precise measurement of active ingredients” is not an acceptable substitute for validated chemical and microbiological finished drug product release testing. You also do not address the lack of specifications.
5. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
You manufactured drug products without any batch records or lot numbers. Such information is necessary to establish that the manufacturing process was followed and is reproducible. Furthermore, lack of lot numbers makes it very difficult for you to track product disposition and investigate product concerns.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. Furthermore, it is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure, injunction, and/or prosecution. Furthermore, FDA may reinspect your facility to verify that corrective actions have been completed.
We note that on February 5, 2019, FDA discussed with you, via phone call, the laboratory analysis of the FDA-collected sample of “Indian Herb.” During the teleconference, you indicated that you would voluntarily recall “Indian Herb” and discontinue manufacturing and distribution of your drug product.
FDA acknowledges that on February 8, 2019, you initiated a voluntary worldwide recall of all lots of “Indian Herb” that were within expiration. You stated in your response that you agree not to process or make “Indian Herb” for human consumption and that you will not sell “Indian Herb” or “Life-Line Water” for human consumption. We also acknowledge that you notified your customers of the recall by press release on February 8, 2019. 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 your products (see Indian Herb FDA Alert).
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA’s website at http://fda.gov/oc/industry.
Your written notification should refer to the Warning Letter Number above (CMS Case #571303). Please address your reply to Rebecca Asente, Compliance Officer, at the FDA address provided on the bottom of the first page of this letter. In addition, please submit a signed copy of your response to ORAPHARM2_Response@fda.hhs.gov.
If you have questions regarding the contents of this letter, you may contact Ms. Asente via (504) 846-6104 or Rebecca.firstname.lastname@example.org.
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations, Division II
CC: Edith Kathleen Parsley, CFO and Secretary
McDaniel Life-Line, LLC