|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Seattle District Office|
|Issued:||May 23, 2008||Closed:||
Department of Health and Human Services
Public Health Service
May 23, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter 08-19
730 Flowerree St.
Helena, Montana 59601
Dear Mr.. Baker:
This letter concerns your firm's marketing of the product E-Mune on your website, www.herbalremission.com. According to the information on your website, your product is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body.
We note that you have attempted to disclaim some of the statements on your site that indicate that the products are intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. For example, your site says regarding E-Mune:
"To U.S. Users: Neither this product, nor the statements made on this site, have been evaluated by the U.S. Food & Drug Administration and this product is not intended to diagnose, treat; cure, or prevent any disease"
However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a"disclaimer:" 21 C.F.R. 202.1(e)(3)(i).
Statements on your website that document the intended uses of E-Mune include, but are not limited to, the following:
• "E-MUNE, a bloodroot-based product; is among the most: effective home treatments for skin cancer on the market today!"
• " Download the latest article on using E-Mune for the treatment of cancer, periodontal disease, skin lesions and more. . . ."
• ". . . Bloodroot preparations can be used as an effective alternative remedy in the treatment of skin cancers and moles."
• "E-MUNE works by altering the tumor antigens inside the body. This stimulates the immune system to recognize them as foreign and push them out of the body. The tumor bed becomes lined with sensitized white blood cells, causing it to become inflamed and slough off. It works similarly on the other conditions mentioned, previously."
• "E-MUNE Bloodroot paste stimulates the body's own immune system to naturally reduce the severity of many skin health problems."
The claims quoted above are supplemented by the metatags that you use to bring consumers to your website through internet searches . The metatags include, "treat skin health problems including skin cancer, melanoma . . ." and "skin cancer. . ."
E-Mune is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and intended to affect the structure or any function of the body of man or other animals. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of E-Mune without an approved application violates these provisions of the Act.
Furthermore, because E-Mune is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, E-Mune's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market E-Mune, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures E-Mune, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Please address your reply to the U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, WA 98021-4421, Attention: Lisa M. Elrand Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm . Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 10903 New Hampshire Ave., W051-2201, Silver Spring, MD 20993.
Charles M. Breen
PO Box 720
Helena, MT 59624
1350 MT Helena Drive
Helena, MT 59601
Ronald J. Klein
Montana Board of Pharmacy
PO Box 200513
301 S Park Ave, 4th Floor
Helena, MT 59620-0513