Inspections, Compliance, Enforcement, and Criminal Investigations
Generation's Black Salve 20-May-08
Department of Health and Human Services
Public Health Service
San Francisco District
RETURN RECEIPT REQUESTED
May 20, 2008
Generation's Black Salve
1485 Country Ln.
Turlock, CA 95382
Dear Ms. Booth:
This letter concerns your firm's marketing of Generation's Black Salve Tablets on your website, www.generations.bz. According to the information on your website, your product is intended to prevent, treat, or cu re disease conditions or to affect the structure or function of the body of man or animals.
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 Black Salve:
"The success of Black Salve is largely based on testimonials, accumulated over a period of 23 years from people who used the Black Salve. No Claims can be legally made about the Black Salve. The information has been prepared as narration of what users have reported to be the most effective way to use the products as an Herbal Remedy, and what some have reported as the results. It is not intended as a report of scientific studies, and it is not offered or endorsed by the AMA or the FDA. It is intended to be an honest report of what is known for those who are interested."
However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer." Cf. 21 C.F.R.202.1(e)(3)(i).
Statements on your website that document the intended uses of Generation's Black Salve Tablets include, but are not limited to, the following:
Generation's Black Salve Tablets
• "Contains natural Organic herbs and Minerals that neutralize and will eliminate carcinogens, prior to their stimulation of any tumor growth and after tumor growth."
• "Internal abnormal cell growth in -the liver, kidneys, colon, prostate, female sex organs, breast, lung and throat areas, to name a few."
• "Detoxing the body by ingestion of one tablet daily for the "twenty eight day run" which will also induce oxygen into the system and affected areas thereby further inhibiting carcinogen [sic] growth."
• "As stated above Black Salve has a variety of healing abilities. Your body has the ability to eject abnormal and foreign objects, such as tumors, just as your body would eject a wood splinter from your finger."
• "He had been diagnosed as having colon cancer. . . . After he checked himself(in to the hospital for surgery the night before surgery, he took the first dose of Black Salve in a capsule without telling his doctors. The next morning they postponed the surgery because he was having cramps, as the Salve had started to work in his system. He then continued to take the salve for 5 more days. [...] When the doctors took x-rays they discovered that the cancerous growth was gone. He lived another 25 years without colon cancer."
The claims quoted above are supplemented by the metatags used to bring consumers to your website through internet searches. The metatags include, "natural malignant tumor and growth cure," "natural cancer cure," "Herbal Alternative Treatment and Cure for tumor growth, bacteria, viruses, and More," and "cancer prevention."
Generation's Black Salve Tablets is a drug, as defined by section 241(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 humans 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 without an effective FDA-approved application. Your sale of Generation's Black Salve Tablets without an approved application violates these provisions of the Act.
Furthermore, because this product 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, Generation's Black Salve Tablets' 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 Generation's Black Salve Tablets. 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 Generation's Black Salve Tablets, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures Generation's Black Salve Tablets, 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, 1431 Harbor Bay Parkway, Alameda, CA 94542-7470, Attention: Lawton Lum, Compliance Officer.
District Director, San Francisco District
Generation's Black Salve
P.O. Box 1538
Turlock, CA 95381
California Board of Pharmacy
1625 N Market Blvd, Suite N219
Sacramento, CA 95834