Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Kansas City District|
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
March 4, 2008
RETURN RECEIPT REQUESTED
Martin Williams, Registered Agent
P.O. Box 265
Boys Town, NE 68010
Ref. KAN 2008-05
Dear Mr. Williams:
This letter concerns your firm's marketing of the product Qina on your website, www.neumalife.com. Based on promotional claims made on your website, Qina is intended to prevent, treat, or cure disease in humans or to affect the structure or function of the body. Statements on your website that document these intended uses include, but are not limited to, the following:
• "Qina is a natural immune booster/modulator that can be used by any age suffering from chronic illnesses, particularly cancer and HIV/AIDS."
• "Why consider Qina?
- REDUCES VIRAL LOADS
- INCREASE IN CD4 & CD8 COUNTS
- DECREASES OPPORTUNISTIC INFECTIONS
- IMPROVES APPETITE
- NON TOXIC
- IMPROVES YOUR QUALITY OF LIFE"
• "Qina can be used by any person who is suffering from a weakened immune system, whether caused from a poor diet, bacterial or viral infections. This includes tuberculosis, herpes B&C, herpes zoster, pneumonia, flu, sinusitis and asthma, sarcoma 180 and piodermites."
• "Results from the Qina studies - 70% of Qina patients started with opportunistic infections. After 6 months this was reduced to 5%. The control group started with 45% infections which dropped to 22% after 1 month but then rose again to 35% after [sic] months. Only 20% of the Qina patients had a drop in viral loads less than 90%, while the control group had a 65% therapeutic failure.… There was an overall improvement in the quality of life and all patients decided unilaterally to continue with the medication even after the trial had been completed."
• "The clinical-pharmacologic approach, different from conventional allopathic medicine, makes Qina suitable, mainly, for Cancer and Aids... "
• "Studies have demonstrated that Qina can influence the decrease of the production of Tumor Necrosis Factor-a by the macrophages. It is known that this cytokine plays an important role in viral replication and that high levels of TNFa are associated with the progress of the disease."
• "In cancer cases, the medicament provides a regression of the symptoms, including pain, thus improving the patient's overall quality of life. Appetite improves, weight is gained and an overall feeling of wellness returns. There is also evidence of the regression of the lesion itself, thus making the disease's prognosis look considerably better."
• "In HIV cases, there is an increase in the number of the active T and B lymphocytes, as well as the number of cytokines. Therefore, patients CD4 and CD8 counts rise sharply as well as a reduction in viral loads. Once a patient's CD4 count has risen above 200 they are no longer considered having AIDS but only being HIV+."
Qina 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 humans, or to affect the structure or any function of the body of man or other animals. Namely, your product is promoted as intending to cure, mitigate, and treat diseases, including HIV and cancer, and to affect the structure and function of the body. 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 use under the conditions prescribed, recommended, or suggested in its labeling. 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 Qina without an approved application violates these provisions of the Act.
On your website, you claim that Qina is a "nutritional supplement." A dietary supplement may not bear claims that it prevents or treats a disease, except for authorized health claims about reducing the risk of a disease. Other disease prevention and treatment claims render the product a drug subject to the drug requirements of the Act. Your product makes disease prevention and treatment claims that are not authorized health claims; accordingly, the product is subject to regulation as a drug.
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, Qina'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).
Additionally, you make false and misleading promotional statements on your website regarding the product. Your website states, "Used for years in South Africa -- now FDA approved for use in the US!" However, your product is not the subject of an FDA-approved application. Thus, your product is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).
Additionally, Qina, which could delay or interfere with appropriate medical therapy for HIV and subsequently cause disease progression of HIV, is dangerous to the health of babies, children, pregnant women, and lactating mothers when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the product's labeling. Therefore, your product is misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j).
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(s). 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.
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 Qina, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures the product identified above, 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. Address your reply to the U.S. Food and Drug Administration, 11630 West 80th Street, Lenexa, Kansas, Attention: Nadine Nanko Johnson, 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.htm1. 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, 5600 Fishers Lane, Rockville, Maryland 20857.
John W. Thorsky
Kansas City District
Nebraska Board of Pharmacy
P.O. Box 94986
Lincoln, NE 68509-4986
This page was posted on July 19, 2010.