Inspections, Compliance, Enforcement, and Criminal Investigations
PRB Pharmaceuticals 23-Nov-05
Department of Health and Human Services
Public Health Service
Los Angeles District
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
November 23, 2005
Charles B. Hensley, Ph.D.
Long Beach, CA 90802
Dear Dr. Hensley:
This letter concerns your firm's marketing of the product "Vira 38" on your website, www,prbpharmaceuticals.com. According to your website, this product is intended to prevent, treat, or cure serious disease conditions. The statements on your website include, but are not limited to, the following:
"Highly effective flu medication."
Shown to inhibit and prevent infection of Bird Flu Virus (H5N1) and Type A human influenza in vitro."
"Human clinical research shows Vira 38 reduces the duration of influenza illness by 78%."
"One of the anti-viral components is v38 AMF-1 which has been shown to inhabit infections from Type A influenza, SARS virus, Avian influenza virus, Staphylococcus aureus, and Streptococcus pneumoniae (two bacteria primarily responsible for secondary infections seen in influenza)."
"Vira 38 is a favorite among the Hong Kong doctors for the prevention and treatment of influenza."
"vira 38 is currently used in Hong Kong to protect the live poultry market workers against the bird flu."
"Vira 38 was used by the major SARS hospital to protect front-line doctors and nurses against SARS during the SARS outbreak of 2003."
These claims are further supplemented by the metatags that you use to bring consumers to your website. These metatags include "life threatening diseases," "influenza virus," "SARS coronavirus." and treatments".
Vira 38 is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321 (g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 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 Vira 38 without such an approved application violates these provisions of the Act.
Furthermore, many of the conditions for which this product is offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use for these conditions cannot be written so that a layman can use thus drug safely for its intended purposes. (See 21 C.F.R § 201.5). Because your product's labeling fails to bear adequate directions for its intended uses, it is misbranded under Section 502(f)(1) of the Act, 21 U.S.C., § 352(f)(1).
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letter about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. It you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and the steps taken to assure that similar violations will not occur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture 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 manufacturing firm. Address your reply to the U.S. Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, Attention: Pamela B. Schweikert, Director of Compliance.
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, 5600 Fishers Lane, Rockville, Maryland 20857.
Alonza E. Cruse
Director, Los Angeles District