HERE IS CHARLES HENSLEY CO-INVENTOR OF ZICAM ON THE FDA'S WEB SITE ENTITLED: "FDA Acts to Protect Public from Fraudulent Avian Flu Therapies"
"I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims.""
MAKE SURE YOU TAKE SOME VIRA38 RAVENEYE AND TELL YOUR FRIENDS.
FDA News
FOR IMMEDIATE RELEASE
P05-99
December 13, 2005
Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Acts to Protect Public from Fraudulent Avian Flu Therapies
The U.S. Food and Drug Administration (FDA) issued warning letters recently to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.
"There are initiatives in place to deter counterfeiters and those who sell fraudulent or phony products to prevent or treat avian flu," said Andrew von Eschenbach, MD, Acting FDA Commissioner. "The use of unproven flu cures and treatments increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren't. I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims."
FDA issued Warning Letters to nine firms marketing products making unproven claims that they treat or prevent avian flu or other forms of influenza. Eight of the products purported to be dietary supplements. Examples of the unproven claims cited in the Warning Letters include: "prevents avian flu," "a natural virus shield," "kills the virus," and "treats the avian flu." These alternative therapies are promoted as "natural" or "safer" treatments that can be used in place of an approved treatment or preventative medical product.
In the Warning Letters, FDA advises the firms that it considers their products to be drugs because they claim to treat or prevent disease. The Warning Letters further state that FDA considers these products to be "new drugs" that require FDA approval before marketing. The letters also note that the claims regarding avian flu are false and misleading because there is no scientific basis for concluding that the products are effective to treat or prevent avian flu. The companies have 15 days to respond to FDA.
Consumers who believe that they have seen a fraudulent product can report it to the FDA at fda.gov.
For information on helping prevent flu, see the Centers for Disease Control and Prevention cdc.gov.
FDA Warning Letters:
Sacred Mountain Management Inc.
fda.gov
fda.gov
BODeSTORE.com
fda.gov
fda.gov
Melvin Williams
fda.gov
fda.gov
Iceland Health Inc.
fda.gov
fda.gov
PolyCil Health Inc.
fda.gov
fda.gov
PRB Pharmaceuticals Inc.
fda.gov
fda.gov
Chozyn, LLC
fda.gov
fda.gov
Vitacost.com
fda.gov
fda.gov
Healthworks 2000
fda.gov
fda.gov
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Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-25062
Telephone : (949) 608-2900
Warning Letter
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
November 23, 2005
W/L 08-06
Charles B. Hensley, Ph.D.
PRB Pharmaceuticals
300 Oceangate
Suite 910
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:
Vira 38
"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 fda.gov. 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.
Sincerely,
/s/
Alonza E. Cruse
Director, Los Angeles District
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