FDA warns maker of Vira-38 and eight other "flu cures"

The botanical product Vira-38 has been the subject of skeptical posts (here and here), in the Forum on the Flu Wiki, on CurEvents and elsewhere. Vira-38 has been touted as an all-purpose anti-viral effective against avian influenza and SARS, among other maladies. Our attitude has been caveat emptor until some reasonable evidence of efficacy is produced. Apparently the US Food and Drug Administration feels the same.

Yesterday it released a warning letter it sent to Vira-38's maker, PRB Pharmaceuticals, on November 23, 2005. Similar letters were sent to eight other vendors of "fraudulent avian flu therapies":

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.

Links to the nine letters and to whom they were sent can be found here.

Here is an excerpt from the FDA's letter to PRB Pharmaceuticals:

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.