FDA Issues Statement on Fraudulent, Unapproved Influenza-Related Products

The U.S. Food and Drug Administration (FDA) says it considers the sale of unlicensed or unapproved influenza -related products as a potentially significant threat to the public health and is taking measures to protect consumers from fraudulent products that claim to prevent or treat seasonal or avian (bird) influenza in people.

Consumers should be aware that currently there are no approved vaccines for preventing avian influenza in people nor are there any drugs approved for treating the specific symptoms of avian influenza. (Although several vaccines and drugs have been approved for the prevention and treatment of seasonal influenza, it is often impossible for unsuspecting consumers to differentiate between these products and those that are not genuine.)

For the most part, the seasonal and avian influenza-related products promoted to consumers without a specific endorsement by a registered pharmacy or healthcare professional and/or without a valid prescription written by a healthcare professional are not approved by the FDA and have not been determined to be safe and effective by the FDA.

Generally, the ingredients used and the conditions under which the products were manufactured are unknown and, therefore, are potentially unsafe and ineffective. Additionally, advertised products may be counterfeit versions of genuine products, or impure, contaminated, sub potent or super potent products. In short, they may endanger the well-being and safety of consumers who take them without providing any therapeutic benefits or protection against any type of influenza.

For example, FDA, in cooperation with the U.S. Customs and Border Protection Agency, recently intercepted products at the border that purported (to be "generic" Tamiflu,) but which, in fact, contained Vitamin C and other ineffective substances. Although the drugs were similar in appearance to genuine Tamiflu, they offer no therapeutic benefit. In another recent case, special agents from the FDA Office of Criminal Investigations (OCI) worked in coordination with the FBI to arrest an individual in Texas who administered counterfeit influenza vaccine to employees attending a corporate-sponsored health fair. And in July, another OCI investigation resulted in the indictment of an individual by a federal grand jury for his role in smuggling foreign, unlicensed influenza vaccines into the United States and attempting to sell the illegal vaccines to hospitals. Most recently, a licensed practical nurse (LPN) was sentenced this month to nine months in prison for operating a series of unauthorized influenza vaccine clinics at a college in Minneapolis after pleading guilty to dispensing drugs without a doctor's prescription. The nurse admitted to diluting some of the vaccine with saline to increase the quantity of her supply, thereby reducing the quality and effectiveness of the vaccines she was administering.

These cases illustrate the dangers of buying drugs from unknown sources and to FDA's commitment to investigating these matters and seeking federal prosecution of those individuals and companies who are involved in the manufacture, promotion, or distribution of illegal, influenza-related products.

Source: FDA