January 22, 2006
The Food and Drug Administration warns that the sale of unlicensed or unapproved influenza-related products is a potentially significant threat to the public health, and said it 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," the agency said in a statement.
Although several vaccines and drugs have been approved for the prevention and treatment of seasonal influenza, the FDA cautions 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 health care 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," the FDA warns.
"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 said it 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, the FDA said 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 allegedly administered counterfeit influenza vaccine to employees attending a corporate-sponsored health fair.
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 was sentenced to 9 months in prison for operating a series of unauthorized influenza vaccine clinics at a college in Minneapolis, MN 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.
