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The Food and Drug Administration considers the sale of unlicensed or unapproved influenza-related products as a potentially significant threat to public health and is taking action to protect consumers from fraudulent products that claim to prevent or treat seasonal or bird (avian) influenza in people.
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. Several vaccines and drugs have been approved to prevent and treat seasonal influenza, but it is often impossible for unsuspecting consumers to differentiate between these approved products and those that are not genuine.
For the most part, the seasonal and avian influenza-related products marketed to consumers without a prescription or a specific endorsement by a registered pharmacy or health care professional are not approved 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, subpotent, or superpotent 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, the FDA, in cooperation with the U.S. Customs and Border Protection, recently intercepted products at the border that purported to be "generic" Tamiflu, but which, in fact, contained vitamin C and other substances not shown to be effective in treating flu. Although the drugs were similar in appearance to genuine Tamiflu, they offered no therapeutic benefit. In another recent case, special agents from the FDA Office of Criminal Investigations (OCI) worked 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 2005, 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.
A licensed practical nurse was sentenced in January 2006 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 vaccine.
In another action in December 2005, the FDA issued Warning Letters to nine companies marketing bogus flu products and making unproven claims that their products could treat or prevent avian flu or other forms of influenza. Eight of the nine products cited in the Warning Letters purported to be dietary supplements.
Examples of the unproven claims are: "prevents avian flu," "a natural virus shield," "kills the virus," and "treats the avian flu." The Warning Letters noted 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 FDA is committed to investigating these matters and to seeking federal prosecution of those who are involved in the manufacture, promotion, or distribution of illegal, influenza-related products. Consumers who believe that they have seen a fraudulent product can visit www.fda.gov/oc/buyonline/buyonlineform.htm to report it.