WASHINGTON -- Federal regulators say a Florida company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.
The Food and Drug Administration and the Federal Trade Commission issued a warning letter to Flu and Cold Defense LLC for making misleading, unproven claims about its GermBullet inhaler.
The warning comes amid a worse-than-usual flu season that has hit the elderly particularly hard. So far, half of confirmed flu cases are in people 65 and older.
FDA regulators say they are seeing an uptick in bogus flu remedies, including fake flu vaccines, counterfeit antiviral drugs and air filters that allegedly remove the flu from the air.
"When there is a particular health issue in the news fraudulent products spike," said Howard Sklamberg, FDA's director of compliance. "So right now fraud products to prevent or treat the flu are big with scammers."
The Boca Raton, Fla.-based Flu and Cold Defense advertises the product as a "proprietary blend of 11 organic botanicals." The company's website claims that "an FDA recognized virology lab" tested the formula and "confirmed that it has the potential capability to kill cold and flu viruses."
But FDA regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations.
All new drugs marketed in the U.S. must be submitted for approval to the FDA before they can be sold to consumers. Sklamberg says consumers should remember that "there aren't any legally marketed over-the-counter products to prevent or treat the flu."