FDA warns company over flu inhaler

January 31, 2013

FDA and the Federal Trade Commission (FTC) issued a warning letter to Flu and Cold Defense LLC (Boca Raton, Fla.) for making misleading, unproven claims about its GermBullet inhaler, and said the company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.

 

FDA and the Federal Trade Commission (FTC) issued a warning letter to Flu and Cold Defense LLC (Boca Raton, Fla.) for making misleading, unproven claims about its GermBullet inhaler, and said the company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.

“The recent letter that was released by FDA and the FTC about the unproven claims of the product GermBullet released by Flu and Cold Defense LLC comes at particularly sensitive time when the flu season begin sooner than expected, and this has made consumers susceptible to false claims of products that can prevent or treat the flu,” said Formulary Advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas. “Healthcare providers should strive to educate their patients on the facts and myths that currently exist about the flu. Patients should be informed that there is currently no cure or treatment for the flu, and only products that have been approved by FDA to treat the signs and symptoms of the flu are on the market. In order for any product to be considered safe and effective for the American public, it must be undergo a strict and sometimes extensive evaluation process before it is approved for release by FDA.”

According to the Associated Press, FDA regulators say they are seeing a rise in bogus flu remedies.

Flu and Cold Defense advertises GermBullet as containing “a scientifically proven, proprietary Inhalation blend of 11 essential oils. Users inhale it before, during and after exposure to coat the nasal passages for 2 to 3 hours. The organic blend is safe and does not contain synthetics, pesticides, preservatives, alcohol or zinc. The protective GermBullet Inhalation Formula is available as a liquid and in a convenient portable On-the-Go inhaler format.”

FDA said the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations.