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 Boca Raton, Fla.-based company 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. The GermBullet is sold online through retailers like CVS.com and at a handful of small pharmacies and natural food stores in Florida.
A man reached by phone at Flu and Cold Defense’s office could not immediately comment on the warning letter.
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.
This year’s flu season started about a month earlier than normal and the dominant flu strain is one that tends to make people sicker. The government doesn’t keep a running tally of adult deaths from the flu, but estimates that it kills about 24,000 people most years. Flu and Cold Defense issued a news release early in the month saying GermBullet “may help protect you so your immune system is not overwhelmed as the flu reaches epidemic levels.”
Get daily headlines to your inbox
Start your day with our top stories delivered to your inbox every morning.
City, county, state and federal offices will be closed Thursday for the Christmas holiday, and U. S. Forest Service offices will be closed Thursday as well as Friday. Post offices will be closed Thursday, and some will close early today. The Deschutes County public libraries will be closed today and Thursday. The Crook County Library will close at 4 p. m. today and will be…
The holiest plant of the Christmas season may be a raggedy shrub with peeling bark that seems to grow best in a dusty backyard in Tempe, Ariz. This is Boswellia sacra, better known as the frankincense tree. The shrub’s gum resin is one of the three biblical gifts that the wise men bestowed on the infant Jesus. Until recently, Americans who wished to cultivate their…
The reality: That is not true, said Dr. Richard Koller, a Bend neurologist. A sneeze does increase the pressure inside the skull a little bit, he said. People have worried that sneezes may kill brain cells because other things that increase pressure on the brain, such as some types of stroke, can lead to brain cell death or even the death of the person. However,…
A barred owl that drew crowds of onlookers while swooping around at Farewell Bend Park earlier this year may well be dead. The owl was seen from mid-January into last month, regularly hunting for mice and voles along the Deschutes River just upstream of the Old Mill District. It then disappeared about a month ago. Two photographers found a dead owl March 3 about 10…
In the days before this weekend’s annual BendFilm Festival, one of the movies that had organizers excited was the critically acclaimed “Meek’s Cutoff. ”Filmed last year in the Harney Lake area near Burns, two hours southeast of Bend, the full-length feature debuted last month at festivals in Venice, Italy, and Toronto. It was scheduled to show Saturday, at the Tower Theatre, one day after its…