FDA warns company over unapproved flu remedy

Matthew Perrone / The Associated Press /

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.”