Company Warned by FDA for Marketing Unapproved Flu Remedy

January 29, 2013

Federal regulators are reporting that 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.

Flu and Cold Defense LLC is based in Boca Raton, Florida. It advertises its 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."

However, FDA regulators report that the mixture has never been reviewed as safe and effective. They also say that the company is violating drug safety regulations. The GermBullet is sold online through retailers like CVS.com, Amazon.com, as well as a few smaller pharmacies and natural food stores in Florida.

This consumer warning arrives during a worse-than-usual flu season that has hit the elderly particularly hard. Half of confirmed cases consists of persons age 65 or older.

Read more about this consumer safety article here.

Consumers are reminded that all new drugs marketed in the United States must be submitted for approval to the FDA before they can be sold to consumers.