WASHINGTON (AP) — 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 are warning Flu and Cold Defense for making misleading, unproven claims about its GermBullet inhaler.

The Boca Raton, Florida-based company advertises the product as a blend of 11 organic botanicals. It sells the product online and at certain pharmacies and grocery stores.

But government regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations.

A man reached by phone at Flu and Cold Defense’s office could not immediately comment on the warning letter.