FDA warns company over unapproved flu remedy

Federal regulators say a Florida company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.

The 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 say the mixture has never been reviewed as safe and effective and the company is violating regulations.

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

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA sends Procter & Gamble a warning

Sep 18, 2007

The U. S. Food and Drug Administration has warned the Procter & Gamble Co. about claims it makes for its Vicks Early Defense Foaming Hand Sanitizer.

FDA issues warning over-the-counter diarrhea drug

Sep 18, 2012

(AP)—The Food and Drug Administration is warning consumers not to use an over-the-counter drug called Intestinomicina because the anti-diarrhea treatment contains a drug linked to life-threatening injuries.

FDA cites claims on 2 green tea beverages

Sep 07, 2010

(AP) -- Federal health regulators have issued warnings to the makers of Canada Dry ginger ale and Lipton tea for making unsubstantiated nutritional claims about their green tea-flavored beverages.

Recommended for you

FDA to start regulating lab-developed tests

Jul 31, 2014

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

User comments