FDA warns Florida company over bogus GermBullet flu remedy

fda-warning-germbulletFederal health officials are warning this week about a bogus flu remedy available to consumers and have sent notification to the company responsible for it that it is in violation of the law.

According to an AP report, the Food and Drug Administration along with the Federal Trade Commission have issued a warning letter to Flu and Cold Defense LLC, a Florida company, regarding its GermBullet inhaler.

The company claims that the GermBullet consists of a “proprietary blend of 11 organic botanicals” that are capable of preventing and curing the flu. Further, claims on the company’s Web site tout that “an FDA recognized virology lab” has confirmed that GermBullet contains the necessary ingredients to help prevent or combat symptoms of the flu, “to kill cold and flu viruses.”

The FDA must approve any drug treatments used in the U.S., particularly ones that make medicincal claims in product packaging or other marketing materials. Regulators say they never received any sort of application from Flu and Cold Defense to approve the GermBullet, an inhaled formula, for use in the U.S. Therefore, GermBullet is an unapproved drug and sales of it are considered illegal.

A warning letter from the FDA typically gives a company 15 days to correct the problems that caused it to be sent. This means that Flu and Cold Defense must either submit the necessary paperwork to show that its product is safe and effective in the treatment of cold and flu symptoms, remove the medicinal claims associated with GermBullet, or remove the product from the market entirely.

GermBullet was available mostly through online vendors but AP indicates that some CVS stores as well as other health and natural food stores in Florida carried it on their shelves. Flu and Cold Defense is just the latest company to get caught making unsubstantiated claims about its product and a recipient of an FDA warning letter. Companies like it often prey on vulnerable consumers who are desperate for some form of relief from the symptoms of a seasonal cold or flu.

The impetus to create a bogus flu remedy certainly exists this year as nearly all the contiguous states reported record numbers of people affected by influenza. There are a number of approve flu vaccines available to consumers already, along with the standard over-the-counter treatments, which is where most consumers turn for relief from the grip of influenza.

An FDA spokesperson told AP that “When there is a particular health issue in the news, fraudulent poducts spike. So right now, fraud products to prevent or treat the flu are big with scammers.”

More than half of all flu victims this year have been over the age of 65. The FDA estimates that about 24,000 people die every year from flu-related illness but the agency does not keep specific data related to flu.

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