Extravagant ‘Germbullet’ Drug Claims Do Not Amuse FDA and FTC

Extravagant ‘Germbullet’ Drug Claims Do Not Amuse FDA and FTC

January 30th, 2013 // 4:06 pm @ jmpickett

source

File this under ‘such chutzpah!’ On a web site that can only be described as breathless, Flu & Cold Defense boasts that its GermBullet, a ‘natural proprietary blend of 11 organic botanicals,’ was ‘independently tested’ by an ‘FDA recognized virology lab’ and the product was found to have ‘the potential capability to kill cold and flu viruses.’

And in testimonials, a variety of people, most of whom are not thoroughly identified, gush over the product, which costs $7.49. “My whole family went on a plane trip to China and everyone in our travel group on the plane got sick except for my family who used your inhalation formulation,” says April, a massage therapist from Ft. Lauderdale, Florida.

Not surprisingly, the FDA is not impressed. Nor is the US Federal Trade Commission. In a rare display, both agencies embossed their seals on a January 24, 2013, warning letter to the Boca Raton, Florida, company to inform its owner that GermBullet is considered a drug because its intended use is to to prevent, treat, or cure diseases.

But there is more. The FDA says it has not recognized any virology lab that has independently tested GermBullet, which means the product is misbranded. And Flu & Cold Defense never submitted an application with the FDA to sell its inhaler, which is consequently considered a new drug that is not considered safe and effective for its “labeled uses” (here is the warning letter).

Meanwhile, the FTC notes it is against the law to advertise a product to prevent, treat or cure human disease without “competent and reliable scientific evidence,” including well-controlled human clinical studies that can substantiate claims are true at the time they are made.” And to make or exaggerate claims on a web site or in testimonials, among other means, “without rigorous scientific evidence sufficient” is also a violatoin of the law.

And the FTC gets tough. The agency gives Flu & Cold Defense 15 days to offer a different kind of defense, and reminds the company that an injunction can be obtained and consumers may wind up eligible to receive their money back. The FDA also says the company can face legal action, although as of today, the web site and the various claims are still visible. We contacted Flu & Cold Defense for comment and will update you accordingly.

One person who does offer a testimonial is Harold Laubach, the dean of the College of Medical Sciences at Nova Southeastern University in Fort Lauderdale. On the web site, he is quoted as saying that “GermBullet is stable and does not irritate sensitive or damaged tissues. These properties, along with the current finding of a broad spectrum of microbiological activity, demonstrate that GermBullet is beneficial as an inhalant.”

There is also a link on the web site to a poster presentation he co-authored that concludes the “in vitro antimicrobacterial activity of GermBullet essential oils suggests that it influences microorganisms in the nasal cavity in a beneficial manner by allowing the mucosa to function normally, resisting damage by pathogens” (here it is). It is not clear when and where this was presented. We reached out to Laubach and will pass along any response that we receive.