FJanuary 31, 2013
(USA TODAY) -- Scammers looking to make money off consumer fears about this year's severe flu season are proliferating, the Food and Drug Administration says. That's causing the agency to take a hard look at products that make claims about protecting against the flu.
The FDA has issued a warning letter to one, GermBullet, saying the nasal spray's claim that it is "laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses" is a "false and misleading promotional statement."
GermBullet is a nasal spray made up of "pure essential oils," according to its website. The product, sold over the counter, is made by Flu & Cold Defense LLC of Boca Raton, Fla.
The FDA says the company is illegally selling a misbranded drug. Specifically, it says:
GermBullet is being sold as a drug that claims to treat or cure a disease, but the company has never presented it to the FDA to be vetted as a drug.
GermBullet's website claims it has been tested by an FDA-recognized virology lab, but such no lab has seen it.
The company has 15 days to answer the warning letter. If the company continues to make unsubstantiated claims about the product, the agency may take enforcement action that could include seizure of the drug or criminal prosecution, says Howard Sklamberg, director of the FDA's office of compliance at the Center for Drug Evaluation and Research.
The FDA's health fraud program monitors the Internet and radio and TV ads.
"This is shocking," says Simone Hobus of GermBullet's research and development department. Reached by phone, she said the company was not aware of the FDA's letter and declined to comment further.
By law, drugs are products that claim to prevent, treat or cure a disease, among other things. The FDA is responsible for the regulation of prescription and over-the-counter drugs.
This flu season has spawned a number of fraudulent products that claim to treat, prevent or shorten the duration of the flu, Sklamberg says.
Consumers also should be wary of online pharmacies selling "generic" Tamiflu or Relenza, antiviral drugs that lessen the severity and duration of flu, he says.
There are no FDA-approved generics for those drugs on the U.S. market. Sklamberg says such products could be counterfeit, contaminated or not stored properly to maintain quality.
Be on guard
Consumers should beware of dietary supplements, foods such as herbal teas, and products such as air filters and light therapies that claim to:
Boost your immunity naturally without a flu shot.
Be a safe and effective alternative to the flu vaccine.
Prevent you from catching the flu.
Support your body's natural immune defenses to fight the flu.
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