The FDA has issued a warning letter to 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."
(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, 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 no FDA-recognized 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
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.
Consumers should also be wary of online pharmacies selling "generic"
Tamiflu or Relenza, antiviral drugs that lessen the severity and
duration of flu, he says. Currently 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.
Elizabeth Weise, USA TODAY