This winter we have experienced one of the worst flu seasons in a long time, particularly affecting the elderly, as half of the confirmed flu cases are in people 65 years and older.
Federal regulators report that a Florida company has been marketing an untested inhaled formula to be used as a flu remedy, in violation of drug safety regulations.
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission’s warning letter said Flu and Cold Defense LLC made “false and misleading promotional statements” on its website and “misbranded” its product.
So many people are concerned about the flu this season and are willing to try products that promise to protect them.
FDA regulators say they have seen a surge in bogus flu remedies, including fake flu vaccines, counterfeit antiviral drugs and even air filters that allegedly remove the flu from the air, as reported in the Washington Post.
“When there is a particular health issue in the news fraudulent products spike,” said Howard Sklamberg, FDA’s director of compliance. “So right now fraud products to prevent or treat the flu are big with scammers.”
The Boca Raton, FL-based Flu and Cold Defense LLC advertises the product as a “proprietary blend of 11 organic botanicals.” The company’s website claims that “an FDA recognized virology lab” tested the formula and “confirmed that it has the potential capability to kill cold and flu viruses.”
However, FDA regulators say that the mixture has never been reviewed as being safe and effective and the company is violating drug safety regulations.
All new drugs marketed in the U.S. must be submitted for approval to the FDA prior to being sold to consumers. Sklamberg says consumers should remember that, “there aren’t any legally marketed over-the-counter products to prevent or treat the flu.”
According to a press release issued January 15th via PRNewswire, inhaling the GermBullet reduces the number of viruses the immune system has to fight.
The GermBullet is sold online through retailers like CVS.com and at a few small pharmacies, as well as natural food stores, in Florida.
Someone reached by phone at Flu and Cold Defense’s office could not immediately comment on the warning letter.
The SunSentinel reports that a “website under reconstruction” message appeared Monday on the home pages of germbullet.com and nsaroma.com, which the letter said were marketing the product. The GermBullet is a bullet-shaped inhaler consisting of 11 essential oils.
This year’s flu season began about a month earlier than normal and this flu strain is one that tends to make people sicker. Although the government does not keep a record of adult flu-related deaths, it estimates that the flu kills about 24,000 people annually. Vaccinations are recommended for people 6 months and older.
“We tend to think we are safe because the government is checking things, but that is far from the truth,” Bill Newton, executive director of Florida Consumer Action Network said. “Many agencies are under budget and sometimes they are restricted in what they can look at.”
The regulators’ January 24th letter said the company has 15 working days, upon receipt, to notify the office of corrective action.
Most people believe that if a product is sold on a reputable pharmacies’ website or at natural food stores, they must be safe and effective. Unfortunately, that is not always the case. This company has lead consumers to believe that their product was a proven flu remedy, but this was simply not true. We think their actions were misleading and irresponsible.
Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).