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WASHINGTON (AP) — Federal regulators say a Florida company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.
The Food and Drug Administration and the Federal Trade Commission issued a warning letter to Flu and Cold Defense LLC for making misleading, unproven claims about its GermBullet inhaler.
The warning comes amid a worse-than-usual flu season that has hit the elderly particularly hard. So far, half of confirmed flu cases are in people 65 and older.
FDA regulators say they are seeing an uptick in bogus flu remedies, including fake flu vaccines, counterfeit antiviral drugs and air filters that allegedly remove the flu from the air.
"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
The Boca Raton, Fla.-based Flu
and Cold Defense 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."
But FDA regulators say the mixture has never been reviewed as 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 before they can be 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."
The GermBullet is sold online through retailers like CVS.com and at a
handful of small pharmacies and natural food stores in Florida.
A man reached by phone at Flu and Cold Defense's office could not immediately comment on the warning letter.
This year's flu season started about a month earlier than normal and
the dominant flu strain is one that tends to make people sicker. The
government doesn't keep a running tally of adult deaths from the flu,
but estimates that it kills about 24,000 people most years. Vaccinations
are recommended for anyone 6 months or older.
Flu and Cold Defense issued a news release early in the month saying
GermBullet "may help protect you so your immune system is not
overwhelmed as the flu reaches epidemic levels." FDA and FTC regulators
take issue with that statement and a number of others from the company's
website, including that the inhaler is "shown to reduce illness-causing
bacteria, cold and flu viruses and fungi."
The letter, dated Jan. 24, was posted to the FDA's website Tuesday.
Regulators gave the company 15 business days to correct the problematic statements.
"The FTC strongly urges you to review all claims for your products
and ensure that those claims are supported by competent and reliable
scientific evidence," states the letter.
The FDA regularly issues warning letters to companies that do not
follow regulations for manufacturing and promoting drugs and medical
devices. The letters are not legally binding, but the FDA can take
companies to court if they are ignored.