A Florida company has been sent a warning letter about marketing an untested inhaled formula as a flu remedy, federal officials say.
Flu and Cold Defense LLC is making misleading and unproven claims about its GermBullet inhaler, according to the letter issued by the Food and Drug Administration and the Federal Trade Commission, the Associated Press reported.
The company's website states that "an FDA recognized virology lab" tested the product and "confirmed that it has the potential capability to kill cold and flu viruses." Ads describe the product as "proprietary blend of 11 organic botanicals."
The FDA said the GermBullet inhaler has never been reviewed as safe and effective and that the company is violating drug safety regulations. The letter, dated Jan. 24, was posted on the FDA's website Tuesday. The company was given 15 business days to correct its claims, the AP reported.
The GermBullet is sold online through retailers such as CVS.com and at a few small pharmacies and natural food stores in Florida.
Proposed Study Would Examine NFL Players' Health Issues
The NFL Players Association is negotiating a $100 million, 10-year study with the NFL to "diagnose, treat and prevent injuries and illnesses," in players, according to CNN.
If a deal is reached, the study would be conducted by Harvard University researchers.
"No one has ever studied these players before," Dr. Lee Nadler, dean for clinical and translational research at Harvard Medical School and co-director of the proposed study, told CNN. "There have been postmortem studies looking at the brains of previous players, but not the players today."
This study is unique in that it will look at the "whole player across his whole life, not just the brain," Nadler said.
In a statement, the NFL said it looked forward to learning more about the study, CNN reported.
"We have no higher priority than player health and safety at all levels of the game," the league said.