The FDA and FTC issued a rare multi-agency Warning Letter to Flu and Cold Defense LLC (FCD) on January 24, 2013 for claiming that its product, “GermBullet,” provides effective protection against the influenza virus on the product website www.germbullet.com. Such claims are considered by FDA to be “drug claims” because they imply GermBullet is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Such multi-agency enforcement is relatively rare, as FTC generally defers initial enforcement action to FDA under a Memorandum of Understanding between the two agencies. However, the FDA and FTC have collaborated in the past on enforcement actions against seasonal cold and flu products making unauthorized treatment and prevention claims. With the current cold and flu season off to a strong start with—29 states reporting flu levels season showing “high” or “severe” levels of flu outbreak—both agencies appear to be taking a very aggressive enforcement strategy against the marketing of unauthorized/unsubstantiated cold and flu remedies.

GermBullet, which, according to the product website, is composed of a “proprietary blend of 11 organic botanicals,” is marketed as an inhaler and claims to reduce illness-causing bacteria, cold and flu viruses, and fungi. The product website further states that GermBullet’s “new inhaler delivery system gives your body’s defenses a higher probability of effectively combating germs, so that you remain healthy.” Examples of claims cited in the Warning Letter for GermBullet include:

  • “…has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and fungi.”
  • “…gives your body defenses a higher probability of effectively combating germs, so that you remain healthy.”
  • “Nova Southeastern University laboratory testing confirmed that GermBullet® inhalation blend has a broad spectrum potential capability to kill illness-causing bacteria, mold, and fungi.”
  • “I use GermBullet whenever I feel that I am coming down with something or having a stuffy nose. So far, it has been working for me.”
  • “I am an airline pilot and I was getting sick all the time, at least once every few weeks. Once I started using GermBullet I’m not getting sick anymore.”
  • “It is truly amazing. I wouldn’t be without it! Especially during this cold and flu season!”

Both FDA and FTC have given Flu and Cold Defense LLC 15 days to respond to the Warning Letter.