Cold and Flu Defense LLC was warned by FDA regarding allegedly unlawful cold and flu claims. Germbullet, the product, is for inhalation and is therefore not a dietary supplement. In its warning letter, FDA noted the claim: "An FDA recognized virology lab independently tested GermBullet inhalation blend and confirmed that it has the potential capability to kill cold and flu viruses." However, FDA noted it has not "recognized" any virology lab that has independently tested the product and that this claim allegedly misbrands the product, as well.
Food and Drug Administration
January 24, 2013
Warning Letter: Cold and Flu Defense LLC
This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your firm's marketing of your product GermBullet on your websites, www.germbullet.com and www.nsaroma.com. According to information on your websites, GermBullet is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on your websites that document these intended uses include, but are not limited to, the following:
- The graphic appearing on your website and product labeling of a germ inside of a target with the words "COLD & FLU VIRUSES" and "BACTERIA FUNGI."
- "[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and fungi."
- "[GermBullet] 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!"
- "I love GermBullet; amazing product and REALLY WORKS! I have major allergies and this has made a huge difference. In addition, I have a low immune system, so when my folks get sick, I normally do too. BUT this time, when I used GermBullet, I didn't get sick when they did. This stuff is amazing."
- "Inhale before, during or after exposure to airborne germs or when you first suspect a cold."
- The Fox News report linked from your website of "how to beat the cold and flu symptoms with a bullet."
- The Wall Street Journalarticle entitled "Keeping Cold, Flu Germs Out."
In addition, your January 15, 2013, PR Newswire press release entitled, "Flu and Cold Defense's GermBullet® May Help Protect You so Your Immune System Is Not Overwhelmed as Flu Reaches Epidemic Levels," further demonstrates the intended use of your product.
GermBullet is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man or other animals. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of GermBullet without an approved application violates these provisions of the Act.
Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, GermBullet's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
Additionally, you make false and misleading promotional statements on your website regarding the product. In particular, www.germbullet.com states, "An FDA recognized virology lab independently tested GermBullet® inhalation blend and confirmed that it has the potential capability to kill cold and flu viruses." However, FDA has not "recognized" any virology lab that has independently tested your product. Thus, your product is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).