The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet.
The warning cites claims such as, “[GermBullet] has been laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses and fungi”; “Nova Southeastern University laboratory testing confirmed that GermBullet inhalation blend has a broad spectrum potential capability to kill illness-causing bacteria, mold, and fungi”; and “Flu and Cold Defense’s GermBullet May Help Protect You so Your Immune System Is Not Overwhelmed as Flu Reaches Epidemic Levels.”
As a result, the FDA notes, “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.”
The letter cites additional violations and gives the company 15 days to respond with details of corrective measures. The GermBullet website currently says that it is “under reconstruction.”
Read the FDA warning letter.
Watch earlier news reports on GermBullet:
