GermBullet Flu Remedy Unapproved, Says FDA Warning Letter
Federal regulators are warning the maker of a new cold and flu remedy that marketing claims for the product violate FDA guidelines.
The Boca Raton, Florida, based company, Flu and Cold Defense LLC, was issued a warning letter by the FDA and Federal Trade Commission (FTC) on January 24, indicating that the company is illegally marketing GermBullet as a cure or treatment for the flu. These claims cause the product to be in violation of the Federal Food, Drug, and Cosmetic Act.
GermBullet was introduced as an inhaled form of flu protection. According to the company website, it is a botanical product with essential oils and wild-grown plant ingredients for the use of preventing germs in association with the flu. It is packaged in a small nasal inhaler bottle to decrease germs “entering through the nose.”
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According to the letter, the marketing violates the act in many areas, including the graphics on the website and product labeling, which specifically indicate the product is a cold and flu prevention.
Additionally, the company made claims that GermBullet is laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses by reducing exposure to germs and illness through its inhaled application.
The advertising claimed the product was tested by an FDA-recognized virology lab which “confirmed” GermBullet’s capability to kill cold and flu viruses. The FDA has not recognized a virology lab that has tested the product, said officials.
The FDA warning letter also noted that the product was fairly new and not recognized as safe and effective for its labeled uses. New drugs must first be approved by the FDA prior to interstate sale.
Another item of concern highlighted in the warning notice detailed the labeling and directions provided for the product were not adequate for persons without medical training to follow correctly, causing the product to be deemed misbranded.
Flu and Cold Defense LLC is required to investigate and identify the violations to prevent recurrences and was given 15 days to notify the FDA of the steps they are taking to correct the violations. Failure to correct the violations may result in legal action, Federal District Court injunction, administrative cease and desist order and seizure. The company may also be liable to pay restitution to consumers for concerning the false advertising claims made.
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