On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler as a cold and flu remedy. The “GermBullet” is sold online as well as in small pharmacies and health food stores. You can read the warning letter here.
According to the text of the Warning Letter, the FDA targeted the Company, Flu & Cold Defense, along with its managing member Todd Whidden, for marketing the “Germ Bullet” as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Flu & Cold Defense makes claims on its website, as well as in a recent press release, promoting its nasal inhaler as a remedy for the cold and flu viruses. Pursuant to the FDCA, products that are intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. 21 U.S.C. § 321(g). Unless the drug is generally recognized as safe and effective for its intended use, however, an application must be submitted to the FDA for approval before it can be marketed to consumers. The “GermBullet” has not yet been presented to the FDA for approval.
Additionally, the FDA notes in the Warning Letter that the “GermBullet” is misbranded pursuant to the FDCA because its labeling both fails to include adequate directions for its intended use and makes false and misleading claims. In particular, the Company’s website falsely states that an FDA recognized virology lab independently confirmed that the product has the potential capability to kill cold and flu viruses.
Finally, under the Federal Trade Commission Act, enforced by the FTC, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertisement is substantiated by competent and reliable scientific evidence indicating that the claims are true at the time they are made.
In all, both the FDA and FTC were involved in the issuance of this Warning Letter, highlighting the overlapping jurisdiction of the FDA and FTC with respect to product claims, and the importance of considering the requirements of both agencies in this context. The responsibilities of each agency are outlined in a Memorandum of Understanding, found here. The FDA has primary responsibility for regulating the labeling of food, drugs, devices, and cosmetics while the FTC has primary responsibility for regulating the advertising of food, over-the-counter drugs, non-restricted devices, and cosmetics.
The FDA and FTC frequently work together in situations where the same or similar claims are made in both labeling and advertising or when printed material, most often claims made on the internet, can be considered both labeling and advertising. Joint warning letters are rare, however, with the first only being issued in 2009.
For more information about compliance with both FDA and FTC regulations, please contact us at: firstname.lastname@example.org.