Prairie Dawn Herbs – FDA Warning Letter, Dec 10, 2020

On December 10, 2020, the FDA issued a Warning Letter to Prairie Dawn Herbs, following a November 2020 review of their website, prairiedawnherbs.com. The FDA determined that products sold, including “Chest Tea,” “Ginger Oil,” “Dandelion root Tincture,” “Echinacea purpurea Tincture,” “Antispasmodic Tincture,” “Ginger Tincture,” and “Cayenne Tincture,” are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are deemed drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] due to claims on the website indicating their intended use for diagnosing, curing, mitigating, treating, or preventing disease. Examples of such claims include "Chest tea is useful for asthma, bronchitis, pneumonia and whooping cough" and "Ginger has strong antibacterial properties and is effective against food borne pathogens."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 30