FDA WARNING_LETTER - Rosebud's Ranch and Garden, LLC - November 22, 2022

The FDA issued a Warning Letter to Rosebud’s Real Food (Ms. Stephenson) on October 18, 2022, following reviews of their websites (www.rosebudsrealfood.com and www.facebook.com/RosebudsRealFood) in June and August 2022. The FDA determined that several products, including Domestic Divas – Colds and Flu (Tea), Domestic Divas - No Pain No Gain Tea, Green Feather Homestead Mad As A Hatter Chai Tea, Rosebud’s Natural Seasonings Elderberry Syrup Kit, Rosebud’s Elderberry Lemonade, Rosebud’s Herbs & Spices Sencha Tea, Rosebud’s Natural Seasonings Jane’s Italian, Rosebud’s Fruit Butters Peach Blueberry, Rosebud’s Real Food Raw! Habanero Sriracha, and Rosebud’s Real Food Supertonic! Sriracha, are unapproved new drugs and misbranded drugs.

The products are deemed drugs under section 201(g)(1)(B) of the FD&C Act due to claims on the websites indicating their intended use in the cure, mitigation, treatment, or prevention of disease (e.g., "Eases the discomfort of a cold or flu," "Eases Muscular Pain," "balancing to blood sugar"). Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section