FDA WARNING_LETTER - The Elderberry Fairy & Co., LLC - August 30, 2022

The FDA issued a Warning Letter to The Elderberry Fairy Co. following a June 2022 review of their website and social media, which identified that products like Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider are being marketed with claims that establish them as unapproved new drugs. These claims, such as fighting common cold/flu, relieving allergies, and improving sinus infections, indicate the products are intended for the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. As "new drugs" under section 201(p), they require prior FDA approval for legal introduction into interstate commerce, which has not been obtained, violating sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed "misbranded drugs" under section 502(f)(1) because they lack adequate directions for use, as their intended disease-related purposes are not suitable for self-diagnosis or treatment by a layperson. Introducing these misbranded drugs into interstate commerce violates section 301(a). The company must respond in writing within 15 working days, detailing corrective actions, prevention steps, and supporting documentation, or explain any delays. Failure to comply may lead to legal action, including product seizure and injunction.