FDA WARNING_LETTER - The Elderberry Co., LLC - September 15, 2020

The FDA issued a Warning Letter to The Elderberry Co. on September 8, 2020, following a July 2020 review of their websites (www.TheElderberryCo.com and www.facebook.com/theelderberryco). The review found that the company's "Elderberry Syrup" and "Elderberry Syrup Kit" products are marketed with claims that establish them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The FDA cited claims such as "Fights Colds, Flus and Allergies," "help fight inflammation, congestion," "anti-inflammatory and anti-viral properties," and "naturally improving colds, the flu, sinus issues, nerve pain, inflammation, chronic fatigue, allergies and constipation." These claims indicate the products are intended for the cure, mitigation, treatment, or prevention of disease, making them drugs under section 201(g)(1)(B) of the Act.

Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) and require prior FDA approval, which they lack, violating sections 301(d) and 505(a). Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson for conditions not amenable to self