The Elderberry Fairy & Co., LLC
FDA issued a warning letter to The Elderberry Fairy & Co., LLC (owner Catie Fasano) in August 2022 after reviewing the company's website and Facebook page, finding that marketing claims for Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider established these products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease. Claims included fighting colds and flu, relieving allergies, suppressing coughs, and acting as a sinus decongestant, none of which have FDA approval. FDA determined the products were also misbranded for lacking adequate directions for use, and warned that failure to correct violations could result in seizure or injunction.
Flagged claims (11)
Elderberry also contains anthocyanins … Anthocyanins are thought to prevent flu viruses from reproducing inside our bodies, which may prevent the onset of flu or decrease the duration of its symptoms.
Elderberry Syrup is a powerful herbal supplement that has been used for many centuries to …fight the common cold & flu*, relieve allergies*, and so much more! Elderberry Syrup can be taken daily for prevention or at the onset of symptoms.
Elderberry… allow you to better fight off infections, such as common viruses like the cold or flu.
In 2004, a study on elderberry extract in flu patients revealed that symptoms were relieved 4 days sooner than patients who didn't receive elderberry.
Health Benefits:… Cold & flu fighter Sinus decongestant Cough suppressant Alleviates headaches…
Supplementing with elderberry has been shown to improve sinus infections
Many clinical research studies have shown that supplementing with the flowers and berries of the Elder plant can have the ability to lessen the severity and duration of colds and flu.
the flu-busting antiviral oseltamivir, known by the brand name Tamiflu, is also a neuraminidase inhibitor and works to reduce flu symptoms by the same mechanism.
Another 2020 review of five elderberry studies concluded that, when taken within 48 hours of initial symptoms, elderberry supplements may reduce the length and severity of fever, headache, runny nose, and congestion associated with cold and flu.
Elderberry is a cost-effective treatment for the flu and it tastes great too! The elder plant has many medicinal uses including: treatment of colds and other infections, allergic conditions (allergies, sinusitis), and more!
Both the flowers and the berries are diaphoretics, meaning they increase perspiration. This action is beneficial during fevers and to excrete toxins from the body. Additionally, elderflowers offer anticatarrhal properties which helps the body eliminate mucus. Both the flowers and berries have recognized anti-viral … properties!
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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