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WARNING LETTER
FY 22-HAFE6-08 CMS 622859

August 15, 2022

Dear Ms. Fasano,

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at https://theelderberryfairyco.com/ in June 2022, and has determined that you take orders there for the products Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider. FDA also reviewed your social media website at https://www.facebook.com/TheElderberryFairyCo/, which directs consumers to your website to purchase your products. The claims on your website and social media establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of website claims that provide evidence that your products are intended for use as drugs include:

Elderberry Syrup with Honey
From the website: https://www.theelderberryfairyco.com/product/elderberry-syrup-with-honey/18

“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 Syrup with Agave
From the website: https://www.theelderberryfairyco.com/product/elderberry-syrup-with-agave/54 “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.”

Benefits of Elderberry
From Facebook https://www.facebook.com/TheElderberryFairyCo/ posted on October 12, 2021:

“Elderberry… allow you to better fight off infections, such as common viruses like the cold or flu.

“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 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.

“In fact, laboratory tests have shown that anthocyanins can inhibit neuraminidase, which is ‘a part of a virus that allows for budding, and thus replication, of a virus,’ says Thomas Holland, MD, a physician-scientist in the departments of internal medicine and clinical nutrition at Rush Medical College in Chicago.

“For example, 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.”

Elderberry 101
From the website: https://www.theelderberryfairyco.com/faqs

• “The flowers and berries of the Elder plant are most frequently used today. 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!”

• “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.”

• “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.”

• “Supplementing with elderberry has been shown to improve sinus infections”

• “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!”

Organic Fire Cider
From Facebook https://www.facebook.com/TheElderberryFairyCo/ posted on February 9, 2021:

“Health Benefits:…

• Cold & flu fighter
• Sinus decongestant
• Cough suppressant
• Alleviates headaches…”

Unapproved New Drugs

Your Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Drugs

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 West Jackson Boulevard, Suite 1500, Chicago, IL 60661. If you have any questions with regards to this letter, please contact Lauren Crivellone at (312) 596-4157 or email [email protected].

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
East Division 6