WARNING LETTER
The Elderberry Co., LLC
MARCS-CMS 608837 —
September 08, 2020
Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Jennifer C. Watson
Recipient Title
Owner
The Elderberry Co., LLC
302 Pearl Street, Suite B
New Albany
,
IN
47150
United States
Issuing Office:
Office of Human and Animal Food Operations East-VI
United States
WARNING LETTER
FY20-HAFE6-WL-05
September 8, 2020
Dear Ms. Watson:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.TheElderberryCo.com in July 2020 and has determined that you take orders there for the products “Elderberry Syrup” and “Elderberry Syrup Kit.” FDA also reviewed your social media website at www.facebook.com/theelderberryco, which directs consumers to your website www.TheElderberryCo.com to purchase your products. The claims on your websites 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 the website claims that provide evidence your products are intended for use as drugs include the following:
Elderberry Syrup
On your homepage:
• “Fights Colds, Flus and Allergies …”
• “[E]lderberry is packed with vitamins, antioxidants and flavonoids … that will help fight inflammation, congestion . . .”
On the page of your website titled “Our Syrup”:
• “Between the anti-inflammatory and anti-viral properties of the elderberries we use…”
On the page of your website titled “Frequently Asked Questions”:
• “Health benefits of the elder plant include naturally improving colds, the flu, sinus issues, nerve pain, inflammation, chronic fatigue, allergies and constipation”
On the Blog section of your website in a post from June 9, 2020 titled, “I’ve never tried Elderberry Syrup. What can I expect in my order?”:
• “Elderberries are anti-viral, anti-inflammatory, anti-bacterial ….”
Elderberry Syrup Kit
On the product page for your “Elderberry Syrup Kit” product:
• “… an easy and healthy way to fight colds, flu and allergies!”
Claims made on your Facebook page at www.facebook.com/theelderberryco, which provides links to your website at www.TheElderberryCo.com, provide additional evidence that your Elderberry Syrup and Elderberry Syrup Kit products are intended for use as drugs:
Claims by your company on your Facebook timeline page include the following:
• On May 18, 2020 in response to a user comment on your August 10, 2019 pinned post, your posting: “Health benefits of the elder plant include naturally improving colds, the flu, sinus issues, nerve pain, inflammation, chronic fatigue, allergies and constipation”
Your 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)]. 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.
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 products “Elderberry Syrup” and “Elderberry Syrup Kit” are intended for treatment of one or more diseases that are not amenable to self-diagnosis 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, “Elderberry Syrup” and “Elderberry Syrup Kit” 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)].
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen 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 lauren.crivellone@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger
Program Division Director
Office of Human and Animal Food Operations East-VI
Content current as of:
09/15/2020
Regulated Product(s)
Drugs
Food & Beverages