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WARNING LETTER
CMS# 611376

January 14, 2021

Dear Ms. May

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at https://www.sagemoonapothecary.net/ and https://www.etsy.com/shop/SageMoonApothecary as well as your social media site https://www.facebook.com/sagemoonapothecarymaine in September, October, and November 2020 and has determined that you take orders there for the products “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk Electuary,” and “Beyond Elderberry Syrup.” The claims on these websites establish that these 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 Food, Drug, and Cosmetic Act (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 claims observed on the above websites that provide evidence that your products are intended for use as drugs include:

• The product description pages on the webpage https://www.etsy.com/listing/852702286/golden-milk-electuary-mushroom-cocoa?ref=shop_home_active_4 for the product “Golden Milk Electuary - Mushroom Cocoa Blend” where your product is sold states:

o “Here’s what some of our customers are saying about Golden Milk Electuary: I am never without my Golden Milk Electuary from Sage Moon Apothecary. I used to take numerous prescriptive pain medications and anti inflammatories for my arthritis, but don't have to anymore. One or two cups of Golden Milk a day does what the medications did, and I have the comfort that it's all natural and I am not going to have strange side effects or other things arise from medications…”

o "Golden Milk Electuary . . . works so well at relieving my joint pain and it doesn't even feel like I'm taking medicine…”

• Your December 28, 2019 post on https://www.facebook.com/sagemoonapothecarymaine/ which states “Elderberry Compounds Directly Inhibit Flu Virus Entry and Replication in Human Cells…”

• Your January 22, 2019 post on https://www.facebook.com/sagemoonapothecarymaine/ about your Golden Milk Electuary product states: “Many of our customers have shared that they no longer need to take prescriptive or OTC pain relievers or anti-inflammatory medications with its regular use. . . .”

• Your November 9, 2018 post on https://www.facebook.com/sagemoonapothecarymaine/ regarding your Golden Milk Electuary product states that it “ . . . is an excellent anti-inflammatory, pain reliever . . . . This is a product that many people across the country have been using with great success for conditions such as arthritis, fibromyalgia, IBS, migraines . . . .”

Your “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk Electuary,” and “Beyond Elderberry Syrup” 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 “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk Electuary,” and “Beyond Elderberry Syrup” 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, your “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk Electuary,” and “Beyond Elderberry Syrup” 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 statement 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 and 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 injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.

Your written reply should be sent to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or E-mail at [email protected].

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1