Sage Moon Apothecary LLC

Warning LetterClosed

Ms. Jennifer May Owner Sage Moon Apothecary LLC 40 Main Street Seal Harbor , ME 04675 United StatesIssued Jan 14, 2021Division of Human and Animal Food Operations East I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJan 14, 2021

Product TypeDrugs

StatusClosed

Closeout LetterMay 24, 2021

Letter Details

Firm: Sage Moon Apothecary LLC
Location: Ms. Jennifer May Owner Sage Moon Apothecary LLC 40 Main Street Seal Harbor , ME 04675 United States
FEI Number: N/A
Country: United States
Issue Date: January 14, 2021
Issuing Office: Division of Human and Animal Food Operations East I
Product Type: Drugs
Status: Closed
Closeout Letter: May 24, 2021

Summary

Sage Moon Apothecary LLC was cited for selling unapproved drugs through their websites and social media, including "Golden Milk Electuary," "Golden Milk Electuary-Mushroom Cocoa Blend," and "Beyond Elderberry Syrup," which violated the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were drugs based on claims made on their Etsy, website, and Facebook pages indicating the products could treat, mitigate, or prevent disease—specifically that the Golden Milk product relieved joint pain and arthritis symptoms and could replace prescription pain medications and anti-inflammatories. The company failed to obtain FDA approval for these new drugs before introducing them into interstate commerce, a requirement under federal law.

Sage Moon Apothecary LLC FDA Warning Letter, January 14, 2021