Graceleigh, Inc. dba Sammy’s Milk

Warning LetterOpen

Erin Hendricks President Graceleigh, Inc. dba Sammy’s Milk 3471 Via Lido, Ste 207 Newport Beach , CA 92663 United StatesFEI 3011837162Issued Aug 14, 2024Division of Human and Animal Food Operations West V

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011837162.

Violations1

Issue DateAug 14, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Graceleigh, Inc. dba Sammy’s Milk
Location: Erin Hendricks President Graceleigh, Inc. dba Sammy’s Milk 3471 Via Lido, Ste 207 Newport Beach , CA 92663 United States
FEI Number: 3011837162
Country: United States
Issue Date: August 14, 2024
Issuing Office: Division of Human and Animal Food Operations West V
Product Type: Food & Beverages
Status: Open

Summary

Graceleigh, Inc. dba Sammy's Milk was cited for misbranding its goat milk product as an infant formula without proper FDA notification and approval. The company's website and social media marketing materials represented Sammy's Milk as suitable for infants by claiming it simulates human milk, supports healthy infant growth and development, and meets FDA nutritional and manufacturing requirements for infant formula—representations that classify the product as a notified infant formula under federal law. The FDA conducted an inspection of the contract manufacturer's facility and reviewed the company's online marketing claims, finding that the product was being marketed and sold as an infant formula without the required FDA notification and compliance with infant formula regulations.

Graceleigh, Inc. dba Sammy’s Milk FDA Warning Letter, August 14, 2024