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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.