FDA WARNING_LETTER - Graceleigh, Inc. dba Sammy's Milk - August 14, 2024

The FDA issued a Warning Letter to Sammy's Milk following an inspection of their contract manufacturer and a review of the company's website and social media. The FDA determined that Sammy's Milk is an infant formula under section 201(z) of the Act, based on various representations, despite being marketed as a "Toddler Formula." The company failed to make the required 90-day submission for a new infant formula under section 412(c)(1)(B) and 412(d)(1) of the Act, which constitutes a prohibited act under section 301(s). Furthermore, the product was misbranded under section 403(a) because its website falsely claimed Cronobacter testing was performed, a claim contradicted by the manufacturer. Although Sammy's Milk initiated a voluntary recall and made some website changes, the FDA remains concerned about images of young infants and firm responses on social media promoting infant use. The company must respond within 15 working days with specific corrective actions and documentation to prevent recurrence, or face potential legal action, including seizure and injunction.