FDA WARNING_LETTER - M.O.M. Enterprises, LLC - September 27, 2024

On April 22, 2025, the FDA issued a Warning Letter to M.O.M. Enterprises, LLC, following an inspection from August 19 to September 27, 2024, at their Richmond, California facility. The inspection, product label review, and website review (www.mommysbliss.com) revealed significant violations of the Federal Food, Drug, and Cosmetic Act and FDA regulations, rendering their dietary supplement products (Gripe Water Original, Gripe Water Night Time, Kids Cough Syrup & Mucus + Immunity Support, and Kids Cough Syrup & Mucus Night Time) adulterated and misbranded.

Key violations include: 1. **Adulterated Dietary Supplements (21 CFR 111):** * Failure to extend product complaint investigations to all relevant batches and records (21 CFR 111.560(c)). This was evident after a market withdrawal due to early spoilage, where subsequent complaints of bulging bottles and popped lids were not adequately investigated across all affected lots, including one not part of the withdrawal. * Failure to follow written procedures for reviewing and investigating all product complaints (21 CFR 111.553). Numerous complaints for Gripe Water products, including serious adverse events, were not investigated between December 2019 and August 2024. * Failure to comply with records