CRITICALNutrition / SupplementsFDA Warning Letter · April 22, 2025

M.O.M. Enterprises, LLC

Atlas ID: 2025-04-fda-m-o-m-enterprises-llc-yvdbsb

FDA issued a warning letter to M.O.M. Enterprises, LLC (Mommy's Bliss) following a 2024 inspection of its Richmond, CA dietary supplement facility, citing serious cGMP violations, failure to submit required Serious Adverse Event Reports for infant injuries, misbranding of supplement labels, and unapproved new drug status for Gripe Water Original. The company's website blog posts made disease-treatment claims linking Gripe Water Original to relief of acid reflux, GERD, asthma, and colic, causing the product to be regulated as an unapproved new drug. FDA warned that failure to address these violations may result in seizure or injunction, and required a written response within 15 working days.

Flagged claims (4)

Fennel is known for its ability to reduce inflammation and acid in the stomach while ginger's phenolic compounds help relieve irritation and reduce gastric contractions.

Unsubstantiated efficacy · ingredient-disease-claim

Mommy's Bliss Gripe Water is a safe and gentle way to help ease your baby's stomach discomfort. The organic ginger and fennel relieve the irritation and prevent the stomach acid from flowing up into the esophagus.

Unsubstantiated efficacy · disease-treatment-claim

Gripe water can also be a great way to ease symptoms of acid reflux in infants. It is a natural approach to help reduce the stomach acid that causes pain.

Cure claim · disease-treatment-claim

The persistent crying of a colicky baby could be a symptom of reflux. The irritation of the stomach and the esophagus from all those digestive juices may trigger your baby into colic.

Cure claim · disease-context-linkage

Required actions (2)

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Response required · 15 days

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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