The U.S. Food and Drug Administration (FDA) has issued a warning letter to M.O.M. Enterprises, a Richmond, California-based company, for allegedly failing to report serious adverse events tied to its infant supplement, Gripe Water, marketed under the Mommy’s Bliss brand. This action underscores the FDA’s commitment to enforcing federal regulations that require dietary supplement manufacturers to report serious adverse events, a rule in place since 2007 to safeguard consumer health.

Company Background and Product Details

M.O.M. Enterprises specializes in supplements for infants and mothers, with Gripe Water being a flagship product designed to relieve gas, bloating, and colic in infants. Available in “daytime” (featuring fennel seed and ginger) and “nighttime” (including chamomile, passionflower, and lemon balm) formulations, the product is administered orally via a dropper. Despite its popularity, the FDA alleges that the company did not comply with mandatory adverse event reporting requirements.

FDA’s Allegations: Unreported Serious Adverse Events

Federal law mandates that dietary supplement manufacturers collect, assess, and report serious adverse events—defined as incidents leading to death, life-threatening conditions, hospitalization, or other severe outcomes—to the FDA. The warning letter to M.O.M. Enterprises details multiple instances where such events allegedly went unreported, including:

• Hospitalization Case: An infant was hospitalized for several days with an E. coli infection. Although the hospital couldn’t pinpoint the source, the parents linked the illness to Gripe Water use.

• Breathing Incident: An infant reportedly choked and stopped breathing after receiving Gripe Water, requiring CPR. Breathing resumed before emergency services arrived, and no hospitalization was noted.

• Additional Reports: Several cases involved infants vomiting or choking post-ingestion, with one child evaluated in an emergency room.

While the exact number of unreported events was redacted, the FDA provided descriptions of six specific incidents, highlighting the severity of the oversight. Beyond reporting failures, the agency also criticized the company’s recall procedures and its use of impermissible disease treatment claims for Gripe Water, which violate dietary supplement marketing rules.

Company’s Response

Yasmin Kaderali, CEO of Mommy’s Bliss, expressed regret over the FDA’s warning letter but reaffirmed the company’s focus on consumer safety. In a statement, she clarified that no current products require market action and noted that the company has enhanced its serious adverse event reporting processes following the FDA’s 2024 observations. A retrospective review of complaints was completed, with relevant reports submitted to the agency. However, the FDA deemed prior corrective efforts inadequate, citing insufficient training for staff handling adverse event evaluations.

Expert Perspective

Rick Kingston, PharmD, a professor at the University of Minnesota’s College of Pharmacy and president of scientific and regulatory affairs at SafetyCall International, emphasized the necessity of robust adverse event reporting systems. “Manufacturers must document and analyze adverse events with policies that support effective signal detection,” Kingston stated. He stressed that trained medical professionals should apply “reasonable medical judgment” to assess report severity, noting that reporters aren’t required to have medical expertise—placing the onus on companies to investigate thoroughly.

Why It Matters

The FDA’s action against M.O.M. Enterprises reflects broader industry challenges. Non-compliance with adverse event reporting can jeopardize consumer safety, particularly for vulnerable groups like infants, and erode trust. Historical cases, such as the 2018 FDA warning to a homeopathic teething product manufacturer over unreported seizures, illustrate the potential consequences of lax surveillance.

Takeaways for Industry Professionals

• Regulatory Compliance: Establish and maintain comprehensive adverse event reporting systems to meet federal standards.

• Staff Training: Ensure personnel are well-trained to evaluate reports, with medical expertise available as needed.

• Proactive Monitoring: Robust post-market surveillance can detect safety signals early, mitigating risks.

This case serves as a critical reminder: adhering to adverse event reporting isn’t just a legal obligation—it’s a cornerstone of consumer safety and industry integrity.