Failure to Report Serious Adverse Events
Investigating customer complaints is a cornerstone of supplement safety and compliance
Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young children was cited for not properly investigating customer complaints, quality issues related to a product market withdrawal, and reporting SAERs to the FDA.
This is a shocking and dangerous lesson in how a supplement company that was not following GMP regulations and properly investigating safety concerns has led to potentially serious health risks for its consumers, including babies.
Here is an example of one of the complaints that were not reported within 15 days to FDA.
From warning letter. “You received a complaint (#(b)(4)) in which the complainant described their six-week-old infant choked on Gripe Water Original. Per your complaint record, the complainant explained their infant “(b)(4).” Your complaint record further explains the complainant attempted cardiopulmonary resuscitation (CPR) multiple times until the infant began breathing again. The complainant also reported that paramedics were called and looked over their infant.”
Side note: Babies are considered a “vulnerable population,” which means the FDA pays special attention to the safety and compliance of products marketed to them, and for good reason. The violations in this warning letter are noncompliant for people of any age, but are dangerous for babies who don’t have fully formed immune systems.
Also, I ran Apex Compliance® on their website and found some crazy disease claims!
This warning letter includes some interesting labeling items that likely would not have been mentioned if there had not been other serious violations.
From warning letter. “The product’s inner bottle labels do not bear nutrition information, as required by 21 CFR 101.36. The unit container is exempted from these requirements if the unit container bears the statement “This Unit Not Labeled for Retail Sale.”
From warning letter. The dosage guide and/or directions for use are placed above the Supplement Facts label, which is not in accordance with 21 CFR 101.2(a) and (e). Nutrition information should appear on the principal display panel (PDP) or directly to the right of the PDP with no intervening material in between.
This warning letter reads like a scary book that has all the plots, including disease claims, improper 483 responses, and the FDA giving lots of opportunities for improvement. I suggest everyone read it.
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