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Is Irie Star LLC Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 06, 2017

MODERATE SEVERITY Kansas City District Office 2017
Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Irie Star LLC on July 06, 2017 citing regulatory violations. The letter was issued by Kansas City District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

“Hemp [(an ingredient in your product)] … reduces redness and is recommended for the treatment of psoriasis and eczema.”

“Niacinamide [(an ingredient in your product)] is included at 4% which is a level proven in studies to be more effective than a 1% clindamycin antibacterial gel at preventing acne breakouts. It maintains ceramide levels …, synthesizes collagen, and evens coloration of the skin.”

Potential Health Risks

Consumers should be aware of potential risks associated with products from Irie Star LLC.

Regulatory Context

“Organic Tamanu [(an ingredient in your product)] oil has proven antibacterial, anti- inflammatory and skin rebuilding properties …”

“Cold-extracted Olive Leaf [(an ingredient in your product)] offers a fraction called Oleuropein known for its potent antibacterial and anti-inflammatory effects.”

“Omega 5 is a rare fatty acid that acts as an… anti-inflammatory,…”

Key Entities Identified

Irie Star LLC FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Irie Star LLC?
The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Irie Star LLC products safe to use?
Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used Irie Star LLC products?
If you have used products from Irie Star LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter
Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.