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Is The Cookie Boys Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 03, 2017

MODERATE SEVERITY San Francisco 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 The Cookie Boys on March 03, 2017 citing regulatory violations. The letter was issued by San Francisco District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in The Cookie Boys's operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from The Cookie Boys.

Regulatory Context

Flavors must be declared in accordance with 21 CFR 101.22(h). The combined declaration “natural and artificial flavors (including barley protein)” is not permitted. In addition, we question the purpose of the parenthetical declaration.

Key Entities Identified

21 CFR 101.22

Frequently Asked Questions

What did the FDA find wrong with The Cookie Boys?
The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are The Cookie Boys 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 The Cookie Boys products?
If you have used products from The Cookie Boys 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.