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Notice: Official Public Record

Bedessee Imports, Inc FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 01, 2017

CRITICAL SEVERITY New York 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 Bedessee Imports, Inc on December 01, 2017 citing labeling violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by New York District Office.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

“Other top nutrition values in coconut water [an ingredient in your Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen]:Lower your risk of heart attacks & high blood pressureHelp with preventing cancerContains trans-zeatin which has been used to treat Alzheimer’s disease or dementia”

Help with preventing cancer

Contains trans-zeatin which has been used to treat Alzheimer’s disease or dementia”

Potential Health Risks

Lower your risk of heart attacks & high blood pressure

Regulatory Context

Ready-to-eat Sardines in Tomato Sauce and Tomato Sauce with Chili imported by your firm andmanufactured by(b)(4)located in(b)(4).

Ready-to-eat Mackerel in Water, Tomato Sauce, Hot Tomato Sauce and Soya Oil imported by your firm and manufactured by(b)(4)located in(b)(4).

The Marshall’s Sardines in Tomato Sauce product label fails to declare the serving size in a household measure in accordance with 21 CFR 101.9(b).

Key Entities Identified

21 CFR 101.9 21 CFR 101.9 21 CFR 101.9

Frequently Asked Questions

What did the FDA find wrong with Bedessee Imports, Inc?
The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
Are Bedessee Imports, Inc products safe to use?
Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
What should I do if I've used Bedessee Imports, Inc products?
If you have used products from Bedessee Imports, Inc 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.