Is Amafruits Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 21, 2017
Executive Summary
The FDA issued a warning letter to Amafruits on July 21, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Chicago District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Anthocyanins … protecting against some chronic diseases, including cancer, cardio- and cerebro-vascular, atherosclerosis and diabetes … potential radiation-protective, chemo-protective, vaso-protective and anti-inflammatory effects.”
“[L]inked with lower heart disease … and lower risk of some cancers”
“Acerola is also used for preventing heart disease, ‘hardening of the arteries’ (atherosclerosis), blood clots, and cancer.”
Potential Health Risks
On April 13, 2017: “#goiaba … protect the colon by reducing the risk of cancer-causing toxins”
“Benefits of Açaí Berry … reduce risk factors for cancer”
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Amafruits?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Amafruits 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 Amafruits products?
- If you have used products from Amafruits 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