What did the FDA find wrong with Core Nutritionals?

The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.

Are Core Nutritionals 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 Core Nutritionals products?

If you have used products from Core Nutritionals and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Is Core Nutritionals Safe? FDA Warning Letter Review (2017)

Name: Is Core Nutritionals Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:22.498891

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

MODERATE SEVERITY 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 Core Nutritionals on October 03, 2017 citing labeling violations. The letter was issued by the FDA.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Core Nutritionals's operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Core Nutritionals.

Regulatory Context

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 447359, issued April 24, 2015. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Latasha A. RobinsonBranch ChiefDietary Supplements and LabelingAssessment BranchDivision of EnforcementOffice of ComplianceCenter for Food Safety and Applied Nutrition

Key Entities Identified

Core Nutritionals FDA Warning Letter

Frequently Asked Questions

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