What did the FDA find wrong with CalmSupport.com, LLC?

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

Are CalmSupport.com, 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 CalmSupport.com, LLC products?

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

CalmSupport.com, LLC FDA Warning (2018)

Name: CalmSupport.com, LLC FDA Warning (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.472998

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 11, 2018

MODERATE SEVERITY Center for Food Safety and Applied Nutrition 2018

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 CalmSupport.com, LLC on January 11, 2018 citing regulatory violations. The letter was issued by Center for Food Safety and Applied Nutrition.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in CalmSupport.com, LLC's operations or product claims.

Potential Health Risks

DEPARTMENT OF HEALTHAND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONSILVER SPRING, MD 20993

Regulatory Context

“ … [W]e at CalmSupport.com are here to help you the natural way. CalmSupport was formulated with the highest quality of organic ingredients, active vitamins, and made specifically to help sooth withdrawal symptoms from opiates.” [Aug 12, Page 149]

Key Entities Identified

Lead

Frequently Asked Questions

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