What did the FDA find wrong with Soothedrawal, Inc.?

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

Are Soothedrawal, Inc. 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 Soothedrawal, Inc. products?

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

Is Soothedrawal, Inc. Safe? FDA Warning Letter Review (2018)

Name: Is Soothedrawal, Inc. Safe? FDA Warning Letter Review (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.636319

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 Soothedrawal, Inc. 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

“Soothedrawal Natural Opiate Withdrawal Remedial Products work directly to alleviate and soothe the symptoms of opiate withdrawal. Our proprietary treatment formulas use natural ingredients that specifically target and relieve the discomforts of acute withdrawals, both in the short term and long term. We help you get through the physical symptoms of withdrawal and get on with your life.”

The video title“Soothedrawal is an all-natural remedies[sic]for opiate withdrawal symptoms product used to treat opiate addiction.”

“Soothedrawal help[sic]you get through the physical symptoms of withdrawal and get on with your life. Our line of opiate withdrawal treatments is designed to work together as a step-by-step process. It all begins by preventing (http://www.soothedrawal.com/products/) supplements for opiate withdrawal symptoms using the Daytime Formula in the morning and afternoon, and then taking the Nighttime Formula before going to bed.”

Potential Health Risks

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

Regulatory Context

This warning letter is part of the FDA's enforcement of federal regulations.

Key Entities Identified

Soothedrawal Inc. FDA Warning Letter

Frequently Asked Questions

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