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Is GnuPharma Corp. Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on December 13, 2017

MODERATE SEVERITY Dallas 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 GnuPharma Corp. on December 13, 2017 citing regulatory violations. The letter was issued by Dallas District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

Website https://gnupharma.com: “you may have an autoimmune disease….the root cause is a disruption in your Endocannabinoid System… [ECS]…the ECS can be influenced by a variety of herbs…we developed our Foundation product line to serve as daily nourishment for a healthy ECS….” and, “our products are designed to provide overall natural allergy relief…containing herbal decongestants and antihistamines…our team would love to get you on the path to optimal health and wellness with our Foundation and Allergy products”

“The GnuPharma model is based on our knowledge and research of the ECS (Endocannabinoid System) It is the daily need for plant based flavonoids that when depleted our bodies potentially bread down along our “weakest” genetic links resulting in inflammation – which in turn can lead to disease and pain….GnuPharma Fit provides the raw resources needed to bolster a health ECS.”

Website www.gnuwellness.com:  “The GnuPharma model is based on our knowledge and research of the ECS (Endocannabinoid System) It is the daily need for plant based flavonoids that when depleted our bodies potentially break down along our “weakest” genetic links resulting in inflammation – which in turn can lead to disease and pain….GnuPharma Foundation provides the raw resources needed to bolster a health ECS.”

Potential Health Risks

Website www.gnupharma.com: “natural way to provide relief from occasional itchy nose, watery, eyes, and occasional sneezing”

Website www.gnuwellness.com: “if your appetite is significantly increased….it could be a symptom of a serious illness, such as diabetes or hyperthyroidism. Mental health conditions, such as depression….can also lead to appetite changes….”

Website www.gnuwellness.com: “How does HNR™ work?  We support a healthy Endocannabinoid System (ECS). The ECS is directly and indirectly responsible for many functions and processes within the body. In particular, the ECS is the lead system and plays a strong role in both feeding and craving behaviors. Feeding craving behaviors are not only how we eat but at a more basic level, they are how our bodies as for resources. People who have addictions are experiencing their bodies craving a substance at a very basic and neurological level. And whether the addiction is food, drugs or other substances, the ECS manages those cravings.  Similar to when we are hungry, a resource need is signaled within the brain and we experience hunger pangs. This is your body asking for resources… We are providing

Regulatory Context

Identity specifications, as required by 21 CFR 111.70(b)(1);

Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and

Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).

Key Entities Identified

21 CFR 111.70 21 CFR 111.70 21 CFR 111.70 Lead

Frequently Asked Questions

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