We often get asked: “Is Fulvic Acid safe to use?” We’re extremely proud to report that, yes, CHD-FA™ (Fulvic Acid) is safe to use for humans and animals. We’ve spent over a decade and millions of rands on safety and toxicity studies completed to allopathic standards for CHD-FA™.
The safety work on CHD-FA™ can be split into two categories, namely Quality in production and In vitro (laboratory) and in vivo (systemic) safety studies.
Carbohydrate-Derived Fulvic Acid (CHD-FA™) is produced in a South African Health Products Regulatory Authority cGMP (License Nr 0000001280) and Manufacturing Pharmacy (License Nr Y54509), as well as FSSC 22000, approved facility. For any product to be considered safe for use in human consumption, batch to batch consistency in production is of paramount importance. In contrast to CHD-FA™, environmental Fulvic Acid varies from batch to batch as it is impossible to ensure consistency.
CHD-FA™ is a unique type of Fulvic Acid, in that it is a supramolecule – it has a fixed structure with a range of backbone structures that have been proven to be consistent from batch to batch using the following methods:
Fourier-transform infrared spectroscopy (FTIR)
Nuclear magnetic resonance spectra (NMR)
Liquid chromatography-tandem mass spectrometry (LC-MSMS)
To further ensure safety and consistency, each batch of CHD-FA™ manufactured has to pass production standards that have been set up and validated. The release parameters and test specifications of CHD-FA™ are as below (see Certificate of Analyses example):
pH
Specific Gravity
Electro Conductivity
Identification by FTIR
Anti-Microbial efficacy
Concentration
Total Organic & Inorganic Impurities
Volatile Organic Impurities
Nitrate & Nitrite
Elemental impurities – No heavy metals
No Microbial contaminants
The safety of CHD-FA™ has been proven at certified GLP laboratories locally and internationally over a period of many years. These studies include the following (this list is not comprehensive – if additional information is required please contact us):
Bacterial Mutation Assay (Ames test): CHD-FA™ was considered to be non-mutagenic.
Micronucleus: The test indicated no genotoxicity for either filtered and unfiltered CHD-FA™ in an in vitro micronucleus assay.
BCO2 Evolution Test – Assessment of Ready Biodegradability: This test proved that CHD-FA™ is readily biodegradable under the terms and conditions of OECD Guideline No 301B.
CHD-FA™ tested for pesticides and pyrogens: Tests indicated that CHD-FA™ contains no pesticides whilst that may be the case with environmental fulvic acids.
Peer-reviewed Safety and Proof of Concept of CHD-FA: This published article proves that CHD-FA™ is safe to systemically use at 40ml twice a day.
Peer-reviewed safety in immune-compromised patients: A clinical trial published proves that CHD-FA™ is safe for use even if immunity is compromised.
Skin Irritation test: Performed in Germany.
We will assist any interested party with advice on research done and formulations. The service provided by Fulvimed ranges from advice on efficacy, formulation, and packaging to stability.
