The approval allows the new line of products to be distributed in the US into big box retail chain stores as well as facilitate entry into more regulated markets such as Mexico and other foreign jurisdictions.
The company expects the latest FDA approval, which follows the company’s successful meetings with two of the largest distributors in US, will accelerate the pace of current overseas sales.
Axxess Pharma president Dr Daniel Bagi said: "We are very excited to receive FDA approval to sell our latest line of all-natural TapouT supplements and protein powders within the US.
"Our all-natural products will be sold under the globally recognized name TapouT, and will have the words ‘FDA Approved’ on every label. Our unique high potency Omega-3 fish oil supplements is anticipated to be one of our top sellers both in the US and internationally."
In the US, over 100 million people are at risk for cardiovascular disease, hypertension, stroke, diabetes, obesity, elevated triglycerides, mood disorders, osteoarthritis and premature aging.