The action comes in response to a Color Additive Petition (CAP) filed by LycoRed Natural Products Industries, and completes a good month for the firm.
The ruling, effective August 26, will add LycoMato to the FDA's listing of Color Additives Exempt from Certification. It comes after the FDA earlier acknowledged that LycoMato Powder fulfills the administration's GRAS (Generally Recognized as Safe) requirements for functional foods.
The color additive green-light from the FDA has been welcomed by LycoRed, which believes that demand for the natural color can only increase given current concerns over additives and artificial colorings.
"We are very pleased that FDA was completely satisfied with the report of the panel of independent experts who determined that LycOMato is safe for use in a wide variety of foods," said Dr. Zohar Nir, LycoRed vice president of marketing.
"Consumers are more concerned about key issues like wellness and prevention when they select products off the store shelf."
LycOMato Powder, which can also be used as a natural red colorant in a variety of foods such as soy meat substitute products, pasta, cereals and smoothie drinks, contains beneficial tomato phytonutrients including lycopene, beta-carotene, and tocopherols.
The synergistic action of these antioxidant phytonutrients transforms an ordinary food into a functional food with numerous health benefits, including the support of cardiovascular and prostate health and prevention of DNA damage.
The company claims that numerous epidemiological studies on the benefits of a diet containing tomato products support the benefits of LycoMato.
"LycoRed has had great success in the US dietary supplement industry with LycoMato oleoresin," said Dr Nir.
"We fully anticipate that the LycoMato powder will be equally successful in the food industry."
In order to amend its color additive regulations, the FDA evaluated two LycoMato concentrations. One contained not less than 5.5 percent lycopene (referred to as tomato lycopene extract); and the other contained not less than 60 percent lycopene (referred to as tomato lycopene concentrate).
LycoRed's patented manufacturing processes and related studies also formed part of the evaluation process.
The US makes up around 50 percent of LycoRed's business, with Europe accounting for 25 percent and Japan and the rest of the world the remainder. Dr Nir said that it has been much easier to launch the ingredient in the US, since the market is more organized.