The self-affirmed GRAS (generally recognized as safe) status significantly expands the scope of the antioxidant ingredient, which has so far been limited to the dietary supplement market.
Derived from citrus peel, Sytrinol is a patented formula combining citrus polymethoxylated flavones (PMFs), alpha, delta and gamma tocotrienols and other constituents which have been shown to lower total cholesterol, LDL cholesterol and triglyceride levels.
The ingredient, which comes in powder form, needs to be used at levels of 300mg per day for its heart health benefits to be achieved.
According to PNI president Dean Mosca, Sytrinol is “quite versatile” and can be used in a range of food and beverage products without affecting their texture. However, it is particularly suited for products such as yogurts, bars and smoothies.
The ingredient’s slight bitter taste can be easily masked, Mosca told NutraIngredients-USA.com.
PNI claims the ingredient has a “moderate price”. The company said it is already working with several clients in the food and beverage arena to incorporate Sytrinol into their products.
The GRAS evaluation was undertaken by an independent panel of experts assembled by Aibmr Life Sciences.
The self-affirmed status means that the dossier has not yet been submitted to the US Food and Drug Administration (FDA) for non-objection, which tends to provide the final green light for companies skeptical of using new ingredients.
However, Mosca said “applying for GRAS non-objection from the FDA will be the natural next step in the ingredient’s evolution”. He did not specify when PNI intended to submit the dossier to the regulator.
PNI only this year took on the distribution of Sytrinol, which was developed by KGK Synergize. Although KGK still holds the production patents, PNI’s parent company – Pharmachem Laboratories – is expected to assume manufacturing of the ingredient.
Sytrinol was originally distributed by SourceOne, but KGK announced in October last year that it would be taking back the global distribution rights as of January 1 2009, when the initial distribution agreement came to an end.
Last month, SourceOne filed a lawsuit against KGK, alleging that the company engaged in unfair competition by threatening SourceOne with infringement lawsuits.
A study conducted by KGK Synergise and the USDA and published in the Journal of Agricultural and Food Chemistry in May 2004 claimed to be the first to show that polymethoxylated flavones – or PMEs – can lower cholesterol.
PMFs were seen to have the most potent cholesterol-lowering effect of any other citrus flavonoid.
According to Dr Elzbieta Kurowska, lead investigator of the study and vice president of research at Canada-based KGK Synergize, "we believe that PMFs have the potential to rival and even beat the cholesterol-lowering effect of some prescription drugs, without the risk of side effect".
The risk for a fatal heart attack is thought to be about five times higher in people with a cholesterol level of 300 mg/dL or more than in those with a cholesterol level below 200 mg/dL.
Sytrinol is said to be able to reduce total cholesterol by 30 percent, to reduce LDL cholesterol by 27 percent, as well as to lower triglycerides by 34 percent.