The U.S. FDA has “no questions at this time” regarding Kemin’s submission for Generally Recognized As Safe (GRAS) status for ZeaONE Zeaxanthin from marigolds (Tagetes erecta, L.), confirming its safety for use in a wide range of functional food and beverages.

ZeaONE is distributed and marketed as OPTISHARP Natural through a strategic partnership with DSM Nutritional Products (DSM). ZeaONE is the first dietary (3R, 3’R) zeaxanthin from marigold flowers to receive FDA GRAS Notification and the first brand to specifically evaluate the safety of zeaxanthin in pregnant women taking a pre-natal, the company claimed.

“With increasing regulatory scrutiny, this FDA GRAS Notification assures our customers the safety and quality of our zeaxanthin brand,” said Anita Norian, president of the Human Nutrition and Health Division of Kemin. “Much like we’ve done in the lutein marketplace with FloraGLO, we’re proud to help set the standard of safety in the dietary zeaxanthin market with ZeaONE.”

Findings from the National Eye Institute’s prestigious second Age-Related Eye Disease Study (AREDS2) have highlighted the importance of supplementing with both lutein and zeaxanthin for eye health benefits. This research, along with other key studies, has shifted eye health standard of care to suggest individuals consume 10 mg lutein and 2 mg zeaxanthin each day. Since this recommendation, supplement manufacturers across the industry have begun to reformulate eye health supplements to include 10 mg of lutein and 2 mg zeaxanthin.

Beyond reformulations across the industry, consumers’ concern for their eye health has the potential to drive the zeaxanthin market forward. More than 57% of American shoppers age 40+ cite eye health as their most prominent health concern and 34% of are “extremely interested” in purchasing supplements to help support eye health, according to HealthFocus International.

“Another growing eye health concern is increasing levels of harmful blue light exposure from the proliferation of digital devices and LED lighting,” said Stacy Dill, worldwide marketing director for the Human Nutrition and Health Division of Kemin. “ZeaONE can help combat this health concern, as it is the only zeaxanthin brand supported by a patent showing how zeaxanthin filters blue light to help protect our eyes. Kemin’s blue light protection patent shows our continued commitment to innovation in the eye health industry.”

ZeaONE is naturally-sourced from marigolds, delivered through a carefully controlled supply chain, manufactured in a GMP certified facility and now FDA GRAS Notified. ZeaONE is available from DSM as OPTISHARP Natural in 5% beadlet and 14% oil suspension forms.