hy, Patent Probiotics Approved as New Dietary Ingredient by US FDA

[Asia Economy Reporter Seungjin Lee] hy announced on the 16th that its patented probiotics ‘HY7601’ and ‘HY7714’ have been approved as ‘New Dietary Ingredients (NDI)’ by the U.S. Food and Drug Administration (FDA).

The newly certified HY7601, along with ‘KY1032,’ is the ingredient of ‘KillFat,’ an individual recognition-type material approved by the Ministry of Food and Drug Safety. KillFat is a functional probiotic that can help reduce body fat. HY7714 is a skin probiotic derived from breast milk. It can help maintain skin health by moisturizing the skin and protecting it from damage caused by ultraviolet rays. Both are the world’s first probiotics certified for body fat reduction and skin health functionality.

In November, hy also obtained FDA ‘self-affirmed GRAS’ status for the two probiotics, KillFat for body fat reduction and HY7714 for skin health. This has enabled overseas sales of all B2B (business-to-business) key strains owned by hy.

The proven safety of the ingredients has driven sales. In 2021, the cumulative sales volume of KillFat and the skin health probiotic HY7714 were 5.2 tons and 2.2 tons, respectively. In May, hy launched the B2B exclusive brand ‘hyLabs’ and is supplying five types of probiotics to more than 10 companies including Chong Kun Dang Health and Nutri.

Lee Jung-yeol, head of hy’s central research institute, said, “FDA NDI registration is the highest safety standard that manufacturers or distributors can achieve,” adding, “Through this certification, we provide confidence in material selection to consumers and manufacturers and have established a foothold for overseas expansion.”

Meanwhile, NDI is a system that recognizes new dietary ingredients after proving ingredient safety to the FDA. It can only be obtained by passing all FDA review procedures, from ingredient composition and manufacturing process to human safety.

This content was produced with the assistance of AI translation services.