USA – Royal DSM, a leading provider of health and nutrition ingredients, just got its newly developed human milk oligosaccharide (HMO), 3-fucosyllactose (3-FL), approved as an ingredient in food applications in the USA and Australia.

This opens new opportunities for DSM in early-life nutrition and food innovation in the US and dietary supplement development in Australia.

In response to DSM’s notification, the United States Food and Drug Administration (FDA) issued a “no questions letter” to the company’s application.

In its response, it stated that 3-FL HMO marketed as GlyCare 3FL 9000 or 9001 is certified as GRAS (Generally Recognized as Safe) for use in early life nutrition applications and conventional foods.

The maximum permitted use level of 3-FL HMO is 0.75 g/L in non-exempt term infant formula and 0.90 g/L in formula and drinks for young children.

This is twice as high as the maximum permitted use level for other 3-FL ingredients in the same food categories in the US.

Australia approves 3-FL HMO

Meanwhile, in Australia, the Therapeutic Goods Administration (TGA) has included 3-FL in the latest update to its Therapeutic Goods (Permissible Ingredients) Determination.

This allows the use of 3-FL as a complementary medicine ingredient in listed medicines, such as dietary supplements.

The HMO has been recommended for oral use at a maximum daily dose of 2g for children aged 0-3 years and 5g for individuals of 4 years and older.

As the first HMO manufacturer to apply for the addition of 3-FL to listed medicines in the country, DSM has secured exclusivity for this use for a period of two years, with the company’s GlyCare HMO portfolio being available for use in more than 160 countries globally.

The approvals come at a time when the global dietary supplements market size which valued at US$151.9 billion as of 2021 is expected to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030.

Approvals to strengthen DSM position in supplements market

This approval of the novel ingredient is sure to strengthen DMS’s position in the dietary supplements market.

It follows the successful authorization of its first manufactured HMOs, 2’-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) in several markets worldwide.

The company also launched difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose sodium salt (3′-SL) and 6’-sialyllactose sodium salt (6′-SL) HMOs.

All 6 HMO products are authorized in markets such as Europe Union, the U.K, the U.S., Russia, Israel, and Singapore, making 3-FL the 7th DSM HMO ingredient to gain international market authorization.

“HMOs are a powerful emerging ingredient capturing increasing attention across the health and nutrition space – especially in the infant nutrition market,” says Christoph Röhrig, Head of HMO Regulatory at DSM.

According to a global infant formula market report published in January 2023, the infant formula market is projected to grow at a CAGR of 4.04% to reach a market size of US$62.066 billion by 2027, from US$47.027 billion in 2020.

This puts DMS in a position to grow as one of the leading end-to-end partners in the early-life nutrition sector.

Marta Mikš, Senior Regulatory & Scientific Affairs Manager at DSM added, “As a leader in HMO research, development and manufacture, DSM is continuously looking at how it can pioneer advancements in the space and expand its HMO offering.

“The approval of 3-FL in these two important markets is another positive step towards delivering the benefits of HMOs to the global population.”

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