According to the annual “In-Depth Analysis Report on FFCs Notified in FY2024″authored by Hisaaki Kato, CEO at Japan-based consultancy Smooth Link Inc., this record builds on the momentum from last year, when 34 such products were notified, and continues to grow.
The FFC framework was introduced in Japan in April 2015, and in 2020, the CAA allowed functional food ingredients to make immune health claims. FFCs can claim to “maintain immune function” if the ingredient(s) have obtained prior approval from the Consumer Affairs Agency (CAA), the body that oversees Japan’s FFCs.
The first ingredient approved to do so was Kirin Holding’s Lactococcus lactis strain Plasma, also known as LC-Plasma. In addition to being marketed as an ingredient in the B2B space, it is also formulated into Kirin’s in-house products as branded ingredient iMUSE and in recent product launches by Australian supplement company Blackmores—a Kirin subsidiary since 2023.
Why a surge in interest?
One reason for the record number of notifications is the growing number of ingredients approved to make immune health claims.
The latest addition is Euglena gracilis EOD-1-derived paramylon as β-1,3-glucan. It is approved to make the claim “supports the function of immune cells (monocytes, naive T cells) and helps maintain immune function in healthy middle-aged and older adults.”
A search on the FFCs database Plusaid showed that a product containing this ingredient by Japanese firm MICAREA was notified with the CAA on Sept. 3. It is slated for market launch on Dec. 9, 2025.
Other companies supplying immune health ingredients include Asahi Group, Morinaga Milk and Kewpie.
“Initially, it was thought impossible to claim immune effects for foods, but Kirin successfully launched Plasma Lactic Acid Bacteria in 2020,” the report stated.
“Despite the industry not anticipating the emergence of similar substances, Asahi obtained an immune-related claim for L. acidophilus L-92 in 2022. This strain had already been applied as a functional ingredient for allergy care. In 2023, QP launched G. hansenii GK-1. Furthermore, in February 2025, paramylon derived from Euglena was notified as a functional food aimed at ‘maintaining immune function’. Additionally, Morinaga Milk Industry applied for and obtained approval for lactoferrin as its fifth immune care ingredient."
According to data on Plusaid, 14 immune health FFCs were notified with the CAA between April and Dec. 9, 2025, including products by Kirin Holdings, Morinaga Milk and AXXZIA.
Record high FFCs notified
In total, 1,584 FFCs were notified with the CAA between April 2024 and March 2025, surpassing last year’s 1,433 notifications.
This is despite the red yeast rice scandal that saw hundreds hospitalized and thousands of consumer complaints lodged in Japan last March. As of Nov. 30 this year, the company behind the incident, Kobayashi Pharmaceutical, is in the process of compensating 500 people, of which, 290 were still undergoing treatment or negotiating compensation details.
“Although sales of functional and health foods overall were expected to decline significantly due to the health-related issue involving Kobayashi Pharmaceutical’s red yeast rice supplement in March 2024, there was no significant consumer backlash,” the report noted.
This increase was mainly due to companies trying to complete their notifications before the new requirement of adhering to PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020) began in April this year, according to the report.
“A significant contributing factor to the increase was the surge in last-minute notifications before the end of March,” Kato wrote. He highlighted that past-year records usually showed around FFCs notified in March but surged to 345 in 2025.
“That was because the research reviews (SR) used for functional evidence were transitioning from the PRISMA 2009 guideline to the PRISMA 2020 guideline starting April 2025, and the PRISMA 2009 guideline remained usable until the end of March 2025.”
In their notifications to the CAA, FFC manufacturers must demonstrate the efficacy of their products by submitting data from clinical trials or systematic reviews.
Companies submitting data from systematic reviews have been following guidelines from PRISMA 2009 but starting this April were required to adhere to the PRISMA 2020 guidelines from, following a string of high-profile FFCs advertising scandals.
