In response to the annual “In-Depth Evaluation Report on FFCs Notified in FY2024″authored by Hisaaki Kato, CEO at Japan-based consultancy Clean Hyperlink Inc., this document builds on the momentum from final 12 months, when 34 such merchandise have been notified, and continues to develop.
The FFC framework was launched in Japan in April 2015, and in 2020, the CAA allowed useful meals components to make immune well being claims. FFCs can declare to “preserve immune operate” if the ingredient(s) have obtained prior approval from the Shopper Affairs Company (CAA), the physique that oversees Japan’s FFCs.
The first ingredient approved to do so was Kirin Holding’s Lactococcus lactis strain Plasma, also referred to as LC-Plasma. Along with being marketed as an ingredient within the B2B area, it is usually formulated into Kirin’s in-house merchandise as branded ingredient iMUSE and in recent product launches by Australian supplement company Blackmores—a Kirin subsidiary since 2023.
Why a surge in curiosity?
One cause for the document variety of notifications is the rising variety of components permitted to make immune well being claims.
The newest addition is Euglena gracilis EOD-1-derived paramylon as β-1,3-glucan. It’s permitted to make the declare “helps the operate of immune cells (monocytes, naive T cells) and helps preserve immune operate in wholesome middle-aged and older adults.”
A search on the FFCs database Plusaid confirmed {that a} product containing this ingredient by Japanese agency MICAREA was notified with the CAA on Sept. 3. It’s slated for market launch on Dec. 9, 2025.
Different firms supplying immune well being components embrace Asahi Group, Morinaga Milk and Kewpie.
“Initially, it was thought unattainable to say immune results for meals, however Kirin efficiently launched Plasma Lactic Acid Micro organism in 2020,” the report said.
“Regardless of the business not anticipating the emergence of comparable substances, Asahi obtained an immune-related declare for L. acidophilus L-92 in 2022. This pressure had already been utilized as a useful ingredient for allergy care. In 2023, QP launched G. hansenii GK-1. Moreover, in February 2025, paramylon derived from Euglena was notified as a useful meals geared toward ‘sustaining immune operate’. Moreover, Morinaga Milk Trade utilized for and obtained approval for lactoferrin as its fifth immune care ingredient.”
In response to information on Plusaid, 14 immune well being FFCs have been notified with the CAA between April and Dec. 9, 2025, together with merchandise by Kirin Holdings, Morinaga Milk and AXXZIA.
File excessive FFCs notified
In whole, 1,584 FFCs have been notified with the CAA between April 2024 and March 2025, surpassing final 12 months’s 1,433 notifications.
That is regardless of the red yeast rice scandal that noticed lots of hospitalized and hundreds of shopper complaints lodged in Japan final March. As of Nov. 30 this 12 months, the corporate behind the incident, Kobayashi Pharmaceutical, is within the means of compensating 500 individuals, of which, 290 have been nonetheless present process therapy or negotiating compensation particulars.
“Though gross sales of useful and well being meals general have been anticipated to say no considerably as a result of health-related concern involving Kobayashi Pharmaceutical’s pink yeast rice complement in March 2024, there was no vital shopper backlash,” the report famous.
This improve was primarily as a consequence of firms making an attempt to finish their notifications earlier than the new requirement of adhering to PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020) began in April this year, in keeping with the report.
“A big contributing issue to the rise was the surge in last-minute notifications earlier than the top of March,” Kato wrote. He highlighted that past-year data often confirmed round FFCs notified in March however surged to 345 in 2025.
“That was as a result of the analysis opinions (SR) used for useful proof have been transitioning from the PRISMA 2009 guideline to the PRISMA 2020 guideline beginning April 2025, and the PRISMA 2009 guideline remained usable till the top of March 2025.”
Of their notifications to the CAA, FFC producers should show the efficacy of their merchandise by submitting information from scientific trials or systematic opinions.
Corporations submitting information from systematic opinions have been following pointers from PRISMA 2009 however beginning this April have been required to stick to the PRISMA 2020 pointers from, following a string of high-profile FFCs advertising scandals.
