Introduced in April 2015 as part of former prime minister Shinzo Abe’s ‘Abenomics’ to revitalise the economy, the FFC model was introduced to make it less time consuming and less costly to market the health benefits of functional food products.
Prior to this, foods that make health claims are categorised as either Foods for Specified Health Uses (FOSHU) introduced in 1991, or as Foods with Nutrient Function Claims (FNFC).
Products that do not make health claims, including nutritional and health supplement, would fall under Foods in General.
Although FFC has grown rapidly, the system has also met its fair share of criticisms over the years.
Some are sceptical of the science and efficacy of FFC products.
The Association to Create a Society with Consumer Citizenship (ASCON), is one of the watchdog groups, that has been keeping a close watch on the FFC category. The association conducts its own evaluation and grades the existing products with either a ‘A’, ‘B’, or ‘C’ grade.
In June, two products from Sakura Forest were removed for making misleading advertising claims. It was also found that there were discrepancies between the products’ functional claims and its scientific evidence notified to the authorities.
This subsequently triggered the Consumer Affairs Agency (CAA) to re-assess other FFC products making similar claims using the same ingredients.
In the words of Dr Seiji Aoyagi, representative director of the International Society of Sports Nutrition (ISSN), the FFC system seems to be “more of a marketing stunt to boost the industry.”
So, what’s next for Japan’s Foods with Function Claims system?
In this series of VitamINSIGHTS, NutraIngredients-Asia spoke with industry bodies Japan Alliance of Health Food Association (JAOHFA), Japan Health and Nutrition Food Association (JHNFA), and food and beverage giant Kirin to find out more.
Part I – The lucrative FFC market: Over 7,000 products developed in less than a decade
A check on CAA’s FFC database shows that there are 7,473 products as of September 11.
Most of the products, numbered at 4,019, were made in the form of supplements, such as capsules and tablets.
Another 3,238 were made in the form of other processed food formats.
Interestingly, fresh products could also make the cut under the FFC system, and this is the case for 216 products.
One example is a banana product from Dole that claims to be rich in GABA and could lower blood pressure in people with hypertension.
The functional claim allowed for the product is: “This product contains GABA, and it has been reported that ingesting 12.3mg/day of GABA could lower blood pressure in people with high blood pressure. If you eat 120g (one to three pieces) of the edible portion of this product, you will be able to ingest 50 per cent of the functional ingredient per day.”
Japan’s FFC market was valued at 546.2bn yen (US$3.71bn) in year 2022, up 24 per cent yoy, according to data published by market research firm Fuji Keizai in March. The market is expected to grow to 593.5bn yen (US$4.03bn) this year.
The FOSHU market, on the other hand, was valued at 286bn yen (US$1.94bn), a yoy decrease of six per cent.
In fact, the FFC category had outgrown the FOSHU sector in 2020, just five years after its inception.
Unlike FOSHU, which needs to go through the government’s evaluation for its claimed effects and safety, FFC products are not individually pre-approved by the secretary-general of the Consumer Affairs Agency (CAA).
These products are labelled with function claims based on the scientific evidence that companies have gathered, which are mostly systematic reviews.
Companies are also supposed to notify the CAA evidence on the products’ safety and effectiveness before marketing the products.
“The FOSHU market is not growing but declining. So, in general, we can say that there is a big accelerating shift from FOSHU to FFC,” said Masafumi Hashimoto, chair of JAOHFA.
Formed in 2009, JAOHFA started as an alliance of eight industry associations, and counts 70 companies as part of its regular members and 30 companies as its supporting members as of June.
The accessibility of functional foods is one of the reasons for its growing popularity.
“The functional food market has continued to grow in recent years, with sales of functional food products such as soft drinks and supplements increasing due to key factors such as accessibility for consumers, including the ability to purchase these products at familiar sales outlets such as supermarkets and convenience stores,” Tatsuya Takada, corporate communications at Kirin said.
Based on the company’s observations, the top five consumer health trends surround prevention of lifestyle-related disease prevention, the use of nutrients and tonics, intestinal regulation, multivitamins, as well as bone, joint, and muscle support.
Part II – Gap between consumer demand and market availability
Although there are already over 7,000 FFC products notified to the CAA, there is still a gap between consumer demand and the types of products available in the market, according to Hashimoto.
One example is the number of FFC products for immune health.
Out of the 7,000 odd FFC products, only 80 were related to immune health, as of September 11.
Body fat related claims, including visceral fats and triglycerides, were the most common claims, with 2,097 products making such claims.
Glucose-related claims, such as glucose absorption, postprandial blood glucose level, ranked second in place, while stomach and intestinal health claims, skin, and eye health related claims, are also commonly seen.
Although only a small number of FFC products made immune health claims, Hashimoto, who is also the managing director of Kemin Japan K.K., said that this did not mean that there was a lack of demand for such products.
In fact, he said that demand for immune health FFC was strong, but only a handful of functional ingredients were approved by the CAA to make immune health claims.
“To my knowledge, there are only three functional ingredients accepted by the CAA for making immune health claims. However, consumer expectation on immune health is much greater than the number of products available.
“That's one of the challenges that we feel may also present significant opportunity for (FFC breakthrough),” he said.
LC-plasma, a Lactococcus lactis strain plasma marketed by Kirin, is the first functional ingredient that the CAA has allowed to make immune health claims. The firm secured the claim last year.
Kirin believes that the market size of FFC products for immune health is expected to grow at a faster rate than the overall health food market.
“Demand for measures towards health and immunity, for which awareness was further raised by COVID-19, is expected to continue to grow, especially demand for measures toward health issues that have increased, such as consumers' heightened health consciousness and stress and sleep issues,” said Takada.
The other ingredients approved to make immune health claims include Lactobacillus acidophilus L-92 and Gluconacetobacter hansenni GK-1.
According to information from the CAA, these three ingredients help maintain immune function in healthy individuals by acting on the plasmacytoid dendritic cells.
Other health areas where there is a gap between consumer demand and market supply are osteoporosis, women’s health, and prostate health, according to Hashimoto.
“There are some other health functions that are not accepted yet. For example, osteoporosis, women's health related claims, and prostate health related claims.
“This is because there are arguments that there would be an overlap between the health areas that the FFC system and pharmaceutical sector would cover, and we are trying to get as many functions and health claims as possible for the FFC system.
“But this is not so easy…Because some of the clinical trials involved the diseased population as the study subjects, and we would need to exclude these types of scientific research (when providing scientific evidence to support the claims of FFC products). That's the reason behind why some health claims were not accepted,” he explained.
Therefore, he believes that there needs to be integration and endorsement for FFC products from the healthcare professionals, such as medical doctors, pharmacists, nutrition professionals, consumer groups and the government.
Watch Hashimoto explain more on how the FFC industry could seek to gain trust and confidence from the health professionals in the following video.
Part III – Ethics and advertisements
To ensure that the FFC market could grow sustainably, Hashimoto said that it was paramount that the industry advertise FFC products ethically.
In June, Japanese firm Sakura Forest was thrown into the spotlight for making misleading advertising claims for two of its products.
“The case was about exaggerated advertising that is outside of what is considered an appropriate advertising for FFC products.
“I think that ethics is important for us to achieve sustainable growth for the market, not just for FFC products, but in this industry, some people have the tendency to exaggerate their advertisements and that is not giving a good impression to the public and consumers, so we need to deal with that aspect, in order for us to achieve sustainable growth," he said.
The CAA and JAOHFA have drafted the “Voluntary Standards for Appropriate Advertising of FFC Vol. 2” and published it on June 5 to help companies adhere to appropriate advertising practices.
Unfortunately, Sakura Forest is not a standalone case.
Noriaki Kikuchi, director, Food with Function Claims Department at JHNFA, said that such cases would happen every year, because advertisement was an important tool in influencing consumers’ purchasing decision.
“FFC products are launched with the manufacturers’ responsibility, not just the government’s responsibility.
“If a case of inappropriate advertising was caught out by a 3rd-party, the case would receive a lot of attention,” he said.
Part IV – Better science needed
Kikuchi said that since the saga around Sakura Forest broke out, JHNFA has received more queries from member companies regarding scientific evidence of their products.
“The number of consultations with member companies have been increasing after the Sakura Forest incident, especially regarding scientific verification and advertisements of the products,” he said.
He is expecting more enquiries to come from member companies, but companies need to be precise and clear with the exact questions that they have, he said.
“There are over 7,000 FFC products and more than 300 functional ingredients. It’s not very easy to check each product or ingredient one by one, that's why JHNFA is expecting members to come to us with more precise questions,” he said.
While Takada said his company could not comment on the impact that the recent Sakura Forest saga had caused to the FFC sector, he said that the episode had “reaffirmed” the importance of reliable scientific evidence.
He said that Kirin had conducted research and clinical trials on ingredients such as LC-plasma, with more than 30 papers showing its mechanism of action, effectiveness, and safety published.
“Food manufacturers need to further strengthen their R&D functions to ensure the reliability of evidence so that customers can choose health foods with peace of mind.
“We will continue to conduct further research (on LC-plasma),” he said.
As part of CAA’s plans in improving the science of FFC products, the agency is planning to replace the out-of-date PRISMA 2009 with PRISMA 2020.
Kikuchi said that almost every year, the CAA would introduce revisions to improve the FFC system, and the focus for the upcoming year would be PRISMA 2020.
The short form for Preferred Reporting Items for Systematic Reviews and Meta-Analyses, PRISMA is an international guideline that sets out the types of information that should be present in systematic reviews.
About 90 per cent of the FFC products make their functional claims based on systematic reviews, said Kikuchi.
The 2020 version has included new reporting guidelines to the 2009 version to reflect advances in the methods used to identify studies.
“The CAA has asked for public comments about the implementation of PRISMA 2020…It is expecting, if possible, to implement it from April 2025,” he said.
His association is preparing the industry for the eventual shift through guidebooks and seminars.
JAOHFA is also working with CAA to help the industry understand PRISMA 2020 and the preparation required, Hashimoto said.
Currently, a challenge that companies are facing, is in selecting the appropriate systematic reviews to back up their products.
This is because Japan only accepts systematic reviews involving clinical trials on healthy population.
However, many systematic reviews come from the US and these reviews included clinical trials conducted on diseased population as well, which made it difficult for companies to collect relevant data, Kikuchi explained.
As such, companies would rely on raw material suppliers for systematic reviews, and sometimes, even the suppliers would need to rely on third parties for these data, which further complicate matters, he said.
In terms of scientific evidence, watchdog group ASCON has been keeping a close tab on the FFC system since it was introduced.
The association evaluates existing FFC products by giving grade A, B, C, based on the sufficiency of the scientific evidence to support the products’ effectiveness.
A product is graded ‘A’ if there are five or more randomised clinical trial (RCT) showing an efficacy of at least 75 per cent on the ingredients used, or the ingredients used are found to be effective in a systematic review, or if there are two or more RCT papers with positive results on the product published.
A product is graded ‘B’ if the ingredients used are backed by two or more RCT papers showing an efficacy of 65 per cent or more, or if a RCT paper with positive results on the product was published.
A report published by ASCON in July that evaluated products sold in the market for the first half of this year showed that most of the FFC products (325) were graded ‘B’. Another 257 products were given the ‘C’ grade.
The grade ‘A’ status was given to 186 products. Another 48 products were not graded as more information is required from the companies for ASCON to make a judgment.
Part V – Review and revamp the entire system?
One of the challenges that the industry is facing, is that consumers do not really know the differences between FFC and FOSHU products, Mitsuru Aoyama, managing director and secretary general at JHNFA pointed out.
To improve consumer understanding, he believes that there is a need to re-evaluating the system of foods with health claims, which FFC and FOSHU products fall under.
“As you know, FFC and FOSHU are naturally different, because FOSHU is evaluated by the government, while (the effectiveness of) FFC products comes under the business operators' responsibility.
“That's why there are some differences in the evidence and consumers are not aware of the differences between FOSHU and FFC.”
He pointed out that the solution was not about consumer education, because the existing system was already difficult for them to understand.
“It's not about consumer education, because currently, it is very difficult for the consumers to understand the whole system.
“That's why we should review the entire system to make sure that everything is clear and easy to understand for consumers.”
The association is currently in discussing the ways to make the entire system better, before requesting the authorities for a review, he revealed.
