The report, titled “Detailed Analysis Report on FFCs Reported in FY 2023,” was prepared by Japan-based nutraceuticals consulting firm Smooth Link Inc.
In fiscal year 2023, 1,443 cases of foods with functional claims (FFCs) were reported to the Consumer Affairs Agency (CAA), the authority responsible for overseeing the FFC system. This was slightly more than the 1,429 cases reported in the previous year.
In terms of product categories, food supplements accounted for 55.6% of the total, processed foods 41.6% and fresh foods the rest.
Notably, the number of FFCs claiming to support femcare increased from six in fiscal year 2015 to 58 in fiscal year 2023.
For example, the first FFC for Lactobacillus GR-1 (Lactobacillus rhamnosus) and Lactobacillus RC-14 (Lactobacillus reuteri) was filed in January 2021 for its ability to promote a favorable vaginal environment and vaginal conditioning. To date, nine such products have been marketed by eight companies.
Well-known names from the industry have also entered the market.
In July 2023, Asahi Group Foods, Ltd. filed an FFC for L. gasseri CP2305 supports “the ability to reduce transient premenstrual dysphoric mood, mental fatigue, and somnolence in healthy women with normal menstrual cycles.”
In December of the same year, Tokiwa Ltd. filed an FFC containing hyperoside and isoquercetin derived from Apocynum venetum, with the health claim that it “helps to improve transient premenstrual dysphoric mood in healthy adult women with regular menstrual cycles”.
Such first-mover products will drive growth in the premenstrual dysphoric disorder and vaginal health sectors, says Hisaaki Kato, president of Smooth Link Inc. and author of the report.
“There is a lot of growth potential in Femcare products. In addition, the current status of the FFCs for the vaginal environment and premenstrual dysphoric disorder that have been reported suggests that these categories will grow if health claims do not violate the strict drug law,” Kato said in the report.
The Medicines Act is now known as the Medicines and Medical Devices Act. It states that a product should be classified as a medicine rather than an FFC if it is suggested or explicitly stated on the packaging, marketing material or advertising that it can treat, prevent or improve bodily functions.
In addition, the use of medical terms such as “prevent,” “cure,” or “treat” is prohibited. Claims of intentional health improvement, such as skin lightening or hair growth treatment, are also prohibited.
For example, phrases such as “a dietary supplement recommended for preventing lifestyle-related diseases” and “effective for skin care” are in violation. Rephrased versions such as “a dietary supplement that supports a healthy body” and “effective for beauty” might work better, Kato suggested.
Over the past year, we have seen an increasing focus on women’s health across Asia Pacific – Haleon is focusing its new product development plans on women’s health, and Glanbia and AstaReal also see great opportunities in women’s health.
Rise of Femcare
The global Sustainable Development Goals (SDGs) for business include gender equality, which led to growing awareness in this area. This increased demand for products and services that help women improve their health and quality of life.
“(That’s why) the need for femcare is growing and more and more companies are entering the market,” said Kato.
In recent years, good results have been achieved in supporting fatigue, stress reduction, sleep, cognitive functions and immunity.
Health claims for specific body parts often include claims of beneficial effects on the stomach, eyes and skin. It also claims to maintain and improve bones, muscles and legs (walking ability), reflecting the ageing population.
Femcare products to be launched in fiscal year 2023 include Femiaid and Saw palmetto F, which “make it easier for older women to go to the toilet more frequently.” They contain punicalagins derived from pomegranates and saw palmetto extract, respectively.
There were also 20 brands submitting FFCs for “reducing evening leg swelling in healthy women with swollen legs,” 20 of which contained Piper longum-derived piperine.
In addition, there were 11 products that are “useful for bone health in middle-aged and older women.” Some of them, like Lover of “Bone,” contain soy isoflavone. Bone Density Care and Bone Density Support contain maltobionic acid Ca.
To support skin health, My Power Beautifly contains reduced coenzyme Q1 and astaxanthin, while Fruit Gummies Lemon & Soda contains reduced coenzyme Q10.
When asked if there were gaps in the market that needed to be filled, Kato said women take oral contraceptives for birth control and to relieve menstrual cramps, acne and premenstrual syndrome.
Therefore, FFCs could be investigated for these categories. However, due to regulatory requirements, it would be difficult to describe these health claims.
