On December 5, 2022, Japan's Consumer Affairs Agency (CAA) officially approved Points to Attention Regarding Health Foods Under the Act Against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act. The regulation came into force upon issuance.
On August 9, 2022, Consumer Affairs Agency (CAA) of Japan unveiled proposition 235070040, a draft version of Points to Attention Regarding Health Foods Under the Act Against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act (hereinafter referred to as the draft). According to the draft, the product in the form of tablets and capsules are clearly included in the scope of health food; a batch of permitted health claims are newly added; the requirements for advertising and labeling claims of health food are further explained. Any comments can be sent to i.kinousei@caa.go.jp before September 7, 2022.
Revisions
1. Foods of tablet/capsule for keeping and improving of health are health foods
Health Promotion Act revealed that products sold as foods with health maintenance and promotion effects are called "health foods". The draft updates the definition of health foods, and further clarified that health foods include those in the form of tablets or capsules with the effects mentioned earlier, as well as foods such as vegetables, fruits, and cooking products that are considered as general food in terms of appearance and shape.
Notably, health foods in Japan include health functional food and so-called health food. Health functional food refers to Food with Function Claims (FFC), Food with Nutrient Function Claims (FNFC), and Food for Specified Health Uses (FOSHU), and each has its regulatory system. The so-called health food refers to health foods other than health functional food, such as nutritional supplementary food, health supplement, nutrient controlling food, etc.
2. 1. Examples of permitted claims for health foods are added
Items | Proposed newly permitted claims (examples) | |
Promoting health effects | Preventing or treating disease | • Prevention of influenza/coronavirus; |
Enhancing body or tissue function | • Increasing metabolism; • Anti-aging; • Improving natural immunity; • Cell activation; • Enhancing natural healing ability; • Increasing active oxygen scavenging enzymes; • Improving walking ability; | |
Effect of food for specific health purpose | • Helping reduce body fat; • This product contains XX (ingredient name), which has the effect of increasing bone density and is suitable for people who are concerned about bone health; | |
Nutrient function | • Promoting the absorption of calcium in gut intestine and aiding in the growth of bone; | |
Suggestive or indirect expression to promote health effects | Labeled by name or slogan | • Detoxing XX; • Removing excess debris from the body; |
Examples of problems such as anxiety and annoyance related to the function of Body or tissues | • Do you have these troubles? Cannot get rid of fatigue? Be pointed out XX in health checkup? Worry about your metabolic syndrome?...; • Feeling of physical decline, possibly because of lack of XX; | |
Notes：
Food with Nutrient Function Claims (FNFC) are subject to the "self-certification system". Marketing as a nutritional food does not require an individual licensing application, but the product must comply with existing specifications and standards (nutrition standards, functional efficacy claims, warning labels, etc.). Read more in Health Food Regulatory System in Japan.
3. Examples of claims with inconsistent actual effects are added
In accordance with Article 7 of the Act Against Unjustifiable Premiums and Misleading Representations, the unmatched labeling claims (including health-enhancing effects of health foods) with the effect displayed in the submission will be regulated. Relevant enterprises with serious circumstances will be sentenced to fixed-term imprisonment of not more than 6 months or a fine of not more than 1 million yen.The draft newly proposed four error cases, such as slimming effect.
Though the human subject research data of using the product was submitted before marketing, and the test results proved that it indeed had a slimming effect, there is a significant difference between the effect (quantity) confirmed by the report and the claims of reducing visceral fat and body weight.
4. Examples of Illegal labeling for health functional food are added
FOSHU has a strict registration system in Japan. Enterprises must register and submit product safety and efficacy information, and only after obtaining the official approval can they attach the logo on the product.
Food for Specified Health Uses Logo
Despite being licensed, as part of quality control, the lack of testing and inspection on the ingredients used in the product after packaging will constitute false and exaggerated sales. In serious cases, related enterprises will be imprisoned for up to 6 months or fined up to 1 million yen.
Inconsistent claims and filing information for Food with Function Claims (FFC)
Japan implements a filing system for FFC, and the information displayed on the label must be consistent with the product filing information.
Error example:
The filing information indicates the product has the effect of "helping reduce visceral fat for obese people". However, judging from the actual information on the label, it seems that anyone can easily get a belly slimming effect without exercise or dietary restrictions, which obviously contradicts with the filling information.
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