Health Claims for Foods: Decoding Global Regulatory Landscape

The global health supplements market size is expected to reach over US$ 624.7 billion by 2030, growing at a notable Compound Annual Growth Rate (CAGR) of 7.1% from 2022 to 2030. As an essential element of food supplements, health claims are subject to complex compliance requirements in different regions, which have held back enterprises in entering overseas markets. 

This article comprehensively introduces the requirements related to health claims for food products in the major and emerging food supplement markets, including South Korea, Japan, Australia, New Zealand, EU, and USA.

1. South Korea

In South Korea, both health functional food¹ (HFF, 건강기능식품, 건기식) and general foods can be attached with health claims, but the regulatory requirements are different. A heath functional product can be manufactured with any noticed functional ingredient and individually recognized ingredient. However, for a general food product with a health claim, only 29 kinds of noticed functional ingredients can be used.

The health claims labeling methods are also different. For health functional food, the health functional food mark and the ingredient’s efficacy should be indicated on the health functional food’s packaging, which are prohibited to be placed on a general food product. General food product can only be labeled with a phrase showing that the product contains certain functional ingredient. 

2. Japan

In Japan, foods are divided into two main categories, namely, food and health food⁶. Different from other countries, fresh vegetables and processed foods can be recognized as health food.

Following the different functional claims, recognition institutes, and necessity for application or filling, Japan’s health foods can be further classified as “Food with Nutrient Functional Claims (FNFC)”, “Food with Specified Health Uses (FOSHU)” and “Food with Function Claims (FFC)”. 

(1) Food with Nutrient Functional Claims (FNFC)

FNFC is a kind of food product designed to supplement nutrition with the nutrient function claims specified by the Ministry of Health, Labour and Welfare (MHLW)⁸. Japan has standards and specifications for the indication of nutritional function, covering 20 ingredients (1 fatty acid, 6 minerals, and 13 vitamins).

The health claims of FNFC do not require an individual approval or assessment from the relevant authority. However, a disclaimer showing the product is without national's assessment must be indicated, along with a suggestion of balanced diets. For example, “this product is not Food with Specified Health Uses (FOSHU) and without CAA approval. Please keep a balanced diet.”

FNFC function claim standards and specifications

(2) Food with Specified Health Uses (FOSHU)

FOSHU are foods that include functional health ingredients with physiological functions and can improve the biological activity of human body. The health claims and product safety of FOSHU should be approved by CAA before being placed on the market. Additionally, they should be labeled with the relevant mark, along with a phrase for reminding of the balanced diet.

Five types of FOSHU products and their marks are as below:

(3) Food with Function Claims (FFC)

FFC refers to food that has been labeled with functionality based on scientific evidence. Enterprises need to be responsible for the function claims. The safety and functionality information are required to be notified with CAA. However, unlike FOSHU, the stakeholders do not need to get an individual license by CAA. Notably, FFC cannot be indicated with any expressions related to reducing disease risks.

There are three methods for scientifically proving the FFC function claims, correspondingly with different labeling approaches.:

• Clinical trials on the final product: “The product contains XX ingredient(s) and demonstrates specific functionality of XX.”

• Literature review on the final product: “The product contains XX ingredient(s) and has been reported to possess specific functionality of XX.”

• Literature review on the functional ingredient(s): “The product contains XX ingredient(s), which has been reported that the specific ingredient(s) possess certain functionality of XX.” 

Besides, “Food with Function Claims (機能性表示食品)” and "without CAA's functional and safety assessment" are mandatory labeling items for FFC.

3. USA

Regardless of food category, both dietary supplements and conventional foods can be placed with health-related claims in US. The claims are sorted as health claims and structure/function claims, according to the level of scientific evidence. 

(1) Health Claims

Health Claims are subject to mandatory review by Food&Drug Administration (FDA)⁹ and its authoritative scientific institutes, such as National Institutes of Health (NIH)¹⁰, Centers for Disease Control and Prevention (CDC)¹¹, etc. After obtaining an official approval, the enterprises can label the “health claims” on the products, including health promotion and diseases prevention efficacies.

Notably, for products with qualified health claims (QHCs), additional disclaimers (marked in red) are required to be accompanied to accurately communicate to consumers the level of scientific evidence supporting the claim. Because although QHCs are supported by scientific evidence, they do not meet the more rigorous “significant scientific agreement” standards.

(2) Structure/Function Claims

Structure/Function Claims refer to expressions related to normal body structure and function benefits. They can be stated on the labels of conventional foods, dietary supplements, as well as drugs, following reviews and empirical evidence conducted by the business entities. 

a. Structure/Function Claims for Dietary Supplements

For dietary supplements, the Structure/Function Claims labeling requirements and procedures should comply with the Dietary Supplement Health and Education Act of 1994 (DSHEA). 

Only a benefit related to a classical nutrient deficiency disease can be placed on the label of the dietary supplements. No pre-approval is required. However, the manufacturer must have substantiation that the claim is truthful and not misleading and notify FDA no later than 30 days after the fisrt marketing of the dietary supplement with the relevant claim. 

Additionally, the dietary supplements with Structure/Function Claims must be clearly indicated with disclaimers as follows: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.

b. Structure/Function Claims for Conventional Foods 

Conventional foods can only be labeled with nutritional value claims, such as “This product contains Vitamin C, Vitamin D, Vitamin B12, which are important nutrients beneficial to immunity.” No pre-approval or pre-notification is required for the conventional food with Structure/Function Claims. Besides, disclaimers are not required for claims on conventional foods, either. 

Differences Lying between Health Claims and Structure/Function claims:

4. EU

All health-related claims are referred to as "health claims" in EU. Enterprises can place health claims both on food supplements and foods in EU.

The health claims are classified according to the below regulations and provisions:

All health claims should be reviewed by the European Food Safety Authority (EFSA)¹⁷. Only when adequate scientific evidences are proven, the claims can be included in the regulations. However, the application for new health claim is difficult. Currently, only about 10% of the applications have been authorized. The permitted claims are predominantly related to nutritional components rather thanfunctionalities. For the permitted health claims, they can be voluntarily used in food products and food supplements. 

*Register for our free webinar on Dec. 5, 2023- Navigating Novel Food Regulation

5. Australia - New Zealand

In Australia and New Zealand, “health claims” refer to a relationship between a food and its health benefits, and are only permitted on foods that meet the nutrient profiling scoring criterion, meaning claims are restricted to foods which may support overall health.

Health effect means the effect on the human body, including theeffect on one or more of the following:

• a biochemical process or outcome;

• a physiological process or outcome;

• a functional process or outcome;

• growth and development;

•  physical performance;

• mental performance;

• a disease, disorder or condition.

There are two types of health claims for food labels, namely “general level health claims” and “high level health claims”.

General level health claims are about a nutrient or substance in a food, or the food itself, and its effect on health. For example: 'calcium for healthy bones and teeth'. While, high level health claims refer to a nutrient or substance in a food and its relationship to a serious disease or to a biomarker of a serious disease. For example, "Diets high in calcium may reduce the risk of osteoporosis in people 65 years and over".

Additionally, Australia and New Zealand also adopt the “nutrition content claims” to show the content of certain nutrients or substances in a food, such as 'low in fat'. 

From January 2016, food businesses must comply with criteria set out in Standard 1.2.7¹⁸ (Nutrition, health and related claims) for food labels and advertisements. However, there is an exception for nutrition content claims about dietary fibre¹⁹, where food businesses have until 18 January 2017 before they need to comply.