Regulation Nation

Japan is one of the world?s most important and developed markets for functional foods. Yet myriad of regulations and government bodies means confusion blights the industry and consumer understanding, says Kaori Nakajima of the Japan Health Food & Nutrition Food Association. First in a two-part series

In Japan, it is law—and not science—that divides food and medicine
Planning a strategy for functional foods in Japan is not an easy task. Food companies are faced with a bewildering choice of paths to follow in a maze of regulations. As a result, the majority of functional foods, health foods and dietary supplements are not recognised as such, and are kept out of the regulatory system altogether. This problem arises from the notorious difficulties of drawing a clear distinction between drugs and functional foods. And in Japan, it is law—not science—that divides food and medicine.

The best-known system for regulating health claims on foods is called Foods for Specified Health Uses (FOSHU), which was set up in 1991 by the Ministry of Health, Labour and Welfare. Since this time, the public?s interest in the relationship between nutrition, diet, and lifestyle-related diseases and disorders has flourished. Functional foods have proliferated, becoming more diverse and complex. As the market has grown, the government has also had to cope with trade frictions and to comply with international regulatory trends, such as the Codex Alimentarius.

FOSHU Trends
Products developed to improve the gastrointestinal system (with functional ingredients such as oligosaccharides, dietary fibre and lactobacillus) still make up a large part of FOSHU products. But foods that address high blood pressure, high blood-sugar levels and obesity are also gaining popularity.

Food types are also diversifying. One-third of all FOSHU products are drinks, but more variety can be seen now in the market, including instant miso soup, fermented soy beans (natto), soy milk products, margarine, bean curd (tofu), jelly drinks, rice and bread.

There has been an increase in the number of TV commercials that show the FOSHU mark of approval, but consumer awareness is still very low at around 30 per cent
In recent years, there has been an increase in the number of TV commercials that show the FOSHU mark of approval, but consumer awareness is still very low, around 30 per cent, according to a Japan Health Food & Nutrition Food Association (JHFNFA) survey. Because the government is reluctant to put any promotional effort into FOSHU, functional foods companies are pretty much on their own. And this means that consumers are also on their own when it comes to assessing nutrition and picking the right foods for their health condition.

Most people recognise FOSHU by the mark of approval. Many, however, feel that the claims are still very vague and difficult to understand. To help combat this, the JHNFA sets up study groups with member companies to plan and produce promotional pamphlets and videos on FOSHU to be distributed at conferences, trade fairs, schools, and health centres, and to chemists.

Functional foods that have a new specified health use can find it difficult to gain approval under the updated FOSHU system
Where FOSHU Stands Now
In April 2001, the government introduced a new category of foods—Foods with Health Claims—to meet new requirements in the evolving market for functional foods. The new regulatory system aims to provide consumers with truthful information so they can supplement their daily nutrition intake or target specific bodily functions or structures. Health claims must be validated by scientific research and foods must be clearly labelled, so they are not confused with medicines. They must not make any statement regarding diagnosis, mitigation, treatment or prevention of disease.

There are two types of foods that fall under the category of Foods with Health Claims—FOSHU and Foods with Nutrient Function Claims. These are the only types of foods that can now carry some kind of claim that might state one or more health benefits.

With the new regulatory system, FOSHU underwent the following changes.

1. Claim statements are now less wordy and more straightforward. Specified health benefits include:

  • Maintenance or improvement of easily measurable health indexes. This enables claims such as, ?helps maintain blood pressure (blood sugar, neutral fat, cholesterol) at a normal level,? or, ?promotes the breakdown of body fat.?
  • Maintenance or improvement of physiological/structural functions ? eg, ?promotes calcium absorption.?
  • Improvement of a health condition that is easily self-detected, and is only temporary ? eg, ?suitable for anyone who feels body fatigue.?

2. Application material must include an extensive and objective report on the reason for application. This must show how the product can be used to improve the diets of people and maintain or promote good health at a national level. It must also include backup material on effectiveness, and also material that indicates any doubt about effectiveness and safety.

3. FOSHU can now come in capsule or tablet forms.

4. The company that applies for FOSHU must notify the government of changes to the food itself and results of re-examinations.

5. It is now mandatory to gather information after the food is marketed by accumulating scientific data, continually checking the effectiveness/safety of the food product, and keeping a record of consumer opinions and complaints.

New Regulatory Layers
The rules are set and they look very clear, but problems can still arise during evaluation. FOSHU applications for health claims are ultimately judged by the Food Investigation Committee (FIC) of the Pharmaceutical/Food Sanitation Council, and its evaluation criteria are very tough. The FIC tends to view functional foods as if they are medicines, so issues such as excess intake are often a concern. As a result of this mentality, functional foods that have a new specified health use can find it difficult to gain approval under the updated FOSHU system. After thoroughly evaluating the exhaustive scientific evidence for a particular food, the FIC can ask for further substantiation, making the system too long and too expensive.

While the FOSHU system is a product-specific (not ingredient-specific) approval system, foods that contain government-approved levels of certain nutrients are covered by another standard—Foods with Nutrient Function Claims. This regulation currently covers 12 vitamins and two minerals (calcium and iron). If a product contains the correct amount of these nutrients, then it can carry specific claims that are stipulated by the government.

Another system of regulation, Foods for Special Dietary Uses (FSDU), which has been in existence for more than 50 years, was not mentioned in the new Foods with Health Claims system. Yet FSDU still exists and covers foods for medical purposes and foods for pregnant and lactating women, infants, and the elderly.

Unregulated Foods
As we have seen, health claims regulations in Japan can be complex, time consuming and expensive. This may explain why there is a raft of functional foods and dietary supplements that are completely unregulated. These products cannot carry health claims and in the eyes of the law are seen as no better for you than everyday processed foods. But they do often contain extracts and purified substances as their main ingredients, making them different to ordinary food. Indeed, these can often have effects comparable to those achieved by medicines.

It?s this gray area that causes confusion among consumers, who, in the absence of proper information, rely on word of mouth and suspect promotional literatures boasting of miracle cures. Since 1980, the JHNFA has tried to deal with the proliferation of health foods by setting standards for categories of foods and awarding its mark of approval to those foods that meet these standards.

The standards set out the definition of the food, lab test methods and labelling rules, while good manufacturing practice guidelines are at the drafting stage. When a member company submits an application, the product is first taken to the labs for ingredients and toxicity tests. Once that is cleared, it goes through the evaluation committee, which comprises dieticians, pharmacists, policymakers and academics. The entire checking procedure takes about three months and, once the food is approved, it can carry the Japan Health Food Authorisation (JHFA) mark of approval for four consecutive years. On the fourth year, the JHFA mark must be renewed.

The mark acts as a safety stamp that can be used by the consumer to make an informed choice. Presently, there are 53 standards and about 900 approved products, but this is a mere drop in the ocean—there are an estimated 50,000 products on the health foods market in Japan. Our system needs greater promotion, along with the creation of more standards and a constant review of existing standards. In this way consumers will not have to worry about the safety or quality of the products they buy.

The popularity of health foods has recently prompted the Ministry of Health, Labour and Welfare to create an investigation committee solely committed to this sector. Its members come from the government, academia, industry and the media; its role is to investigate how health foods can promote good health in the population and ways to regulate such foods. For the first time, these types of functional foods will be defined and given a clear legal status.

Yet Another Law
In a move that makes the situation even more complicated, the government introduced a new law on May 1, 2003, called the Health Promotion Law. This substitutes the Nutrition Improvement Law set in 1952, which was mainly concerned with improving nutrition deficiencies after World War II.

The Health Promotion Law aims to improve long-lasting health and counter lifestyle-related diseases through better dietary habits. It also sets out policies for ?secondary prevention?, such as the early detection and treatment of diseases through health check-ups, and ?tertiary prevention?, which covers treatment after the onset of the disease and after recovery.

So far so good, but the law does not mention functional foods except for FOSHU. To be fair, it was amended last August to restrict the exaggerated advertising of health foods, but this came before, and separate to, the draft regulatory system being drawn up by the investigation committee mentioned earlier.

This is a good example of what is wrong with the Japanese system. There is no single policy that encompasses functional foods as a whole. This leaves both industry and the public confused. Despite this lack of clarity, the market is steadily growing. Japanese people are already familiar with functional foods and are willing to take them to maintain and promote good health. Indeed, some foods are so popular that the industry is struggling to meet demand.

To iron out the complexities of the regulatory system, there has to be collaboration and compromise between policymakers, industry and the public, as well as scientists. Policymakers must become more food-oriented, while scientists must determine how much substantiation is realistically possible for functional foods. Science depends on public support, so the public and industry must participate more in the debate on science. Thus the difficult task continues, working toward a better quality of life for everyone.

Kaori Nakajima is chief of staff, scientific and regulatory affairs for the Health Food Department at the Japan Health Food & Nutrition Food Association.
Respond: [email protected]

Japan?s Regulatory System At A Glance
Foods with Health Claims: This government system comprises two sections:

  • Foods for Specified Health Uses (FOSHU), which is the main regulatory system for health claims
  • Foods with Nutrient Function Claims, which covers 12 vitamins and two minerals (calcium and iron)
  • Foods for Special Dietary Uses (FSDU): This was not mentioned in the new Foods with Health Claims system. FSDU covers foods for medical purposes and foods for pregnant and lactating women, infants and the elderly
  • Health Promotion Law: This aims to improve long-lasting health and counter lifestyle-related diseases through better dietary habits
  • Japan Health Food Authorisation (JHFA): The Japan Health Food & Nutrition Food Association?s mark of approval

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