Japan’s Nutraceuticals Today - FOSHU Ready to Change -- Again

By Paul Yamaguchi

FOSHU Ready to Change -- Again

A Brief History of Recent Changes in FOSHU

It has been 13 years since the Foods For Specified Health Uses, or FOSHU program was implemented in Japan. TheJapanese government developed FOSHU to identify conventional foods that positively contribute to physiological systems in the human body from other foods by allowing these foods to have health claims and an approved logo printed on their package. In 2001, FOSHU began to cover dietary supplements. In 2002, the law governing FOSHU has changed from the “from from Nutrition Improvement Law” to the “Health Promotion Law”

In May 2003, the government created another category for foods that can make health claims called “Foods with Nutrient Functional Claims.” Now FOSHU is apart ofthe Health Promotion Law under the section of “Foods with Health Claims”. The industry is accustomed to change, and by now, so is FOSHU.

Creation of the Panel

FOSHU may change the rules again in the near future. Getting FOSHU-approval for a new product requires scientifically based evidence from clinical and human testing. The cost of these studies in order to gain approval can reach as high as $1 million for new applications. This high cost prevents many small companies who have developed a new product from gaining FOSHU status.About a year ago, the Ministry of Health, Labor and Welfare (MHLW) appointed 14 members of industry experts to form a study group called “What Health Foods Regulatory Ought To Be” (loosely translated) to improve the current regulatory situation for health foods. Since the industry claimed that current law limits the recognition ofa wider range of evidence based scientifically developed products, they were now seeking a bigger umbrella to cover those products under the laws. The panel also looked the future of the industry and discussed what the health food regulatory environment should ideally be.

Outcomes a Surprise

On May 26 the panel concluded its 13th and final meeting and published its recommendation for the MHLW. The industry expected to see DSHEA (the Dietary Supplement Health and Education Act of 1994) type of new regulations to govern and recognize dietary supplements, however, the recommendations were far from what was expected and were basically watered-down versions of current FOSHU regulations. The panel just couldn’t ignore the $4 billion monster. The recommendations were to create second and third tiers of FOSHU, one is tentatively called “FOSHU with a Condition (FWC).” This tier does not require as rigorous scientific evidence as FOSHU does, but requires the product to carry some type of disclaimer showing that the product’s effectiveness is not as solidly established scientifically as FOSHU products are. FWC will likely create a larger number of foods with health claims and may help the nutrition industry flourish with the introduction of new products. Another recommendation from the panel is that products with ingredients that have been already formulated in the FOSHU category and have a proven, high level of scientific evidence and safety can be classified as a newly created and tentatively named, “Standardized FOSHU” product. The panel also recommended to create new “Health risk-reduction health claims”.

Give Consumers a Break – educate not regulate

The recommendations give a chance for many products which could not otherwise gain FOSHU status for whatever reason to now gain FOSHU status.

However, I believe multiple FOSHU classifications may confuse consumers, but more importantly, the new recommendations from the panel lower the standard for FOSHU foods. Is the food industry’s ability to market more products as “healthy” in the best interest of the consumers? Rather than amending the laws and letting the government decide what’s good for us, let’s start printing ALL the ingredients, quantity and daily value on every product, just like in the US. Then let people decide what’s best for them. Don’t tell consumers what to consume. Educate us and let us make our own decisions regarding what to consume. “Educate not regulate” This will help raise the industry to the next level. The MHLW may announce the final changes as early as this year.Stay tuned…

Paul Yamaguchi is president of Paul Yamaguchi & Associates, Inc., Tarrytown, NY. His company publishes a number of Japanese nutrition market reports, including Nutraceutical Japan 2003, Nutritional Supplement Japan 2003. His latest report is Functional Foods and FOSHU Japan 2004, Market & Product Report. For details and information on the reports, visit: www.functionalfoodsjapan.com or contact Paul at [email protected]

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