There’s a New Sheriff in Town…
Equipped with New Rules, the MHLW is Cracking Down on Supplements
By Paul Yamaguchi
Although the US Food and Drug Administration's ban on Ephedra and crackdown on androstenedione ("andro") is still fresh in our minds, 7,000 miles away in Japan, a similar story has already played itself out with the Japanese MHLW (Ministry of Health, Labor and Welfare ).
Unlike the US, Japan does not have a law, like DSHEA, that recognizes dietary supplements. Dietary supplements in Japan are still regulated under several different laws, and every time a death occurs due to the alleged use of a dietary supplement, the government scraps the old laws that would apply and enforces a ban on the product. The absence of adequate dietary supplement laws forces the Japanese government agency, the MHLW, to flex its muscles and tighten laws in the industry. The government has amended three particular laws that affect the industry.
New Sets of Laws
1. Implemented in August 2003, the “Health Promotion Law” (formally the Health Improvement Law) restricts exaggerated advertisements. The law restricts health claims on foods that may mislead the consumer. However, there is no specific guideline or definition of what “exaggerations” are from the agency.So the law is enforced solely by the opinion of the agency (MHLW --www.mhlw.go.jp). The absence of definitions and details regarding what is an “exaggerated” claim leaves the industry in the dark when promoting its products.
The agency enforces the law not only for manufactures, distributors and retail outlets but also for advertising agencies and the media broadcasting the advertisements. Publishing books that endorse the product (“Bible marketing”) and using doctors’ recommendations to promote products are also prohibited.
2. Also in August, a second set of laws was amended, the “Sanitary Food Law”. This new amended portion of the law gives the agency the right to enforce a temporary ban on unusual type of foods, defined as foods that have no proof of safety and potentially harmful foods even if no problems have ever occurred through their consumption. This is strictly in place to prevent accidents.
3. In November 2003, a third set of laws was amended, the “Unfair-Giveaway and Unfair-Display Prevention Law.” This amended portion of the law restricts the advertisement of efficacy on goods and services, including dietary supplements. If the manufacturer expresses its product’s efficacy in advertisements, the agency can request documentation to support the alleged efficacy. If the manufacturers fail to comply in 15 days, the agency has the right to enforce the law to remove the company’s product from the market immediately.
Violation of the law carries a steep penalty. After a warning is issued and the company refuses to comply, the offender will be fined up to $10,000 and repeated violators will be fined up to $1 million or 6 months in jail.
Results Are In
All this happened in the second half of 2003, and now, some 6 months since the implementation of these laws, results arecoming in. According to the Health Food Journal, direct sales, (especially the mail order business), are down as much as 70 percent from a year ago in some cases. Industry organizations predict that the crackdown will damage the industry widely in coming years. However, marketing techniques that do not depend on advertisements or written promotional materials (like door-to -door and MLM) continue to flourish.
The MHLW’s tougher approach could treat dietary supplements more like medicines, according to industry organizations, and this may hurt the industry financially and a majority of industry organizations are opposed to the MHLW’s crackdown. On the other hand, however, strong regulations strengthen consumers’ faith in the industry and its products. Hopefully a balance can be struck so that both manufacturers and consumers will benefit from the new regulatory environment.
In the meantime, companies planning to enter the Japanese market should be aware that new rules are in effect and a new sheriff is in town enforcing them.
I’ll talk about more about the current nutraceutical environment in the next issue.
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, Functional Foods and FOSHU (Foods for Specified Health Use) Japan 2003. For details and information on the reports, visit: www.functionalfoodsjapan.com or contact Paul at [email protected]