薬食同源 Japan’s Nutraceuticals Today
By Paul Yamaguchi
A State of Unfair Restrictions
It is safe to say that the majority of people do not blindly believe what is stated in advertisements. We see these ads all the time in newspapers, magazines and the Internet; advertisements saying things like “’ABC’ chair lets you relax” or ”’XYZ’ cream helps you look younger”. These statements may not be true (which is hard to prove) but they are not necessarily deceptive or false. And nobody really cares if the chair relaxes you or the cosmetic cream helps you to look young, including us, consumers, the governments and law enforcement groups, unless someone brings the issue to the courts. A statement like the ones above is relatively harmless and usually not illegal both in the US and in Japan, unless you are in the dietary supplement business in Japan.
In the US, the law, (DSHEA) to a certain extent, protects dietary supplements and allows some claims associated with them. Therefore, you may see an advertisement like, “ABC helps renew ….” or “XYZ supports ….” all over the place and this can frequently be allowed as a structure function claim. In Japan though, you are alone in a war zone without protection and the laws are all around you. One slightly wrong move, and you would be fined or in the worst case prosecuted, or both, just because of using a wrong phrase. Choosing the “right word” has become such a critical and hot subject in our industry that several organizations are conducting seminars and organizing study groups just on “how to say it legally”.
For instance, let’s look at the phrase I used previously, “ABC supports prostate function”. This phrase is clearly a violation of the Pharmaceutical Affair Laws (PAL) in Japan. This is because of the product and the organ (prostate) connection. PAL prohibits connection between the product and diseases or body organs or parts. Not only that, it prohibits products with health, physical and mental connections too. Also, the phrase is a violation of The Premiums and Representations Act (PRA), because this law prohibits expressing a “function” that exceeds conventional food capability. It’s also a violation of The Health Promotion Laws (HPL), because the word “support” is characterized as an over- statement of the product, which is a food. Foods can’t support prostate in their definitions. The HPL prohibits the so-called misleading of consumers and over-statement of an advertisement. There is not much room to express the product’s function in plain Japanese.
So, what do I say to express product function without violating the laws? Not much. You can’t mention any specific diseases, cure, treatment, support or anything about diseases or condition related verbs or suggest anything that may change the current condition by using the products, in an advertisement or any printed materials or product labels. Finally “ABC supports prostate function” would become “ABC is friendly with men’s problem” Well, this may be misleading to other men’s problems. And “ABC helps renew cartilage” would become “ABC is for comfortable daily activities” Nothing specific. That’s their (the Japanese government agencies’) intention. Dietary supplements should not be directed to any particular purpose. That makes the product’s objective extremely unclear.
I personally believe this is a form of censorship and unfairly restricts freedom of expression. In a recent article in Nutritional Outlook titled, ‘Legal Eagle’, Jonathan Emord from the law firm of Emord & Associates, wrote, “FDA censorship of how basic foods and elements in foods affect disease helps no one in the country except for drug companies” This sentence would apply more to the Japanese government than to the USA.
The Japanese laws prohibit any health claims on foods, including dietary supplements and functional foods, even scientifically supported claims, unless the product has been approved as FOSHU (or Tokuho in Japanese) or fall into the Foods with Nutrient Function Health Claims category.
So, what will happen if the product violates the law? It depends on the violation, but in most cases the agency issues a warning to the company and gives the company 15 days to comply with the law or present proof of advertised health claims. The proof must include not only clinical studies and scientifically supported documents but also human tests. Not mentioned is its safety. So far there has been no health claim granted for products that violate the law.
As a result, glucosamine products still can’t mention cartilage or joint or lubrication or anything that has to do with what glucosamine would do. Lutein products can’t mention anything about the eye, vision or macular degeneration. Moreover, the agency never defines its standard in the approval process.
Sadly enough (for us), the governments, both central and local, are strengthening their muscles to enforce the laws. For instance, recently, the Tokyo Metropolitan Government (TMG) announced its plan to dispense 320 local agencies to monitor the health foods industry (dietary supplements and functional foods) for manufacturing practices, promotional activities and advertisements, according to The Health Industry News (April 28, 06). Last year, TMG checked 138 products from Internet shops and 90 percent of these products were found to have some type of violation. This may be why almost 50 percent of the $10 billion dietary supplements business is conducted behind closed doors.
|Paul Yamaguchi is president of Paul Yamaguchi & Associates, Inc., Tarrytown, NY.|
His company publishes a number of Japanese nutrition market reports. His latest report is Nutritional Supplement Japan 2005, Inside of $11.1 billion Japanese dietary supplement market. Other report is Functional Foods and FOSHU Japan 2004, Market & Product Report.
For details and information on the reports, visit: http://www.functionalfoodsjapan.com/ or contact Paul at firstname.lastname@example.org