Japan's Nutraceuticals Today - A Big Disappointment in Food-Drug Reclassification: Expectations are not always realized

薬食同源 Japan’s Nutraceuticals Today

By Paul Yamaguchi

The current Japanese nutraceutical industry is like a sitting on a surfboard in the ocean and looking behind, waiting for the next big wave to arrive. When you finally see the big wave coming and get ready to ride, the big wave just disappears. It’s disappointing to say the least.

I’m referring to a recent announcement from the Japanese Ministry of Health, Labor and Welfare (MHLW) regarding food-drug reclassification (de-regulation). Since 2001, the agency has conducted 3 food-drug reclassifications. They have been conducting reclassifications almost once a year, but over the last 3 years the agency still hasn’t completed one. This year will be the 4th.

Many ingredients in the U.S. are still tightly guarded under Japan’s Pharmaceutical Affair Law. They can’t be formulated into foods or supplements. Both the U.S. government and industry organizations are putting pressure on the MHLW to open the drug gate and move the ingredients from drugs to the non-drug category. When ingredients get moved to the non-drug category, they can be used as supplements and the nutraceutical market flourishes and the industry grows. It also creates business opportunities for U.S companies and others. Best of all, consumers will have more choices and control over their own health and well-being. This has happened in the past, and that’s why industry leaders anxiously wait for the reclassification announcement every year.

In 2002, CoQ 10 moved to non-drug status and the market grew from almost zero to $100 million in two short years. Echinacea, ginkgo biloba, lutein, glucosamine, and L-Carnitine also have stimulated the market in the past. In 2003, it was alpha lipoic acids (ALA). Since then, the agency hasn’t done any food-drug reclassification. After three years of silence, the MHLW announced for the first time, its intent to open a public hearing for the potential next reclassification ingredient lists, prior to making a final announcement. This is a significant improvement on their part; it has never happened before. Last December, the MHLW published the potential next reclassification ingredient list.

In the list, there were 55 botanical, animal and chemical ingredients listed. The largest number were in botanicals with 33 ingredients. Pyrola japonica, canarium album, citrus tachibana, panax quinquefolium, juncus effuses, agreratum conyzoides, clitoria ternatea are some of the botanicals with reclassification potential.
In the animal category, candida utilis, and hyriopsis cumingii are included. L-citruline is the only chemical ingredient among the ingredients list.

Absent from the list are the industry’s highly anticipated ingredients for reclassification: taurine and glutathione. Taurine is a nonessential sulfur-containing amino acid that is an active ingredient in many energy drinks. And glutathione is the strong antioxidant widely used in dietary supplements in the U.S. If these ingredients were to be de-classified, industry anticipated it would become the next CoQ 10 or ALA, and it might restart the Japanese nutrition industry which has been stalled for the last 15 months. But, it didn’t happen. Despite the fact that they are among the U.S government and the Japanese health organizations requested reclassification ingredients, taurine and glutathione weren’t on the list. There were no explanations from the MHLW as to why these two ingredients were missing from the list, and no scientific or safety reasons either.

Immediately after the list was published, the U.S. Camber of Commerce in Japan and other Japanese industry organizations filed petitions indicating that the lists are not reflecting their requests and asking them to include omitted products in the list.

Now, the pressure is on MHLW. Whether MHLW will change their mind remains to be seen. No date has been set for the announcement of the final reclassification ingredients list.

Stay tuned. I’ll report when the 4th reclassification is published by the MHLW.

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