The first batch of products with new “functional food” labels will hit stores nationwide this week, amid controversy over regulatory policy that critics say is too lax.

The labeling system for kinosei hyoji shokuhin, which roughly translates as “foods with function display,” was introduced in April, giving manufacturers a third way to advertise health-enhancing ingredients in their products.

The Consumer Affairs Agency said it has received some 200 applications so far from companies wanting to put the new label on their products, out of which 37 items have been registered and are expected to hit the market soon.

The product lineup includes a dietary supplement containing hyaluronate sodium to relieve dry skin, and PET-bottled tea with indigestible dextrin, which is known to slow rises of neutral fat and blood-sugar levels.

The new system is meant to be a middle road between two existing food labels: tokuho, short for tokutei hokenyo shokuhin, or food with specified health uses, and eiyo kino shokuhin, or food boasting nutrient functions.

Tokuho, launched in 1991, allows manufacturers to make certain health claims on their products if the government judges there’s enough scientific evidence of their benefits and safety. The tokuho certification system is tightly regulated but has been criticized by market players as too costly and time-consuming.

Eiyo kino shokuhin, on the other hand, is a label that manufacturers can freely use as long as the products contain designated vitamins and minerals — without even reporting to authorities.

The new functional foods are similar to tokuho in that manufacturers can make specific health claims, but unlike tokuho, the government does not review or guarantee the safety and efficacy of the individual products.

As scientific evidence for the health claims, manufacturers are required to submit either previously published research on the ingredients or carry out clinical tests on their own. The manufacturers need to notify the agency 60 days before selling the products, while the government merely checks if they have submitted all the necessary documents.

The government explicitly states that it is not responsible for verifying the health claims made by the businesses, and that consumers try the products at their own risk. All the documents filed by the companies on the foods’ risks and benefits are uploaded on the agency’s website.

The system, part of “growth strategies” spearheaded by Prime Minister Shinzo Abe and modeled after U.S. regulations on dietary supplements, aim to provide consumers with some measure of guidance as interest in health foods rises.

With the introduction of new functional foods, Japan’s health foods market — including food, beverages, sweets and supplements — is expected to top ¥2.14 trillion in 2017, up from ¥1.84 trillion in 2013, according to market research firm Seed Planning.

Representatives from the General Incorporated Association of International Foods and Nutrition (AIFN), an industry group of dietary supplement vendors, have welcomed the move.

“The primary purpose of the new system is deregulation and allowing for more diverse labels for foods,” AIFN managing director Kazuo Sueki told a recent media briefing in Tokyo. “It is in line with what our group has long sought.”

Sueki said that the system still has room for improvement, adding that, unlike in the U.S., manufacturers in Japan cannot cite clinical research covering sick people.

But consumer rights advocates charge that some of the newly labeled foods lack sufficient evidence about their safety and effectiveness.

Shodanren, a confederation of consumer rights groups across the country, said in a May 26 opinion paper addressed to the consumer agency that the government should reject applications covering foods whose health benefits have been questioned by authorities at home or abroad.

The group also says that the agency should not allow manufacturers to use the history of ingredients that have only been sold for a short period as evidence that they are safe.

Currently, ingredients are considered safe if they “have a history of being consumed as food” even for a few years. But the consumer rights groups say the “history of consumption” should span decades or centuries, in line with practices in the West.

Critics in particular have called into question the product Shushiryu, a dietary supplement containing chitoglucan derived from enoki mushrooms. The consumer agency registered it as a functional food under the new scheme on April 15, and its Tokyo-based manufacturer Ricom can now say on the supplement’s package that the product will work to lower body fat.

But Ricom had submitted another product, Shushicha, a diet tea containing the same mushroom extracts, for tokuho certification. In response, the Food Safety Commission, a panel of third-party experts under the Cabinet Office, said in February that its “safety cannot be confirmed,” citing insufficient evidence on the mushroom extracts’ pharmacological effects on various parts of the body, including the cardiovascular system and respiratory and urinary organs.

This led critics to argue that the new regulatory framework is faulty, since it has allowed the company to advertise the product as “healthy” despite it being rejected from tokuho.

Shunichi Yamaguchi, minister in charge of consumer affairs and food safety, hinted April 28 that the product might have its functional food registration stripped.

“In general, if the Food Safety Commission concludes a food product has safety problems, we would have no choice but to remove the functional food label,” Yamaguchi said at a news conference on April 28. “If the commission points out safety issues, not only would it be rejected from tokuho but also it would not be accepted as functional food.”

When asked about the product’s status by The Japan Times, however, an official in the food labeling section at the Consumer Affairs Agency said last week the minister was “talking in general terms” and that supplement’s April 15 registration as functional food stands.

“The Food Safety Commission did not say the Shushicha (diet tea) was not safe; it said it could not evaluate its safety,” said the official, who declined to be named. “At this point, we are not thinking of taking further action on the supplement.”

Shodanren is calling for businesses to stay away from registering products with “low-level” evidence as health foods, and to make their claims easier for consumers to understand.

“The agency guidelines say businesses should give information on safety and functionality of the foods in a way ordinary consumers with no expert knowledge can understand,” the group’s May 26 statement read. But businesses often leave technical terms unexplained or oversimplify their explanation, failing to provide crucial information.

“The Consumer Affairs Agency does not review the content of the submitted documents. Consumers therefore must judge based on information given by the businesses,” the statement continued. “We urge businesses to be more sincere in their communication with consumers.”

Examples of products that will carry the new label
Product type Functional ingredient Statements on the product
Dietary supplement Lactoferrin Will reduce visceral fat and help keep BMI down
Dietary supplement Rose hip Includes rose hip-derived tiliroside, which will work to reduce body fat
Dietary supplement Hyaluronate sodium Is reported to keep skin moisturized and relieve dry skin
Dietary supplement Bifidobacterium longum Contains live bifidobacterium longum, which reportedly improves intestinal flora and bowel conditions
Beer-flavored nonalcoholic beverages Indigestible dextrin Will help prevent absorption of fat in meals; is reported to reduce sugar absorption in meals
Soft drink Lactotripeptides Are reported to work favorably for people with high blood pressure

In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.