Japan companies punished over dodgy 'antibacterial' labels

JAPAN - The Consumer Affairs Agency imposed administrative punishments last month on 17 companies for violating the law to prevent misleading presentation by exaggerating the effects of their pharmaceutical products that supposedly sterilize living spaces.

The agency said the companies failed to present reasonable data to prove the effectiveness of their products.

The 25 products in question were so popular that they disappeared from store shelves during the flu season. How did the makers evaluate their effectiveness before marketing them?

Experiment data 'lacking'

All of the products contain chlorine dioxide, which has antiseptic effects and is used to sterilize water in swimming pools, according to the Health, Labor and Welfare Ministry.

However, since the chemical substance is not certified as either medicine or quasi-medicine, advertising for products containing chlorine dioxide is not permitted to claim such effects as preventing infectious diseases by killing viruses.

Thus, pharmaceutical firms and other manufacturers have marketed such products as general merchandise, labeling them as effective for "sterilization."

The best seller among the 25 products is Cleverin Gel, manufactured by Taiko Pharmaceutical Co. The Osaka-based firm spent more than ¥900 million over the five years through fiscal 2012 to prove the product's sterilizing and odour-eliminating effects.

According to the company, Cleverin Gel was tested by placing it in a naturally ventilated apartment room, whereupon it was confirmed that its chlorine dioxide had spread evenly within the space.

Using an enclosed space as wide as a standard living room, the company verified that the chlorine dioxide at a density level equal to the product which could kill 99 per cent of airborne germs in an hour.

However, the consumer agency concluded that the company conducted the experiments without considering air currents and movement of people in and out of the room.

In response to the agency, a Taiko official said the firm "accepts the agency's judgment that our experiments did not provide sufficient data [to prove effectiveness]. We'll conduct more experiments under various conditions to improve the product's labeling."

The company also said it published an ad, in which Cleverin Gel was described as having germ-killing effects, four days after the agency imposed the administrative punishment on it only because Taiko wanted consumers to learn about its continued efforts to improve the product. However, the agency found the action to be a problem.

Tests to prove the effectiveness of Ohki Pharmaceutical Co.'s Uiru-ofu-baria-a portable product that comes with a neck strap-were also basically conducted in enclosed spaces.

An official of the firm admitted that its labeling for the product's "sterilization" effects was exaggerated and that a gap existed between the test conditions and the actual environment in which the agency believes such products would be used.

While Taiko and Ohki conducted their own tests, the other 15 companies include some that have never evaluated their products' effectiveness.

Aside from the 17 companies, Denso Corp., the maker of Sharyo-yo Cleverin (Cleverin for vehicles, literally)-a chloride dioxide product it jointly developed with Taiko-made the unusual move of posting a notice on its website insisting that the product's sterilization effectiveness has been proven, highlighting the difference between Sharyo-yo Cleverin and other sterilization products for living spaces.

Betrayal of consumers

Questions about the effectiveness of "germ-killing" products are nothing new, as many consumers have voiced doubts for years.

Antibacterial products came onto the market around 2009, when a new strain of influenza became an epidemic, according to industry sources. Over the past few years, the market has grown at a fast pace, with purchases made mainly by hospital managers and mothers of young children. The market is said to be valued at more than ¥10 billion (S$122 million) each year.

The National Consumer Affairs Center of Japan received many complaints from users who were sceptical about the products' antibacterial effects.

In 2010, the NCAC warned consumers over the issue, saying it is not clear how effective such products are as bactericidal agents. The NCAC asked makers to prove the germ-killing effects and safety of their products.

Earlier this year, Japan Pharmaceutical Association posted a statement regarding the issue on its website, asking consumers to exercise greater caution in the use of such products.

"Currently available products are incapable of diffusing sufficient chlorine dioxide in the air. The chemical's aerial density level won't be enough to work in a general living environment, according to the guidelines of the Japan Chlorine Dioxide Industry Association," said Hiromi Komine, a professor at Chiba Institute of Technology's Engineering Faculty and expert on indoor air pollution and antipollution measures.

"The makers have never presented an aerial density level [of the chemical] that could have germ-killing effects. They bear a huge responsibility for having betrayed consumers' trust," Komine said.

An official of the Consumer Affairs Agency said consumers "may have been deceived if it is not clear whether the products have germ-elimination effects in their living environment."

An official of the JCDIA said the makers "conducted tests only in limited spaces to prove the products' effectiveness. They have to regain public trust by accumulating more solid experimental data."