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Japan Updates the Labeling Requirements of High-Concentration Fluoride Toothpaste

The typography requirements of warning information and the marking method of fluorine concentration were modified for medicated toothpaste with a high fluoride concentration.

As revealed by MHLW's notice on Aug 18, 2020, Japan Dentifrice Manufacturers Association (JDMA) has made two modifications to the voluntary standards “Notes on Warning Labels of Medicated Toothpaste with High Concentration of Fluoride.” The details are as follows:

1. An emphasis technique is required to highlight the warnings information on the label of high-concentration fluoride medicated toothpaste. Two or more of the following methods for format emphasis can be used to make the warnings more noticeable.

Methods for format emphasis include: Underline, add borders, bold fonts, enlarging the font, change the font color, change the background color, etc.

2. The marking method of fluorine concentration has been updated to “The method of marking the fluorine concentration is not specified. However, do not make any indication that the product effect will be enhanced by adding a high concentration of fluoride.”

High-concentration fluoride toothpaste stakeholders should note that the manufacture of new labels shall refer to the notice mentioned above. For products already on the market, the labels shall be revised in line with the notice by August 2022 at the latest.

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