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[2025 Edition] An easy-to-understand explanation of the Pharmaceutical and Medical Device Act (Pharmaceutical Affairs Act) that you should know before starting vaping in Japan!

Hello everyone.
Why is it important to understand the Pharmaceutical and Medical Device Act when using a vape device?

In Japan, regulations regarding VAPE (electronic cigarettes) are much stricter than in Europe and the United States, and nicotine-containing liquids in particular are strictly restricted by the Pharmaceutical and Medical Device Act (formerly the Pharmaceutical Affairs Act).

"Is it OK to use it for personal use?"
"There are stores that sell it, but is that okay?"
Is it legal to buy from overseas sites?

To answer these questions, this article will clearly explain the key points of the Pharmaceutical and Medical Device Act that you should know when dealing with VAPE in Japan.

Puffing Kiwi Japan Online Site

In Japan, nicotine-containing vapes are treated as "drugs"

In Japan, vape liquids containing nicotine are classified as "drugs" under the Pharmaceutical and Medical Device Act.

Therefore,

  • manufacturing
  • Imports (excluding personal use)
  • sale

All such actions require approval from the Ministry of Health, Labour and Welfare.

In addition, nicotine pods are sometimes classified as "drugs" and atomizers as "medical devices," and regulations are very strict.

Is it possible to import nicotine liquid for personal use? The line between legal and illegal

To put it simply...
Personal imports are legal as long as they are for personal use .

however" There is a clear limit on the amount permitted for personal import ( up to 120 mL per month) .

According to the Ministry of Health, Labor and Welfare guidelines, the amount that can be imported by individuals is as follows:

  • Liquid: 120 mL/month
  • Pods: 12,000 puffs/month

Importing more than this amount at one time may be treated as an unauthorized import of medicines.

If you wish to import more than 120mL, you must apply for a "Yakukan Certification" from the Ministry of Health, Labor and Welfare. However, it is rare for a Yakukan Certification to be accepted for nicotine products intended for vaping.

Examples of cases where your item may be stopped at customs

  • Orders of 120mL or more
  • Importing large quantities in multiple batches over a short period of time
  • Product content deemed to be commercial

In this case, the item may be confiscated or returned.

And now we come to the most important point.

In order to sell nicotine-containing VAPE in Japan, it must be approved as a pharmaceutical product .

However, this system can only be obtained by large pharmaceutical companies, and requires enormous costs and lengthy screening, making it nearly impossible for ordinary companies or individuals to obtain.

In some shops, They explain that "it's legal because the customer is importing it personally" and "there's no problem because we're just acting on your behalf," but this is not just a loophole in the law; it's said to be a method that carries a very high risk of illegal activity. The Ministry of Health, Labor and Welfare has also announced that it will strengthen its monitoring, so caution is advised.

In addition, the Ministry of Health, Labour and Welfare has issued the following notice to local governments in Japan.

  • Increased oversight of nicotine-containing e-cigarettes
  • If unauthorized products are found, instruct them to stop selling them.

There are also warnings about the health risks.

Health risks

  • Dependence from long-term use
  • Health hazards caused by mislabeling and counterfeit products
  • The dangers of products with unknown ingredients

This risk is not zero even when purchasing from an overseas site.

What about nicotine-free vapes? Regulations are loose, but there are some things to be aware of.

Vaping products that do not contain nicotine are not subject to the Pharmaceutical and Medical Device Act.

However, please note the following points:

  • Reliability of ingredient labeling
  • Sales to minors
  • Health hazards caused by inferior products

Enjoy vaping safely and legally

As we have explained so far, Japan's vaping regulations are among the strictest in the world, but if you understand the rules you can enjoy vaping safely.

To summarise the most important points:

  • Nicotine-containing products are only available for personal import
  • Legal if it's under 120mL
  • Sales and agency work are almost impossible
  • Safety and quality are always confirmed

Keep these things in mind and enjoy your vaping life correctly and safely.

If you have any questions about customs clearance, tariffs, legal import restrictions, etc., please contact your local customs office.

■Puffing Kiwi Japan Online Site
https://puffingkiwijapan.shop/

■Official Instagram
https://www.instagram.com/puffingkiwi.jp/

■Official LINE account
https://line.me/R/ti/p/@661nmqii
Right now, we are offering a $5 discount coupon (equivalent to approximately 500 yen) when you add a new LINE friend!

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