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[July 2013]

E-cigarettes which turned out to contain nicotine

The following shows a case where e-cigarettes sold as nicotine-free turned out to contain nicotine.

Details of the inquiry

I used to be a heavy smoker using two packs of cigarettes per day. After getting a disease, I decided to stop smoking. When I was looking for an alternative to it, I heard about nicotine-free electronic cigarettes.

Therefore, I bought e-cigarettes indicated as nicotine-free through an internet shopping site. When I used it, I felt it contained nicotine. I want the e-cigarettes to be examined.

Structure and mechanism of e-cigarettes in general

A typical e-cigarette consists of a battery, an atomizer (the component to heat and atomize the liquid inside the cartridge into vapor), and a cartridge. Most assembled e-cigarettes have a shape and size that resembles a cigarette. If a user inhales vapor from the mouthpiece on the cartridge side, the sensor inside the battery reacts to it and turns on the light on the tip. At the same time, the liquid inside the cartridge is delivered to the atomizer, and the liquid is transformed into vapor, which flows into the mouthpiece.

Cartridges containing nicotine are sold outside Japan. Nicotine is domestically categorized as an active pharmaceutical ingredient, and in principle, it shall be only contained in pharmaceutical products except for cigarettes in the Japanese market. In Japan, tobacco is defined as follows under Article 2 of the Tobacco Industries Act.

  1. Tobacco: plant categorized into the tobacco family
  2. Leaf tobacco: leaves of tobacco
  3. Manufactured tobacco: product manufactured to be used for smoking, chewing and smelling. It is all or partly made of leaf tobacco.

Summarized outcome

The local consumer center which received the above inquiry (hereinafter called "the center") asked the National Consumer Affairs Center of Japan (hereinafter called "NCAC") to examine the products. As a result of the product test, NCAC found out the following.

  • The products of complaint are three brand cases containing e-cigarettes (A, B and C) and replacement cartridges (D, E and F).
  • The internet shopping site advertising the products of complaint included sales messages like "Carcinogenic substances such as nicotine and tar are not contained at all". However, all the three cartridges of complaint actually contained nicotine, which was contradictory to the advertisement.
  • The household use charger for e-cigarettes requiring power supply 100V is considered to be categorized into "the direct current power supply device", one of the Specified Electrical Appliances and Materials prescribed by the Electrical Appliances and Materials Safety Act. However, the PSE mark was not displayed on the case of the product B. While the PSE mark was displayed on the case of the product C, marks of accreditation/inspection bodies and name of the manufacturer were not indicated on it. Therefore, products B and C were suspected to infringe the Electrical Appliances and Materials Safety Act.

In order to determine whether the products containing nicotine fall under the category of "drugs without approval or authorization" and whether the seller of the products of complaint infringes the Pharmaceutical Affairs Act, the relevant administrative agency needs to interview the seller to judge the matters.

The center informed the inquirer of the findings of the product test, which showed that three types of cartridges contained nicotine and that some of the chargers might have infringed the Electrical Appliances and Materials Safety Act. The inquirer communicated the findings to the manufacturer and asked for a refund. Later, all the money was refunded by the manufacturer.

Information provision

(1) Information provided by NCAC

NCAC received several inquiries related to e-cigarettes like "After using an e-cigarette for 4 or 5 days, I became addicted to it", "I bought an e-cigarette which vapors and is shaped like a cigarette. I feel like as if I smoked while vaping it. I want to know about safety of the product" and so on. NCAC conducted a series of product tests of e-cigarettes and released an article titled "Considering the safety of e-cigarettes" on August 18, 2010.

After researching the cartridge liquid, nicotine was detected from 11 brands and 15 flavors out of the 25 brands and 45 flavors sold domestically. Though labels and instruction manuals stated product safety, grounds of safety were lacking or vague in many cases.

Based on these findings, NCAC advised consumers as follows.

  • Avoid lighthearted use of electronic cigarettes as the grounds regarding their safety are insufficient.
  • Avoid continuous use of electronic cigarettes in expectation of achieving smoking cessation or reduction since their effect is thought unclear, as mentioned below (3).
  • Guardians shall pay careful attention so that the product is not easily accessible to minors.
  • When overseas, beware of purchase/use/handover of foreign electronic cigarettes since some contain nicotine.

(2) Observation by the Ministry of Health, Labour and Welfare

In December 2010, the Ministry of Health, Labour and Welfare clarified its observation that if e-cigarettes containing nicotine which fall under the category of medicines and medical equipment under the Pharmaceutical Affairs Act are sold in Japan, the action of selling them is suspected to infringe the Act (stated on the document titled "Response to the request for cooperation in submitting materials based on Article 5 of the Act for the Establishment of a Consumer Affairs Agency and Consumer Commission").

(3) Result of overseas survey

In September 2008, the World Health Organization (WHO) questioned the safety and effect of e-cigarettes.*
In May 2009, the Food and Drug Administration (FDA) released findings that nicotine and diethylene glycol were detected from some of e-cigarette cartridges advertised as nicotine-free.

  1. * News release Marketers of electronic cigarettes should halt unproved therapy claims(WHO)