LANGUAGE
Last updated: September 17th 2019

Main Policies

Sale of e-cigarettes

Sale of e-cigarettes

Banned except as medicinal products
Analysis

Administrative Order No. 2014-0008 classifies electronic cigarettes as combination drugs and medical devices, and not as tobacco products. As such, electronic cigarettes must pass the FDA's safety, efficacy and quality evaluation before the FDA issues a market authorization as a health product and health-related device. It appears as though no manufacturer or distributor has applied for FDA approval, and yet there are many products available on the market.


Main policies

Use in indoor public places, workplaces, and public transport

Some Restrictions
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Analysis

Administrative Order No. 2014-0008 requires that use of electronic cigarettes in public places follow 'clean air laws.' Rep. Act No. 9211 contain the ‘clean air laws’ which restrict the places where smoking is allowed, and prohibits smoking in specific enumerated public places like gas stations, elevators, food preparation areas, hospitals, health centers, dispensaries, laboratories, schools, playgrounds, centers of youth activity, recreational facilities, and places frequented by minors. Other public places are permitted to establish designated smoking areas. Smoking is prohibited in all land transportation vehicles and aircraft.

As a result of electronic cigarette use being prohibited in only specified places, the regulatory status code “Some Restrictions” is given.

Additionally, several cities have included the use of electronic cigarettes in public places in their smoke free ordinances. Thus, in those cities, the use of electronic cigarettes is not allowed where smoking is prohibited.

Advertising, promotion and sponsorship

Allowed
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Analysis

Administrative Order No. 2014-0008 requires that the FDA regulate electronic cigarette advertisements and promotions. DOH Circ. No. 2011-0101 prohibits health products, including electronic cigarettes, from being advertised, promoted or subjected to any marketing activities unless that health product has been registered or authorized. The law requires that the FDA approve all claims made in advertisements, promotions, sponsorships, and other marketing activities, and specifically prohibits therapeutic or scientific claims without FDA approval. Although, it appears as though no manufacturer or distributor has applied for FDA approval.

Given that the advertising, promotion or sponsorship of electronic cigarettes is allowed with market authorizations, the regulatory status code “Allowed” is given.

However, several cities have included advertising electronic cigarettes in their smoke free ordinances. Thus, in those cities, advertising of electronic cigarettes is not allowed.

Sale of e-cigarettes via the internet

Allowed
Analysis

Administrative Order No. 2014-0008 classifies electronic cigarettes as combination drugs and medical devices, and not as tobacco products. As such, electronic cigarettes must pass the FDA's safety, efficacy and quality evaluation before the FDA issues a market authorization as a health product and health-related device. Although, electronic cigarettes are widely available for sale through the internet, it appears as though no manufacturer or distributor has applied for FDA approval.

Given that the sale via internet is allowed with market authorizations, the regulatory status code “Allowed” is given.

Health claims in advertising (modified risk claims)

Allowed
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Analysis

DOH Circ. No. 2011-0101 requires advertising, promotion, sponsorship and other marketing activity adhere to FDA standards. The circular requires that the consumer be protected against false or misleading product advertising. However, Admin. Order No. 2014-0008 permits claims that electronic cigarettes can be a "cessation aid to smoking" or "less harmful alternative or reduced harm compared to smoking" provided that health product safety, efficacy and quality standards are met. Although, it appears as though no manufacturer or distributor has applied for FDA approval.

Given that certain health claims in electronic cigarette advertising are allowed with market authorizations, the regulatory status code “Allowed” is given.

Flavors

Allowed
Analysis

Administrative Order No. 2014-0008 classifies electronic cigarettes as combination drugs and medical devices, and not as tobacco products. As such, electronic cigarette cartridges containing the ingredients or "electronic juice" are required to pass the safety, efficacy and quality standards of the FDA. It appears as though no manufacturer or distributor has applied for FDA approval of “electronic juice.” The Administrative Order does not specifically address flavors, and there are many flavored electronic cigarettes and e-liquids available on the market.

Health warnings on product packaging

Not Required
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Analysis

There are no requirements for the size or location of health warnings. DOH Circ. No. 2011-0101 requires that the FDA approve all product packaging. However, it appears as though no manufacturer or distributor has applied for FDA approval, though many products, without health warnings, are available on the market.

Maximum nicotine concentration

Not Required
Analysis

Administrative Order No. 2014-0008 requires that the nicotine delivery dose be subject to pharmaceutical standards. The order does not provide further information on what is the pharmaceutical standard.

As a result of the order not prescribing a maximum nicotine concentration, the regulatory status code “Not Required” is given.

False or misleading labels

Banned
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Analysis

DOH Circ. No. 2011-0101 prohibits health product labels, including electronic cigarette labels, from providing information that is “false and misleading or does not conform to current labeling requirements.” DOH Circ. No. 2011-0101 requires that the FDA approve all product packaging. Although, it appears as though no manufacturer or distributor has applied for a FDA approval, though many products are available on the market.

Child-proof cartridge and device

Required
Analysis

Administrative Order No. 2014-0008 requires that both the cartridge and device are child-proof to prevent accidental ingestion or leakage of ingredients and misuse of the device. Additionally, the order classifies electronic cigarettes as combination drugs and medical devices, and not as tobacco products. As such, electronic cigarettes must pass the FDA's safety, efficacy and quality evaluation before the FDA issues a market authorization as a health product and health-related device. Although, it appears as though no manufacturer or distributor has applied for a FDA approval, though many products are available on the market.