Last updated: May 23, 2022
Sale of e-cigarettes
The sale of e-cigarettes is allowed subject to an FDA license. Sales of e-cigarettes are subject to a number of restrictions including location-based sales, a minimum sales age of 21, flavor restrictions, and retail licenses.
Use in indoor public places, workplaces, and public transport
The law prohibits the use of e-cigarettes where smoking is prohibited, which includes public conveyances and enumerated indoor public places and workplaces, such as government facilities, healthcare facilities, educational institutions, and facilities frequented by minors. There is an exception for use within “designated smoking and vaping areas (DSVAs).” DSVAs are permitted in specified public places and workplaces, including bars and nightclubs. Therefore, the regulatory status code "Some Restrictions" is given.
Advertising and promotion (excluding point of sale product display)
Executive Order No. 26, as amended by Executive Order No.106, prohibits the advertisement and promotion of e-cigarettes in areas where their sale and distribution are prohibited, which includes schools, public playgrounds, facilities and areas frequented by minors, and within 100 meters of any of these places. It is also prohibited to advertise e-cigarettes or components outside or inside the premises of point-of-sale retail establishments. Therefore, the regulatory status code "Some Restrictions" is given.
Point of sale product display
There are no laws that restrict the display of e-cigarettes at point of sale; therefore, product display is allowed.
Health claims in advertising (modified risk claims)
Any health claims in e-cigarette advertising must comply with the regulatory requirements and standards for drug/pharmaceutical products under the jurisdiction of the Center for Drug Regulation and Research (CDRR). Further, any e-cigarette products making health claims are subject to additional requirements as may be prescribed by the Department of Health (DOH) and Food and Drug Administration (FDA).
Sale of e-cigarettes via the internet
The sale of e-cigarettes through the internet is allowed and online sellers and distributors of e-cigarettes must be licensed by the Food and Drug Administration and only sell through platforms that require customers to have a verified customer account to access the content of the online store.
The law prohibits the manufacture, importation, sale, and distribution of e-cigarettes and e-liquids with flavoring other than plain tobacco or plain menthol. Additionally, Executive Order No. 106 prohibits “[i]ncorporating e-liquids, solutions and refills with flavors and additives that are proven or suspected to be appealing or enticing to persons below twenty-one (21) years of age, toxic, harmful, addictive or sensitizing.” Administrative Order No. 2020-0055 also prohibits the retail sale of ingredients and materials for the purpose of modifying e-cigarettes, such as but not limited to flavorings, nicotine shots, and other additives.
Executive Order No. 26, as amended by Executive Order No. 106, prohibits the addition of tetrahydrocannabinol (THC) or cannabinoid compounds to liquids used in e-cigarettes.
Administrative Order No. 2020-0055 also prohibits the retail sale of ingredients and materials for the purpose of modifying e-cigarettes, such as but not limited to flavorings, nicotine shots, and other additives.
Health warnings on product packaging
The law requires pictorial health warnings on unit packets and any outside packaging of e-cigarettes (retailers will have until July 2022 to comply with the requirements). These warnings must be compliant with Republic Act No. 10643 (Graphic Health Warnings Law). Under Administrative Order No. 2021-0051 (Guidelines on Graphic Health Warnings on Vapor Products, Heated Tobacco Products and Other Similar Products), rotating and combined picture and text health warnings are required to be placed on 50% of each of the principal display areas of e-cigarette packaging. An additional health warning and/or cessation hotline or website is required on 30% of one side panel.
Other product packaging and labeling requirements
E-cigarette product packaging must not display any misleading descriptors, including any term that claims or misleads a consumer to believe that an e-cigarette product is healthier, safer, less harmful, or approved for use as a smoking cessation device, unless otherwise approved for use by the Food and Drug Administration. The law also requires e-cigarette product packaging to indicate the actual volume in milliliters of the liquid solutions and gels. Further, there may be national standards providing for other product packaging and labeling requirements as well as fiscal markings required by certain agencies.
Maximum nicotine concentration
The law does not prescribe a maximum nicotine concentration level in e-cigarettes. However, e-cigarette product refills and cartridges containing nicotine concentrations above 65 mg/mL (>65mg/mL) must comply with the regulatory requirements and standards for drug/pharmaceutical products under the jurisdiction of the Center for Drug Regulation and Research (CDRR).
Executive Order No. 106 requires that devices forming components of e-cigarettes meet product standards imposed by the Department of Trade and Industry and the Food and Drug Administration, in accordance with Act Nos. 7394 and 11467. However, it is not clear that such standards have been developed to date.
Manufacturer/importer disclosures and/or notification requirements
The law requires registration of all e-cigarettes prior to sale or distribution under the FDA Electronic Registration Number (FERN) process and batch declaration process (for e-cigarette refills and cartridges).
Manufacturers, importers, and distributors of e-cigarettes must submit to the Commissioner of Internal Revenue within the first five days of every month a sworn statement of the volume of sales for each e-cigarette brand sold in the preceding three months.
Location-based sales restrictions
The law prohibits sales in or within 100 meters from any point of the perimeter of a school, public playground, youth hostel, or other facility or area frequented by minors.
Specific retail license
Executive Order No. 106 requires all establishments engaged in the manufacture, distribution, importation, marketing, and sale of e-cigarettes or their components to secure a License to Operate (LTO) from the Food and Drug Administration.