Last updated: July 19, 2024
Main Policies
Sale of e-cigarettes
The sale of e-cigarettes is allowed subject to restrictions including product registration, a maximum nicotine concentration, and a minimum sales age.
Use in indoor public places, workplaces, and public transport
The law prohibits the use of e-cigarettes in indoor public places, workplaces, and public transport. Instead, the law expressly permits their use only in “open spaces.” Additionally, the law requires notices to be posted in these places indicating that smoking and the use of e-cigarettes is prohibited and that they are “harmful to health.”
Advertising and promotion (excluding point of sale product display)
The law prohibits all forms of e-cigarette advertising and promotion. Law No. 7508 does not contain any exceptions for advertising at the point of sale, which is permitted under Ministry of Public Health Resolution S.G. No. 630. Because Law No. 7508 was adopted more recently and is a superior legal instrument, the law is interpreted as prohibiting advertising at the point of sale. Instead, only signs indicating the cost of the products are permitted.
In addition, the law prohibits the free distribution of e-cigarettes.
Sponsorship
The law prohibits e-cigarette sponsorship. Sponsorship of tobacco and e-cigarette products is defined as “any form of contribution to any action, activity, or individual with the purpose, effect, or possible effect of directly or indirectly promoting a tobacco product or tobacco use.” Therefore, the law is interpreted as prohibiting all tobacco industry sponsorship of events, activities, individuals, organizations, and governments.
Point of sale product display
The law allows the display of e-cigarettes at points of sale so long as they are not directly accessible to the end consumer (such as gondolas, displays, open showcases, and supermarket counters). The display of e-cigarettes must be locked. Therefore, the regulatory status code “Some Restrictions” is given.
Sale of e-cigarettes via the internet
The law prohibits the sale of e-cigarettes through the internet.
Flavors (other than tobacco flavor)
The law does not prohibit or restrict flavors in e-cigarettes. Indeed, the definition of e-cigarettes specifically acknowledges that e-cigarettes may contain flavors.
Specified ingredients/additives
The law prohibits substances that are (1) vitamins and other additives that give the impression that a product has health benefits or reduces health risks; (2) caffeine, taurine, or other additives and stimulants associated with energy and vitality; (3) additives with coloring proper-es during combustion; (4) additives that facilitate the inhalation or ingestion of nicotine; (5) additives that have carcinogenic, mutagenic, or nephrotoxic properties; and (6) cannabis in any form.
Health warnings on product packaging
The law requires that packs display pictorial health warnings covering at least 60% of the main surface of the pack, which should be rotated. The accompanying text warning must be in equal parts Spanish and Guarani. However, the contents and rotation requirements of the warnings under the law have not yet been issued.
Other product packaging and labeling requirements
The following must be printed on the packaging: sale to minors is prohibited, qualitative list of components and harmful effects of product, date manufactured, expiration date, and information on proper use and storage. A leaflet must be included containing recommendations on use, warnings about the harmful effects of its use, the quantitative and qualitative formula of the components, contraindications, addiction and toxicity.
The law prohibits the use of descriptive terms or elements, trademarks, device marks, or other marks that have the direct or indirect effect of creating the false impression that the e-cigarettes are less harmful than other products in terms of content, risks, or emissions. The law also prohibits the use of expressions such as “light”, “ultra-light”, or “mild” on primary and secondary packaging of e-cigarettes.
Maximum nicotine concentration
The law establishes a maximum nicotine concentration of 20 mg/ml or 2%.
Device requirements
The law requires that e-cigarettes and refill containers and cartridges have a safety mechanism to prevent their handling and use by children. Additionally, these must be protected against breakage and fluid leaks. E-cigarettes must also be able to deliver a dose of nicotine at consistent levels under normal conditions of use.
Manufacturer/importer disclosures and/or notification requirements
The law requires that all products placed on the market be registered with DINAVISA (National Health Surveillance Directorate) and be in compliance with all requirements established by DINAVISA.
Specific retail license or equivalent approval
The law requires that establishments or points of sale may only sell e-cigarettes if authorized by DINAVISA (National Health Surveillance Directorate).
Sale of e-cigarettes via vending machines
Law No. 5538 requires that all e-cigarette sales only be carried out in person and directly, which would prohibit vending machine sales. However, Law No. 7508 appears to permit the sale of e-cigarettes via vending machines with adult (at least 18 years old) age verification. Because these provisions are inconsistent, the regulatory status code “Uncertain” is given.
Location-based sales
The law restricts the sale of e-cigarettes based on location, such as prohibiting sales in healthcare centers, educational centers, and sports facilities.
Sale of disposable e-cigarettes
The law does not address the sale of disposable e-cigarettes; therefore, the disposable e-cigarettes is allowed.
