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Draft Bill No. 5008 of 2023 on the Control of Electronic Cigarette Products in Brazil

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LCS

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2023-10-31

On October 17, 2023, Brazilian Senator Soraya Thronicke drafted a draft law on the manufacturing, import, export, sales, control, supervision, and advertising of electronic cigarette products. Bill No. 5008 of 2023 provides for the production, import, export, marketing, control, supervision, and advertising of electronic cigarettes, and makes other provisions. The draft law is currently under discussion in the Economic Affairs Committee of the Brazilian Parliament.


The partial requirements of the draft decree are as follows:
1、 Registration requirements
1. Electronic cigarette products (with and without nicotine) listed in Brazil must be registered with the Brazilian National Health Supervision Agency (Ag ê ncia Nacional de Vigil â ncia Sanit á ria, Anvisa), with a registration fee of one hundred thousand reais (R $100000.00 (one hundredthousand). At the time of registration, a toxicity risk assessment report of the product must be submitted.
2. According to appropriate regulations, the National Institute of Metrology, Quality, and Technology (Inmetro) determines non hygienic operating standards for electronic cigarettes, such as charging safety and battery specifications. For quality control purposes, products must be registered with Inmetro.
3. According to appropriate regulations, the National Telecommunications Administration (Anatel) determines non hygienic operating standards for electronic cigarettes, such as Bluetooth technology or other similar wireless technologies. If the product uses wireless technology, it must be registered with Anatel.
2、 Product requirements
1. Only closed e-cigarette products are allowed to be sold (non open e-cigarette products cannot be refilled).
2. The volume of tobacco oil should not exceed 22ml, and the concentration of nicotine should not exceed 35mg/ml.
3. The additives in tobacco oil must be food and drug grade high-purity substances, and substances such as vitamins, caffeine, taurine, colorants, vitamin E acetate, mineral oil, vegetable oil, animal oil, etc. are prohibited.
4. The product must have anti child opening and anti opening functions.
The product requirements apply to e-cigarette products containing nicotine and those without nicotine (excluding nicotine concentration).
3、 Packaging and instruction manual requirements
1. The outer packaging of the product must include the following information:
(a) List the ingredients contained in tobacco oil by additive category;
(b) Clear and easy to understand labeling of nicotine concentration;
(c) Batch number, production date, and shelf life;
(d) Clear instructions for placing it out of reach of children or adolescents;
(e) Health warning message: For e-cigarettes containing nicotine, cover 20% of the maximum main display area of the outer packaging, with the following content: "Este produto cont é m nicotina que é uma subst â ncia que causa depend ê ncia. N ã o é recomendado o consulmo por n ã o fumantes".
(This product contains nicotine, a substance that can lead to addiction. It is not recommended for non-smokers to use.)
2. The product must be accompanied by a manual containing the following content:
(a) Instructions for use and storage, including that the product is prohibited for children under the age of 18 and is not recommended for use by non-smokers;
(b) Suggestion not to let pets come into contact with the product;
(c) Contraindications;
(d) Warnings for pregnant women, diabetes patients, heart disease and other specific risk groups;
(e) Possible adverse effects;
(f) Addiction and toxicity;
(g) The contact information of the manufacturer or importer, including CNPJ and synthetic address (information ç Å es de contato, including CNPJ e endere ç o sint é tico, para o fabricante ou Importator.).
Regarding the requirements for packaging and instructions, the draft law specifically mentions that descriptive text, patterns, and logos related to desserts and candies that attract children and adolescents should not be included.
Background: Anvisa issued a resolution prohibiting the import, sale, and advertising of electronic cigarette products on August 28, 2009 (Prohibits sale, import, and advertising for any kind of electronic smoking devices, known as electronic cigarettes - RDC Resolution No. 46 of August 28, 2009), and decided to continue this ban on July 6, 2022.
Official public information link: https://www.congressonacional.leg.br/materias/materias-bicamerais/-/ver/pl-5008-2023

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