LANGUAGE
Last updated: October 16th 2018

Regulated Contents in Cigarettes

Regulatory Authority

Are contents and/or ingredients of cigarettes regulated?

Yes
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Regulatory Authority:

Agência Nacional de Vigilância Sanitária [ANVISA National Health Surveillance Agency]

Analysis

Decree No. 3029 delegates broad authority to ANVISA to regulate "on subjects within the competence of the agency." ANVISA RDC No. 14/2012, invoking this authority, regulates additives in tobacco products sold in Brazil.

Law Source, Section
Decree No. 3029 of April 16, 1999
Art. 11(IV)

Are cigarette emissions regulated?

Yes
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Regulatory Authority:

Agência Nacional de Vigilância Sanitária [ANVISA National Health Surveillance Agency]

Analysis

Decree No. 3029 delegates broad authority to ANVISA to regulate "on subjects within the competence of the agency." ANVISA RDC No. 14/2012, invoking this authority, regulates the maximum level of emissions of tobacco products sold in Brazil.

Law Source, Section
Decree No. 3029 of April 16, 1999
Art. 11(IV)
Status of Regulated Ingredients in Cigarettes

Sugars and sweeteners

Some Restrictions
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Examples of sugars and sweeteners include: glucose, molasses, honey and sorbitol.

Analysis

The law prohibits tobacco products that contain "sweeteners, honey, molasses or any other substance that can impart a sweet flavor, apart from sugars." The law permits "sugars, exclusively for the restitution of the sugar originally present in tobacco leaf prior to the curing process." Companies that use "sugar" must submit a declaration of losses and the need for restitution to ANVISA when applying for registration or renewal of registration of the tobacco product. Because sweeteners are prohibited but sugars are restricted, the regulatory status code "Some Restrictions" is given. These restrictions apply to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients used to increase palatability such as sugars and sweeteners in cigarettes.

Menthol, mint or spearmint (including analogues and derivatives)

Banned
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Analysis

The law prohibits tobacco products that contain "synthetic and natural substances in any form (pure substances, extracts, oils, distillates, balms, among others), with flavoring properties that can impart, intensify, modify or enhance the flavor of the product" and "seasonings, herbs and spices or any substance that can impart a flavor of seasonings, herbs and spices" in tobacco products. These categories encompass menthol, mint, and spearmint. The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients used to increase palatability such as menthol, mint, or spearmint in cigarettes.

Spices and herbs (excluding mint)

Banned
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Examples include: cinnamon and ginger.

Analysis

The law prohibits tobacco products that contain "seasonings, herbs and spices or any substance that can impart a flavor of seasonings, herbs and spices." The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients used to increase palatability such as spices and herbs (excluding mint) in cigarettes.

Other flavorings (not covered above)

Banned
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Includes fruit flavorings. Examples of flavoring substances include benzaldehyde, maltol and vanillin.

Analysis

The law prohibits tobacco products that contain "synthetic and natural substances in any form (pure substances, extracts, oils, distillates, balms, among others), with flavoring properties that can impart, intensify, modify or enhance the flavor of the product, including additives identified as flavoring agents: a) by the Joint FAO/WHO Expert Committee on Food Additives - JECFA; or b) by the Flavor and Extract Manufacturers Association - FEMA." Therefore, all flavorings, including benzaldehyde, maltol and vanillin, are prohibited in tobacco products. The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients used to increase palatability such as other flavorings (not covered above) in cigarettes.

Ingredients that facilitate nicotine uptake

Some Restrictions
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Examples include: ammonia.

Analysis

The law prohibits tobacco products that contain ammonia or any of its compounds and derivatives. The ban applies to all tobacco products. However, the law does not prohibit other ingredients that facilitate nicotine uptake. Therefore, the regulatory status code "Some Restrictions" is given.

The law furthers FCTC Arts. 5.2 and 9 in that it regulates ingredients that facilitate nicotine uptake, such as ammonia.

Ingredients which may create an impression of health benefits

Banned
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Examples include: vitamins, such as vitamin C and vitamin E, fruit and vegetables (and products resulting from their processing such as fruit juices), amino acids, such as cysteine and tryptophan, and essential fatty acids such as omega-3 and omega-6.

Analysis

The law prohibits tobacco products that contain "additives with nutritional properties, including: a) amino acids; b) vitamins; c) essential fatty acids; and d) minerals, except for those that are demonstrably essential to the manufacture of the tobacco products" and "fruits, vegetables or any product originating from the processing of fruits and vegetables, except activated charcoal and amides." Thus, ingredients which may create an impression of health benefits are banned. The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that the law prohibits the use of ingredients in cigarettes that may create an impression of health benefits.

Ingredients associated with energy and vitality

Banned
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Examples include: caffeine, guarana, taurine and glucuronolactone.

Analysis

The law prohibits tobacco products that contain "additives associated with alleged stimulating or invigorating properties, including taurine, guaraná, caffeine and glucuronolactone." The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that the law prohibits the use of ingredients in cigarettes that are associated with energy and vitality.

Pigments

Banned
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Analysis

The law prohibits tobacco products that contain "pigments (or coloring agents)." The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients that have coloring properties in cigarettes.

Processing aids for flavorings

Banned
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Analysis

The law prohibits tobacco products that contain "processing aids for flavorings." The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients that may be used to increase palatability in cigarettes.

Ameliorants

Banned
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Analysis

The law prohibits tobacco products that contain ameliorants, which are defined as "a substance that reduces irritating aspects of the smoke of tobacco products." The ban applies to all tobacco products.

The law aligns with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines in that it regulates ingredients that may be used to increase palatability in cigarettes.