Laws
Law No. 6.437 of 1977, Federal Sanitary Legislation (as amended)
COMMENTS: Law No. 6.437 of 1977 provides for penalties for violations of the packaging and labeling requirements, among other things. Law No. 6.437 has been amended several times, most recently by Provisional Measure No. 2.190-34 of 2001, providing that fine amounts for violations take into consideration the economic capacity of the offender.
Brazilian Aeronautics Code, Law No. 7.565 of 1986 (as amended)
COMMENTS: Brazilian Aeronautics Code, Law No. 7.565 of 1986 provides definitions for several forms of public transportation. It was amended on March 3, 1998 by Law No. 9.614.
Law No. 8069 of 1990 on Prohibiting Sale to Minors Under 18 (as amended)
COMMENTS: Law No. 8069 of 1990 prohibits the sale of cigarette products, and any product that might cause physical or psychological dependence, to minors. Only an excerpted portion of the law is available here.
Consumer Rights Code, Law No. 8.078 of 1990 (as amended)
COMMENTS: The Consumer Rights Code, Law No. 8.078 of 1990, prohibits misleading advertising, among other things. Only an excerpted portion of the law is available here.
Law No. 9.294 (as amended)
COMMENTS: Law No. 9.294 (July 16, 1996) is a Federal law establishing restrictions on the use and advertising of smoking products, alcoholic beverages, medicines, therapeutic remedies, and pesticides.
The text of Law No. 9.294 uploaded here contains the provisions amended by Law No. 10.167/00 (prohibiting the use of smoking products in aircraft and other means of public transportation and restricting or prohibiting various forms of advertising, promotion and sponsorship of tobacco products); Provisional Measure No. 2.190-34/01 (requiring that all advertising and packaging of tobacco products, except those for exporting, display pictorial health warnings); and Law No. 10.702/03 (covering the text of health warnings).
Decree No. 2.018 on Regulations of Law No. 9.294
COMMENTS: Decree No. 2.018 (October 1, 1996) regulates Federal Law No. 9.294 (July 15, 1996) by defining the key terms related to restrictions on public smoking and listing those places exempted from the smoking ban, among other measures. Decree No. 2.018 was subsequently amended by Decree No. 8.262 of May 31, 2014.
Brazilian Traffic Code, Law No. 9.503 of 1997 (including Annex 1) (as amended)
COMMENTS: Brazilian Traffic Code, Law No. 9.503 of 1997, Appendix 1 of Concepts and Definitions provides definitions for several forms of public transportation. It has been amended several times, most recently by Law No. 12.058 on October 13, 2009.
Decree No. 3029 of April 16, 1999
Note: This law has not been reviewed by our legal staff and was not relied upon for purposes of our analysis. We are providing it here for informational purposes only.
Law No. 10.167 of December 27, 2000
COMMENTS: Law No. 10.167 (December 27, 2000) amends Law No. 9.294 (July 15, 1996) by prohibiting the use of smoking products in aircraft and other means of public transportation and restricting or prohibiting various forms of advertising, promotion and sponsorship of tobacco products.
ANVISA Resolution No. 46 of March 28, 2001 (as amended)
COMMENTS: ANVISA Resolution No. 46 of March 28, 2001 (as amended by ANVISA Resolution No. 335 of November 24, 2003) prohibited the use of terms such as light, soft, mild, or any other term that could mislead consumers as to the levels contained in the cigarettes in question. In addition, it established the maximum percentage of tar, nicotine, and carbon monoxide allowed. This resolution was repealed by ANVISA Resolution No. 14 of March 15, 2012.
ANVISA Resolution No. 104 of May 31, 2001
Note: This law has not been reviewed by our legal staff and was not relied upon for purposes of our analysis. We are providing it here for informational purposes only.
Provisional Measure No. 2.190-34
COMMENTS: Provisional Measure No. 2.190-34 (August 23, 2001) amends Federal Law No. 9.294 (July 15, 1996) by requiring that all advertising and packaging of tobacco products, except those for exporting, display pictorial health warnings.
ANVISA Resolution No. 304 of November 8, 2002
COMMENTS: ANVISA Resolution No. 304 of November 8, 2002 prohibits the use of packages of food that resemble cigarette packaging and the use of tobacco brand names for food products.
ANVISA Resolution No. 15 of January 17, 2003
COMMENTS: ANVISA Resolution No. 15 of January 17, 2003 regulates certain provisions of Law No. 9.294 of 1996 by defining key terms such as “tobacco products propaganda and advertising” and "inside the points of sale" and prohibits the internet sales of tobacco products. This resolution was revoked by ANVISA Resolution No. 558 of August 30, 2021.
ANVISA Resolution No. 335 of November 24, 2003
COMMENTS: ANVISA Resolution No. 335 of November 24, 2003 mandated new pictorial health warnings and other packaging and labeling information. This resolution was repealed by ANVISA Resolution No. 195 of December 14, 2017.
ANVISA Resolution No. 90 of December 27, 2007
COMMENTS: ANVISA Resolution No. 90 of December 27, 2007 provides key definitions such as “smoking product,” “brand name,” and “descriptor.” This resolution was subsequently amended by ANVISA Resolution No. 32 of May 30, 2008 and revoked by ANVISA Resolution No. 226 of April 30, 2018.
ANVISA Resolution No. 32 of May 30, 2008
COMMENTS: ANVISA Resolution No. 32 of May 30, 2008 amends portions of ANVISA Resolution No. 90 of December 27, 2007. ANVISA Resolution No. 90 of December 27, 2007 was subsequently revoked by Resolution No. 226 of April 30, 2018.
ANVISA Resolution No. 54 of August 6, 2008
COMMENTS: ANVISA Resolution No. 54 of August 6, 2008 mandates the text of the health warnings prescribed by ANVISA Resolution No. 335 of November 24, 2003. These health warnings were rescinded and replaced by health warnings contained in ANVISA Resolution No. 195 of December 14, 2017.
ANVISA Resolution No. 46 of August 28, 2009 Prohibiting the Sale, Importation, and Advertising for Any Kind of Electronic Smoking Devices (Electronic Cigarettes)
COMMENTS: ANVISA Resolution No. 46 of August 28, 2009 prohibits the sale, importation and advertising of e-cigarettes and heated tobacco products, but the resolution does provide a potential avenue for the sale of these products in the future. This resolution was revoked by ANVISA Resolution No. 855 of April 23, 2024.
Decree No. 7212 of June 15, 2010 (as amended)
COMMENTS: Decree No. 7212 of June 15, 2010 regulates the administration of taxes on manufactured goods, including tobacco products. The provisions include a requirement that cigarettes be sold in packs of 20 sticks.
Act No. 12.402 of May 2, 2011
Note: This law has not been reviewed by our legal staff and was not relied upon for purposes of our analysis. We are providing it here for informational purposes only.
Law No. 12.546 of December 14, 2011
COMMENTS: Law No. 12.546 of December 14, 2011 makes several amendments to Law No. 9.294. In particular, the amendments prohibit smoking in all shared enclosed spaces; extend the ban on forms of tobacco advertising, promotion and sponsorship; and require text health warnings on the front of packaging (in addition to the graphic health warning occupying 100% of the back of the package).
ANVISA Resolution No. 14 of March 15, 2012
COMMENTS: ANVISA Resolution No. 14 of March 15, 2012 bans the use of additives and flavorings in all tobacco products, including the use of menthol, clove and ammonia among others. The resolution also extends the ban on misleading descriptors on tobacco product packages to all tobacco products including little cigars.
Administrative Rule No. 713 of April 17, 2012
COMMENTS: Administrative Order No. 713 contains ethical guidelines adopted by Brazil’s national tobacco control commission, the National Comissão da Convenção Implementação or Control-Quadro to do Snuff e seus Protocols (CONICQ), which regulates certain conflicts of interest, CONICQ-tobacco industry interactions, participation of government servants in events sponsored by industry, and employment proposals. The administrative order also establishes the following principles for action for members of the CONICQ: transparency, the primacy of the interests of public health, access to information about the tobacco industry and its interference in tobacco control policies, and publicity of interactions between the tobacco industry and CONICQ.
ANVISA Resolution No. 30 of May 23, 2013
COMMENTS: ANVISA Resolution No. 30 of May 23, 2013 amended ANVISA Resolution No. 335 of November 21, 2003 and established the contents of the health warnings required to be displayed on packaging beginning January 19, 2014. The new set of health warnings replaced the set established in ANVISA Resolution No. 54 of August 6, 2008. The resolution also updated the quitline phone number. This resolution was repealed by ANVISA Resolution No. 195 of December 14, 2017.
ANVISA Resolution No. 43 of September 3, 2013
COMMENTS: ANVISA Resolution No. 43 of September 3, 2013 amended the deadlines established in ANVISA Resolution No. 30 of May 23, 2013 for the display of a new round of health warnings. The new effective date was established as January 19, 2014. This resolution was repealed by ANVISA Resolution No. 195 of December 14, 2017.
Law No. 12.921 of December 26, 2013
COMMENTS: Law No. 12.921 prohibits the manufacture, distribution, sale, and advertisement of products intended for children that resemble tobacco products.
Decree No. 8.262 of May 31, 2014
COMMENTS: Decree No. 8.262 of May 31, 2014 amends Decree No. 2.018 of December 1, 1996 with respect to places where designated smoking rooms are permitted, the display of tobacco products at points of sale, and product packaging and labeling.
Interministerial Edict No. 2.647 of December 4, 2014
COMMENTS: Interministerial Edict No. 2.647 of December 4, 2014 establishes the conditions for isolation, ventilation, and removal of air and other worker protections in designated smoking rooms.
ANVISA Resolution No. 14 of April 10, 2015
COMMENTS: ANVISA Resolution No. 14 of April 10, 2015 established the requirements for the health warning required to appear on the lower 30% of the front of tobacco product packages beginning January 1, 2016. This resolution was repealed by ANVISA Resolution No. 195 of December 14, 2017.
Application Manual, Health Warnings on Tobacco Product Packaging
COMMENTS: The Application Manual was issued by ANIVISA to provide additional details related to pictorial health warnings and qualitative constituents and emissions information required to appear on tobacco product packaging under Resolution No. 195 of December 14, 2017.
ANVISA Resolution No. 195 of December 14, 2017
COMMENTS: ANVISA Resolution No. 195 of December 14, 2017 establishes the packaging and labeling requirements for all smoked tobacco products, including a new round of health warnings. This resolution was rescinded by ANVISA Resolution No. 838 of December 14, 2023.
ANVISA Resolution No. 213 of January 23, 2018
COMMENTS: ANVISA Resolution No. 213 of January 23, 2018 was rescinded by ANVISA Resolution No. 558 of August 30, 2021.
ANVISA Resolution No. 226 of April 30, 2018
COMMENTS: ANVISA Resolution No. 226 of April 30, 2018 was rescinded by ANVISA Resolution No. 559 of August 30, 2021.
ANIVSA Resolution No. 559 of August 30, 2021
COMMENTS: ANVISA Resolution No. 559 of August 30, 2021 establishes the processes through which manufacturers, importers, and exporters must register their smoked tobacco products. Registration for manufacturers and importers includes the annual disclosure of contents and emissions information for each product. This resolution rescinds ANVISA Resolution No. 226 of April 30, 2018 and ANVISA Resolution No. 452 of December 17, 2020.
ANVISA Resolution No. 558 of August 30, 2021
COMMENTS: ANVISA Resolution No. 558 of August 30, 2021 sets out the restrictions and requirements for the display of tobacco products at point of sale. It also contains some restrictions on the sale of tobacco products (e.g., via internet and postal delivery) and on promotion of tobacco products. This resolution rescinds ANVISA Resolution No. 15 of January 17, 2003 and ANVISA Resolution No. 213 of January 23, 2018.
ANVISA Resolution No. 838 of December 14, 2023
COMMENTS: ANVISA Resolution No. 838 of December 14, 2023 establishes the packaging and labeling requirements for all smoked tobacco products. This resolution rescinds ANVISA Resolution No. 195 of December 14, 2017.
Normative Instruction No. 271/2023
COMMENTS: Normative Instruction No. 271 of December 14, 2023 contains the picture and text warnings that implement ANVISA Resolution No. 838 of December 14, 2023. These picture and text warnings replace the warnings in ANVISA Resolution No. 195 of 2017.
ANVISA Resolution No. 855 of April 23, 2024
COMMENTS: Resolution No. 855 of April 23, 2024 bans the manufacture, import, marketing, distribution, storage, transportation, and advertising of electronic smoking devices, which is defined to include e-cigarettes and heated tobacco products. It repeals ANVISA Resolution No. 46 of August 28, 2009.