Anvisa Updates Regulation, Maintains Electronic Cigarettes Ban

The Brazilian Health Regulatory Agency (Anvisa) upheld the prohibition on electronic smoking devices (ESDs), commonly known as electronic cigarettes. The decision is the outcome of a regulatory process that reviewed the regulation of these products in the country in light of the latest scientific information available.

The updated regulation maintains the ban on manufacturing, importing, commercializing, distributing, storing, transporting, and advertising all electronic smoking devices. This means that all forms of importation, including personal use and traveler’s hand luggage, are prohibited.

While individual use is not banned by the regulation, it’s crucial to note that the use of any smoking device is prohibited in enclosed public spaces, as stipulated by Law 9.294/1996 since 1996.

The new resolution also includes provisions for the systematic updating of literature by Anvisa whenever there is scientific justification and the possibility for interested parties to submit new data for the Agency’s analysis.

Here are the key points of the updated regulation:

  • The prohibition on manufacturing, importing, commercializing, distributing, storing, transporting, and advertising all electronic smoking devices, including accessories, parts, and refills, remains in place.
  • The entry of any electronic smoking product brought by travelers into the country, through any form of importation, including accompanied luggage, remains prohibited.
  • The use of any electronic smoking device in enclosed public spaces is prohibited by law.
  • Anvisa will periodically review the literature on the topic whenever there is scientific justification.
  • Literature reviews must be independent and free from conflicts of interest. Anvisa will issue a call for scientific studies for these reviews.
  • Interested parties may submit toxicological studies, specific scientific tests, and peer-reviewed scientific articles published in indexed journals to demonstrate the alleged purposes of any electronic smoking device, which will be subject to Anvisa’s technical analysis.

Non-compliance with the resolution constitutes a sanitary infraction and may result in penalties under Laws 9.294, dated July 2, 1996, and 6.437, dated August 20, 1977, including warnings, closures, recalls, fines, among others.

This decision by Anvisa represents the continuation of a long-standing prohibition. Since 2009, all types of electronic smoking devices, including electronic cigarettes, have been prohibited in Brazil according to RDC 46, dated August 28, 2009. This prohibition encompasses the commercialization, importation, and advertising of any electronic smoking devices.