National Health Surveillance Agency  
www.anvisa.gov.br  
Public Consultation No  41 of 23  June 2009.   
D.O.U (Official Gazette of the Union) of 24/06/09  
The Board of the National Health Surveillance Agency (ANVISA) , in the exercise of 
the powers granted by Article 11(IV) and Article 35 of ANVISA’s Regulations, approved by 
Decree No. 3029 of 16 April 1999, and having regard to the provisions of Article 54, indent (V) 
and paragraphs (1) and (3) of the Internal Regulations approved in accordance with Annex I of 
ANVISA Administrative Ruling No. 354 of 11 August 2006, republished in the Official Gazette 
of the Union of 21 August 2006, at a meeting held on 16 June 2009,  
hereby approves the following Public Consultation, and I, the Director -President, order its 
publication:  
Article 1. Criticism and suggestions concerning the draft Resolution prohibiting the sale of 
Electronic Smoking Devices (ESD) may be submitted up to 30 (thirty) days from the date of 
publication of this Public  Consultation.  
Article 2. The full text of the draft Resolution will be available on Anvisa's website, 
http://www.anvisa.gov.br . Suggestions should be submitted in writing, using the dedicated form 
available on Anvis a’s website at:  http://www.anvisa.gov.br/divulga/consulta/formulario.doc , to 
one of the following addresses:  Avenida Graça Aranha 206 - 2º andar - Centro - Rio de Janeiro - 
RJ, CEP 200 30-001, or by e -mail to:  controle.tabaco@anvisa. gov.br . 
Article 3. At the end of the period specified in Art. 1, the National Health Surveillance 
Agency will talk to the Bodies and Entities involved and o ther parties with an interest in the 
matter, and ask them to nominate representatives for subsequent discussions, in order to arrive at 
a final wording.  
DIRCEU RAPOSO DE MELLO  
ANNEX A   
Form for submission of contributions as part of a Public Consultation  
 National Health 
Surveillance Agency  FORM FOR SUBMISSION OF 
CONTRIBUTIONS AS PART OF A PUBLIC 
CONSULTATION  
 
Introduction and guidelines  
This form is intended to enable members of the public to send their contributions to aid in the 
process of making a dec ision on a Public Consultation organised by Anvisa.  
When completing the form, please note the instructions below:  
• Completed forms can be returned to Anvisa by e -mail, fax or post, using the addresses given 
in the Public Consultation . 
• Complete all sections of this Form and send your comments within the period during which 
the Public Consultation is open for contributions.  • Any contributions received outside this period or not sent using this Form will not be taken 
into consideration for the preparation of the  final text of the regulation.  
• If the information provided on this Form is incomplete or imprecise Anvisa may not be able 
to use it.   
• The contributions received by Anvisa will be published and will remain available to the 
public on Anvisa’s website.  
• This p rocess will help to increase transparency and public participation, and will help Anvisa 
to prepare the final text of the proposed regulation.  
Thank you for your contribution!   
 
 National Health 
Surveillance Agency  FORM FOR SUBMISSION OF 
CONTRIBUTIONS AS PART OF A PUBLIC 
CONSULTATION  
 
Public consultation:  No_____________/ year ________________  
 
I. Identification of the participant  
 
Full name:  
Address :  
Town:  Federal 
Unit:  
Telephone:  (    )  Fax:  (   ) E-mail:  
 
 1. Please tick the one that applies to yo u. (Choose one only)  
(    ) Consumer  (natural person)  
(    ) Consumer protection association or body  
(    ) Health professional (natural person)  
(    ) Body or organisation of health professionals  
(    ) Entrepreneur or owner of business establishment  
(    ) Association or body representative of the regulated sector  
(    ) Academia or teaching and research institution  
(    ) Federal, State or Local Government body or entity  
(    ) Other.  Please specify:  
  
2. How did you hear of this Public Consultation?  (More than one reply possible)   
(    ) Official Gazette of the Union   
(    ) Anvisa website   
(    ) Circular or letter from Anvisa   
(    ) Other websites   
(    ) Television   
(    ) Radio   
(    ) Newspapers and magazines   
(    ) Association, body or institut ion representative of your category or sector of civil society   
(    ) Friends, colleagues or work professionals   
(    ) Other.  Please specify:  
 
 
3. In general terms, what is your opinion on the proposal under discussion?  
(Choose one only)  
(    ) Strongl y approve   
(    ) Approve   
(    ) Somewhat approve   
(    ) Somewhat disapprove   
(    ) Disapprove   
(    ) Strongly disapprove  
 
  
II. Contributions to the Public Consultation  
Existing published text (if any)  Proposal (addition, deletion or rewording)  
  
Reasons:  
 
Existing published text (if any)  Proposal (addition, deletion or rewording)  
  
Reasons:  
 
Existing published text (if any)  Proposal (addition, deletion or rewording)  
  
Reasons:  
 
Existing published text (if any)  Proposal (addition, deletio n or rewording)  
  
Reasons:  
Appendix I  
Rules governing the Public Consultation  
1. Participation in the public consultation procedure shall take place by identification of the 
interested parties and use of the dedicated form.   
2. The form for the submission of contributions shall be available on Anvisa’s website at the 
address www.anvisa.gov.br  and can also be obtained from the Agency’s head office in Brasilia or 
by fax on request of the interested party to the sector resp onsible for the public consultation as 
indicated on the relevant call for contributions.  
3. Contributions delivered in person to the Agency’s head office in Brasilia or sent by e -mail, fax 
or post, according to the guidelines laid down in the call for contrib utions to the public 
consultation, will be accepted.  
4. All contributions received will be examined by Anvisa and will remain available to the public 
on the Agency’s website at www.anvisa.gov.br . 
5. Contributions sent afte r the deadline, unidentified contributions and contributions not sent on 
the corresponding form will not be accepted.  6. At the end of the consultation period, and following discussions by the Board, a report 
containing an analysis of the contributions and gi ving reasons for the institutional position will be 
made public.  
7. The result of the analysis of the contributions may include replies consolidated into blocs.  
8. The Report of the Analysis of the Contributions shall be available on Anvisa’s website at the 
address www.anvisa.gov.br  and can also be obtained from the Agency’s head office in Brasilia or 
by fax on request of the interested party to the sector responsible for the public consultation as 
indicated on the relevant  call for contributions.   
9. After discussions of the Board the consolidated version of the draft regulatory instrument put 
to public consultation will also be made available.  
10.Responsibility for clarifying any queries related to the public consultation rests with the sector 
responsible for the consultation as indicated on the relevant call for contributions . 
ANNEX B  
RESOLUTION OF THE BOARD (RDC) No  … OF … … 2009  
The Board of the National Health Surveillance Agency , in the exercise of the powers 
granted by Art icle 11(IV) of the Regulation approved by Decree No. 3029 of 16 April 1999, and 
having regard to the provisions of Article 54, indent (II) and paragraphs (1) and (3) of the 
Internal Regulations approved in accordance with Annex I of ANVISA Administrative R uling 
No. 354 of 11 August 2006, republished in the Official Gazette of the Union of 21 August 2006, 
at a meeting held on xxxx xxxxx 2009, and  
having regard to the provisions of RDC Resolution No 90 of 27 December 2007 and 
amendments thereto;  
hereby adopts  the following Resolution of the Board and I, the Director -President, order its 
publication:  
Article 1. The sale of any electronic smoking devices, known as electronic cigarettes, e-
cigarettes, e -ciggy, e -pipe, e -cigar, among others, intended as a replacem ent for cigarettes, 
cigarillos, cigars, pipes and similar in the smoking habit or as an alternative anti -smoking 
treatment, is hereby prohibited in the absence of any scientific data demonstrating their efficiency 
and effectiveness and the safety of the us e and handling thereof.  
Sole paragraph.  The prohibition laid down in Article 1 extends to all accessories and refills 
intended for use in any electronic smoking device.  
Article 2. Any applications to register for trading purposes any electronic device inte nded 
to replace cigarettes, cigarillos, cigars, pipes or similar in the smoking habit will only be accepted 
by Anvisa if toxicological studies and specific scientific tests demonstrating all of the alleged 
purposes are provided.  
1. The toxicological study and tests mentioned in this Article must be conducted in 
accordance with internationally recognised and accepted scientific protocols and methods, 
accompanied by an assessment of the risk of damage to the user’s health and proof that they do 
not contaminat e the environment with toxic compounds.  2. All of the results of the toxicological studies and tests mentioned in this Article shall be 
subject to expert analysis.  
Article 3. Any type of incitement to use the devices listed in Article 1, by means of 
advert ising, publicity, promotion or information, including on the Internet, is hereby prohibited.  
Article 4. This Resolution shall enter into force on the date of its publication.  
DIRCEU RAPOSO DE MELLO