Subject: RE: Regarding Novel tobacco products with added nicotine_ Herbal nicotine sticks _ Other News
From: Dace Vasiļvolfa <[email-masked]>
To: "Mikaela Pakosta" <[email-masked]>,ΤΜΗΜΑ ΛΟΙΠΩΝ ΕΞΑΡΤΗΣΕΩΝ <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, "TA Info" <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <[email-masked]>, <
Cc: LABARBE Benoît <[email-masked]>, <[email-masked]>, <[email-masked]>
Date: Thu, 15 Feb 2024 17:26:20 +0200

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Dear Mikaela,

Dear all,

Thank you all for your opinion!

It helped to make a decision.

I would like to inform that we have asked to provide additional information 
and data regarding added amount (1.5 mg and 3 mg)  of nicotine.  Submitter 
must provide data and tests that during the use of such products, the toxic 
or addictive effects of the tobacco product will not increase significantly 
or to a measurable extent or carcinogenic, mutagenic, reproductive system 
toxic properties. We have not received an answer yet.

Regarding herbal nicotine sticks,

For my point of view,  herbal nicotine sticks cannot be accepted as herbal 
smoking products, based on the fact that the health warnings do not contain 
an indication to consumers about the occurrence of addiction!

But, tobacco with herbs and nicotine can be as NTP if the industry can 
justify that the nicotine amount added during the use of such products, the 
toxic or addictive effects of the tobacco product will not increase 
significantly or to a measurable extent or carcinogenic, mutagenic, 
reproductive system toxic properties.

Therefore, tobacco-free herbal nicotine sticks (heated products) are 
classified as tobacco substitutes (also known as "surrogates").

The definition is included in the 
<https://likumi.lv/ta/id/282077-tabakas-izstradajumu-augu-smekesanas-produktu-elektronisko-smekesanas-iericu-un-to-skidrumu-aprites-likums> 
Tobacco Law on 08.02.2024.

Moreover,  Tobacco Law includes the following product device definition:

"c) an electronic heating device, which is a product or a part of this 
product, which is intended for the use of a newly introduced tobacco 
product, tobacco substitute product, herbal smoking product or other product 
(except medicinal products) to inhale nicotine-containing or non-nicotine 
vapor through the mouthpiece;” .

From 01.08.2024 such devices will apply a display ban!

From January 1, 2025, the ban on flavorings (except for 16 tobacco) for 
e-cigarettes comes into force!

Full amendments of 
<https://likumi.lv/ta/id/282077-tabakas-izstradajumu-augu-smekesanas-produktu-elektronisko-smekesanas-iericu-un-to-skidrumu-aprites-likums> 
Tobacco Law please see from  section   : “ Attēlotā redakcija 
01.01.2025.-... Nākotnes”

Kind regards,

Dace Vasilvolfa

Senior official of the Product Safety and Market Surveillance Division

[email-masked] <mailto:[email-masked]>

Health Inspectorate of Latvia
Klijanu street 7, Riga, LV-1012, Latvia

+371 67081600

 <mailto:[email-masked]> [email-masked]

From: Mikaela Pakosta <[email-masked]>
Sent: Friday, February 9, 2024 2:06 PM
To: dati <[email-masked]>; ΤΜΗΜΑ ΛΟΙΠΩΝ ΕΞΑΡΤΗΣΕΩΝ 
<[email-masked]>; [email-masked]; [email-masked]; 
[email-masked]; [email-masked]; 
[email-masked]; [email-masked]; [email-masked]; [email-masked]; 
[email-masked]; TA Info <[email-masked]>; [email-masked]; 
[email-masked]; [email-masked]; 
[email-masked]; [email-masked]; [email-masked]; 
[email-masked]; [email-masked]; [email-masked]; 
[email-masked]; [email-masked]; [email-masked]; 
[email-masked]; [email-masked]; 
[email-masked]; [email-masked]; [email-masked]; 
[email-masked]; [email-masked]; 
[email-masked]; [email-masked]
Cc: LABARBE Benoît <[email-masked]>; 
[email-masked]; [email-masked]
Subject: Vs: Regardin Novel tobacco products with added nicotine

UZMANĪBU: Šis e-pasts ir saņemts no ārēja avota.

Dear Dace, dear colleagues,

Unfortunately, we can only confirm that there is no legal bases to say 
nicotine cannot be added to tobacco products.

Which category would you place herbal nicotine sticks (heated product)?

Kind regards,

Mikaela Pakosta

Chief Specialist

Department of Chemical Safety

 <mailto:[email-masked]> [email-masked]

Republic of Estonia

Health Board

+372 794 3500

 <mailto:[email-masked]> [email-masked]

 <http://www.terviseamet.ee> www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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together with all its attachments.

Saatja: Dace Vasiļvolfa < <mailto:[email-masked]> 
[email-masked]> Nimel dati
Saatmisaeg: teisipäev, 23. jaanuar 2024 10:17
Adressaat: ΤΜΗΜΑ ΛΟΙΠΩΝ ΕΞΑΡΤΗΣΕΩΝ < <mailto:[email-masked]> 
[email-masked]>;  <mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked];  <mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked];  <mailto:[email-masked]> [email-masked]; TA Info 
< <mailto:[email-masked]> [email-masked]>; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> 
[email-masked]; 
<mailto:[email-masked]> 
[email-masked];  <mailto:[email-masked]> 
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<mailto:[email-masked]> 
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<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]; 
<mailto:[email-masked]> [email-masked]
Koopia: LABARBE Benoît < <mailto:[email-masked]> 
[email-masked]>;  <mailto:[email-masked]> 
[email-masked]; 
<mailto:[email-masked]> 
[email-masked]
Teema: Regardin Novel tobacco products with added nicotine

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Dear colleagues,

I hope that some of the EU-CEG data processors or colleagues from JATC2 WP5 
or WP6 can share national opinion!

I also ask question in 
<https://circabc.europa.eu/ui/group/2b610146-1cc4-4d94-8f7c-2171ac3ffa50/forum/topic/fcef3ce7-14d6-4fa7-a17a-9935538766e7> 
Forum on October, 2023

Do you accept the fact that heated tobacco, notified via EU-CEG, can contain 
nicotine in addition to tobacco?

I think they should be filed under the "Other" item category!

Unfortunately, I don't find any legal justification that nicotine cannot be 
added to tobacco products!

For example, brands HEECHI and LEME:

 <https://kscambodiaofficial.com/product/leme-device/> 
https://kscambodiaofficial.com/product/leme-device/

 <https://www.heechitech.com/> https://www.heechitech.com/

I would also appreciate it if you could forward it to someone from your 
member state who can give an opinion or send me contacts where I can ask.

Kind regards,

Dace Vasilvolfa

Senior official of the Product Safety and Market Surveillance Division

 <mailto:[email-masked]> [email-masked]

Health Inspectorate of Latvia
Klijanu street 7, Riga, LV-1012, Latvia

+371 67081600

 <mailto:[email-masked]> [email-masked]