UNDANG-UNDANGDI BAWAH KKM BERKAITAN

VAPE (CECAIR NIKOTIN)

9 DECEMBER 2015

CIAST, SELANGOR

Oleh:

Desmond Chong

Penolong Pengarah (Kanan) Farmasi

CAWANGAN PENGUATKUASA FARMASI, BPF

NEGERI SELANGOR

KANDUNGAN

1) Vape and E-cigarrette

2) Kawalan undang-undang semasa ke atas

Nikotin

3) Kesimpulan

VAPE /E-CIGARRETTE

An electronic cigarette (EC, e-cig, or e-cigarette),

personal vaporizer (PV), or electronic nicotine

delivery system (ENDS) is a battery-powered

vaporizer which simulates the feeling of smoking, but

without tobacco combustion

* E-cigarettes typically have a heating

element which atomizes a liquid solution

known as e-liquid.

* E-liquids usually contain propylene glycol,

glycerin, water, nicotine, and flavorings.

Vape-peranti elektronik yang tidak mengandungi nikotin

KAWALAN KE ATAS E-CIG/VAPE

• As of 2014 electronic cigarettes had not been approved as a smoking cessation device by

any government.(1).

• As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.

Regulation of e-cigarettes vary from across countries and states with no regulation to others

banning them entirely

• Brazil, Singapore, the Seychelles, and Uruguay have banned e-cigarettes

• In Canada, they are technically illegal to sell, but this is generally unenforced and they are

commonly available for sale Canada-wide.

• In the United Kingdom, the use and sale of e-cigarettes are legal.

• In the US, the use and sale of e-cigarettes are legal.

WHO. "Electronic nicotine delivery systems" (PDF). pp. 1–13. Retrieved 28 August

2014

KAWALAN KE ATAS E-CIG/VAPE

• Currently in the United States, the Food and Drug Administration (FDA) can regulate only

e-cigarettes that manufacturers market as therapeutic.

• in April 2014, the FDA proposed a rule that would extend its tobacco authority to cover

commercial sales of e-cigarettes as nontherapeutic tobacco products.[1] This FDA action

focuses on e-cigarettes as a harm reduction strategy,

• In October 2014, the WHO Framework Convention on Tobacco Control acknowledged

the need for regulation of e-cigarettes along the lines of policies concerning other

tobacco products, including banning or restricting promotion, advertising, and

sponsorship.[2]1.US Food and Drug Administration. Deeming tobacco products to be subject to the

Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking

Prevention and Tobacco Control Act; regulations on the sale and distribution of

tobacco products and required warning statements for tobacco products. Available

at:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/Economi

cAnalyses/UCM394933.pdf. Accessed December 11, 2014.

2. . World Health Organization. WHO tobacco treaty makes significant progress

despite mounting pressure from tobacco industry. Available at:

http://www.who.int/mediacentre/news/releases/2014/cop6-tobacco-control/en/.

Accessed December 11, 2014.

PETIKAN MEDIA

UNDANG-UNDANG DI BAWAH KKM BERKAITANNIKOTIN

AKTA-AKTA DAN PERATURAN-PERATURANNYA

1) Akta Racun 1952

* Peraturan-peraturan Racun 1952

2) Akta Jualan Dadah 1952

* Peraturan-peraturan Kawalan Dadah Dan

Kosmetik 1984

“POISON"

• bermakna sebarang bahan yang dinamakan secara

spesifik di dalam Jadual Pertama Akta Racun 1952

iaitu Senarai Racun (Poisons List) dan termasuk

sebarang persediaan, larutan, sebatian, campuran

atau bahan asli yang mengandungi bahan tersebut,

selain daripada persediaan yang dikecualikan atau

artikel atau persediaan yang pada masa ini

dimasukkan dalam Jadual Kedua Akta Racun 1952

NICOTINE-JADUAL PERTAMA AKTA RACUN 1952

SEK 13(A) AKTA RACUN 1952

• Section 13.

• Memiliki racun untuk tujuan jualan dan menjual racun yang melanggari akta adalah

satu kesalahan.

• Mana-mana individu yang-

(a) Memiliki racun untuk tujuan jualan; kecuali dia dilesenkan dibawah Akta ini

untuk menjual racun tersebut atau diberikuasa di bawah Sek 18 untuk

menjual atau membekal racun; or

(b) menjual atau membekal racun dengan melanggari akta dan peraturan-

peraturanya atau syarat-syarat lesen yang telah ditetapkan di bawah akta ini

berkaitan jualan atau bekalan racun di dlm Bahagian atau Kumpulan Racun di

dalam Senarai Racun; yang mana jualan atau bekalan tersebut adalah

melanggari Akta ini.

SECTION 18. RESTRICTION ON THE SALE OF PART I POISONS GENERALLY.

(1)Part I Poison shall not be sold or supplied to any person except-

(a) by wholesale in accordance with section 15; or

(b) by retail sale effected by or under the immediate personal

supervision of a licensed pharmacist;

Provided that a Group F Poison may be sold or under the immediate

personal supervision of a listed seller as well as by a licensed

pharmacist; or

(c) as an ingredient of a dispensed medicine, by a registered

medical practitioner, registered dentist or veterinary surgeon in

accordance with section 19; ……

SECTION 19. SUPPLY OF POISONS FOR THE PURPOSE OF TREATMENT BY PROFESSIONAL

MEN

• . (1) Any poison other than a Group A Poison may be sold, supplied or administered

by the following persons for the following purposes-

• (a) a registered medical practitioner may sell, supply or administer such poison to his

patient for the purposes of the medical treatment of such patient only;

• (b) a registered dentist Division I may sell, supply or administer such poison to his

patient for the purposes of the dental treatment of such patient only; and

• (c) a veterinary officer may sell or supply such poison to his client for the purposes

of animal treatment only. ……

SECTION 22. GROUP C POISONS

Group C Poison shall not be sold or supplied by retail to any person

except:

(a) where the sale or supply of such poison, if it had been a Group

B Poison, would have been authorized under or by virtue of, and is

effected in accordance with section 21; or

(b) as a dispensed medicine or an ingredient in a dispensed

medicine.

HUKUMAN DI BAWAH AKTA RACUN 1952:

•Seksyen 32(2) Akta Racun 1952

-Denda tidak melebihi RM3000.00 atau

penjara tidak melebihi setahun atau kedua-

duanya sekali

AKTA JUALAN DADAH 1952PERATURAN-PERATURAN KAWALAN DADAH

DAN KOSMETIK 1984

REGULATION 2: INTERPRETATION OF PRODUCT

"product" means—

(a) a drug in a dosage unit or otherwise, for use wholly or mainly

by being administered to one or more human beings or animals

for a medicinal purpose; or

(b) a drug to be used as an ingredient of a preparation for a

medicinal purpose.

AKTA JUALAN DADAH 1952(PERATURAN-PERATURAN KAWALAN DADAH &

KOSMETIK 1984)

Regulation 7.

Prohibition against manufacture, sale, supply , importation, possession

and administration.

(1) Except as otherwise provided in these Regulations, no person

shall manufacture, sell, supply, import or possess or administrator

any product unless -

(a) the product is a registered product;

Tahukah Anda?Semua Produk Ubat-ubatan yang

dijual & digunakan di Malaysia hendaklah

BERDAFTAR dengan Pihak Berkuasa

Kawalan Dadah (PBKD),

Kementerian Kesihatan Malaysia

KENAPA UBAT PERLU BERDAFTAR?

Untuk memastikan:

Selamat (memastikan produk tidak dicemari dengan

bahan-bahan asing yang merbahaya seperti logam berat)

Berkualiti (produk dikilangkan di premis berstatus GMP –

Good Manufacturing Practice)

Berkesan (melalui kajian saintifik)

PRODUK BERDAFTAR MENGANDUNGI NICOTINE

HUKUMAN:SEKSYEN 12 AKTA JUALAN DADAH 1952

• -Individu-Denda tidak melebihi RM25,000.00

atau penjara tidak melebihi 3 tahun atau

kedua-duanya sekali

• -Badan korporat- Denda tidak melebihi RM

50,000.00

E-LIQUID DISYAKI MENGANDUNGI NIKOTIN

KESIMPULAN

• 1) Cecair Nikotin dikawal dibawah Akta Racun 1952

• 2) Hanya Ahli Farmasi berrlesen dan pengamal perubatan

berdaftar boleh membekalkan sediaan/produk nikotin.

• 3) Sediaan/produk nikotin perlu berdaftar dengan Pihak

Berkuasa Kawalan Dadah, KKM sebelum dipasarkan

• 4) Penguatkuasaan ke atas cecair Nikotin akan dilaksanakan

berdasarkan undang-undang sedia ada.

TERIMA KASIH