Last updated: October 28, 2019

Penalties

Violation
Enforcement Agency
Sanction(s)

Content regulation

Ministry of Health, Food and Drug Agency, Local Government - once the government clarifies its regulation
N/A
Entities that can be held responsible

Manufacturer - once the government clarifies its regulation

Analysis

Regulation No. 109 of 2012 states: "Any person who produces tobacco products using additives that are dangerous to health . . . shall be subject to administrative sanctions by the Minister in the form of recall of the product at the expense of the producer." The law does not explicitly call for other penalties. The law further states: "the Minister [of Health], relevant ministers, the Agency Head [of Food and Drug Agency], and Local Governments can take administrative action against violations of the provisions of this Regulation of the Government in accordance with statutory provisions." The law on its face bans all "additives" in tobacco products and imposes sanctions for violations of the ban. However, because the term "additive" is not defined, the scope of this ban is unclear. Given the lack of clarity in the scope of the ban, the status of sanctions is listed as "N/A."

To align with FCTC Art. 9 and the FCTC Arts. 9 & 10 Partial Guidelines, the law should regulate the contents of tobacco products and establish clear sanctions for content regulation violations.

Disclosure requirement

Ministry of Health, Food and Drug Agency, Local Government
Fine, Business License suspension or revocation, Jail, Warning, Other

(e.g., seizure of the product, publication of the violation/violator)

Entities that can be held responsible

Manufacturer and Importer

Analysis

A violation of emission disclosure requirements are subject to criminal sanctions (which is interpreted to mean fines and prison) and administrative sanctions, which "may include: 1) verbal warnings; 2) written warnings; 3) withdrawal of products, to be carried out by the producer or importer on the basis of a warrant of withdrawal from the Agency Head; 4) recommendations for temporary suspension of activities; and/or 5) recommendations for action to be taken by the relevant authorities in accordance with the provisions of laws and regulations."

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that the law imposes sanctions for disclosure violations.