February 2018
Circular on the Provisions to Enhanced Law Enforcement for Food and Drug Safety and Strict Implementation of Penalties Against Individuals Liable for Food and Drug Violations (Mainland China)
2018.01.24
Joline Chen
To thoroughly implement food and drug laws and regulations, carry out the "four toughest" requirements of the CPC Central Committee and the State Council on food and drug safety, and intensify legal enforcement of food and drug safety violations, the China Food and Drug Administration and the Ministry of Public Security jointly promulgated the Provisions to Enhanced Law Enforcement for Food and Drug Safety and Strict Implementation of Penalties Against Individuals Liable for Food and Drug Violations (the "Provisions") on January 24, 2018. The Provisions are highlighted below:
1. To thoroughly implement the "four toughest" requirements of the CPC Central Committee for food and drug safety, all levels of food and drug supervisory and regulatory authorities and public security agencies are required to strictly follow the law in their administration and to strictly enforce the relevant laws and regulations regarding "penalizing the individuals", conduct regulations and rules through serious investigation and pursuit of the legal liabilities of relevant responsible personnel, so that food and drug safety can be guaranteed through tough supervision and severe punishment.
2. For individuals engaging in food and drug violations, their personal legal liabilities will be prosecute in accordance with law. For an organization that engages in food and drug violations, not only will the organization be penalized, the management personnel directly in charge and other directly responsible personnel of the organization will also be prosecuted.
3. Specific circumstances where food and drug supervisory and regulatory authorities fail to impose administrative sanctions pursuant to law include: production and operation of foods, food additives, production and drugs, Category II or Category III medical devices, operation of Category III medical devices, or production of cosmetics, without obtaining a license pursuant to law; providing a production business site or other conditions despite knowledge that the other entity is engaged in the production of foods or food additives without a license; production or sale of counterfeit or inferior drugs; import or sale of cosmetics which are not approved or inspected, or production or sale of cosmetics that do not meet national standards for cosmetics; falsification, alteration, sale, lease or lending of drug production and operation licenses, drug approval supporting documents or certificates of approval for relevant medical devices; issuance of false examination reports by a drug examination agency; and other circumstances where administrative penalties shall be imposed pursuant to relevant food and drug laws, regulations or rules.
4. The circumstances where a public security agency may engage in administrative detention pursuant to law include where: an illegal act involves products valued at above RMB20,000; an illegal act has continued for at least three months; foodborne illnesses and deaths have resulted or foodborne illnesses to over 30 people have occurred without death; a food safety violation re-occurs within one year after an administrative sanction was previously imposed for a food safety violation of the same nature, or a food safety violation after a criminal sanction was previously imposed; as well as other serious violations.
5. Circumstances for imposing prohibition and restrictions pursuant to law include where: a food producer or operator is subject to revocation of its license for engaging in any act that violates food safety; an organization has produced or sold counterfeit drugs or has engaged in the selling of inferior drugs at a serious scale; false materials are provided or other deceptive means are taken to obtain certificates or licenses, such as medical device registration certificates, medical device production licenses, medical device operation licenses, advertising approval documents, etc.; false materials are provided in material aspects during the recordation application for medical devices; a medical device examination agency issues false examination reports; an administrative license applicant conceals relevant circumstances or provides false materials in its application, or a licensee obtains an administrative license through unlawful means such as deception or bribery; or any other circumstance where prohibitions and restrictions are imposed pursuant to relevant food and drug laws and regulations.
6. The linkage between administrative enforcement and criminal justice shall be improved, and the linkage between the administrative enforcement by the food and drug supervisory and regulatory authorities and the administrative detention by public security agencies shall be enhanced. Food and drug supervisory and regulatory authorities and public security agencies shall timely disclose food and drug related administrative penalties issued under the principle that the "agency imposing the penalty shall be responsible for the disclosure" in order to fully carry out the functions of the linked information sharing platform for administrative enforcement and criminal justice, timely record information about "penalizing individuals" for food and drug violations, and actively promote data sharing.
Joline Chen
To thoroughly implement food and drug laws and regulations, carry out the "four toughest" requirements of the CPC Central Committee and the State Council on food and drug safety, and intensify legal enforcement of food and drug safety violations, the China Food and Drug Administration and the Ministry of Public Security jointly promulgated the Provisions to Enhanced Law Enforcement for Food and Drug Safety and Strict Implementation of Penalties Against Individuals Liable for Food and Drug Violations (the "Provisions") on January 24, 2018. The Provisions are highlighted below:
1. To thoroughly implement the "four toughest" requirements of the CPC Central Committee for food and drug safety, all levels of food and drug supervisory and regulatory authorities and public security agencies are required to strictly follow the law in their administration and to strictly enforce the relevant laws and regulations regarding "penalizing the individuals", conduct regulations and rules through serious investigation and pursuit of the legal liabilities of relevant responsible personnel, so that food and drug safety can be guaranteed through tough supervision and severe punishment.
2. For individuals engaging in food and drug violations, their personal legal liabilities will be prosecute in accordance with law. For an organization that engages in food and drug violations, not only will the organization be penalized, the management personnel directly in charge and other directly responsible personnel of the organization will also be prosecuted.
3. Specific circumstances where food and drug supervisory and regulatory authorities fail to impose administrative sanctions pursuant to law include: production and operation of foods, food additives, production and drugs, Category II or Category III medical devices, operation of Category III medical devices, or production of cosmetics, without obtaining a license pursuant to law; providing a production business site or other conditions despite knowledge that the other entity is engaged in the production of foods or food additives without a license; production or sale of counterfeit or inferior drugs; import or sale of cosmetics which are not approved or inspected, or production or sale of cosmetics that do not meet national standards for cosmetics; falsification, alteration, sale, lease or lending of drug production and operation licenses, drug approval supporting documents or certificates of approval for relevant medical devices; issuance of false examination reports by a drug examination agency; and other circumstances where administrative penalties shall be imposed pursuant to relevant food and drug laws, regulations or rules.
4. The circumstances where a public security agency may engage in administrative detention pursuant to law include where: an illegal act involves products valued at above RMB20,000; an illegal act has continued for at least three months; foodborne illnesses and deaths have resulted or foodborne illnesses to over 30 people have occurred without death; a food safety violation re-occurs within one year after an administrative sanction was previously imposed for a food safety violation of the same nature, or a food safety violation after a criminal sanction was previously imposed; as well as other serious violations.
5. Circumstances for imposing prohibition and restrictions pursuant to law include where: a food producer or operator is subject to revocation of its license for engaging in any act that violates food safety; an organization has produced or sold counterfeit drugs or has engaged in the selling of inferior drugs at a serious scale; false materials are provided or other deceptive means are taken to obtain certificates or licenses, such as medical device registration certificates, medical device production licenses, medical device operation licenses, advertising approval documents, etc.; false materials are provided in material aspects during the recordation application for medical devices; a medical device examination agency issues false examination reports; an administrative license applicant conceals relevant circumstances or provides false materials in its application, or a licensee obtains an administrative license through unlawful means such as deception or bribery; or any other circumstance where prohibitions and restrictions are imposed pursuant to relevant food and drug laws and regulations.
6. The linkage between administrative enforcement and criminal justice shall be improved, and the linkage between the administrative enforcement by the food and drug supervisory and regulatory authorities and the administrative detention by public security agencies shall be enhanced. Food and drug supervisory and regulatory authorities and public security agencies shall timely disclose food and drug related administrative penalties issued under the principle that the "agency imposing the penalty shall be responsible for the disclosure" in order to fully carry out the functions of the linked information sharing platform for administrative enforcement and criminal justice, timely record information about "penalizing individuals" for food and drug violations, and actively promote data sharing.
