SPC Guiding Case: Distinction between Counterfeit and Substandard Health Food and Counterfeit and Substandard Drugs

Summary of the trial

In the case of the crime of producing and selling "health products", distinguishing whether the sales target is food or medicine will directly affect the characterization of the case. The "health products" involved in the case are food or drugs, and can generally be judged by the product approval number, whether the product description stipulates that there are indications or functional indications, usage, dosage, and other appearance marks. If the product label is unclear, it can be judged by the name of the operator to publicize and sell the "health care products" involved in the case to the outside world, so that they can enter the circulation field. When the product labeling is consistent with the external publicity, the product attributes can be determined directly in accordance with the label; when the product labeling is inconsistent with the external publicity or the label is not clear, whether it is food or medicine shall be determined according to the performance of the product advertised by the actor and the purpose for which the purchaser purchased and used the product. It should be noted that the business premises and the occupation of the operator are not the basis for distinguishing between food and drugs.

1. Basic facts of the case

Defendant Zhong Mouben, male, was born in October 1974. He was released on bail on 13 November 2019. The People's Procuratorate of Yongan City, Fujian Province, accused the defendant Zhong of the crime of selling toxic and harmful food, and filed a public prosecution with the People's Court of Yongan City, Fujian Province. The Yongan Municipal People's Court investigated and ascertained that between June 2018 and September 2019, the defendant Zhong had purchased products such as "Black King Kong", "Ant Power God" and "Special Effect Viagra" marked with "aphrodisiac function" from others, and sold them at the Yongan Changshun health care product store he operated with a sales amount of 5,000 yuan, knowing that there was no product qualification certificate. On September 19, 2019, the Yongan Municipal Administration for Market Regulation and the Yongan Municipal Public Security Bureau seized some unsold products in the store on the spot. After inspection, sildenafil was detected in the product involved.

2. Judgment results

After trial, the Yongan Municipal People's Court held that the "Black King Kong" and other products involved in the case were foods adulterated with toxic and harmful non-food raw materials, and that the defendant Zhong Mouben knew that the "Black King Kong" and other products were food adulterated with toxic and harmful non-food raw materials, but still sold them, constituting the crime of selling toxic and harmful food. Zhong had confessed and pleaded guilty and accepted punishment, and actively returned the stolen goods, and was given a lighter punishment. In accordance with Article 144, Article 67, Paragraph 3, and Article 64 of the Criminal Law, Article 20, Paragraph 2 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Handling Criminal Cases of Endangering Food Safety (Fa Shi (2013) No. 12) and Article 15 of the Criminal Procedure Law, the judgment is as follows: (1) Defendant Zhong was sentenced to eight months imprisonment and a fine of RMB 10,000 for the crime of selling toxic and harmful food; 5,000 yuan of defendant Zhong's illegal gains are to be confiscated and turned over to the state treasury; After the verdict was announced, the defendant Zhong did not file an appeal, and the procuratorate did not raise a prosecutorial counter-appeal. The judgment has taken legal effect.

III. Main Issues

How to distinguish between fake and substandard health food and fake and inferior medicine?

IV. Grounds for the Trial

Regarding the characterization of this case, there are the following two opinions. The first opinion holds that the products involved in the case, such as "Black King Kong" and "Ant Lishen", all belong to health food, and health food belongs to the category of food. According to Article 144 of the Criminal Law and Article 20, Item 2 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Handling Criminal Cases Endangering Food Safety issued in 2013, the substances on the List of Substances that May Be Illegally Added to Health Foods published by the relevant departments of the State Council shall be identified as "toxic and harmful non-food raw materials". Those who add the above-mentioned substances to health food shall be convicted and punished as the crime of producing or selling toxic or harmful food. The sildenafil added to the health care products sold by the perpetrator is a prohibited substance in the above list, so this case should be found to be the sale of food adulterated with toxic and harmful non-food raw materials, constituting the crime of selling toxic and harmful food. The second opinion holds that in this case, the products such as "Black King Kong" and "Ant Lishen" did not have the approval number of health food, and the perpetrator sold them in the name of "aphrodisiacs", which was a non-drug counterfeiting drug, and according to the provisions of Article 98, Paragraph 1, Item 2 of the Drug Administration Law, "passing off non-drugs as drugs" should be found to be counterfeit drugs, so this case constitutes the crime of selling counterfeit drugs. We agree with the first view. Based on the concepts of food and drugs and the specific judgment ideas of fake and shoddy health foods and fake and inferior drugs, the application of the charges in this case is analyzed as follows. (1) The criteria for distinguishing food and drugs and their impact on the characterization of the case can be combined with the legal definition of food and drugs to distinguish between the two. According to Article 150 of the Food Safety Law, food refers to all kinds of finished products and raw materials for human consumption or drinking, as well as articles that are both food and Chinese herbal medicines according to tradition, but do not include articles for therapeutic purposes. According to the second paragraph of Article 2 of the Drug Administration Law, drugs refer to substances that are used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or functional indications, usage and dosage, including traditional Chinese medicine, chemical drugs and biological products. Therefore, the essential difference between the two lies in whether it is for the purpose of preventing, treating and diagnosing human diseases, and whether it stipulates indications or functional indications, usage and dosage. According to the provisions of the National Food Safety Standard Health Food (GB16740-2014), health food refers to food that claims to have specific health care functions or is for the purpose of supplementing vitamins and minerals, that is, it is suitable for specific groups of people to eat, has a regulatory function, is not for the purpose of treating diseases, and does not cause any acute, subacute or chronic harm to the human body. It can be seen that health food is a special food, which is different from general food and medicine, and is a specific type of functional food that has the effect of regulating human body functions, so health food is also called functional food. In the case of the crime of producing and selling "health products", distinguishing whether the sales target is food or medicine will directly affect the characterization of the case. If the "health products" involved in the case meet the characteristics of food, consideration may be given to applying the Criminal Law article 143 for the crime of producing and selling food that does not meet safety standards, article 144 for the crime of producing and selling toxic or harmful food, and article 140 for the crime of producing and selling counterfeit and shoddy products; Item 2 of Article 9 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in the Handling of Criminal Cases Endangering Food Safety, which came into effect on January 1, 2022, stipulates that substances listed in the List of Substances Likely to Be Illegally Added to Health Foods by the relevant departments of the State Council due to their endangerment of human health shall be identified as "toxic and harmful non-food raw materials". (2) Specific judgment that "health care products" are food or drugs In specific cases, the "health care products" involved in the case are food (health foods) or drugs, and can generally be judged by the product approval number, whether the product description provides for indications or functional indications, usage and dosage, and other appearance marks. If the product label is unclear, it can be judged by the name of the operator to publicize and sell the "health care products" involved in the case, so that they can enter the field of human circulation. Specifically, when the product label is consistent with the external publicity, it indicates that the actor is operating externally according to the product label, and the product attributes can be determined directly according to the label; when the product label is inconsistent with the external publicity or the label is not clear, it shall be determined whether it is food or medicine according to the performance of the product advertised by the actor and the purpose of the purchaser's purchase and use of the product. It should be pointed out that the business premises and the occupation of the operator are not the basis for distinguishing between food and drugs. There is no direct and necessary correlation between the business premises and the operator's occupation and the product category, and the product involved in the case cannot be directly determined to be a drug or food solely on the ground that the business premises are pharmacies or health care product stores, nor can the category of the products involved in the case be determined solely on the basis that the business operator is an employee of the food or pharmaceutical industry. According to Article 78 of the Food Safety Law, the labels and instructions of health foods shall not involve disease prevention and treatment functions, and the content shall be true and consistent with the content of registration or filing, indicating suitable groups, unsuitable people, functional ingredients or iconic ingredients and their contents, etc., and stating that "this product cannot replace drugs". The functions and ingredients of health foods should be consistent with the labels and instructions. (3) In this case, the "Black King Kong" and other products are toxic and harmful health foodsIn this case, the products involved in the case, such as "Black King Kong" and "Ant Power God", did not indicate the product approval number, and their outer packaging showed "tonifying the kidney and strengthening yang, consolidating the foundation and cultivating the yuan, treating both the symptoms and the root causes, and the effect is rapid, and the consumption of this product can enhance kidney motility and anti-fatigue", and it is impossible to directly define their product attributes from the appearance identification such as the approval document number and product description. From the analysis of the communication information between the actor and the purchaser, the defendant Zhong X originally sold the product in the name of "aphrodisiac and kidney supplementation", and did not publicize the therapeutic function and treatment effect, and the consumer mainly purchased and used it for the purpose of "sexual health care" rather than treating a specific disease, and there was no consequence of "delaying the disease" caused by the purchase or use of the product. Therefore, the products involved in the case, such as "Black King Kong", do not meet the essential characteristics of drugs that are "for the purpose of preventing, treating, and diagnosing human diseases, and have specific indications or functional indications", and should be found to be health foods with nourishing and health care functions. The health food involved in the case was tested to contain sildenafil, which belongs to the substance on the "List of Substances Likely to Be Illegally Added to Health Foods (First Batch)" issued by the General Office of the State Food and Drug Administration, and should be identified as "toxic and harmful non-food raw materials" according to Article 20, Item 2 of the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Handling Criminal Cases Endangering Food Safety, issued in 2013. To sum up, the defendant Zhong Mouben clearly knew that "Black King Kong" and other products were health foods adulterated with toxic and harmful non-food raw materials and sold them, and the court was correct in finding that Zhong's conduct constituted the crime of selling toxic and harmful food. (Written by: Fujian Provincial High People's Court, Zhong Qiaoyan, Editor: Sun Changshan, Criminal Division 1, Supreme People's Court) (This case is the Supreme People's Court's Criminal Trial Reference No. 1531 Guiding Case: Zhong Mouben's Case of Selling Toxic and Harmful Food)

Reprinted from: Criminal Trial Research Official Account, only for learning and discussion, such as invasion and deletion, thank you.