Guangdong Food and Drug Administration issued the "Hygiene License for Health Food Trading Enterprises", which caused controversy. According to media reports, since October this year, food and drug regulatory authorities in some cities in Guangdong Province have successively issued documents requiring health food trading enterprises to apply for the "Hygiene License for Health Food Trading Enterprises", and those who operate such goods without a license will be severely punished. This behavior is undoubtedly a disaster for all enterprises selling functional drinks and producing health food in Guangdong Province, and its legitimacy has also been widely questioned. On February 3rd, a group of lawyers, including associate professor of China Youth University for Politics and lawyer Zhou Ze of Beijing Zhanda Law Firm, sent a letter to the State Food and Drug Administration, asking for justice from the State Food and Drug Administration on behalf of these enterprises, calling on it to correct the behavior of the local food and drug administration in Guangdong Province, or it will resort to law. The relevant media reports and the core views of the lawyers' group are summarized as follows. It is understood that since October this year, businesses dealing in health foods in Shunde, Dongguan and other places in Guangdong Province have received a notice or notice from the local food and drug administration, saying that "they are not allowed to deal in health foods without a' health license for health food business enterprises', otherwise they will be banned, their illegal income will be confiscated and they will be fined". Then, the products of Red Bull Beverage, Wang Laoji, Coconut Island Deer Turtle Wine, Shark's fin and Bird's Nest and other enterprises were ordered to be removed from the shelves by the local food and drug administration in some supermarkets in Guangdong. The relevant notice said that the merchant "operated health food without a license, which violated Articles 27 and 41 of the Food Hygiene Law of the People's Republic of China". (1) The subject of establishing health administrative license is the health administrative department. China's Administrative License Law stipulates that "a license shall be exercised by an administrative organ". The Food Hygiene Law promulgated by the National People's Congress in 1995 has established an administrative license for food hygiene, stipulating that food production and marketing enterprises need to obtain the Hygiene License from the health administrative department. The Hygiene Permit for Health Food Business Enterprises required by the food and drug supervision and administration department and the Hygiene Permit for food production and business enterprises required by the Food Hygiene Law have different names, but they are exactly the same in nature and are essentially the same administrative licensing act. Article 27 of the Food Hygiene Law stipulates: "Food production and marketing enterprises and food vendors must first obtain a hygiene license issued by the administrative department of health before applying for registration with the administrative department for industry and commerce. Those who have not obtained a hygiene license shall not engage in food production and business activities. " Article 41 is the relevant penalty for violating Article 27. Obviously, the hygiene license referred to in the Food Hygiene Law should be issued by the administrative department of health, and the main body of law enforcement of the Food Hygiene Law is the administrative department of health. However, the so-called "Hygiene License for Health Food Business Enterprises" set up by some local drug supervision departments in Guangdong Province is an administrative license set up by itself in violation of the administrative licensing law. Its content and form overlap with the hygiene license implemented by the health department for food sales operators, which is a second repeated hygiene license and should be revoked. (2) The legal basis for establishing the hygiene license for health food trading enterprises is insufficient. The Administrative Licensing Law stipulates that "if no law has been enacted, an administrative license may be established by administrative regulations". In some places, the basis for drug supervision departments to require health food retail enterprises to apply for the Hygiene License for Health Food Trading Enterprises is actually the Measures for the Administration of Health Food formulated by the Ministry of Health and the Measures for the Administration of Health Food Hygiene License formulated by the Ministry of Health according to the Measures for the Administration of Food Hygiene License. For example, the notice of "Beijing Health Food Supervision and Management Measures (Revised Draft)" issued by Beijing Drug Administration wrote impressively: "According to the relevant provisions of the" Food Hygiene License Management Measures "of the Ministry of Health, our bureau revised the" Beijing Health Food Supervision and Management Measures (Provisional) "and now it is released." Article 1 of the Measures for the Supervision and Administration of Health Foods in Beijing (Provisional) also states: In order to strengthen the supervision and administration of health foods, ensure their hygiene and safety, and safeguard people's health, these measures are formulated in accordance with the Food Hygiene Law of the People's Republic of China (hereinafter referred to as the Food Hygiene Law), the Measures for the Administration of Health Foods and other relevant laws and regulations. As we all know, the Measures for the Administration of Health Food and the Measures for the Administration of Health Food Hygiene License of the Ministry of Health are only departmental regulations, which are only normative documents for food hygiene license set for the implementation of the food hygiene law, and cannot be used as the basis for the drug supervision department to set the health license for health food trading enterprises. It is somewhat absurd for the drug supervision department to set the health license for health food trading enterprises on the basis of rules not formulated by its superior competent department. In 2114, in the Decision of the State Council Municipality on Setting Administrative License for Administrative Examination and Approval Items that Need to Be Preserved, the Food and Drug Administration has no food hygiene license items, and there is no independent health food business enterprise hygiene license items. Moreover, from the Notice of the Central Organizing Committee on Further Defining the Division of Responsibilities of the Food Safety Supervision Department, it has been made clear: "The health department is responsible for the hygiene license and hygiene supervision of the food circulation link, the catering industry, canteens and other consumption links, and the hygiene license of the food production and processing link. The main contents of the hygiene license are the hygiene conditions of the place, the hygiene protection and the evaluation and audit of the health and hygiene status of employees. It is necessary to severely investigate and deal with illegal acts within the above scope. And inform the quality inspection and industrial and commercial departments of the issuance, revocation and cancellation of health licenses in a timely manner. According to the regulations, the responsibility of food and drug supervision departments for health foods does not involve the scope of business licenses. It is precisely because of this that many merchants have questioned the practice of Guangdong Food and Drug Administration: Why do you need two licenses to sell health food? Second, the driving force of departmental interests is the driving force for setting up licenses on their own. For a long time, health foods have been sold in supermarkets, convenience stores or pharmacies, and these places generally have health licenses from the health department. Now it is unnecessary for the drug supervision department to apply for a "Health Permit for Health Food Business Enterprises". As lawyer Zhou Ze said, the business of health food should of course be included in the hygiene license of food business. Even if the hygiene license of the health administrative department does not include the hygiene license of health food, it is absolutely unnecessary for the food and drug supervision and administration department to set the hygiene license of health food business enterprises and require these supermarkets and convenience stores to "Hygiene License of Health Food Business Enterprises". Although Article 25 of the Administrative Licensing Law stipulates that with the approval of the State Council, the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may decide an administrative organ to exercise the administrative licensing rights of the relevant administrative organs according to the principles of simplification, unification and efficiency. As long as the Guangdong provincial government reports to the State Council for approval, it can decide that the Food and Drug Administration will exercise the health licensing right of the health administrative department. At the same time, however, the Administrative Licensing Law also clearly stipulates that administrative licensing may not be set for matters that can be solved by administrative organs using other administrative methods such as post supervision, and the administrative licensing that has been set "shall be revised or abolished in time". Since the seller has never had the Hygiene Permit for Health Food Business Enterprises, there is no problem in selling health food, and under the condition that the production process of health food is strictly controlled, it is actually impossible to have any problems in selling health food. Even if there may be problems, the regulatory authorities can solve them by routine inspection of the relevant operators, so it is completely unnecessary to set the hygiene permit for health food business enterprises. Although the food hygiene license is classified according to the business items, separating the licensing rights of different items and putting the hygiene license of health food business under the responsibility of the Food and Drug Administration will inevitably increase the regulatory links and administrative costs and increase the burden on enterprises. According to insiders, the reason why the food and drug supervision department requires operators who already have food hygiene licenses to apply for health food hygiene licenses separately is to gain power and seek benefits. On the surface, it is to raise the threshold of administrative licensing, but in fact it is ultra vires law enforcement, which seriously increases the burden on enterprises and disrupts the market order of fair competition. Not only that, its abusive licensing and arbitrary charges have also spawned a market of several hundred million yuan. It is understood that in Guangdong, the comprehensive cost of health license issued by the health department to food retailers according to the Food Hygiene Law is generally 211 yuan per license, while the Food and Drug Administration also issues a health license for health food business enterprises with exactly the same content and form, but the fee is much higher than the Health License issued by the health department. Taking Guangzhou as an example, the lowest comprehensive cost of handling a health food business license is more than 1,111 yuan per license, which includes 211 ~ 411 yuan for handling the license, 311 ~ 811 yuan for training and 1,51 yuan for handling the health license. Some people have calculated that functional health foods such as "Li Health Care", "Wang Lao Ji" and "Red Bull" have 311,111 sales terminals in Guangdong. If all of them apply for this certificate, the cost of repeated certification will reach 311 million yuan. It is no wonder that Guangdong Provincial Drug Administration has set up an administrative license illegally for the benefit of the department. Because there is no "Hygiene License for Health Food Business Enterprises", distribution is not allowed. For a time, the registration windows of drug supervision departments in Guangdong are crowded, and health food dealers come to apply for certificates one after another. Because of the cumbersome procedures and slow registration, some businesses are eager to get certificates and do not hesitate to pay high prices to buy certificates. In Guangdong Province, where the market economy is developed, with the implementation of repeated administrative licensing for health food, some underground intermediary companies specializing in such certificates have emerged. Some media reporters have contacted these underground intermediary companies in the name of dealers. Their staff said that it costs 4,111 yuan to apply for a license, and they can not participate in business training. At the same time, the price is negotiable, and the licenses they apply for are guaranteed to be true and effective. In addition, some merchants have reached an agreement with such intermediary companies, entrusting them to handle the hygiene business license of health food, with a total amount of RMB 2,111, with RMB 411 yuan paid in advance, and the balance will be paid after both parties obtain the hygiene license from the functional departments. Third, the reply of the State Food and Drug Administration changed the subject lightly. Some withheld health care products have been unsealed. According to the lawyer Zhou Ze who submitted the lawyer's letter, when he asked about the lawyer's letter from the State Food and Drug Administration, the staff who received him told him that the lawyer's letter had been received and transferred to the Policy and Regulation Department. The staff also told him that these things were done by the local food and drug administration, and the situation is still being understood, but the State Food and Drug Administration has not issued relevant documents. In an interview with reporters, the staff of Guangdong Food and Drug Administration said that they had submitted their response to this matter to the State Food and Drug Administration on February 5. In response to the lawyer's letter that "the drug regulatory authority is suspected of illegally establishing an administrative license, and it overlaps with the hygiene license implemented by the health department for food business operators, and should be revoked", the staff of Guangdong Food and Drug Administration clearly stated that it is not illegal to require local retailers to obtain the Hygiene License for Health Food Business Enterprises because the current health food market is chaotic, and counterfeit products and falsely advertised products are emerging one after another. This move is to standardize the market and unify management, and it is not illegal, and it is documented. I don't know if the basis of these documents he mentioned is the Measures for the Administration of Food Hygiene License and the Measures for the Administration of Health Food Hygiene License formulated by the Ministry of Health. If so, it is awkward and not serious, and even ridiculous to implement the rules formulated by a department that is not its superior, both in form and procedure. On February 7, according to the Beijing News, the State Food and Drug Administration sent a written statement to the reporter: "After the institutional reform in 2113, the State Food and Drug Administration assumed the health food registration function originally undertaken by the Ministry of Health according to law, that is, according to the applicant's application, it evaluated and reviewed the safety, effectiveness and quality controllability of the health food applied for registration, and decided whether to allow it to be registered." It also said: "In the institutional reform in 2113, the provincial people's government made regulations on the adjustment of health food supervision functions, and the situation varied from place to place. Regarding the issue of health food hygiene license by Guangdong Food and Drug Administration, I learned from Guangdong Provincial Bureau that the administrative license was approved by Guangdong Provincial People's Government during the institutional reform in 2113. " In this regard, Zhou Ze said that the lawyers' team did not deny that the drug regulatory authorities have the right to register health food. The lawyer's letter pointed out that the local government's request for the Hygiene License for Health Food Business Enterprises was "suspected of overcharging", and National Medical Products Administration obviously "changed the subject". Zhou Ze stressed that although the Guangdong Provincial Government has a document that the Guangdong Drug Administration will exercise the power to implement the "health food hygiene license", it does not mean that it is legal for the Food and Drug Administration to implement the health food business license for businesses selling health food. Food hygiene license involves production license and business license, and the legal subject of the license right is the health administrative department. It is unreasonable for businesses that sell food and health food to re-implement the health license for health food business after they have obtained the health license from the health department. Therefore, it is obviously "illegal" for the drug supervision department to implement the "Hygiene License for Health Food Business Enterprises". Recently, it was reported that xuwen county Food and Drug Administration of Zhanjiang City had unsealed the health food that it had withheld from retailers in advance. The reason for this is said to be that Zhanjiang Food and Drug Administration has an instruction, and it is still unknown whether Zhanjiang Food and Drug Administration has implemented the instruction of Guangdong Food and Drug Administration, and whether its behavior has anything to do with the lawyer's letter. But in any case, unsealing is always a good thing for operators. We will continue to pay attention to the direction of this matter.