Analysis on Epidemiology Causality Relationship Theory under Food and Drug Safety Context

Violation of food and drug safety and other hazard crimes have the features of long latency and multiple factors. Traditional criminal law causality theory is no controversy to determine causality of criminal responsibility, thus it is necessary to introduce the epidemiology causality theory-it is a kind of causality theory based on epidemic diseases, and it is the high degree of probability in the determination of causality in criminal laws so as to solve the traditional attribution problem, but the theory also exists applicable restriction conditions in judicial practice.

The State Food and Drug Administration:Supervisory Regulations on Cosmetics May Be Introduced This Year

On May 28, 2019 Chinese Cosmetics Development Conference was held in Beijing. At the conference, Li Nan, chief of the General Division, Supervision Department of the State Food and Drug Administration introduced China’s development concerning the cosmetics supervisory rules and regulations from the perspectives of legislation plan and thinking. He mentioned that the regulations on supervision and administration of cosmetics are expected to be released this year, and the regulations on cosmetic registration and label management.

Work Hard to Ensure Food,Drugs Safety for the People——An interview with Shao Mingli,director-general of the State Food and Drug Administration(SFDA)

Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.

Research Progress on Analysis and Detection Techniques of Veterinary Drug Residues in Animal Foods

As an important guarantee for the prevention and control of animal diseases,veterinary drugs have important functions in improving animal production performance and product quality and maintaining ecological balance.They are an important guarantee for the healthy development of animal husbandry,food safety and public health.However,the irrational use and abuse of veterinary drugs and feed pharmaceutical additives are widespread,causing harmful substances in animal foods and damage to human health,and threatening the sustainable development of the environment and animal husbandry as well.In order to ensure human health,it is urgent to develop a simple,rapid,high-sensitivity,high-throughput and low-cost veterinary drug residue detection technology.In this paper,the sample pretreatment methods and detection techniques for the analysis of veterinary drug residues in animal foods were reviewed.

Repurposing Loperamide as an Anti-Infection Drug for the Treatment of Intracellular Bacterial Pathogens

Infections caused by intracellular bacterial pathogens are difficult to treat since most antibiotics have low cell permeability and undergo rapid degradation within cells.The rapid development and dissemination of antimicrobial–resistant strains have exacerbated this dilemma.With the increasing knowledge of host–pathogen interactions,especially bacterial strategies for survival and proliferation within host cells,host-directed therapy(HDT)has attracted increased interest and has emerged as a promising antiinfection method for treating intracellular infection.Herein,we applied a cell-based screening approach to a US Food and Drug Administration(FDA)-approved drug library to identify compounds that can inhibit the intracellular replication of Salmonella Typhimurium(S.Typhimurium).This screening allowed us to identify the antidiarrheal agent loperamide(LPD)as a potent inhibitor of S.Typhimurium intracellular proliferation.LPD treatment of infected cells markedly promoted the host autophagic response and lysosomal activity.A mechanistic study revealed that the increase in host autophagy and elimination of intracellular bacteria were dependent on the high expression of glycoprotein nonmetastatic melanoma protein B(GPNMB)induced by LPD.In addition,LPD treatment effectively protected against S.Typhimurium infection in Galleria mellonella and mouse models.Thus,our study suggested that LPD may be useful for the treatment of diseases caused by intracellular bacterial pathogens.Moreover,LPD may serve as a promising lead compound for the development of anti-infection drugs based on the HDT strategy.

Situations and Countermeasures on Veterinary drug residues and Detection to Animal Material Food of Entry-Exit Trade

With the people's lives improving,the demands of livestock products on the import and export aspects were growing. Veterinary drug residues as the important factor which might influence animal products safety has become a major concern. In this paper,the status quo and inspection of the veterinary drug residue and the corresponding control measures were put forward.

Background, Current Situation and International Experience of Food and Drug Police System

Establishing the food and drug police system is particularly important for effectively striking at illegal and criminal activities related to food and drug. This study firstly revealed actual background of establishment of the food and drug police system. Taking the high profile gutter oil case in 2013 as an example,it analyzed advantages of the police in food safety supervision. Then,it summarized some pilot projects in China and analyzed characteristics of the Office of Criminal Investigations of FDA. Finally,it came up with problems and recommendations for improving food and drug police system.

Textual Research on Name, Variety and Property of the Multi-origin Tibetan Herb "Azhong"

By consulting ancient Tibetan medical literature such as books of materia medica,medical works,and prescription books,as well as modern and contemporary literature and materials,and in combination with the interview and investigation of clinical use and expert consultation,we collated and verified the name,variety classification,plant origin,application and other recorded information of Tibetan herb"Azhong",and summarized and analyzed the phenomenon of mixed use or substitution of medicinal plants.According to textual research,it first appeared in the Four Medical Tantras.The Tibetan herb"Azhong"is simply recorded in the ancient books and Materia Medica,which are collectively called"Azhong".Since the 15 th century,there have been varieties such as Za Azhong,Kan Azhong,Xing Azhong,Pumou Azhong,Zha Azhong,Bang Azhong,and the top grade is called Azhong Nabu and Nacang Azhong,and the bottom grade is Azhong Gabu.According to modern literature,the origin of"Azhong"involves 12 species of plants belonging to 8 genera,5 families.At present,Arenaria kansuensis Maxim,Ajania purpurea Shih.and Thalictrum squamiferum Lecoy are the mainstream medicinal materials of"Azhong".There is a certain basis for clinical application and theoretical records in the literature in terms of the mutual alternative use of Tibetan medicinal materials such as"Azhong"and traditional medicinal materials in different regions.Therefore,it is necessary to use modern chemical technology and pharmacological experiments to conduct a comparative study on the material basis and biological activity of different varieties of medicinal materials,and carry out a survey on resources and use status,so as to standardize the use of their varieties and origins and improve the safety of clinical medication.

美国食品药物管理总局(FOOD AND DRUG ADMINISTRATION,简称 FDA)情况简介

FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。

The origins of food

Where does our food come from?Once upon a time carrots were purple, there were no pineapples in Asia or lemons in America, and many people thought potatoes were poisonous. Many types of fruit and vegetable grew only in one place. So how did they spread all over the world?

The origins of food

Where does our food come from?Once upon a time carrots were purple,there were no pineapples in Asia or lemons in America,and many people thought potatoes were poisonous.

Rapid testing methods for food contaminants and toxicants

Food safety is one of the major concerns in every country regardless of the economic and social development. The frequent occurrence of food scandals in the world has led the Chinese government to implement several strategies to fortify the food supply system to a high food safety standard. This relies heavily on laboratory testing services but conventional methods for detection of food contaminants and toxicants are limited by sophisticated sample preparation procedures, long analysis time, large instruments and professional personnel to meet the increasing demands. In this review, we have incorporated most of the current and potential rapid detection methods for many notorious food contaminants and toxicants including microbial agents, toxic ions, pesticides, veterinary drugs and preservatives, as well as detection of genetically modified food genes and adulterated edible oil. Development of rapid, accurate, easy-to-use and affordable testing methods could urge food handlers and the public to actively screen for food contaminants and toxicants instead of passively relying on monitoring by the government examination facility. This review also provides several recommendations including how to encourage the public to engage in the food safety management system and provide optimal education and financial assistance that may improve the current Chinese food safety control system.

Effects of tomato juice on the pharmacokinetics of CYP3A4-substrate drugs

We previously demonstrated that tomato juice(TJ) contains potent mechanism-based inhibitor(s) of CYP3A4. In this study, we investigated the effects of TJ and grapefruit juice(GFJ)on the pharmacokinetics of the CYP3A4-substrate drugs, nifedipine(NFP) and midazolam(MDZ), in male Wistar rats. Oral administration of GFJ 90 min before the intraduodenal administration of NFP or MDZ increased the area under the concentration–time curves(AUCs)of NFP and MDZ by 32.4% and 89.4%, respectively. TJ increased MDZ blood concentrations and AUC after intraduodenal MDZ administration;however, it had no effect on NFP. When MDZ and NFP were intravenously administered, GFJ significantly increased the AUC of MDZ,but only slightly increased that of NFP. In contrast, TJ only slightly increased the AUC of MDZ.These results suggest that, similar to GFJ, TJ influences the pharmacokinetics of CYP3A4-substrate drugs;however, it may be a drug-dependent partial effect.

Determination of Veterinary Drug Residues in Animal-derived Foods by Liquid Chromatography-Mass Spectrometry

[Objectives]This study was conducted to establish a rapid and effective method for simultaneous extraction of 54 kinds of veterinary drug residues in animal-derived food, including sulfonamides, quinolones, tetracyclines, malachite greens, penicillins, nitroimidazoles, tranquilizers and macrolides, by HPLC-MS. [Methods] The samples were extracted with 80% acetonitrile water(containing 0.1% formic acid), combined with QuEChERS extraction technology and C18 and PSA purification, analyzed by high performance liquid chromatography-mass spectrometry, and quantified by external standard method. The target substances were analyzed on ZORBAX Eclipse C18 chromatographic column using 0.2% formic acid water and 0.2% methanol as mobile phases. The gradient elution mode was used for chromatographic separation and multiple reaction detection. [Results] In the linear range of 0.5-50.0 ng/ml, the linear relationship of the 54 kinds of veterinary drug residues was good, with correlation coefficients(r~2) greater than 0.995, and the detection limits ranged from 0.30 to 1.00 μg/kg. The results showed that the recovery ranged from 75.4% to 118.2% when different matrixes were added for recovery. [Conclusions] This method is simple, efficient, accurate, stable, and highly operable. It is applicable to simultaneous batch screening of veterinary drug residues in animal-derived food, and has high practical application value.

Investigation of Geographical Origin and Production Method of L（＋）-Tartaric Acid by Isotopic Analyses with Chemometrics

The determination of the geographical origin as well as the adulteration of natural products is a technical problem due to similar chemical composition between an adulterant and the original. It is assumed that tartaric acid comes from natural sources, however there is no specific regulation for this claim. This paper describes the use of isotope mass spectrometry associated with chemometrics to classify different samples of tartaric acid. The results showed that the variables δ^13C, δ^18O and δ^2H allowed the discrimination of tartaric acid samples by geographical origin and production method. By using a combination of chemometfic analysis it was possible to confirm a notoriousseparation of the samples. Thus, this is a promising method to be applied in the quality control and authenticity of tartaric acid.

Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Microbiological Quality of Freshly Prepared, Packaged Fruit and Milk Juices Sold in Cafés, Shops, and Supermarkets in Hargeisa, Somaliland

Background: Due to their delicious taste, high nutritional content, and health benefits, fruit juices are well-known drinks in many countries and are now an essential component of the modern diet. Objective: Determining the microbiological quality of both packaged and freshly made fruit and milk juices. Method: The spread-plate approach was employed to isolate and count the bacteria. 90 ml of sterile peptone water were blended with 10 ml of well-mixed, packed, and freshly made fruit juices. The samples were sequentially diluted (101 - 105) in accordance with the Indian Manual of Food Microbiological Testing Methods. Results: From eight samples of imported packaged fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 1.39 × 102, and 2 × 102 CFU/ml, respectively. In contrast, from three samples of locally produced fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 5.83 × 102, and 2.73 × 103 CFU/ml, respectively. Four samples of handmade prepared fruit and milk juices had a mean of total coliform, staphylococci, and viable bacterial count of 1.441 × 104, 4.1 × 103, and 2.35 × 105 CFU/ml, respectively. Conclusion: 33.3% of the results from microbiological analysis of freshly made fruit and milk juices met the permissible range of the Revised Microbiological Standards for Fruit and Vegetables and Their Products, which were published in 2018 and as well as the Hong Kong Center for Food Safety, whereas 66.7% of the microbiological analyses of freshly prepared fruit and milk juices were above the permissible reference range of GSO standard 2000. 12.5% of the investigated imported and packed fruits and milk juices had one failed test (TSC), which was above the acceptable limit, 87.5% of the tested samples of fruit and milk juices fulfilled the necessary standards of TCC, TVBC, and TSC. 100% of the tested locally manufactured fruit and milk juices complied with TSC, TCC, and TVBC requirements. All investigations showed that freshly made fruit and milk juices were heavily contaminated (Total viable bacterial count, total coliform count, and total staphylococcus count). .

Research on Drug-Patent Linkage System under the New Situation

Objective To explore the extent to which the drug-patent linkage system should be implemented in China. Methods The present situation of drug-patent linkage system internationally was analyzed. Then the practices of drug-patent linkage system were discussed through such methods as literature reviews and quantitative scoring methods in combination of selecting the representative countries. Finally the extent to which the drugpatent linkage system should be implemented in China was explored through comparative analysis. Results and Conclusion Compared with the United States, China should establish a drug-patent linkage system that will weaken the protection of original patented drugs and promote the timely marketing of high-quality generic drugs and appropriately prevent the patent abuse.

Sulfuryl Group-Involved Drugs Approved by the Food and Drug Administration(FDA)from 2021 to 2023

Organic sulfone compounds,exhibiting interesting bioactivities,were widely applied in the field of pharmaceutical and medicine.And numerous of sulfuryl group-involved drugs were approved by the Food and Drug Administration(FDA).Odevixibat,maralixibat chloride and belzutifan approved in 2021 could be applied in the treatment of progressive familial intrahepatic cholestasis(PFIC),cholestatic pruritus and clear cell renal cell carcinoma(ccRCC),respectively.In 2022,abrocitinib,pyrukynd and voquezna were approved for the treatment of atopic dermatitis,pyruvate kinase deficiency(PKD)and acid-related disorders,respectively.Defencath for preventing bloodstream infections,sparsentan for treatment of proteinuria related to IgA nephropathy,and xacduro for treatment of hospital-acquired bacterial pneumonia(HABP)were approved in 2023.In this review,the synthesis and therapies of these sulfuryl group-involved drugs approved from 2021 to 2023 are discussed in details.

Anti-obesity drugs currently used and new compounds in clinical development

Obesity is a chronic disease which requires treatment. As lifestyle interventions alone hardly ever result in long-term weight loss, pharmacotherapy is an impor-tant adjunct to lifestyle measures to improve the induc-tion and maintenance of weight loss. Owing to the lim-ited options currently available for the pharmacological treatment of obesity, it is imperative to develop new safe compounds. This study aims to review the current medications approved by European Medicines Agency and United States Food and Drug Administration （FDA） for the treatment of obesity, focusing essentially on their benefits and risks, as well as on the new drugs which are presently under clinical trials. Moreover, it lists the anti-obesity agents that have been recently withdrawn from the market. A revision of the scientifc literature was carried out, through a search on Pubmedfor papers published from January 2010 to January2013. Orlistat （Xenical？） is currently the only long-termpharmacotherapy for obesity available in the Europeanmarket, as rimonabant and sibutramine were with-drawn in 2008 and 2010, respectively, due to serious psychiatric and cardiovascular adverse effects. Lorca-serin （Belviq？） and the association of phentermine and topiramate （QsymiaTM） were recently approved by FDA. Orlistat suppresses appetite inhibiting gastrointestinal lipase, being its adverse effects mostly gastrointestinal. Lorcaserin activates 5-HT2C receptors, phentermine is a norepinephrine releasing drug, and topiramate is an anticonvulsivant drug with weight loss properties.