Data provided by the European Commission show that public expenditures for food supplements have been constantly increasing over the last decade. The aim of the present study was to analyze the major food supplements regulations in the European Union and in Bulgaria. Relevant publications were searched and found in MEDLINE/PubMed, Scopus Database, Web of Knowledge, and in Internet-based search with predefined keywords. Numerous authors support the opinion that there is a real risk that low quality products may be distributed in countries with poor production control. Bulgarian national legislation have 6 regulations with different legal force for provision of healthy and safe food supplements on the market. Currently, the European Community is concerned about food products, including FS, launched on the market because the citizens require reliable protection of their health. This concern provoked the European Parliament and the Council to undertake a number of legislative initiatives in the field of production and control of food products. It is necessary to set more precise quality and safety criteria in future strategies associated with those products.

Recent studies have announced that many food supplements for weight loss contained undeclared sibutramine. We have analysed 10 samples of herbal weight loss food supplements (FS) by HPLC/HRMS and UHPLC/MS-MS. We have established that two of the analysed samples contained sibutramine: respectively 5 µg/per capsule and 20 µg/per capsule. Illegal inclusion of this substance in FS could cause serious side effects and long term health consequences. The regulatory requirements for FS should be enhanced for more comprehensive consumers' protection. The need for mandatory quality control of these products and public awareness is undeniable.

The aim of the study was to analyze the presence of undeclared sildenafil, tadalafil, and vardenafil in food supplements (FSs) for erectile dysfunction. The presence of sildenafil, tadalafil, and vardenafil was determined using the generated ultraviolet (UV)-spectra and mass-spectrometry (MS)-spectra as well as chromatograms produced by the photodiode array (PDA)-detector and ion trap MS-detector. The results were processed by Xcalibur ver. 2.0.7. Fourteen of the 20 analyzed FSs contained undeclared ingredients. Sildenafil was present in 12 of them. Many violations and discrepancies between the label information and the real composition of the FS were identified. 70% of the samples contained undeclared ingredients of an erectile dysfunction medicinal product. The quantities varied within broad limits from 2 mg per tablet to 116.55 mg per tablet. Sildenafil was present in amounts exceeding 16.55 mg that is the maximum recommended dose, thus creating risk of overdose. Besides that, food supplements adulterated with sildenafil analogues are a health risk for consumer’s health as there is no evidence of modified sildenafil toxicity. All analyzed FSs were claimed to be 100% natural, not provoking side effects. No information for any FS contained indications of age limits or risk for interaction with other FSs or medical products.

Aim: Arthrosis of the hip joint is a condition that is becoming more and more common-it affects 1% of the population and constitutes a serious problem for their working efficiency and active way of life. The deforming arthrosis limits the functional capacity of the affected patients, worsens their quality of life and leads to incapacitation of the patients. The treatment of patients with coxarthrosis has to be planned and carried out comprehensively, in accordance with the pathological findings, the stage, duration and individual abilities of each patient. In the early stages of the condition, conservative therapy plays an essential role in the prophylaxis of complications and in slowing down the process. Physical and rehabilitation methods, in combination with medicamentous therapy, yield good results. This article focuses on the application of the comprehensive effect of conservative physiotherapeutic methods and complementary drug therapy in the early stage of coxarthrosis. The aim of the study is to investigate the efficiency of the combined application of physiotherapeutic electrical procedures and kinesitherapy methods and means in the treatment of coxarthrosis in the initial stage. Material and methods: 18 outpatients with coxarthrosis at an average age of 68, were subjected to a treatment schedule including: interferential current, low-frequency magnetic field, ultra phoresis with non-steroid anti-inflammatory medications, followed by a program of remedial exercise administered in 2 courses of 7 d at 'St. Panteleymon' Hospital in Plovdiv, in the period from September 2017 to May 2018. Results: The range of motion in terms of degrees exhibits a tendency towards increasing at the end of the course of therapy, as compared to that at the beginning of the course. The results from the initial and final muscle tests of the hip joint showed an improvement of the muscle function (from a degree of 3.50 to a degree of 4.50). Conclusion: In patients with coxarthrosis in the initial stage, the pain subsides after the physical and rehabilitation therapy administered in combination with medications.

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes.   Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states.   Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice.   Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017. The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents.   Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements. Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.