Bades: Legislative regulation and control

Section 1: Definition and classification of dietary supplements

1. 1. The essence of dietary supplements: What are biologically active additives?
   • 1. 1. 1. Definition of dietary supplements under the legislation of various countries (Russia, USA, EU).
   • 1. 1. 1. The distinction between dietary supplements from drugs, specialized foods and traditional food products.
   • 1. 1. 1. Key dietary supplements: concentration of biologically active substances, form of release, method of application, expected effect.
   • 1. 1. 1. The role of dietary supplements in maintaining health and prevention of diseases: potential advantages and risks.
2. 2. Classification of dietary supplements: variety of composition and purpose
   • 1. 1. 1. Classification according to the composition: vitamin-mineral complexes, plant extracts, probiotics, prebiotics, amino acids, polyunsaturated fatty acids (PNZHK), etc.
   • 1. 1. 1. Classification in the form of release: tablets, capsules, powders, solutions, bars, etc.
   • 1. 1. 1. Classification for its intended purpose: dietary supplement to maintain immunity, improve digestion, increase energy, strengthen bones, improve cognitive functions, etc.
   • 1. 1. 1. Functional classification: nutricetics (additional sources of food substances), parapharmaceuticals (means for prevention and auxiliary therapy), probiotics and prebiotics (regulation of intestinal microflora).
3. 3. Dietary supplements: active ingredients and auxiliary substances
   • 1. 1. 1. Requirements for active ingredients: identification, cleanliness, concentration, bioavailability.
   • 1. 1. 1. Requirements for excipients: safety, inertia, technological necessity.
   • 1. 1. 1. Quality control of raw materials for the production of dietary supplements: certification of suppliers, verification for compliance with specifications.
   • 1. 1. 1. Using standardized plant raw materials extracts: advantages and disadvantages.
   • 1. 1. 1. Problems of falsification and impurities in dietary supplements: solutions.
4. 4. Bad output forms: features and impact on efficiency
   • 1. 1. 1. Tablets: advantages (ease of dosing, stability) and disadvantages (slow solubility, effects of gastric juice).
   • 1. 1. 1. Capsules: advantages (protection of contents, disguise of taste) and disadvantages (higher cost).
   • 1. 1. 1. Powders: advantages (quick solubility, possibility of mixing with other products) and disadvantages (inconvenience of dosing).
   • 1. 1. 1. Solutions: advantages (fast absorption, ease of use for children) and disadvantages (instability, the need for preservatives).
   • 1. 1. 1. Bats and other forms: advantages (ease of use, attractiveness for consumers) and disadvantages (high sugar content, the need for stabilizers).
5. 5. The effect of dietary supplements on the body: action mechanisms and expected effects
   • 1. 1. 1. Vitamins and minerals: role in metabolic processes, maintaining immunity, antioxidant protection.
   • 1. 1. 1. Plant extracts: antioxidant, anti -inflammatory, adaptogenic effect.
   • 1. 1. 1. Probiotics and prebiotics: normalization of intestinal microflora, improving digestion, strengthening immunity.
   • 1. 1. 1. Amino acids: participation in protein synthesis, regulation of metabolism, improvement of sports indicators.
   • 1. 1. 1. PNSK: maintaining health of the cardiovascular system, improving cognitive functions.
   • 1. 1. 1. Clinical studies of the effectiveness of dietary supplements: methodology and interpretation of results.
6. 6. Differences of dietary supplements and drugs: key aspects
   • 1. 1. 1. Purpose of use: Dietary supplies – maintaining health and prevention, drugs – treatment of diseases.
   • 1. 1. 1. Registration procedure: BAD – notifying registration, drugs – multi -stage registration with clinical trials.
   • 1. 1. 1. Requirements for evidence: BAD – minimal requirements, drugs – strict requirements for effectiveness and safety.
   • 1. 1. 1. Side effects and contraindications: dietary supplements – less strict control, medicines – strict control and mandatory indication in the instructions.
   • 1. 1. 1. Responsibility of the manufacturer: BAD – responsibility for safety, drugs – responsibility for efficiency and safety.
7. 7. Risks associated with the use of dietary supplements: possible side effects and interaction
   • 1. 1. 1. Individual intolerance and allergic reactions.
   • 1. 1. 1. An overdose: the consequences of the use of dietary supplements in doses exceeding the recommended.
   • 1. 1. 1. Interaction with drugs: potentiation or weakening of the action of drugs.
   • 1. 1. 1. Unwanted side effects: digestive disorders, headache, skin rashes, etc.
   • 1. 1. 1. The risk of falsification and content of harmful impurities.
   • 1. 1. 1. Unreasonable use of dietary supplements instead of full nutrition and treatment.
8. 8. Choice of dietary supplements: recommendations for consumers
   • 1. 1. 1. Consultation with a doctor or nutritionist before starting dietary supplements.
   • 1. 1. 1. The choice of dietary supplements from trusted manufacturers with a good reputation.
   • 1. 1. 1. A careful study of the composition and instructions for use.
   • 1. 1. 1. Taking into account the individual characteristics of the body and possible contraindications.
   • 1. 1. 1. Compliance with the recommended dosage and duration of admission.
   • 1. 1. 1. Avoiding the purchase of dietary supplements in doubtful places (Internet sites, markets).
   • 1. 1. 1. Checking the availability of a certificate of state registration (SGR) or a declaration of conformity.

Section 2: Legislative regulation of dietary supplements in the Russian Federation

1. 9. Regulatory framework: Basic laws and by-laws
   • 1. 1. 1. Federal Law of 02.01.2000 N 29-ФЗ “On the quality and safety of food products”.
   • 1. 1. 1. Technical Regulation of the Customs Union TR TS 021/2011 “On food safety”.
   • 1. 1. 1. Technical regulations of the Customs Union TR TS 022/2011 “Food products regarding its marking.”
   • 1. 1. 1. Technical Regulations of the Customs Union TR TS 029/2012 “Requirements of food supplements, flavorings and technological auxiliary tools.”
   • 1. 1. 1. SanPiN 2.3.2.1290-03 “Hygienic requirements for the organization of production and turnover of biologically active food additives.”
   • 1. 1. 1. Decisions of the Commission of the Customs Union and the Eurasian Economic Commission (EEC).
2. 10. State registration of dietary supplements: procedure and requirements
   • 1. 1. 1. The notifying nature of the registration of dietary supplements in the Russian Federation.
   • 1. 1. 1. The state registration body: the Federal Service for Supervision of the Protection of Consumer Rights and Human Welfare (Rospotrebnadzor).
   • 1. 1. 1. The necessary documents for registration: application, technical documentation, product samples, research protocols.
   • 1. 1. 1. Stages of registration: examination of documents, laboratory research, decision -making.
   • 1. 1. 1. The validity of the certificate of state registration (SGR): indefinitely.
   • 1. 1. 1. The grounds for refusal to register: non -compliance with security requirements, inaccurate information, lack of necessary documents.
3. 11. DAVs: GMP and other standards
   • 1. 1. 1. GMP principles (good manufactoring practice): Assembly of the quality and safety of products at all stages of production.
   • 1. 1. 1. Requirements for industrial premises, equipment, personnel, raw materials, technological processes, quality control, documentation, storage and transportation.
   • 1. 1. 1. Certification of production for compliance with the requirements of GMP: a voluntary procedure confirming the compliance of production by international standards.
   • 1. 1. 1. Quality management systems in enterprises producing DAA: ISO 9001, HACCP.
   • 1. 1. 1. The role of self -regulatory organizations (SRO) in the quality control of the production of dietary supplements.
4. 12. Bad Marking: Information Requirements for Consumers
   • 1. 1. 1. Mandatory information on the label: product name, composition, nutritional value, purpose, method, method of application, contraindications, shelf life, storage conditions, manufacturer, number of the SCR or declaration of conformity.
   • 1. 1. 1. Forbidden information on the label: indicating the treatment properties, inaccurate information, the introduction of the consumer.
   • 1. 1. 1. Requirements for the font and the size of the text on the label.
   • 1. 1. 1. Marking with a sign of conformity to the technical regulations of the Customs Union (EAS sign).
   • 1. 1. 1. The manufacturer’s responsibility for false or incomplete information on the label.
5. 13. Advertising Bad: restrictions and requirements
   • 1. 1. 1. Law “On Advertising”: General requirements for advertising of goods and services.
   • 1. 1. 1. Special requirements for Advertising BAD: a ban on indicating the treatment properties, a mandatory warning about contraindications, the need for the presence of a SCR or a declaration of conformity.
   • 1. 1. 1. The responsibility of the advertiser for an inaccurate or misleading advertising.
   • 1. 1. 1. Control of Advertising Bad: Federal Antimonopoly Service (FAS).
   • 1. 1. 1. Self -regulation of advertising activities in the field of dietary supplements.
6. 14. Turnover Dad: Storage, transportation and implementation conditions
   • 1. 1. 1. Requirements for storage conditions of dietary supplements: temperature, humidity, illumination.
   • 1. 1. 1. Requirements for transportation of dietary supplements: compliance with the temperature regime, protection against damage.
   • 1. 1. 1. Places of the sale of dietary supplements: pharmacies, specialized stores, online stores.
   • 1. 1. 1. Requirements for personnel engaged in the implementation of dietary supplements: the availability of qualifications, knowledge of the properties and purpose of dietary supplements.
   • 1. 1. 1. The seller’s responsibility for violation of the rules of the trading of dietary supplements.
7. 15. Control and supervision of dietary supplements: functions and powers of Rospotrebnadzor
   • 1. 1. 1. Functions of Rospotrebnadzor: state sanitary and epidemiological supervision, consumer protection.
   • 1. 1. 1. The powers of Rospotrebnadzor: conducting checks, selection of products for research, making instructions for eliminating violations, suspension of production and sale of products, and bringing to administrative responsibility.
   • 1. 1. 1. Planned and unscheduled inspections of enterprises that produce and implement dietary supplements.
   • 1. 1. 1. Response to consumer appeals about poor -quality or dangerous products.
   • 1. 1. 1. The interaction of Rospotrebnadzor with other regulatory authorities (prosecutor’s office, police).
8. 16. Responsibility for violations of legislation in the field of Bad turnover
   • 1. 1. 1. Administrative responsibility: fines, confiscation of products.
   • 1. 1. 1. Criminal liability: for the production and sale of hazardous products, for falsification of documents.
   • 1. 1. 1. Civil liability: compensation for damage caused to consumers.
   • 1. 1. 1. Liability measures applied to legal entities and individual entrepreneurs.
   • 1. 1. 1. Practice of holding accountable for violations in the field of dietary supplements.

Section 3: Foreign experience in regulating dietary supplements

1. 17. USA: DShea and FDA
   • 1. 1. 1. Dietary Supplement Health and Education Act (DSHEA) 1994: the main provisions and impact on the regulation of dietary supplements in the United States.
   • 1. 1. 1. Functions Food and Drug Administration (FDA) regarding dietary supplements: safety control, labeling and advertising.
   • 1. 1. 1. FDA notification procedure on new dietary supplements.
   • 1. 1. 1. Dad Production Requirements: Current Good Manuapacturn Practice (CGMP).
   • 1. 1. 1. Monitoring statements about the benefits of human health (Health Claims).
   • 1. 1. 1. Responsibility of manufacturers for safety and product quality.
2. 18. European Union: Directives and Regulations
   • 1. 1. 1. Directive 2002/46/EC on Food Supplements: the main provisions and harmonization of the legislation of the EU countries.
   • 1. 1. 1. Regulation (EC) No. 1924/2006 On Nutrition and Health Claims Made on Foods: Requirements for statements about food and health value.
   • 1. 1. 1. European Food Safety Authority (EFSA): role in assessing safety and effectiveness of dietary supplements.
   • 1. 1. 1. National features of the regulation of dietary supplements in the EU countries (Germany, France, Italy, etc.).
   • 1. 1. 1. The procedure for notification on the placement of dietary supplements in the EU market.
   • 1. 1. 1. Control over the content of vitamins and minerals in dietary supplements.
3. 19. Канада: Natural Health Products Regulations
   • 1. 1. 1. Natural Health Products Regulations (NHPR): the main provisions and dietary supplements in Canada.
   • 1. 1. 1. Licensing of Natural Health Products: Procedure for obtaining a license for the production and sale of dietary supplements.
   • 1. 1. 1. Health Canada: The role in the control of safety and the effectiveness of dietary supplements.
   • 1. 1. 1. Good Manufactoring Practices (GMP) for natural health products.
   • 1. 1. 1. Requirements for labeling and advertising Bad.
   • 1. 1. 1. Responsibility of manufacturers for safety and product quality.
4. 20. Australia: Therapeutic Goods Administration (TGA)
   • 1. 1. 1. Therapeutic Goods Act 1989: The main provisions and regulation of therapeutic goods, including some dietary supplements.
   • 1. 1. 1. Therapeutic Goods Administration (TGA): the role in the safety control and effectiveness of therapeutic goods.
   • 1. 1. 1. Registration of Therapeutic Goods: The procedure for registering therapeutic goods, including dietary supplements with the therapeutic effect.
   • 1. 1. 1. Listing of Therapeutic Goods: The procedure for introducing therapeutic goods, including low -risk dietary supplements.
   • 1. 1. 1. Good Manufactoring Practice (GMP) for therapeutic products.
   • 1. 1. 1. Requirements for labeling and advertising of therapeutic goods.
5. 21. Comparison of dietary supplement regulation systems in different countries
   • 1. 1. 1. General features and differences in approaches to the regulation of dietary supplements in the USA, EU, Canada and Australia.
   • 1. 1. 1. The degree of rigidity of regulation: from notifying registration to a compulsory license.
   • 1. 1. 1. Requirements for evidence -based database of dietary supplements.
   • 1. 1. 1. Control over the safety and quality of products.
   • 1. 1. 1. Approaches to marking and advertising Bad.
   • 1. 1. 1. Trends in the development of legislation in the field of dietary supplements.

Section 4: Problems and prospects for regulation of dietary supplements

1. 22. Actual problems of dietary supplement regulation in Russia
   • 1. 1. 1. Insufficient harmonization of legislation with international standards.
   • 1. 1. 1. Weak control over the quality and safety of products.
   • 1. 1. 1. Distribution of falsified and counterfeit products.
   • 1. 1. 1. Aggressive and inaccurate advertising of dietary supplements.
   • 1. 1. 1. Insufficient awareness of consumers about risks associated with the use of dietary supplements.
   • 1. 1. 1. Difficulties in distinguishing between dietary supplements from medicines.
2. 23. Ways to improve legislation in the field of Bad turnover
   • 1. 1. 1. Strengthening the quality and safety of products: Implementation of a system of mandatory production certification for compliance with GMP requirements.
   • 1. 1. 1. Tighten the requirements for labeling and advertising BAD: a ban on false information, a mandatory indication of contraindications and side effects.
   • 1. 1. 1. Strengthening the responsibility of manufacturers and sellers for violations of the law.
   • 1. 1. 1. Development and implementation of a trace system from a manufacturer to the consumer.
   • 1. 1. 1. Increasing consumer awareness of risks and advantages of dietary supplements.
   • 1. 1. 1. Development of the Institute for Self -Regulations in the Field of Production and Turnover of Bad.
3. 24. The role of scientific research in the regulation of dietary supplements
   • 1. 1. 1. The need to conduct scientific research to confirm the effectiveness and safety of dietary supplements.
   • 1. 1. 1. Development of standards for conducting clinical research of dietary supplements.
   • 1. 1. 1. Using the results of scientific research in the development of regulatory documents.
   • 1. 1. 1. Support for scientific research in the field of dietary supplements by the state and private companies.
   • 1. 1. 1. Publishing research results in scientific journals and their distribution among consumers.
4. 25. BAD market development prospects
   • 1. 1. 1. The increase in demand for dietary supplements due to an increase in life expectancy and health care.
   • 1. 1. 1. The development of new dietary supplements production technologies.
   • 1. 1. 1. The emergence of new types of dietary supplements with improved properties.
   • 1. 1. 1. Expansion of the range of dietary supplements intended for various age groups and categories of consumers.
   • 1. 1. 1. An increase in the share of dietary supplements made from natural raw materials.
   • 1. 1. 1. Development of online trading dietary supplements.
5. 26. International cooperation in the field of regulation of dietary supplements
   • 1. 1. 1. Harmonization of the legislation of different countries in the field of dietary supplements.
   • 1. 1. 1. Exchange of experience and information between regulatory authorities of different countries.
   • 1. 1. 1. Joint scientific research in the field of dietary supplements.
   • 1. 1. 1. The fight against falsified and counterfeit products at the international level.
   • 1. 1. 1. Development of international standards for the production and quality control of dietary supplements.
6. 27. The role of public organizations in the control of the back of the dietary supplement
   • 1. 1. 1. Consumer protection.
   • 1. 1. 1. Information of consumers about risks and advantages of using dietary supplements.
   • 1. 1. 1. Conducting independent examinations of quality and safety of dietary supplements.
   • 1. 1. 1. Participation in the development of regulatory documents in the field of dietary supplements.
   • 1. 1. 1. Interaction with regulatory bodies and dietary supplements.
7. 28. Ethical aspects of the use of dietary supplements
   • 1. 1. 1. Informed consent of the consumer to use dietary supplements.
   • 1. 1. 1. Reliable information about the composition, properties and possible risks of dietary supplements.
   • 1. 1. 1. Prevention of abuse in the advertising of Bad.
   • 1. 1. 1. Ensuring the availability of dietary supplements for all categories of consumers.
   • 1. 1. 1. Compliance with consumer rights in the sale and application of dietary supplements.

Section 5: Practical application of knowledge about the regulation of dietary supplements

1. 29. The algorithm of actions when choosing and using dietary supplements
   • 1. 1. 1. Determining the purpose of the use of dietary supplements (maintenance of health, prevention of diseases, improvement of sports indicators, etc.).
   • 1. 1. 1. Consultation with a doctor or nutritionist to determine the need to use dietary supplements and select an optimal product.
   • 1. 1. 1. Studying information about the manufacturer of dietary supplements and its reputation.
   • 1. 1. 1. A careful study of the composition of dietary supplements and instructions for use.
   • 1. 1. 1. Verification of the presence of a SGR or a declaration of conformity.
   • 1. 1. 1. Compliance with the recommended dosage and duration of admission.
   • 1. 1. 1. Tracking possible side effects and interaction with drugs.
   • 1. 1. 1. Continuation of dietary supplements with the appearance of undesirable reactions.
2. 30. Development of dietary supplies in accordance with the requirements of the law
   • 1. 1. 1. Mandatory labeling elements: product name, composition, food value, purpose, method, method of application, contraindications, shelf life, storage conditions, manufacturer, number of the SCR or declaration of conformity.
   • 1. 1. 1. Rules for indicating the composition: listing the ingredients in the order of waning mass, indicating the concentration of active substances.
   • 1. 1. 1. Requirements for the font and size of the text: readability, contrast, compliance with the requirements of technical regulations.
   • 1. 1. 1. Label design: attractive design, compliance with the requirements of advertising legislation.
   • 1. 1. 1. Checking the label for compliance with the requirements of the technical regulations of the Customs Union.
3. 31. Development of advertising materials for dietary supplements in accordance with the law
   • 1. 1. 1. Compliance with the requirements of the law “On Advertising”: reliability, objectivity, lack of misleading information.
   • 1. 1. 1. A ban on indicating the healing properties of dietary supplements.
   • 1. 1. 1. Mandatory warning about contraindications and side effects.
   • 1. 1. 1. Indication of the number of the SGR or the declaration of conformity.
   • 1. 1. 1. The use of reliable sources of information and research results.
   • 1. 1. 1. Verification of advertising materials for compliance with the requirements of the Federal Antimonopoly Service (FAS).
4. 32. Preparation of documents for state registration of dietary supplements
   • 1. 1. 1. Application for state registration.
   • 1. 1. 1. Technical documentation: composition, production technology, specification for raw materials and finished products, research results.
   • 1. 1. 1. Products for laboratory research.
   • 1. 1. 1. Research protocols: microbiological, toxicological, physico-chemical.
   • 1. 1. 1. Documents confirming the safety and effectiveness of dietary supplements.
   • 1. 1. 1. Translation of documents into Russian (if necessary).
   • 1. 1. 1. Copying of copies of documents.
5. 33. Organization of dietary supplement production in accordance with GMP requirements
   • 1. 1. 1. Development and implementation of a quality management system.
   • 1. 1. 1. Ensuring the compliance of industrial premises and equipment with the requirements of GMP.
   • 1. 1. 1. Quality control of raw materials, semi -products and finished products.
   • 1. 1. 1. Validation of technological processes.
   • 1. 1. 1. Personnel training with the requirements of GMP.
   • 1. 1. 1. Maintaining documentation confirming compliance with the requirements of GMP.
   • 1. 1. 1. Conducting internal audits to assess the effectiveness of the quality management system.
6. 34. Conducting an internal audit of an enterprise producing dietary supplement
   • 1. 1. 1. Audit planning: Definition of goals, objectives, scope and audit criteria.
   • 1. 1. 1. Preparation for the audit: information collection, development of checklists, preparation of a team of auditors.
   • 1. 1. 1. Conducting an audit: collection of evidence, interviews with personnel, analysis of documentation, inspection of production facilities.
   • 1. 1. 1. Identification of inconsistencies with GMP requirements.
   • 1. 1. 1. Development of a plan for corrective and preventive actions.
   • 1. 1. 1. Control over the implementation of the plan for corrective and preventive actions.
   • 1. 1. 1. Assessment of the effectiveness of corrective and preventive actions.
7. 35. Actions when detecting falsified dietary supplements
   • 1. 1. 1. Identification of falsified products: non -compliance of the composition, marking, packaging.
   • 1. 1. 1. Isolation of falsified products from other products.
   • 1. 1. 1. Information of Rospotrebnadzor on the identification of falsified products.
   • 1. 1. 1. Conducting an investigation to identify a source of falsified products.
   • 1. 1. 1. Taking measures to prevent the further spread of falsified products.
   • 1. 1. 1. Information of consumers about the identified falsified products.
8. 36. Response to consumer claims to the quality of dietary supplements
   • 1. 1. 1. Registration of consumer claims.
   • 1. 1. 1. Analysis of the claim and the causes of its occurrence.
   • 1. 1. 1. Investigation to establish the fact of violation of the quality of dietary supplements.
   • 1. 1. 1. Satisfaction of the reasonable requirements of the consumer: replacement of products, return of funds, compensation for losses.
   • 1. 1. 1. Taking measures to prevent repeated claims.
   • 1. 1. 1. Informing the consumer about the results of consideration of the claim.

Section 6: Cases and examples from the practice of regulating dietary supplements

1. 37. Case 1: Violation of the requirements for marking dietary supplements
   • 1. 1. 1. Description of the situation: identifying dietary supplements with incomplete or inaccurate information on the label.
   • 1. 1. 1. Violated requirements of the law: TR TS 022/2011 “Food products regarding its marking.”
   • 1. 1. 1. Actions of Rospotrebnadzor: issuing an order to eliminate violations, bringing to administrative responsibility.
   • 1. 1. 1. Corrective actions of the manufacturer: bringing the marking in accordance with the requirements of the legislation.
   • 1. 1. 1. Consequences for the manufacturer: fine, removal of products from turnover.
2. 38. Case 2: Valuation of dietary supplements without state registration
   • 1. 1. 1. Description of the situation: identifying the implementation of dietary supplements that have not passed state registration.
   • 1. 1. 1. Violated requirements of the law: Federal Law of 02.01.2000 N 29-ФЗ “On the quality and safety of food products”.