Bad: Legislative regulation and liability of manufacturers

I. Bades: definition, classification and role in maintaining health

The dietary supplements, or biologically active additives, are concentrated sources of food substances, such as vitamins, minerals, amino acids, fatty acids, probiotics, prebiotics, dietary fiber, as well as plant extracts and products of animal origin. They are designed to supplement the diet and maintain health, and not for the treatment of diseases. It is important to emphasize that dietary supplements are not drugs, although they can have a certain physiological effect on the body.

1.1. Classification of dietary supplements in composition and purpose:

Bades are classified according to various criteria, including the composition, form of release and purpose.

• By composition:

  • Vitamin-mineral complexes: Contain combinations of vitamins and minerals necessary to maintain optimal functioning of the body. Often are used to prevent deficiency of vitamins and minerals, especially during periods of increased need (pregnancy, lactation, intensive physical activity).
  • Plant dietary supplements: Contain extracts, powders or other forms of plant processing with biological activity. They can be used to maintain immunity, improve digestion, reduce stress and other goals. Examples: Echinacea extract, ginseng, ginkgo biloba.
  • Amino acid complexes: Contain amino acids, construction blocks of proteins necessary for the growth and restoration of tissues. They are used by athletes to improve sports results, as well as people with a protein deficit in the diet.
  • Probiotics and prebiotics: Contain living microorganisms (probiotics) or substances that contribute to their growth (prebiotics). Used to maintain intestinal health, improve digestion and strengthen immunity.
  • Fatty acids: Contain polyunsaturated fatty acids (omega-3, omega-6), necessary for the health of the heart, brain and joints.
  • Other dietary supplements: Include substances that are not related to the above categories, such as coenzyme Q10, chondroitin, glucosamine, etc.

• By the form of release:

  • Tablets: Convenient form for admission, the dosage is easily controlled.
  • Capsules: They can contain both powders and fluids, protect active substances from the effects of gastric juice.
  • Powders: They are divorced in water or added to food, convenient for people who have difficulty swallowing tablets or capsules.
  • Liquids (solutions, syrups): Easily dosed, quickly absorbed.
  • Bars, chewing gums: Convenient form for receiving “on the go”.

• By purpose:

  • To maintain immunity: Contain vitamins, minerals, plant extracts, probiotics.
  • To improve digestion: Contain probiotics, prebiotics, dietary fiber, enzymes.
  • To maintain the cardiovascular system: Contain omega-3 fatty acids, coenzyme Q10, B vitamins B.
  • To maintain joint health: Contain chondroitin, glucosamine, collagen.
  • To improve cognitive functions: Contain ginkgo biloba, omega-3 fatty acids, vitamins of group B.
  • To maintain energy and vital tone: Contain ginseng, eleutherococcus, B vitamins B.

1.2. The role of dietary supplements in maintaining health and preventing diseases:

Bad can play an important role in maintaining health and preventing diseases, especially in a modern way of life characterized by unbalanced nutrition, stress and exposure to adverse environmental factors.

• Compensation of nutrient deficiency: Bades can help to make up for the lack of vitamins, minerals and other nutrients that do not enter the body in sufficient number of food.
• Maintaining the health of individual organs and systems: Bades can have a directed effect on certain organs and systems, supporting their normal functioning. For example, dietary supplements with probiotics can improve the condition of the intestines, and dietary supplements with omega-3 fatty acids can support the health of the heart.
• Strengthening immunity: Some dietary supplements, such as vitamin C, zinc and echinacea extract, have immunomodulating properties and can help strengthen immunity.
• Increasing stress resistance: Adaptogens, such as ginseng and eleutherococcus, can increase the body’s resistance to stress and improve overall well -being.
• Prevention of chronic diseases: Some dietary supplements, such as omega-3 fatty acids and antioxidants, can reduce the risk of chronic diseases, such as cardiovascular diseases, cancer and diabetes.

It is important to remember that dietary supplements are not a panacea and should not be used as a replacement for good nutrition and a healthy lifestyle. Before taking dietary supplements, it is recommended to consult a doctor to make sure their safety and effectiveness in your specific case.

II. Legislative regulation of dietary supplements in the Russian Federation

Legislative regulation of dietary supplements in the Russian Federation is aimed at ensuring the safety and quality of products, protecting consumer rights and preventing unfair competition. The main regulatory act governing the turnover of dietary supplements is the Federal Law of January 2, 2000 No. 29-ФЗ “On the quality and safety of food products”.

2.1. Basic normative acts:

• Federal Law of January 2, 2000 No. 29-ФЗ “On the quality and safety of food products”: Establishes general requirements for the quality and safety of food products, including dietary supplements.
• Technical regulations of the Customs Union TR TS 021/2011 “On the safety of food products”: It contains requirements for food safety, including dietary supplements, including hygienic standards, labeling, packaging and transportation requirements.
• Technical Regulation of the Customs Union TR TS 022/2011 “Food products regarding its marking”: Establishes requirements for labeling of food products, including dietary supplements, regarding the information about the composition, food value, expiration date and other product characteristics.
• Decision of the Commission of the Customs Union dated April 7, 2011 No. 667 “On the form of certificate of state registration of products”: Establishes the form of a certificate of state registration of products, including dietary supplements.
• SanPiN 2.3.2.1290-03 “Hygienic requirements for the organization of production and turnover of biologically active additives to food (BAD)”: Contains hygienic requirements for the production, storage, transportation and sale of dietary supplements.
• Order of Rospotrebnadzor dated July 23, 2012 No. 781 “On State Registration of Products”: Regulates the state registration procedure of dietary supplements.
• GOST R 51074-2003 “Food products. Information for the consumer. General requirements “: Establishes general requirements for the information provided to the consumer about food products, including dietary supplements.

2.2. State registration of dietary supplements:

Before issuing in the territory of the Russian Federation, all dietary supplements are subject to mandatory state registration in Rospotrebnadzor. State registration is a confirmation of the compliance of dietary supplements with security requirements established by the technical regulations of the Customs Union and sanitary rules.

• State registration procedure:

  1. Application and necessary documents: The applicant (manufacturer or importer) submits an application for state registration of dietary supplements to Rospotrebnadzor, to which documents confirming the safety and quality of products (research results, technical documentation, product samples) are attached.
  2. Examination of documents and product samples: Rospotrebnadzor conducts an examination of the submitted documents and product samples to assess their compliance with security requirements.
  3. Making a decision on state registration: Based on the results of the examination, Rospotrebnadzor decides on state registration of dietary supplements or refusing state registration.
  4. Issuance of a certificate of state registration: If a positive decision is made, Rospotrebnadzor issues a certificate of state registration of dietary supplements, which confirms the right to production and sale of products in the Russian Federation.

• Necessary documents for state registration:

  • Application for state registration.
  • Technical documentation for dietary supplements (technical conditions, technological instructions).
  • Bad recipe.
  • Samples of products for conducting research.
  • Testing protocols confirming safety and quality of dietary supplements.
  • Documents confirming the origin of raw materials.
  • Label or label layout.
  • A document confirming the authority of the applicant.

2.3. Dad requirements Requirements:

The production of dietary supplements must comply with the requirements established by sanitary rules and norms (SanPiN 2.3.2.1290-03). These requirements relate to:

• Premises and equipment: Production rooms should be clean, dry and well ventilated, and the equipment should be made of materials allowed for contact with food products.
• Raw materials: The raw materials used to produce dietary supplements must comply with safety and quality requirements. It is necessary to monitor the quality of the incoming raw materials.
• Technological process: The technological process of producing dietary supplements should ensure the preservation of the beneficial properties of the ingredients and the prevention of production pollution.
• Quality control: It is necessary to carry out quality control at all stages of dietary supplements, including control of raw materials, intermediate products and finished products.
• Personnel: Personnel engaged in the production of dietary supplements must have appropriate qualifications and undergo regular medical examinations.
• Packaging and markings: Packing dietary supplements should ensure the safety of products, and the marking should contain reliable information about the composition, food value, expiration date and other product characteristics.

2.4. Bad Requirements for Marking:

The marking of dietary supplements must comply with the requirements of the technical regulations of the Customs Union (TR TS 022/2011) and provide the consumer with reliable and complete information about products. Mandatory information that should be indicated on the dietary supplement label includes:

• Name of dietary supplement: Must be clear and understandable to the consumer.
• Composition: The list of all the ingredients that make up the dietary supplements in the order of decreasing their mass fraction.
• Food value information: Calorie content, content of proteins, fats, carbohydrates, vitamins, minerals and other biologically active substances.
• Recommendations for use: Method of application, dosage, duration of admission.
• Contraindications: The list of states in which dietary supplements are not recommended.
• Best before date: The date to which the dietary supplement retains its properties.
• Storage conditions: Recommendations for storage of dietary supplements.
• Name and location of the manufacturer: Full name and address of the manufacturer.
• Information about state registration: Number and date of certificate of state registration.
• Inscription: “It is not a drug.”

2.5. Control over the back of the dietary supplement:

Control over the turnover of dietary supplements is carried out by Rospotrebnadzor and other authorized bodies. Control includes:

• Checking the compliance of dietary supplements with safety and quality requirements: Planned and unscheduled inspections of manufacturers, importers and dietary supplements are carried out.
• Selection of products for conducting research: Samples of dietary supplements are selected for laboratory research in order to verify their compliance with safety and quality requirements.
• Consideration of consumer complaints: Consumer complaints about the quality and safety of dietary supplements are considered.
• Application of administrative measures: If violations are detected, administrative measures are used, such as fines, suspension of activity, removal of products from circulation.

III. Responsibility of dietary supplements

Dad manufacturers are responsible for the safety and quality of their products in accordance with the legislation of the Russian Federation. Responsibility can be civil law, administrative and criminal.

3.1. Civil liability:

Civil liability of dietary supplement manufacturers arises in case of harm to the health or property of the consumer as a result of the use of poor-quality or unsafe products. In this case, the consumer has the right to compensation for losses caused to him as a result of defects of the goods (Article 1095 of the Civil Code of the Russian Federation).

• The grounds for the onset of civil liability:

  • Causing the health of consumer as a result of the use of poor -quality or unsafe dietary supplements.
  • Causing the property of the consumer as a result of the use of poor -quality or unsafe dietary supplements.
  • Providing inaccurate or incomplete information about dietary supplements, resulting in harm to the consumer.

• Types of losses subject to compensation:

  • Treatment costs.
  • Lost earnings.
  • The costs of restoring damaged property.
  • Compensation for non -pecuniary damage.

3.2. Administrative responsibility:

Administrative liability of dietary supplement manufacturers occurs for violation of the requirements of legislation in the field of ensuring quality and safety of food products, including for:

• Production or implementation of dietary supplements that do not meet safety requirements (Article 6.3 of the Code of Administrative Offenses of the Russian Federation): Violation of sanitary and epidemiological requirements for the production and turnover of dietary supplements.

• Violation of the requirements of technical regulations (Article 14.43 of the Code of Administrative Offenses of the Russian Federation): Violation of the requirements of the technical regulations of the Customs Union regarding the safety and quality of dietary supplements.

• The introduction of consumers regarding the consumer properties or quality of the goods (Article 14.7 of the Code of Administrative Offenses of the Russian Federation): Providing false or incomplete information about dietary supplements, misleading consumers.

• Violation of the rules for the sale of certain types of goods (Article 14.15 of the Code of Administrative Offenses of the Russian Federation): Violation of the rules for the sale of dietary supplements established by law.

• Non -compliance with the requirements for labeling products (Article 14.46 of the Code of Administrative Offenses of the Russian Federation): Violation of the requirements for the marking of dietary supplements established by technical regulations.

• Types of administrative punishments:

  • Warning.
  • Administrative fine.
  • Product confiscation.
  • Suspension of activity.

3.3. Criminal liability:

The criminal liability of dietary supplement manufacturers can occur in the case of the production, storage, transportation or sale of goods and products that do not meet the requirements of the safety of life or health of consumers, if these acts resulted in negligence causing serious harm to health or the death of a person (Article 238 of the Criminal Code of the Russian Federation).

• Grounds for criminal liability:

  • Production, storage, transportation or sale of dietary supplements that do not meet the requirements of the safety of life or health of consumers.
  • Causing serious harm to the health of the consumer by negligence as a result of the use of poor -quality or unsafe dietary supplements.
  • The death of a person by negligence as a result of the use of poor -quality or unsafe dietary supplements.

• Types of criminal punishments:

  • Fine.
  • Mandatory work.
  • Correctional labor.
  • Restriction of freedom.
  • Imprisonment.

IV. The practice of applying legislation and judicial precedents

The practice of applying the legislation on dietary supplements in the Russian Federation shows that the most common violations related to the inconsistency of products with safety requirements, violation of the rules of labeling and misleading consumers regarding the consumer properties of the goods.

4.1. Examples of administrative cases:

• Bad production without state registration: The production and implementation of dietary supplements without receiving a certificate of state registration is a gross violation of the law and entails administrative responsibility in the form of a fine and confiscation of products.
• Implementation of dietary supplements with an expired expiration date: The implementation of dietary supplements with an expired shelf life is prohibited and entails administrative responsibility in the form of a fine and removal of products from circulation.
• Inaccurate information on the Bad label: An indication of inaccurate or incomplete information on the composition of dietary supplements about the composition, food value, properties or contraindications is a violation of consumer rights and entails administrative responsibility in the form of a fine.
• Violation of sanitary requirements for dietary supplements: Failure to comply with sanitary requirements for industrial premises, equipment, raw materials or staff is a violation of sanitary rules and entails administrative responsibility in the form of a fine or suspension of activity.

4.2. Examples of civil cases:

• A claim for compensation for harm caused to health as a result of dietary supplements: The consumer, who was caused by harm to health as a result of the use of poor -quality dietary supplements, has the right to apply to the court with a claim for compensation for losses, including treatment costs, lost earnings and compensation for non -pecuniary damage.
• A claim for the protection of consumer rights in connection with the provision of inaccurate information about dietary supplements: The consumer, misleading regarding the consumer properties or quality of dietary supplements, has the right to apply to the court with a claim for the protection of consumer rights and demand compensation for losses caused to him as a result of inaccurate information.

4.3. Judicial precedents:

Judicial practice in cases related to dietary supplements is diverse and depends on the specific circumstances of the case. However, several general trends can be distinguished:

• Courts pay special attention to safety issues: When considering cases of harm to consumer health, the courts carefully examine evidence confirming the causal relationship between dietary supplements and the occurrence of harm to health.
• Courts protect consumers’ rights to reliable information about dietary supplements: Courts recognize the right of consumers to receive reliable and complete information about the composition, properties, contraindications and the method of application of dietary supplements.
• Courts hold manufacturers accountable for poor -quality products: The courts are attracted to civil, administrative and criminal liability of dietary supplements, guilty of production and sale of poor-quality or unsafe products.

V. Trends and prospects for the development of legislation on dietary supplements

The development of legislation on dietary supplements in the Russian Federation is aimed at improving the mechanisms of control over the quality and safety of products, strengthening the responsibility of manufacturers and protecting consumer rights.

5.1. Harmonization with international norms:

Currently, work is underway to harmonize Russian legislation on dietary supplements with international norms and standards, in particular with the requirements of the European Union and the World Health Organization.

5.2. Strengthening control over dietary supplements:

It is planned to strengthen control over the advertising of dietary supplements in order to prevent consumers in misconception regarding the properties and efficiency of products.

5.3. Development of a system of traceability of dietary supplements:

The possibility of introducing a traceability system of dietary supplements, which allows to track the movement of products from the manufacturer to the final consumer, is considered.

5.4. Improving the requirements for marking dietary supplements:

It is planned to improve the requirements for marking dietary supplements in order to provide the consumer with more complete and reliable information about products.

5.5. Strengthening responsibility for violations:

The possibility of strengthening administrative and criminal liability for violations of the legislation on dietary supplements is considered.

Improving the legislation on dietary supplements is an important factor in ensuring the safety and quality of products, the protection of consumer rights and the development of a competitive industry for the production of dietary supplements in the Russian Federation.