Definition of a dietary supplement
The definition of a dietary supplement varies from region to region due to local regulations and guidelines.
In the European Union: Dietary supplement is defined by Directive 2002/46/EC. Under this directive, dietary supplements are treated as sources of concentrated sources of substances having a nutritional or other physiological effect, which are intended to supplement a normal diet. Dietary supplements are sold in dosed forms such as tablets, capsules, powders, liquids and other forms intended for consumption in small, measured units. Such ingredients may include vitamins, minerals, amino acids, fatty acids, and other substances.
In United States: The definition of a dietary supplement is set by the US Dietary Supplement Health and Education Act (DSHEA) of 1994. According to DSHEA, a dietary supplement is a product intended for consumption that supplements the diet and contains one or more of the following ingredients: vitamins, minerals, herbs or other botanicals, amino acids, and substances used to increase the total nutritional value of the daily diet. Supplements in the US can be sold without the need to provide pre-market evidence of their effectiveness or safety, as long as the manufacturer does not claim specific medicinal properties of its products.
Both definitions emphasize that dietary supplements are intended to supplement the diet and are not considered ordinary foods or medicines, although detailed regulations regarding their composition, labeling and acceptable health claims vary significantly between regions.
Labeling of dietary supplements in the European Union and the United States must adhere to strict regulations designed to ensure safety and clarity of information for consumers. Below I will present the current regulations on the labeling of dietary supplements in both regions and a comparative table of the recommended daily intake (RDI) for selected vitamins and minerals.
Labeling in the European Union
In the European Union, dietary supplements are regulated by Regulation (EC) No 1924/2006 of the European Parliament and of the Council and Directive 2002/46/EC, which specify:
- Obligation to include the inscription "dietary supplement".
- Requirement to provide categories of nutrients or other substances characterizing the product.
- Recommended portion of the product to be consumed per day.
- Warning not to exceed recommended serving.
- Information that the product cannot replace a varied diet.
- Information about the need to store the product out of the reach of children.
- Prohibition of attributing medicinal properties to products.
Marking in the United States
In the USA, according to the Dietary Supplement Health and Education Act (DSHEA) of 1994:
- Products must be labeled "dietary supplement".
- It is required to indicate all ingredients, including the basis of their action.
- Ingredient content must be expressed in metric measurements.
- Information about the suggested daily serving and a warning not to exceed this serving.
- Supplements cannot be promoted as medicinal products.
Differences in markings
In the EU, there is more emphasis on precautionary health claims and potential risks, while in the US there is more flexibility in presenting the health benefits of supplements as long as they are not advertised as medicinal products.
Comparison table of reference values for vitamins and minerals
Below is a table showing the recommended daily allowances for selected vitamins and minerals in both regions.
Europe
Table with reference values for selected minerals and vitamins according to information obtained from the EFSA document. The table contains described columns in Polish that correspond to the values AI (Adequate Intake), AR (Average Requirement), PRI (Recommended Intake for the Population), RI (Reference Range for Macronutrients) and UL (Maximum Tolerable Intake).
| Type | Age | AI | AR | PRI | RI | UL |
|---|---|---|---|---|---|---|
| Calcium | 18-24 years | no data | 860 mg/day | 1000 mg/day | no data | 2500 mg/day |
| Chlorine | ≥ 18 years old | 3,1 g/day | no data | no data | no data | no data |
| Copper | ≥ 18 years old | 1.3 mg/day | no data | no data | no data | 5 mg/day |
| Fluorine | ≥ 18 years old | 2.9 mg/day | no data | no data | no data | 7 mg/day |
| Iodine | ≥ 18 years old | 150 μg/day | no data | no data | no data | 600 μg/day |
| Iron | Women before menopause | no data | 7 mg/day | 16 mg/day | no data | no data |
| Magnesium | ≥ 18 years old | 300 mg/day | no data | no data | no data | 250 mg/day |
| Molybdenum | ≥ 18 years old | 65 μg/day | no data | no data | no data | 0.6 mg/day |
| Phosphorus | ≥ 18 years old | 550 mg/day | no data | no data | no data | no data |
| Potassium | ≥ 18 years old | 3500 mg/day | no data | no data | no data | no data |
| Selenium | ≥ 18 years old | 70 μg/day | no data | no data | no data | 300 μg/day |
| Sodium | ≥ 18 years old | 2 g/day | no data | no data | no data | no data |
| Zinc | ≥ 18 years old | no data | 6.2-10.2 mg/day | 7.5-12.7 mg/day | no data | 25 mg/day |
Here is a table containing reference values for selected vitamins according to the latest data from EFSA:
| Vitamin | Age | AI | AR | PRI | RI | UL |
|---|---|---|---|---|---|---|
| Biotin | ≥ 18 years old | 40 µg/day | no data | no data | no data | no data |
| Choline | ≥ 18 years old | 400 mg/day | no data | no data | no data | no data |
| Cobalamin (B12) | ≥ 18 years old | 4 µg/day | no data | no data | no data | no data |
| Foils | ≥ 18 years old | no data | 250 µg DFE/day | 330 µg DFE/day | no data | 1000 µg/day |
| Niacin | ≥ 18 years old | no data | 1.3 mg NE/MJ | 1.6 mg NE/MJ | no data | 900 mg/day (nicotinamide) |
| Pantothenic acid | ≥ 18 years old | 5 mg/day | no data | no data | no data | no data |
| Riboflavin | ≥ 18 years old | no data | 1.3 mg/day | 1.6 mg/day | no data | no data |
| Thiamine | ≥ 18 years old | no data | 0.072 mg/MJ | 0.1 mg/MJ | no data | no data |
| Vitamin A | Women 18-59 years old | no data | 490 µg RE/day | 650 µg RE/day | no data | 3000 µg/day |
| Vitamin B6 | ≥ 18 years old | no data | 1.3 mg/day | 1.6 mg/day | no data | 25 mg/day |
| Vitamin C | ≥ 18 years old | no data | 80 mg/day | 95 mg/day | no data | no data |
| Vitamin D | ≥ 18 years old | 15 µg/day | no data | no data | no data | 100 µg/day |
| Vitamin E | ≥ 18 years old | 11 mg/day | no data | no data | no data | 300 mg/day |
| Vitamin K | ≥ 18 years old | 70 µg/day | no data | no data | no data | no data |
The table shows values for adults and may vary depending on gender and age group. If data is missing (NA) in some columns, it means that there is insufficient data to determine the value or it is not needed for a healthy population.
- Estimated Average Requirement (EAR) – Average demand,
- Recommended Dietary Allowance (RDA) – Recommended daily allowance,
- Adequate Intake (AI) – Adequate intake,
- Tolerable Upper Intake Level (UL) – The maximum tolerable level of intake.
Dietary supplements - general regulations
In today's global world, where the trade and distribution of dietary supplements and food products knows no borders, knowledge and compliance with legal regulations is becoming a key aspect of running a business. From Poland, through the European Union, to the United States and other countries, regulations regarding dietary supplements and food are evolving, adapting to new health challenges, scientific discoveries and consumer needs. For entrepreneurs operating in this industry, understanding these regulations is no longer just a matter of legal compliance, but also an element of building customer trust and ensuring high quality products. In this article, we provide a comprehensive overview of regulations in various regions of the world to provide readers with essential information and guidance to help navigate the complex world of dietary supplement and food regulations.
Poland: In Poland, regulations regarding dietary supplements and food are regulated by several institutions. Chief Sanitary Inspectorate (GIS) gis.gov.pl deals with food safety supervision, including dietary supplements. Journal of Laws dziennikustaw.gov.pl is the official law publication source for laws and regulations regarding food and supplements. Ministry of Health mz.gov.pl also publishes information on health policies and regulations.
European Union: At European level, legal provisions are available on the EUR-Lex portal thumb up, which provides access to all EU legal regulations. European Food Safety Authority (EFSA) efsa.europa.eu provides scientific data and opinion that influences EU food and supplement regulation.
United States: In the United States, U.S. Food and Drug Administration (FDA) fda. gov is the main regulatory body for food and supplement safety. CFR (Code of Federal Regulations) ecfr.gov contains all applicable U.S. federal regulations, including those relating to supplements and foods.
Other countries: Regulations in other countries may vary significantly. These are usually available on the government websites of the relevant regulatory bodies in each country. For companies operating internationally, it is crucial to understand and comply with these local regulations.
Importance for Entrepreneurs: For companies operating in the dietary supplements and food industry, knowledge and compliance with legal regulations is essential. Differences in regulations between countries require careful analysis and adaptation of production and marketing processes. Failure to comply with the regulations may lead to serious legal and financial consequences.
Poland
In Poland, the issues of regulation of dietary supplements and food safety are extensively regulated by several key institutions and legal acts.
Chief Sanitary Inspectorate (GIS): GIS is responsible for the supervision and control of food safety, including dietary supplements. An important document available at gis.gov.plis the "Regulation of the Minister of Health on dietary supplements", which details the requirements for dietary supplements in Poland.
Journal of Laws: As the official source of law publication in Poland, Journal of Laws dziennikustaw.gov.pl contains the full texts of laws and government regulations, including those relating to food and supplements. The key legal act here is the "Act on Food and Nutrition Safety", defining the rules regarding food production, processing, distribution and control.
Ministry of Health: Ministry of Health mz.gov.pl publishes information on health policies, including regulations relating to dietary supplements and food. The website provides guidelines and information on new product approvals, labeling standards and safety.
Here are the main legal acts in force in Poland regarding food and dietary supplements, along with links to full texts:
Food and Nutrition Safety Act – This is the basic act regulating the principles of production, processing, distribution, control and food safety and quality requirements. The full text of the act is available at: Food and Nutrition Safety Act - Journal of Laws 2023.1448.
Regulation of the Minister of Health on dietary supplements – This legal act specifies requirements for dietary supplements, including rules regarding their composition, labeling and conditions of marketing. The text of the regulation can be found here: Composition and labeling of dietary supplements - Journal of Laws 2023.79.
Act on the commercial quality of agricultural and food products – This Act concerns quality requirements for agri-food products, including aspects related to labeling and quality control. The text of the act can be found at: Commercial quality of agri-food products - Journal of Laws 2023.1980.
Regulation on additives permitted for use in food – Specifies a list of permitted additional substances that may be used in the production of food and dietary supplements. The full text of the regulation is available here: Permitted additional substances – Journal of Laws 2010.232.1525.
Regulation of the Minister of Health on dietary supplements, available at: here, regulates aspects related to dietary supplements in Poland. The main points of this document include:
Definitions and scope: Defines what is considered a dietary supplement, including their composition and intended use.
Allowed and prohibited ingredients: It contains a list of substances that can be used in supplements and those that are prohibited.
Labeling and consumer information: Establishes requirements for the labeling of supplements, including information on ingredients, dosage, and warnings for consumers.
Notification procedures: Describes the process of reporting dietary supplements to the appropriate regulatory authorities before they are placed on the market.
This document is a key legal element that shapes supplement market diets in Poland, ensuring safety and information for consumers.
For full details, please read the available document here.
To sum up, in Poland, as a member of the European Union, all EU regulations regarding dietary supplements and food apply. Polish legal acts are consistent with EU directives and regulations, which ensures a uniform standard of product safety and quality throughout the European market. For companies operating in Poland, understanding both local and EU legal regulations is crucial to effectively manage risk and ensure compliance with standards. Regular monitoring of changes in regulations and cooperation with legal experts is the best practice for companies operating on the dietary supplements market.
Europe
The main legal acts in force in the European Union regarding food and dietary supplements are:
- Directive 2002/46/EC on dietary supplements: Sets out the legal framework for dietary supplements in the European Union, including definitions, permitted ingredients and labeling requirements.
- Text of the directive: Directive 2002/46/EC
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 establishes basic requirements for food labeling and the provision of food information to consumers in the European Union.
- Clear and understandable labelling: Ensures that information on food labels is easy to understand for consumers.
- Nutritional information: Requires nutritional information to be included on product labels.
- Allergen designation: It imposes an obligation to distinguish allergens in the product composition.
- Regulation (EC) No. 1924/2006 of the European Parliament and of the Council applies to nutrition and health claims on food.
- Regulation of Nutrition and Health Claims: It specifies what claims may be used on food and under what conditions.
- Restrictions and Conditions of Use of Statements: It establishes detailed conditions that must be met for a nutrition or health claim to be legally used.
- Scientific Justification of the Statements: It requires health claims to be based on sound scientific evidence and approved by the European Food Safety Authority (EFSA).
- Regulation (EC) No. 178/2002 establishes the general principles and requirements of food law in the European Union.
- Food safety rules: It establishes general principles of food safety, including the precautionary principle in the event of scientific uncertainty.
- Food Tracking: It introduces the requirement to trace food products at every stage of production, processing and distribution.
- Quick warning system: Establishes a rapid warning system for food and feed hazards.
USA
Here are the main pieces of legislation in the United States relating to food and dietary supplements, with links to the full texts:
Federal Food, Drug, and Cosmetic Act (FD&C Act): The primary law regulating foods, drugs, cosmetics, and dietary supplements in the United States.
Dietary Supplement Health and Education Act of 1994 (DSHEA): An Act establishing a regulatory framework for the safety, labeling and advertising of dietary supplements.
- Text of the Act: DSHEA https://ods.od.nih.gov/About/DSHEA_Wording.aspx
Nutrition Labeling and Education Act of 1990 (NLEA): An act regulating nutritional labeling and health information on food products.
The Nutrition Labeling and Education Act (NLEA) of 1990 is a federal statute in the United States. It was signed on November 8, 1990 by President George H. W. Bush.
The Act gives the Food and Drug Administration (FDA) authority to require nutrition labeling for most foods regulated by the agency and requires that all nutrient content claims (e.g., 'high fiber', 'low fat', etc.) and health claims meet the regulations FDA. This act does not require restaurants to apply the same standards.
These regulations came into force on May 8, 1993 for health claims, ingredient labeling and juice content labeling (although juice content labeling was exempt until May 8, 1994).
As of January 1, 2006, nutrition labels on food packages required by the FDA must state how many grams of trans fatty acids (trans fats) are contained in one serving of the product.
- "Food Additives & Ingredients". Ingredients, Packaging & Labeling. US Food and Drug Administration.
- "Label Claims". Ingredients, Packaging & Labeling. Labeling & Nutrition. US Food and Drug Administration.
- "Labeling & Nutrition". Ingredients, Packaging & Labeling. US Food and Drug Administration.
- "Nutrition Facts Label Programs & Materials". Ingredients, Packaging & Labeling. Labeling & Nutrition. US Food and Drug Administration.
- Nutritional Health Alliance v. Shalala, 953 F.Supp. 526 (SDNY, 1997) Challenge, on First Amendment grounds, the NLEA framework requiring advanced FDA authorization for health claims made on vitamin labels.
These pieces of legislation underpin the regulation of food and dietary supplements in the United States, ensuring consumers are safe and properly informed.
China
In China, the main legal acts regulating the dietary supplements market are:
Food Safety Law of the People's Republic of China: This Act regulates food safety and provides general guidelines for the production, distribution and control of food, including dietary supplements.
Regulations regarding registration and health inspection of food: These include requirements for registration, labeling and quality control of health products, including supplements.
These pieces of legislation are intended to ensure the quality and safety of dietary supplements and protect the health and rights of consumers in China.
Russia
In Russia, the main legal acts regulating the dietary supplements market are:
Federal Law on Technical Regulation: This Act contains general principles of technical regulations, including standards regarding the quality and safety of food, as well as dietary supplements.
Federal Law "On Safety and Quality of Food Products": It contains detailed requirements regarding the safety and quality of food products, including supplements.
These documents are available on official Russian government websites, but may be difficult to find online in a language other than Russian. To access the full texts of these legal acts, we recommend visiting the official government websites of the Russian Federation or using specialized legal databases.
In conclusion, the dietary supplement market is a global phenomenon, spanning diverse regions, from the United States, through Europe, Asia, including China and Japan, to Russia. Each of these markets is regulated by specific legal acts that ensure the safety and quality of dietary supplements.
Conclusions and Recommendations:
Understanding Local Regulations: Companies operating in the international dietary supplement market should be aware of and comply with local regulations in each country in which they operate.
consultations with Experts: We recommend consulting with local legal experts or consulting firms specializing in food law for detailed information and assistance with compliance with local regulations.
Ongoing Monitoring of Changes in Regulations: Laws regarding dietary supplements may change, so it is important to regularly monitor legal updates in each country.
Searching for Information on Official Government Websites: Official government websites and legal databases are the best sources of information about applicable legal acts.
In summary, the global dietary supplement market offers enormous opportunities, but also requires awareness and understanding of various regulatory frameworks. Ensuring compliance with local regulations is crucial to success in this dynamic market.
