In recent years, the dietary supplements market has developed significantly, both in Poland and throughout the European Union. Despite this dynamic development, outdated opinions on legal regulations regarding dietary supplements are often encountered. Contrary to common myths, dietary supplements are carefully regulated, which ensures their safety and appropriate quality. Unfortunately, even among health professionals - doctors, pharmacists and dietitians - you can encounter outdated knowledge on this subject. They are often a source of incorrect information that misleads both patients and consumers.
Common claims that supplements are not regulated by law are far from true and may influence the purchasing decisions of people who are looking for reliable and safe products. This situation indicates an urgent need to update knowledge among professionals, which would allow for reliable and reliable advice on the use of dietary supplements.
In this article, we will try to dispel these myths by presenting reliable information on the applicable regulations regulating the dietary supplements market in Poland and the European Union. We invite you to read it, which I hope will equip you with the necessary knowledge and allow you to make informed decisions related to the use of dietary supplements.
What are dietary supplements and how are they regulated?
Dietary supplements are products intended for consumption that are intended to complement the normal diet. These are concentrated sources of vitamins, minerals or other substances with a beneficial effect on health, offered in the form of doses, for example tablets, capsules, liquids or other similar forms in the food industry.
Definition according to Polish law
According to Polish law, regulations regarding dietary supplements are mainly contained in the Food and Nutrition Safety Act. Dietary supplements are treated as food for special purposes, which means that they must meet general food safety requirements specified for all food products. Additionally, supplement labels must include precise information about ingredients, suggested daily doses, and warnings regarding maximum intake amounts.
Definition according to European Union law
At the European Union level, dietary supplements are regulated by Directive 2002/46/EC, which defines them as sources of concentrated nutrients or other substances having a nutritional or physiological effect. Within the EU, all supplements must be safe, both in terms of the ingredients used and the recommended doses. Member States are obliged to monitor the market to ensure that products available for sale meet these standards.
Approval process for dietary supplements in the EU
Products that will be placed on the market must be notified to the relevant national authorities in the EU, which maintain a register of products authorized for marketing. Manufacturers must provide evidence that their products have been manufactured in accordance with good manufacturing practices (GMP) and that product labels include all required information, such as composition, contents, suggested dosages and use warnings.
These regulations are intended not only to protect consumers, but also to ensure that the information provided to consumers is clear, truthful and based on sound scientific evidence.
If this chapter is satisfactory, we can move on to the next subsection regarding what can and cannot be written on the packaging of dietary supplements.
Overview of the regulatory authorities responsible for supervising supplements in Poland and the EU
Regulatory organizations in Poland
In Poland, the main body supervising the dietary supplements market is the Chief Sanitary Inspectorate (GIS). GIS is responsible for quality control of food products, including dietary supplements, in terms of their safety for consumers' health. The inspectorate checks the compliance of products with applicable standards and legal regulations, which includes analyzing labels, ingredients and health and nutrition declarations. GIS also has the right to withdraw illegal products from the market and to impose sanctions on producers violating the regulations.
Regulatory organizations in the European Union
At the European Union level, dietary supplements are supervised by several authorities, the most important of which are the European Food Safety Authority (EFSA) and the national regulatory authorities of individual Member States. EFSA plays a key role in assessing the risks associated with food and dietary supplements on the European market. This authority analyzes and reviews scientific evidence about ingredients used in supplements, which helps establish safe levels of use. EFSA also advises on possible health claims that may be used on supplement labels.
EFSA works with national regulatory authorities, such as GIS in Poland, which are responsible for enforcing EU rules in their countries. This cooperation includes the exchange of information about potential threats and the coordination of actions in the event of detection of dangerous products on the market.
The importance of harmonizing regulations
Harmonization of regulations on dietary supplements within the European Union is crucial to ensuring that all products available on the market are safe and effective. Thanks to uniform standards, consumers can be sure that dietary supplements purchased in any Member State meet the same high quality and safety requirements.
Examples of specific regulations and directives regarding dietary supplements
European Union regulations and directives
Directive 2002/46/EC – It is the main regulatory framework for dietary supplements in the European Union. This directive specifies what substances can be used in dietary supplements and how they should be labelled. It requires all dietary supplements sold in the EU to be safe, both in terms of composition and recommended doses. This directive also obliges producers to notify their products to the relevant national authorities before placing them on the market.
Regulation (EC) No 1924/2006 – Applies to health and nutrition claims on food products, including dietary supplements. This regulation prohibits the use of misleading, false or unscientifically unsubstantiated claims on packaging. Health claims must be approved by EFSA (European Food Safety Authority) before they can be used on the European market.
Regulation (EC) No 178/2002 – Establishes the general principles and requirements of food law, introduces the European Food Safety Authority (EFSA) and food safety procedures. This regulation also creates a legal framework for actions to ensure food safety across the EU, including for dietary supplements.
Polish regulations regarding dietary supplements
Food and Nutrition Safety Act – Regulates issues related to food safety, including dietary supplements. It requires that products are safe to eat and properly labeled, informing consumers about the composition, function and correct use of products.
Regulation of the Minister of Health on dietary supplements – Specifies what substances and in what quantities may be added to dietary supplements. This regulation also specifies what information must be included on supplement labels, including health claims, which are only allowed after prior verification by the GIS.
Implementation and enforcement of regulations
The implementation and enforcement of these rules takes place at both national and EU level. In Poland, GIS is responsible for monitoring the market for compliance of products with the above-mentioned regulations. At EU level, EFSA supports Member States by providing scientific evaluation of health claims and monitoring the safety of ingredients used.
We dispel myths - what can and cannot be written on packaging?
There are various myths and misunderstandings surrounding the labeling of dietary supplements. In this section, we will look at what information is allowed on the labels of dietary supplements in Poland and the European Union, and what manufacturers cannot put on the packaging.
Permitted information on labels
Ingredients: Each label must clearly indicate all product ingredients, including active and excipients. This information should be presented in a way that is easy for the average consumer to understand.
Recommended daily intake: Manufacturers must provide the recommended daily serving amount of the product, which helps consumers use supplements safely and effectively.
Health Claims: This is one of the most regulated areas of labeling. Health claims are permitted but must be approved in advance by the relevant authorities. In the European Union, EFSA assesses applications for the approval of health claims to ensure they are supported by scientific evidence and do not mislead consumers.
Nutrition claims: Like health claims, nutritional claims (e.g. 'source of protein', 'low fat') must comply with established criteria and standards.
Non-conforming or Prohibited Labeling Practices
Unconfirmed claims: A manufacturer cannot make claims on the label that have not been scientifically proven or approved by the appropriate authorities. This is particularly important in the case of health claims.
Misleading information: Any information that may mislead the consumer as to the properties or effectiveness of the product is strictly prohibited. This applies to both exaggerated claims and false information about ingredients.
Comparisons with drugs: Dietary supplements must not be advertised as substitutes for medicines or imply that they can treat, prevent or alleviate disease, unless such claims have been thoroughly verified and approved by the appropriate authorities.
Examples of violations and their consequences
Products that do not comply with these rules may be withdrawn from the market and manufacturers may face financial penalties or other legal sanctions. For example, in Poland, the Chief Sanitary Inspectorate can impose fines on companies that violate labeling regulations.
Law Enforcement for Supplements with Suggested Medicinal Effects
In Poland
In Poland, if supplement dietary supplements are advertised as having medicinal properties, this may attract the attention of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). The URPL is responsible for supervising the trade in medicinal products and has the authority to take action in the event of violations of pharmaceutical law. Presenting supplements as medicines without appropriate authorizations is illegal and may result in both administrative and legal penalties for manufacturers.
At the European Union level
Within the European Union, each Member State has an equivalent of the URPL that monitors the medicinal products market. In addition, the European Medicines Agency (EMA) plays a key role in assessing and approving medicines at EU level. If a food supplement is advertised in a way that suggests medicinal properties, EMA, together with national authorities, can intervene to ensure that the products are not misleading and are safe for consumers.
Legal consequences
When the Chief Pharmaceutical Inspectorate (GIF) or other relevant authorities notice that dietary supplements are incorrectly advertised as having medicinal properties, they may initiate proceedings that may result in high financial penalties, withdrawal of sales authorizations, and even criminal proceedings against producers and distributors. Enforcing these laws is crucial to protecting public health and ensuring that misleading products are not sold to consumers.
When companies fail to comply with regulations regarding dietary supplements and drugs, they can face a variety of legal and financial consequences. Below are some examples of penalties and consequences that may be imposed on companies in Poland and the European Union for violating applicable regulations.
Examples of penalties for companies in Poland
Financial penalties: The Chief Sanitary Inspectorate (GIS) may impose fines on companies that violate the regulations on the labeling and safety of dietary supplements. For example, if a product contains unapproved ingredients or if the information on the label is misleading, the company may be fined up to several dozen thousand zlotys.
Product withdrawal from the market: If a product is deemed unsafe for consumer health or does not meet quality standards, it may be withdrawn from the market. This not only generates costs related to the logistics of the withdrawal, but also affects the company's reputation and its financial results.
Sales prohibited: In extreme cases, where a company systematically violates regulations, regulators may decide to ban the sale of certain products or even suspend the company's operations.
Examples of penalties for companies under EU law
Penalties imposed by the European Food Safety Authority (EFSA): EFSA has the power to assess the safety of products available on the EU market and can recommend that national regulatory authorities take appropriate action, including imposing financial penalties. These fines can be very high, depending on the scale of the violation and the potential risk to public health.
Legal sanctions for false health claims: If a company uses unapproved health claims, it may face fraud charges, which may result in criminal penalties. These types of violations are taken very seriously, especially if they affect the health of consumers.
International cooperation in law enforcement: Organizations such as Interpol can work with local authorities to combat the international trade in illegal or unsafe dietary supplements. Under such cooperation, companies operating in more than one country may face coordinated enforcement actions.
The importance of compliance
Penalties and consequences for companies that do not comply are designed to discourage unethical business practices and protect consumers. Strict regulation and the ability to impose serious sanctions are key to maintaining consumer confidence and ensuring that products on the market are safe and effective. It is important for companies to track changes in regulations and comply with them, thus avoiding the risk of legal and financial consequences.
What rights do you have as a consumer?
When you buy dietary supplements, you have certain rights that are protected by national and EU regulations. These laws are designed to ensure that the products you buy are safe, correctly labeled and effective. Here's an overview of your basic rights and tips on how to choose dietary supplements safely.
Consumer rights
The right to information: As a consumer, you have the right to receive complete and understandable information about the product, including its ingredients, recommended doses and potential side effects. This information should be available on the product label and in promotional materials.
The right to safety: Any product sold as a dietary supplement must be safe to use. EU and national regulations guarantee that all dietary supplements available on the market have undergone appropriate safety assessment procedures.
Right to complaint and compensation: If a dietary supplement is defective, does not meet the manufacturer's promises or has caused health damage, as a consumer you have the right to file a complaint and demand a refund or compensation.
Tips on how to choose dietary supplements safely
Check labels: Always read product labels to make sure you understand what they contain and how they should be used. The label should include information on ingredients, dosage and expiration date.
Look for approved health claims: In the EU, health claims on dietary supplements must be approved by the EFSA. Avoid products that make unsubstantiated or unreliable claims.
Buy from trusted sources: Purchasing dietary supplements from reputable suppliers and pharmacies. Avoid buying supplements from unreliable sources, such as unverified online sellers or stalls.
Consult a professional: It's always a good idea to check with your doctor or pharmacist before starting a new supplement, especially if you already take medications or have existing health conditions.
Check opinions and reviews: Before purchasing a supplement, it is worth checking the opinions and reviews of other consumers, which can help assess the effectiveness and safety of the product.
By keeping these laws and tips in mind, you can make informed and safe decisions about dietary supplements. Your health and well-being are a priority and following these rules will help protect you from potentially harmful products.
Summary
In summary, dietary supplements are regulated at both national and EU level to ensure the safety and effectiveness of these products. These regulations are intended to protect consumers against irregularities, dangerous ingredients or misleading information.
Key points to remember:
Legal regulations: Dietary supplements are strictly regulated in Poland and the European Union. Bodies such as the Chief Sanitary Inspectorate in Poland and the European Food Safety Authority at the EU level ensure compliance with these regulations.
Compliance with labeling: Supplement labels must include accurate information about ingredients, dosage, and potential side effects. Health claims must be approved by the relevant authorities to be used in communications with consumers.
Consumer rights: As consument, you have the right to complete and understandable information about the product, the right to product safety, as well as the right to complain and compensation if the product turns out to be defective.
- Choosing supplements responsibly: To use dietary supplements safely, it is important to buy products from trusted sources, check labels, consult a doctor before starting new supplements, and track approved health claims.
Encouragement to use consciously
Conscious use of dietary supplements is crucial to maintaining health and well-being. We encourage anyone considering using these products to thoroughly understand their rights as a consumer and to familiarize themselves with applicable regulations, which are in place to protect us all. Remember that a healthy approach to supplementation starts with knowledge and responsibility.
Take care of yourself by making informed choices that support your health based on solid, proven information. Making informed decisions will help you avoid unnecessary risks and maximize the benefits of dietary supplements.
