Medicinal product vs. dietary supplement – what is the difference?

Very often patients have trouble distinguishing medicines from other preparations available in pharmacies. Although the regulations introduce their clear definitions, the way producers communicate makes these differences often invisible. So what is the difference between a dietary supplement and a medicinal product?

Dietary supplement — definition

What is a dietary supplement? Dietary supplements are foodstuffs that are a concentrated source of nutrients or other substances. Their purpose is to supplement the basic diet. Dietary supplements are not medicinal products even though they are manufactured in the form of capsules, tablets, sachets with powder, ampoules with liquid, or other forms that enable dosing. In Poland, the introduction of supplements to the market is regulated by the Act on food and nutrition safety. This means that all general quality requirements for food products also apply to dietary supplements. Detailed requirements regarding the composition and labeling of dietary supplements have been specified in the regulation of the Minister of Health. Therefore, the packaging must contain information such as:

• the term “dietary supplement“,
• names of the categories of nutrients or substances characterizing the product or an indication of the nature of these substances,
• the portion of the product recommended for consumption during the day,
• a warning not to exceed the recommended portion for consumption during the day,
• a statement that dietary supplements cannot be used as a substitute for a varied diet,
• a statement that dietary supplements should be kept out of reach of small children.

The content of vitamins, minerals, and other substances with a nutritional or other physiological effect must be given in numerical form in relation to the daily dose of the product recommended for consumption by the manufacturer. The percentage in relation to the reference intake values is also determined.

Medicinal product — definition

What is a medicinal product? The definition is set out in the Pharmaceutical Law Act. According to the regulations, a medicinal product is: a substance or mixture of substances presented as having properties for preventing or treating diseases occurring in humans or animals, or administered to make a diagnosis or to restore, correct, or modify physiological functions by exerting a pharmacological, immunological or metabolic action (Article 2(32)). The introduction of a medicinal product to pharmacies requires obtaining a marketing authorization (exception: medicinal products listed in Article 3(4)). The permit may be issued in Poland by the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) or at the European Union level. To register a medicinal product, it is necessary to submit:

• detailed documentation of its production,
• mode of action,
• researched effects.

A medicinal product must have proven efficacy, quality, and safety. The URPL and the Chief Pharmaceutical Inspectorate (GIF) are responsible for the supervision of medicinal products. The characteristics of a medicinal product must contain the necessary information about the medicinal product, i.e. indications for use, suggested dosage, possible side effects, and interactions with other medicinal products. There are three groups of medicinal products:

• Rx drugs — issued only with a doctor’s prescription,
• OTC drugs — issued without a prescription
• medicinal products approved for sale outside of pharmacies, e.g. in shops, petrol stations.

Medicinal product and dietary supplement — differences

It should be remembered that medicines are administered to prevent or treat diseases. Additionally, each drug has indications in which its effectiveness has been proven in scientific studies. These agents are the most thoroughly tested and subject to the greatest control. They also have the strongest effect on the body, which is why the patient must pay special attention to potential interactions and side effects. On the other hand, the basic purpose of dietary supplements is to supplement a normal diet. They cannot be attributed medicinal or prophylactic properties. This information should also not be placed on packaging, leaflets, or communicated in advertisements.

Want to know more? Are you interested in news about dietary supplements? On our blog, there is also a text about dietary supplements and consumer safety.