What is the difference between a dietary supplement and a drug?
Definition of a prescription drug can be found in Article 2 point 32 of the Act of 6 September 2001 Pharmaceutical Law (unified text with amendments Dz. U. z 2008 r. nr 45, poz. 271): a medicinal product shall mean any substance or combination of substances presented as able to prevent or treat disease in human beings or animals, or administered to make a medical diagnosis or to restoring, correcting, or modifying physiological functions of an organism through pharmacological, immunological or metabolic action. The definition of a dietary supplement can be found in Article 3 paragraph 3 point 3 of the Polish Law is set by the Food and Nutrition Safety Act (Dz.U. 2006 r. nr 171, poz. 12250): dietary supplement - a foodstuff intended to supplement a regular diet, is a concentrated source of vitamins or minerals or other substances with nutritional or other physiological effects, single or multiple, marketed in a dosage form, in the form of capsules, tablets, dragees and other similar forms, sachets with powder, ampoules with liquid, dropper bottles and other similar forms of liquids and powders intended for consumption in small, measured unit amounts, excluding products having the properties of a medicinal product within the meaning of the pharmaceutical law.
It is clear that, under law, there are differences between a prescription drug and a dietary supplement. The consumers, however, often equate these products, especially with OTC medications.
A dietary supplement is a foodstuff (food) a very different legal category than a drug (medicinal product). Dietary supplements are regulated by food law, drugs by the pharmaceutical legislation. A prescription is designed to heal, prevent or diagnose, and the supplement by supplementing the healthy diet is meant to keep the body in a state of the so-called homeostasis (perfect condition). The drug is intended primarily for sick people, and the supplement is for healthy people. It is sufficient to notify the Chief Sanitary Inspector to introduce a dietary supplement to the market, for a drug a permit is required. In practice, many cases are not that obvious. There are many borderline products which classification raises doubts. For example, there are products on the market with vitamins or minerals that are dietary supplements containing a higher dosage of vitamins or minerals than drugs. Even more complicated are cases of substances of vegetable origin.