Supplements are an extremely popular way to maintain the body among people around the world. In many cases, the patient trusts them more than drug treatment, linking the composition of the supplement with natural origin. But since this concept can mean a large number of the most diverse supplements, many of which do not have a therapeutic effect, it is necessary to more carefully consider the classification of dietary supplements and their differences from both drugs and food.
What it is?
A dietary supplement, or dietary supplement, is a mixture of certain substances that possess (or presumably possess) beneficial properties and make up for human malnutrition. The definition and classification of dietary supplements in Russia is the responsibility of the state structure of Rospotrebnadzor. And registration of these additives is conducted since 1997. The sale of such drugs began even earlier: already in 1985, people could purchase the first bioactive additives.
Currently, the number of dietary supplements on the market is growing rapidly, there are new names, new forms, and the scope of food additives is expanding. But even despite this, difficulties with determining the quality and controlling the turnover of these products contribute to the appearance on the market of low-quality products that do not fulfill the declared functions.
The negative effects of changes in nutrition
The nutritional quality of people around the world is rapidly deteriorating. This is a consequence of not only environmental degradation, but also the appearance in the diet of people of new food, which does not bring in the body a sufficient amount of the substances it needs. In order to replenish the diet with such substances, dietary supplements for food are produced, the classification of which directly depends on what effect it is supposed to have with them.
First of all, in the human environment, the level of consumption of such specific nutrients as trace elements and unsaturated fatty acids is quite low. This can lead to a huge number of disorders: from problems with memory and attention to violations of the digestive tract. Supplements successfully fill in the missing nutrients, and they can be used to treat diseases caused by a lack of these substances.
Food quality requirements
The main requirement for the quality of human nutrition is the usefulness of his diet. This means that the food consumed should completely cover all the energy needs of the body, be easily digested and not cause harm in the process of assimilation.
It is extremely difficult for an ordinary person to follow all the factors, so many people prefer to drink a course of dietary supplements so as not to worry about the amount of nutrients consumed. However, picking up supplements also needs to be wisely. First of all, it is necessary to find out what type of the selected supplement belongs to the classification of dietary supplements, and then examine it for compliance with the requirements of the law and the medical community.
General quality requirements and regulatory documents
The main requirements for dietary supplements are set out in state regulatory documents. There are a lot of documents regulating the safety and quality of additives, but the main one is SanPin 2.3.2 1078-01 "Hygienic requirements for safety and nutritional value of food products". According to this document, the supplement should not harm the health of the consumer and should contain the declared amount of nutrients.
There is also a document that lists all dietary supplements registered in the country - "Register of products that have passed state registration." The document can be freely studied on the official website of Rospotrebnadzor. In accordance with the Federal Register, the classification of dietary supplements is carried out only by field of application and most of them are registered only for sale to the public. As for the other distinguishing features of various additives, there are no indications in the Register.
Food or medicine: what is closer to dietary supplements?
It should immediately be noted that dietary supplements have never been medicines in full. They do not pass clinical trials and they are examined in the same way as they are examined in food products.
However, the presence of active components in dietary supplements does not allow calling them ordinary food products. These are functional supplements, excessive consumption of which can also harm health, like an overdose of drugs.
That is why, despite the position of a particular additive in the classification of dietary supplements, it must be handled carefully, in consultation with the doctor about the application, but not to expect immediate results. Most supplements need to be applied in long courses.
However, many dietary supplements are also included in food. This is done to saturate foods with nutrients and improve their quality. In general, bioactive food additives can be defined as a cross between food and medicinal products.
Supplements and legislation of other countries
Most countries recognize the phenomenon of dietary supplements and actively regulate the circulation of additives on their territory. So, in the USA the vast majority of the population accepts such funds; in Germany this figure is more than half of the number of people; and in Japan, the use of additives is almost universal.
The classification of dietary supplements in these countries is also very different from the approach of the post-Soviet states. For example, in Germany, supplements are strictly related to nutrition, but according to the regulation on a pharmacy, they can be sold in pharmacies along with conventional medicines.
How are supplements classified?
The medical community seeks to facilitate the selection of a suitable dietary supplement for both patients and doctors. Therefore, a rather conditional, but nevertheless, applicable classification of dietary supplements by application was developed, dividing all additives into nutraceuticals and parapharmaceuticals. However, most additives can be successfully attributed to one group as well as to another, and therefore, specialists are currently trying to find new classification methods for this large group of products.
Nutraceuticals
The main function of drugs that are classified as nutraceuticals is to replenish the missing substances in the patient's body. The class of nutraceuticals can have subclasses, which is, in fact, a separate classification of dietary supplements in composition:
- Diet modifiers.
- Sources of minerals.
- Sources of Vitamins.
- Sources of polyunsaturated fatty acids and dietary fiber.
All these subclasses can intersect each other, and therefore this separation is also not strict, and does not require an exact indication of the class on the package. Fish oil is a source of polyunsaturated fatty acids, however, some brands saturate it with vitamins, combining several different types of nutrients and several different subclasses.
The main requirements for dietary supplements-nutraceuticals are requirements for their composition. At the same time, regulatory authorities pay attention not only to the deficiency of the substances declared on the package, but also to their excess. In particular, vitamin complexes have strict restrictions on the dosage of fat-soluble vitamins in the tablet, because an excessively high dose can adversely affect the health of patients.
Parapharmaceuticals
Parapharmaceuticals are a group of drugs that are primarily used to regulate the vital processes in the body. The composition of such dietary supplements includes components that have a positive effect on the patient's body: bioflavonoids, essential oils, organic acids and other active substances.
It is parapharmaceutical dietary supplements that are closest to drugs in their functions in the body. However, they are distinguished from drugs, first of all, by the content in the composition of natural substances related to food components.
The classification of dietary supplements by purpose distinguishes the following subclasses among parapharmaceuticals:
- Tonic.
- Adaptogenic.
- Immunomodulatory.
- Regulators of body functions.
- Sources of natural enzymes.
The requirements for parapharmaceuticals are inherently close to the requirements for pharmaceuticals. This is not only the control of the dosage included in the supplement, but also the requirements for the general toxicological safety of these products. The law does not require any studies of side effects in the case of dietary supplements, on the basis of which it was believed that the additives as a whole do not have a negative effect on health.
Since nutraceuticals and parapharmaceuticals can intersect both in composition and in purpose, the classification of dietary supplements is still quite complicated.