In the section devoted to biological active additives (BAS), several articles were published about the “Russian” view of this category of products. According to Russian legislation, dietary supplements are natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms. which are intended to be consumed at the same time as food or to be introduced into food products,but do our ideas of dietary supplements coincide with those of the world community? 

1. Supplements in the United States.

According to U.S. law, a dietary supplement is considered to be a product that meets the following criteria:

– taken by mouth (tablets, capsules, powders or liquids);

– are made to supplement the diet;

– has one or more dietary ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, enzymes, tissues from organs or glands, or extracts of these;

– labeled as being dietary supplements.

Regulation in the field of circulation of dietary supplements in the United States is provided by the FDA.  Interestingly, information about the safety of the ingredients in the dietary supplement is checked only if they were not sold in the dietary supplements until 1994. In other cases, the FDA does not evaluate efficiency and safety.

2. Supplements in Europe.

The European vision of the BAS includes the following main characteristics:

– Supplements are a source of nutrients in concentrated form in a dosage form (capsule tablets, etc.);

– Supplements are designed to eliminate nutrient deficiency, maintain their optimal level in the body or to maintain specific physiological functions;

– Supplements related to vitamins, minerals and substances based on them are subject to regulation by “food” normative documents, and other supplements have their own legislative base;

It is worth noting that in Europe the term “Novel food” is widely used. Supplements that had not been marketed before 1997, such as oil rich in omega-3 acidsderived from krill fat, also fall into this category of products. The safety of such products is under closer supervision.

3. Supplements in India.

In some countries, regulation of dietary supplements is quite a complex system. This is due to the close intertwining of traditional medicine in health care. In India, for example, the quality of food supplements is controlled by the Food Safety and Standards Authority of India and includes the following criteria for categorization:

– A significant difference from “normal” fooddue to physical or psychologicaldisorders. However, the Standard emphasizes that dietary supplements are not intended for diagnosis and treatment;

– The composion includes plant components (in the form of powders, concentrates or aqueous extracts, extracts), minerals, vitamins, proteins, enzymes, amino acids or animal products origin/combinations of the above substances;

– Intended for oral administration;

Interestingly, preparations intended for use in Ayurvedic practices do not belong to dietary supplements and are subject to regulation on an equal basis with medicines.

Thus, in general, the view of the dietary supplements in the three countries reviewed has much in common:  all normative documents emphasize the fact that dietary supplements are not used for diagnostic and therapeutic purposes, and the regulation of dietary supplements is carried out by the state structures of the food industry. However, there are also differences due to cultural differences, the approach to ensuring the safety of this type of product in the market.

References

1. Dwyer, J.T.; Coates, P.M.; Smith, M.J. Dietary Supplements: Regulatory Challenges and Research Resources. Nutrients 2018, 10, 41.
2. https://nccih.nih.gov/health/supplements/wiseuse.htm#hed2
3. https://www.efsa.europa.eu/en/topics/topic/food-supplements
4. https://archive.fssai.gov.in/home/fss-legislation/food-safety-and-standards-act.html