The dietary supplement market in Russia is gradually moving toward stricter evidence-based standards. Following the introduction of new requirements for substantiating the effectiveness of dietary supplements, the topic of clinical studies has become especially relevant.
Many consumers believe that all dietary supplements undergo the same testing procedures as pharmaceutical drugs. In practice, this is not entirely the case. Let's examine what clinical studies of dietary supplements are, why they are necessary, and what types of data can genuinely support the effectiveness of supplements.

What Are Clinical Studies?
A clinical study is a scientific investigation of a product's effects on the human body.
The main objectives of such studies are to:

• assess safety;
• determine effectiveness;
• evaluate the effects of active ingredients;
• confirm the claimed properties of the product.

During a study, specialists analyze how a dietary supplement affects health status, well-being, or specific physiological indicators.

How Do Dietary Supplement Studies Differ from Drug Studies?
Pharmaceutical drugs undergo mandatory multi-stage testing.
To register a pharmaceutical product, the following are required:

• preclinical studies;
• several phases of clinical trials;
• strict safety monitoring;
• confirmation of therapeutic efficacy.

Without these requirements, a drug cannot be brought to market.

Dietary Supplements Are Subject to Less Stringent Requirements
Dietary supplements are classified as food products rather than medicines.
Therefore, to bring a dietary supplement to market, it is generally necessary to provide:

• confirmation of safety;
• state registration;
• compliance with technical regulations.

However, in recent years, requirements for the evidence base supporting dietary supplements have become more rigorous. Both regulators and consumers increasingly demand scientific confirmation of product effectiveness.
What Types of Dietary Supplement Studies Exist?
Clinical Trials Involving Human Participants
This is considered the most valuable form of research.
Participants take the dietary supplement at a specified dosage, while specialists assess:

• changes in health indicators;
• tolerability;
• the presence of side effects;
• overall outcomes of use.

Observational Studies
Researchers analyze the experience of using a product among a group of people without strictly intervening in their treatment or dietary practices.
Although these data are considered less conclusive, they are still widely used in scientific research.
Laboratory Studies
These studies evaluate:

• product composition;
• content of active ingredients;
• biological activity of components;
• product safety.

What Data Are Considered Evidence of Effectiveness?
According to modern approaches, the effectiveness of dietary supplements may be supported by:

• clinical studies;
• scientific publications;
• systematic reviews;
• meta-analyses;
• clinical practice guideline data;
• studies of individual active ingredients.

Why Is There So Much Debate Around Dietary Supplements?
The main reason is the varying levels of scientific evidence supporting different products.
The market currently includes:

• supplements supported by substantial scientific research;
• products with limited research data;
• dietary supplements whose effectiveness has been minimally studied.

As a result, consumers often find it difficult to distinguish genuinely researched products from marketing claims.
Can Manufacturer-Sponsored Studies Be Trusted?
Manufacturers frequently conduct their own studies of their products. This is an acceptable practice; however, several factors should be considered:

• who conducted the study;
• how many participants were involved;
• whether a control group was included;
• whether the results were published;
• whether the study methodology can be independently evaluated.

The more transparent the data, the greater the confidence in the findings.

What Will Change in Russia in 2026?
In 2026, Russia approved official criteria for assessing the effectiveness of dietary supplements.
The following types of evidence may now be used to substantiate product claims:

• scientific publications;
• clinical practice guidelines;
• research results;
• data on active ingredients and dosages.

This represents a gradual transition toward a more scientific and transparent market approach.

How Can Consumers Evaluate a Dietary Supplement?
Before purchasing a dietary supplement, consumers should consider:

• whether it has state registration;
• whether the full composition is disclosed;
• whether studies of its ingredients exist;
• whether references to scientific publications are provided;
• whether the product promises "miraculous cures."

When a manufacturer openly publishes research data and clearly explains the product's mechanism of action, this generally increases credibility.

Conclusion
Clinical studies of dietary supplements are an important tool for scientifically evaluating product safety and effectiveness. Although dietary supplements do not undergo the same rigorous approval process as pharmaceutical drugs, requirements for scientific evidence are gradually becoming more stringent.

Today, the market is moving toward greater transparency: manufacturers are increasingly required to substantiate product claims with scientific data rather than advertising. For consumers, this means the opportunity to make more informed choices and reduce the risk of encountering misleading information.

Our team is also prepared to organize and conduct clinical studies of dietary supplements through our own clinic as well as other specialized medical centers and healthcare institutions relevant to the product's intended use. All studies are carried out in accordance with modern requirements for scientific methodology, data collection, and efficacy assessment. We support projects at every stage—from study protocol development to the preparation of final documentation and analysis of research outcomes.