Which dietary supplements may come under increased regulatory scrutiny: New requirements for scientific evidence and product safety
The dietary supplement (DS) market in Russia continues to develop rapidly. According to industry research, consumer demand for dietary supplements is increasing every year, while the range of available products is becoming increasingly diverse. At the same time, government authorities are placing greater emphasis on the quality, safety, and scientific substantiation of the claimed properties of dietary supplements.
In recent years, regulators have consistently introduced measures aimed at improving market transparency and protecting consumers from misleading information. Particular attention is now being paid to scientific evidence, clinical studies, and the accuracy of marketing claims.
This article examines which categories of dietary supplements may receive increased attention from regulatory authorities, which criteria for evaluating effectiveness are becoming increasingly important, and what these developments mean for manufacturers and consumers.
Why is regulatory oversight of dietary supplements increasing?
Dietary supplements are classified as food products and are not medicinal products. Their primary purpose is to supplement the diet and serve as an additional source of biologically active substances.
However, in practice, some manufacturers use wording that may lead consumers to believe that a product has therapeutic effects. As a result, the distinction between dietary supplements and medicinal products may become blurred.
From the regulators' perspective, the main reasons for strengthening oversight include:

• the continued growth of the market and the increasing number of new products;
• the need to protect consumers from misleading claims;
• higher expectations regarding the quality of scientific substantiation;
• the growing adoption of evidence-based medicine principles in the field of preventive health products;
• the need to monitor the safety of active ingredients and their dosage levels.

The modern regulatory approach assumes that any claimed product benefits should be supported by objective scientific evidence rather than marketing materials alone.
Which dietary supplements are receiving increased attention?
It is important to understand that regulatory oversight is focused less on specific categories of supplements and more on the nature of the claimed effects and the product's potential impact on the human body.
Dietary supplements claiming to treat diseases
Products that are directly or indirectly marketed as treatments for diseases traditionally receive the greatest regulatory attention.
Such claims may include:

• promises to cure diseases;
• claims regarding the treatment of chronic conditions;
• recommendations to replace prescribed medical therapy;
• statements guaranteeing therapeutic effects.

Under current legislation, dietary supplements are not intended to diagnose, treat, or cure diseases. Therefore, such claims may be considered a violation of product marketing regulations.
Weight management dietary supplements
Weight-loss supplements remain one of the largest categories within the dietary supplement market.
Regulators may pay particular attention to products claiming:

• rapid weight loss;
• "fat burning" without lifestyle changes;
• guaranteed results;
• significant acceleration of metabolism.

Such claims require especially strong scientific substantiation and careful safety evaluation.
Sports nutrition supplements
Specialized products intended for athletes often contain high concentrations of biologically active substances.
Potential concerns include:

• the possible presence of undeclared ingredients;
• insufficient quality control of raw materials;
• the use of ingredients supported by limited scientific evidence;
• potential effects on the cardiovascular system and metabolism.

For this reason, transparency of formulation and the quality of supporting research are particularly important.
Hormonal health supplements
A separate category includes supplements claiming to influence:

• hormonal balance;
• reproductive health;
• age-related physiological changes;
• menopausal symptoms;
• men's health.

The more significant the physiological effects claimed by the manufacturer, the stronger the supporting scientific evidence should be.
Dietary supplements for children
Products intended for children represent a category requiring particularly high levels of responsibility.
Key evaluation criteria include:

• ingredient safety;
• age-appropriate dosage;
• quality of supporting research;
• availability of tolerability data.

Children have physiological and metabolic characteristics that differ from those of adults; therefore, safety requirements for these products are traditionally more stringent.
What Evidence of Effectiveness Is Considered the Most Reliable?
One of the key trends in market development is the application of evidence-based medicine principles through clinical research.
The level of confidence in scientific findings largely depends on the study design.
What Types of Study Designs Are Used?
1. Randomized Clinical Trials
Randomized clinical trials are considered one of the most reliable methods for evaluating the effectiveness of an intervention.
Participants are randomly assigned to different study groups, helping minimize systematic bias and improve the reliability of the results.
2. Double-Blind Placebo-Controlled Studies
In a double-blind study, neither the participants nor the investigators know who receives the investigational product and who receives the placebo.
This approach minimizes subjective bias and is widely regarded as the gold standard of clinical research.
3. Systematic Reviews and Meta-Analyses
The highest level of scientific evidence is generally provided by systematic reviews and meta-analyses.
These methods combine the results of multiple studies, allowing researchers to evaluate the overall strength of evidence on a particular topic.
Why Safety and Effectiveness Are Different Concepts
One common misconception is that a registered dietary supplement automatically has proven effectiveness.
In practice, this is not always the case.
Safety addresses the question:
"Does the product cause harm when used as recommended?"
Effectiveness addresses a different question:
"Has the claimed beneficial effect of the product been scientifically demonstrated?"
Even if a product has an excellent safety profile, its effectiveness should still be confirmed through dedicated scientific studies.
Common Regulatory Issues in Dietary Supplement Marketing
The most common issues attracting regulatory attention include:

• the use of medical terminology without adequate justification;
• promises of guaranteed results;
• claims regarding the treatment of diseases;
• failure to provide references to scientific evidence;
• inappropriate use of research findings relating to individual ingredients when promoting the finished product.

Particularly problematic are statements that may mislead consumers regarding the actual capabilities of a product.
What Does Increased Regulatory Oversight Mean for Manufacturers?
For manufacturers, the evolving regulatory environment means placing greater emphasis on the scientific substantiation of their products.
Increasingly important areas include:

• conducting clinical studies;
• building a robust scientific evidence base;
• preparing scientific dossiers;
• evaluating ingredient safety;
• ensuring transparency for healthcare professionals and consumers.

Companies that invest in scientific research and verification of their product claims gain additional competitive advantages.
What Does This Mean for Consumers?
For consumers, increased regulatory oversight provides additional protection against misleading information.
When choosing a dietary supplement, consumers are encouraged to consider:

• state registration of the product;
• the complete ingredient list;
• information on active ingredient dosages;
• availability of clinical studies;
• references to scientific publications;
• the absence of promises of rapid or guaranteed therapeutic effects.

The more transparent the information about a product and its supporting scientific evidence, the greater the confidence consumers can place in it.
 
The strengthening of regulatory oversight in the dietary supplement market reflects a global trend toward higher standards for scientific evidence and product safety. Particular attention is being given to supplements claiming significant physiological effects, weight management products, sports nutrition supplements, hormonal health products, and dietary supplements intended for children.
The modern regulatory approach requires that product claims be supported by scientific evidence, including clinical studies, systematic reviews, and other evidence-based medicine methodologies. For manufacturers, this means developing a robust scientific evidence base, while for consumers it provides an opportunity to make more informed decisions when selecting dietary supplements.
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, in full compliance with current scientific methodology, data collection standards, and product effectiveness evaluation requirements. We support projects throughout every stage of the process—from study protocol development to the preparation of final documentation and comprehensive analysis of study results.