The Russian market for dietary supplements (DS) is transitioning to new regulatory requirements. By Resolution No. 398 of the Government of the Russian Federation dated April 13, 2026, criteria for the quality and efficacy of dietary supplements, as well as requirements for substantiating their claimed properties, have been approved.
In essence, the government is taking an important step toward stricter market regulation: manufacturers can no longer simply launch a product for sale—they must now provide scientific evidence supporting its safety, composition, and efficacy.
What Has Changed?
The Resolution establishes two key categories of requirements:

• Quality criteria for dietary supplements;
• Efficacy criteria for dietary supplements.

To maintain a lawful and full presence on the market, products must now comply with several mandatory conditions.
What Makes a Dietary Supplement “High Quality”?
According to the new rules, dietary supplements must meet a number of requirements.
1. State Registration
A product must have a valid state registration certificate. This confirms that the supplement has undergone the safety assessment procedures required by law.
2. Mandatory Labeling
Dietary supplements must be included in the national product labeling and traceability system.
Identification means must be present on the packaging, and product information must be recorded in the state monitoring system. This makes it possible to:

• track product movement;
• combat counterfeit products;
• increase market transparency.

3. Confirmation of Composition and Safety
Particular attention is now being paid to the actual content of active ingredients.
The quantity of components declared on the label must correspond to the actual composition of the product. Verification must be conducted by accredited Russian laboratories.
In addition, dietary supplements must comply with established safety standards.
4. Compliance with EAEU Technical Regulations
Products must comply with the technical regulations of the Eurasian Economic Union (EAEU). This applies to:

• composition;
• manufacturing;
• storage;
• circulation of products on the market.

The Key Innovation: Proof of Efficacy
One of the most significant changes is the introduction of official efficacy criteria for dietary supplements.
Previously, the market relied largely on manufacturers’ marketing claims. Now, the government requires an evidence-based foundation for efficacy claims.
What Evidence Will Be Accepted?
The Resolution provides several ways to substantiate efficacy.
Scientific Publications
Manufacturers may rely on:

• clinical studies;
• scientific reviews;
• publications concerning active ingredients and their effects on the body.

Such studies must be published in reputable scientific sources, including:

• the Russian Science Citation Index (RSCI);
• international scientific databases;
• journals included in the “White List.”

Clinical Practice Guidelines
If active ingredients contained in dietary supplements are mentioned in current clinical practice guidelines, this may also serve as evidence of efficacy.
Manufacturer’s Own Research
The use of a company’s internal research is permitted, including:

• clinical observations;
• trials;
• product-use data.

However, such materials must contain:

• a description of the beneficial effect;
• dosage information;
• duration of use.

What Does This Mean for the Market?
The new requirements may significantly reshape the dietary supplement industry in Russia.
For Manufacturers
Companies will need to:

• strengthen the scientific foundation of their products;
• invest in research;
• document and substantiate claimed properties.

This will particularly affect brands whose marketing strategies have relied primarily on promotional claims.
For Consumers
Consumers may benefit from:

• more transparent product information;
• additional quality assurances;
• a lower risk of encountering misleading claims.

For the Market as a Whole
The new regulatory framework gradually aligns the dietary supplement market with the principles of evidence-based medicine.
Although dietary supplements are still not classified as medicinal products, the government is clearly demonstrating its intention to strengthen oversight of both product quality and claimed efficacy.

Frequently Asked Questions
Is it now necessary to prove the efficacy of dietary supplements?
Yes. The Resolution introduces criteria for the scientific substantiation of product efficacy.
What types of studies are acceptable for dietary supplements?
Clinical studies, scientific publications, and evidence derived from clinical practice guidelines.
Are all dietary supplements required to undergo labeling?
Yes. Products must be included in the national monitoring system for labeled goods.

Conclusion
Resolution No. 398 can be considered one of the most important developments in the regulation of the dietary supplement market in recent years.
Manufacturers will now be required not only to claim product benefits but also to substantiate those claims with scientific evidence. For the industry, this represents a transition toward more transparent and standardized operating practices, while for consumers it may lead to greater confidence in high-quality products supported by genuine research.

Vita Aeterna can help develop an optimal and cost-effective study design to generate the scientific evidence required to substantiate the efficacy of your product in accordance with the new regulatory requirements.