1. Federal state control over the prescription of dietary supplements is introduced
2. The appointment of dietary supplements begins to be regulated by Federal Law No. 323 “On the Fundamentals of Health Protection of Citizens in the Russian Federation”. The regulator focuses on efficiency, not just safety.
3. A list of dietary supplements and a list of indications for their use are introduced, for inclusion in which it is necessary to provide evidence of the effectiveness of dietary supplements and their impact on human health.
5 Key Takeaways
1. Without an evidence base, dietary supplements will lose the market in 2025.
The key competitive advantage today is proven efficacy and safety. Evidence is becoming a prerequisite for entering the dietary supplement market.
2. Are clinical trials of dietary supplements necessary?
Now it is the number one tool for confirming the marks on the product packaging.
A properly planned study allows the results to be legitimately used in advertising and promotion, and also increases the trust of doctors and the pharmaceutical community.
3. New Federal Law No. 150 ‑FZ – what is changing?
Dietary supplements were first mentioned in Federal Law ‑323 “On the Protection of Citizens’ Health”.
Federal control over the prescription of additives is being introduced.
A List of dietary supplements and application schemes will appear, in which a dietary supplement will be included only if there is evidence of its effectiveness.
4. Can a doctor now officially prescribe dietary supplements?
– Yes, but only those included in the List and meeting the quality and health impact criteria established by the Government of the Russian Federation. Doctors and pharmacies rely on clinical data when choosing a product.
5. What can a manufacturer do today to maintain its position in the future?
Plan and launch clinical trials in accordance with Russian requirements; Prepare a dossier for inclusion of the product in the List.
