🌍 Regulatory Compliance Calculator
Check the legal requirements for dietary supplements in your chosen market
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Summary: Dietary Supplement Regulations – Key Information
🇵🇱 POLAND
Organ: Chief Sanitary Inspectorate (GIS)
Legal act: Act on Food and Nutrition Safety (2006) + Regulation of the Minister of Health (2007)
Key:
🇪🇺 EUROPEAN UNION
Organ: EFSA (European Food Safety Authority)
Legal act: Directive 2002/46/EC
Key:
🇺🇸 UNITED STATES
Organ: FDA (Food and Drug Administration)
Legal act: DSHEA 1994 (Dietary Supplement Health and Education Act)
Key:
🌏 ASIA – System Comparison
Country | Regulatory Model | By requirements |
Japan | FOSHU – rigorous | Approval for products with health claims |
China | "Health Foods" | Registration/notification, import only after one year of sale in the country of origin |
South Korea | Health Functional Food (HFF) | Mandatory assessment of safety and effectiveness |
Singapore | Dealer liability | NO pre-market approval, safety standards |
Indie | FSSAI | FSSAI license mandatory |
🌍 OTHER KEY MARKETS
📊 KEY DIFFERENCES BETWEEN THE SYSTEMS
Pre-Market Approval
✅ YES: Japan (FOSHU), China (Health Foods), Korea (HFF), Australia (registered)
❌ NIE: USA, Singapore, EU/Poland (notification, not approval)
Responsibility for Safety
🔴 Producer: USA, Singapore
(I.e. State body: Japan, Korea, China, Australia (registered)
🟡 Hybrid: EU/Poland (producer + GIS/EFSA supervision)
Health Claims
💡 KEY FINDINGS
📚 SOURCES – TOP 5 MOST IMPORTANT
Supplement Regulation Analysis: EU vs. US
Interactive infographic based on the 2025 analysis
The Main Battle: Two Philosophies of Surveillance
Global supplement market define two fundamentally different approaches: the EU's precautionary principle and the US's post-market surveillance model. The chart below visualizes how these philosophies translate into risk and innovation for companies.
🇪🇺 European Union
Philosophy: The Precautionary Principle
- Approach: Pre-Market Authorization.
- Requirement: The burden of proof of safety rests with the manufacturer *before* entering the market.
- Positive Letters: An ingredient or claim must be on a list (e.g., Novel Food, Health Claims) to be legal.
🇺🇸 United States
Philosophy: Market Access (DSHEA 1994)
- Approach: Post-Market Surveillance.
- Requirement: FDA bears the burden of proof that a product is *unsafe* (except for NDI notification).
- Responsibility: Product considered safe until proven otherwise.
Key Events 2025: NMN and CBD
Two key components – NMN and CBD – perfectly illustrate the divergence between the EU and US systems. Regulatory decisions in 2025 *de facto* froze one market while opening the other under new rules.
✅ NMN in the United States
Status: Open Market (with conditions)
In a landmark decision in the fall of 2025, the FDA reversed its position, confirming that NMN *is* not excluded from the definition of a dietary supplement.
- Key Takeaway: NMN was sold as supplement *before* drug trials.
- Key Condition: NMN is a "New Dietary Ingredient" (NDI).
- Implication: *Every* company must submit an NDI notification demonstrating safety. "GRAS" status is insufficient.
❌ CBD in the European Union
Status: Market Frozen
In 2025, EFSA published a critical assessment of the safety of CBD as a "Novel Food", identifying serious data gaps (including liver toxicity, endocrine disruption).
- Key Takeaway: Insufficient data to assess safety.
- Key Condition: EFSA proposes a temporary safe level of... **2 mg/day**.
- Implication: *De facto* freezing of the authorization process for commercial CBD doses.
FDA's New Enforcement Strategy (2024-2025)
Faced with systemic regulatory failures (recording only about 1% of adverse events), the FDA has made a strategic pivot. Unable to monitor the market, the agency is changing the rules of the game to force the market to self-regulate.
Evolution of the FDA Strategy
ISSUE
Inefficient post-market supervision (only 1% of AEs).
LEGAL TACTICS
Health Fraud is classified as "Unapproved New Drugs."
NEW GOAL (JULY 2024)
Warning letters sent directly to e-commerce platforms (Amazon, Walmart).
Implications
This is a strategic breakthrough. The FDA shifts the burden of market oversight from a public agency to private tech giants. This forces platforms (Amazon, Walmart) to actively filter and remove illegal products to avoid their own legal liability.
Strategic Conclusions for the Industry (after 2025)
Analysis of the latest regulatory trends leads to clear conclusions for every company operating in the global supplements market.
❌ The end of the "One Global Product" strategy
The "one size fits all" strategy is dead. Products for the EU and US markets must be developed, formulated, and labeled as two completely separate projects.
🇪🇺 EU Strategy: Risk Minimization
- Invest in products based on ingredients *already* authorized (Novel Food, Health Claims lists).
- In your marketing, use *only* precise wording from the Health Claims Register.
- Introducing a new innovation (like CBD) requires a budget and data at the pharmaceutical research level.
🇺🇸 US Strategy: Risk Management
- NDI notification is *mandatory* for new components (case NMN).
- Be ultra-conservative in your marketing. One "word too far" (suggesting a treatment) can reclassify the product as "unapproved" lek".
- Monitor FDA Warning Lists – an early warning system for the agency's priorities.
Key Registers and Databases
Compliance relies on continuous monitoring of authoritative databases. Below is a summary of key resources for the EU and US, as outlined in the report.
| Resource | Region | Sky | Link (Source) |
|---|---|---|---|
| EU List of Novel Foods | 🇪🇺 EU | Legally binding "positive list" of authorized ingredients. | [11] |
| EU Health Claims Register | 🇪🇺 EU | Legally binding list of authorized and rejected statements. | [14, 16] |
| New Food Catalog | 🇪🇺 EU | *Tips* (non-binding) regarding Novel Food status. | [13] |
| List of Products Reported to GIS | 🇵🇱 Poland | Register of products *registered* for the Polish market. | [15] |
| NDI Notification Process | 🇺🇸 United States | Information about the New Dietary Ingredients submission process. | [8, 18] |
| Information on Select Ingredients (Watch List) | 🇺🇸 United States | FDA list of ingredients of concern (de facto "negative list"). | [22] |
| Warning Letter Database | 🇺🇸 United States | FDA enforcement action log; key for monitoring trends. | [4, 23] |
🌐 Market Comparison Tool
Select 2-4 markets to compare regulatory requirements
Comprehensive Review of Legal Regulations Concerning Dietary Supplements
An interactive tool for analyzing and comparing global legal frameworks
Introduction to Global Regulation
The dietary supplement market is a rapidly growing global industry. As these products become increasingly popular, governments around the world are introducing and enforcing regulatory frameworks to ensure the safety, quality, and proper labeling of supplements.
These regulations vary significantly by region, presenting challenges for manufacturers, importers, and consumers. This app allows for an interactive comparison of key legal systems.
Global Regulatory Models: Summary
An analysis of global legal regulations reveals a complex and heterogeneous picture. Key differences boil down to regulatory philosophy:
- Pre-Market Approval: Government agencies must approve a product before it is brought to market (e.g., in some Asian systems, for higher-risk complementary medicines in Australia).
- Producer Responsibility (Post-Market): Manufacturers are responsible for safety, and agency oversight is reactive (e.g., in the US).
- Hybrid Model: Used, among others, in the European Union, where the composition (vitamins, minerals) and health claims are strictly regulated and require scientific verification, but the product itself does not require pre-market approval in the sense that a medicine does.
The chart below illustrates these three main approaches. Use it to understand the fundamental differences in the global regulatory landscape.
Regulations in Poland
In Poland dietary supplements are subject to strict regulations of food law, and the main supervisory body is Chief Sanitary Inspectorate (GIS)According to the statutory definition, diet supplement is a food whose purpose is to supplement the normal diet.
It is crucial to distinguish a supplement from a medicinal product – products with medicinal properties are subject to the Pharmaceutical Law. The basic legal act is Act of 25 August 2006 on food and nutrition safety.
Key Aspects of Regulation in Poland
| Key Aspect of Regulation | Requirements in Poland |
|---|---|
| Main supervisory authority | Chief Sanitary Inspectorate (GIS) |
| Basic legal acts | Act on Food and Nutrition Safety, Regulation of the Minister of Health on composition and labeling |
| marking | Mandatory designation "dietary supplement", information on the recommended daily dose, a warning not to exceed it, a statement that it cannot be used as a dietary substitute and that it should be stored out of the reach of children. |
| Advertising | It is prohibited to attribute medicinal properties or to suggest that a balanced diet does not provide sufficient nutrients. |
| Introduction to the market | Requires notification to the Chief Sanitary Inspector about the first introduction of the product into the territory of the Republic of Poland. |
Legal Framework in the European Union
At the European Union level, the basic legal act harmonizing the regulations on dietary supplements is Directive 2002/46/ECIts aim is to harmonise regulations across Member States to ensure a high level of consumer protection and the free movement of goods.
The scientific body supporting the legislation is European Food Safety Authority (EFSA), which is responsible for assessing the safety and bioavailability of nutrients.
Key Aspects of EU Regulation
| Key Aspect of Regulation | Requirements in the European Union |
|---|---|
| Main legal act | Directive 2002/46/EC of the European Parliament and of the Council |
| Advisory body | European Food Safety Authority (EFSA) |
| Composition | Only vitamins and minerals listed in the directive's annexes are permitted. Work is underway to harmonize the maximum and minimum levels for these nutrients. |
| marking | It must comply with the general rules on food labelling (EU Regulation No. 1169/2011) and contain specific information, such as the term "food supplement". |
| Health Claims | Regulated by Regulation (EC) No 1924/2006; only claims authorised by the European Commission after scientific assessment by EFSA are permitted. |
The Regulatory System in the United States
In the United States, dietary supplements are regulated by Food and Drug Administration (FDA) under separate regulations than those relating to food and medicines. The key legal act is Dietary Supplement Health and Education Act of 1994 (DSHEA).
Under DSHEA, manufacturers and distributors are responsible for assessing the safety and properly labeling their products. before before they are put on the market. The FDA does not approve dietary supplements before they are sold, but it does have the authority to take action po their introduction to the market (post-market supervision).
Key Aspects of US Regulation
| Key Aspect of Regulation | Requirements in the United States |
|---|---|
| Main supervisory authority | Food and Drug Administration (FDA) |
| Basic legal act | Dietary Supplement Health and Education Act of 1994 (DSHEA) |
| Responsibility | Manufacturers are responsible for safety and labeling. FDA approval is not required before marketing (except for new ingredients). |
| marking | Must include a "Supplement Facts" panel and the mandatory statement "This statement has not been evaluated by the Food and Drug Administration...". |
| Statements | Structure/function claims (e.g., "supports heart health") are permitted, but claims about treating diseases are not. Manufacturers must notify the FDA of such claims. |
| New ingredients | New Dietary Ingredient (NDI) notification is required to be submitted to the FDA at least 75 days before the product is introduced to the market. |
Comparison of Regulations in Asia and Other Regions
Regulatory systems in Asia vary widely, from the strict, quasi-pharmaceutical models of Japan and South Korea to the more liberal approach of Singapore. Other countries, such as Australia and Canada, have also developed unique legal systems.
Key Asian Markets
| Country | Supervisory Body | Key Regulatory Concept | Registration Requirements |
|---|---|---|---|
| Japan | Ministry of Health, Labor and Welfare (MHLW) | FOSHU (Food for Specified Health Use) – a system for products with proven health benefits. | Rigorous evaluation and approval for FOSHU products. |
| China | State Administration for Market Regulation (SAMR) | Division into "Health Foods" (health food) requiring registration (blue hat) or notification. | Registration or notification depending on ingredients and claims. |
| South Korea | Ministry of Food and Drug Safety (MFDS) | Health Functional Food (HFF) – products must undergo a safety and effectiveness assessment. | Mandatory pre-market assessment and notification. |
| Singapore | Health Sciences Authority (HSA) | System based on dealer liability; no pre-market approval required. | Lack of licensing and pre-market approvals. |
| Indie | Food Safety and Standards Authority of India (FSSAI) | Regulation as "Nutraceuticals" and "Food for Special Dietary Use". | FSSAI license and compliance with guidelines required. |
Other Important Markets
- Australia: Supplements are regulated by Therapeutic Goods Administration (TGA) as "complementary medicines" under a rigorous, two-tier risk-based system ("listed" and "registered").
- Canada: Health Canada regulates "Natural Health Products (NHP)", requiring product and manufacturing facility licensing and compliance with Good Manufacturing Practices (GMP).
- Brazil: ANVISA requires pre-market registration for higher-risk products and regularly updates lists of permitted ingredients.
- New Zealand: Regulations are subject to Dietary Supplements Regulations 1985 and are supervised by Medsafe.
- RPA: SAHPRA implements new, more stringent guidelines regarding the safety and effectiveness of supplements.
Sources
The list below contains links to the key legal acts and publications on which this analysis is based.
- [1] Act of 25 August 2006 on food and nutrition safety
- [2] Regulation of the Minister of Health of 9 October 2007 ...
- [3] GIS, "Dietary supplements vs. medicinal products"
- [4] GIS, "Detailed legal requirements..."
- [5] Biznes.gov.pl, "I'm introducing food to Poland for the first time"
- [6] Wróbel, K. et al. (2022), "Dietary Supplements Questioned..."
- [7] Directive 2002/46/EC...
- [8] EUR-Lex, "Ensuring safe food supplements..."
- [9] European Food Safety Authority, "Food supplements"
- [10] European Commission, "Food supplements"
- [11] Your Europe, "Labelling of Dietary Supplements"
- [12] Vettorazzi, A. et al. (2020), "European Regulatory Framework..."
- [13] US Congress, "DSHEA of 1994"
- [14] US FDA, "Dietary Supplements"
- [15] National Institutes of Health, "DSHEA_Wording"
- [16] Electronic Code of Federal Regulations, "21 CFR Part 190"
- [17] Wallace, T. C. (2015), "Twenty Years of the DSHEA"
- [18] Blaze, J. (2021), "A Comparison of Current Regulatory Frameworks..."
- [19] Thakkar, S. et al. (2020), "Regulatory landscape... global perspective"
- [20] ChemLinked, "South Korea Health Functional Food Regulation"
- [21] Health Sciences Authority Singapore, "Regulatory overview..."
- [22] WJARR, "Regulatory requirements... under FSSAI guidelines"
- [23] TGA, "How are vitamins regulated in Australia?"
- [24] Government of Canada, "Natural health product regulation..."
- [25] Artixio, "ANVISA Dietary Supplements Regulations in Brazil"
- [26] Artixio, "Mexico's COFEPRIS Regulation..."
- [27] Medsafe New Zealand, "Regulation of Dietary Supplements"
- [28] SAHPRA, "HEALTH SUPPLEMENTS SAFETY AND EFFICACY"
