You already know that claims like “Boosts energy,” “Promotes better sleep” sell products. But here’s the catch: what you say on your packaging, website, or Instagram ad is regulated, and getting it wrong can be expensive. The tricky part? Regulations vary by market. If your products are manufactured by a partner, you’re still legally responsible for what’s on your packaging and in marketing communication. That means you need to understand the basics of dietary supplement claims. Let’s break down the essentials, so you can stay compliant without getting lost in regulatory jargon.
1. EU compliance: strict rules, multiple jurisdictions
The EU has one of the strictest regulatory frameworks for dietary supplements. Products are classified as food, not drugs, but must comply with both general food laws and supplement-specific rules.
Health claims rules
The EU regulates supplements under Directive 2002/46/EC and health claims are strictly controlled under Regulation (EC) No 1924/2006.
- Only authorized health claims from the EU Register may be used—exact wording included.
- All claims must undergo EFSA (European Food Safety Authority) evaluation with strong scientific evidence. Btw: EFSA has approved over 260 claims—but rejected more than 70% for lack of scientific support.
- Disease prevention, treatment, or cure claims are strictly prohibited.
This means all dietary supplement claims on your packaging or website must be carefully checked against the EU Register before launch.
Notification requirements
Placing supplements on the EU market often requires mandatory notification in each member state. Here’s what you need to know:
- No centralized EU notification system exists.
- Each member state sets its own process – ranging from free, instant notifications (Germany, France) to 3-month reviews costing up to €250 per product in others.
- Belgium is often considered strategically advantageous due to efficient procedures and recognized expertise.
Planning market entry early helps you avoid delays and unexpected costs.
Brand owner responsibilities in the EU
You remain legally responsible even if you use manufacturers:
- Appoint a Food Business Operator (FBO) if manufacturing occurs outside the EU.
- Keep a Product Information File (PIF) with safety assessments, test results, and compliance documents.
- Ensure labeling accuracy and only use authorized claims.
- Handle recalls and regulatory inquiries promptly.
If you want a deeper dive into labeling rules, check out our blog post on dietary supplement labeling requirements in the EU. It covers everything you need to keep your product labels compliant.
2. US compliance: Flexibility with clear boundaries
The US system gives brands more flexibility than the EU, but it still sets clear boundaries around what you can and cannot use as dietary supplement claims. The US regulates supplements under the Dietary Supplement Health and Education Act (DSHEA) and 21 CFR Part 111 cGMP regulations.
Types of permissible claims
US law recognizes three main types of claims:
- Structure/function claims: e.g., “Supports immune health.” These do not require pre-approval but must be truthful, substantiated, and notified to the FDA within 30 days. Labels must carry the disclaimer:
“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” - Health claims: e.g., “May reduce the risk of osteoporosis.” These require FDA pre-approval based on strong scientific evidence.
- Nutrient content claims: e.g., “High in vitamin C.” These specify nutrient levels and also need FDA authorization.
Your manufacturer can guide you on claim wording, but final responsibility for accuracy rests with you.
New Dietary Ingredient (NDI) Notifications
If your supplement uses ingredients not marketed in the US before 1994, you must submit NDI notifications 75 days before launch, with safety documentation included. Skipping this step can trigger enforcement actions.
Brand owner responsibilities in the US
You must ensure product safety and compliance by:
- Confirming manufacturers follow cGMP regulations and hold third-party certifications like NSF or UL.
- Keeping quality documentation and supplier agreements on file.
- Reporting serious adverse events to the FDA within 15 business days.
Maintaining testing and batch records for all products.
While manufacturers often manage production and testing, you must verify that processes meet FDA expectations.
3. UK compliance: Post-Brexit adaptations
The UK now maintains its own Great Britain Nutrition and Health Claims Register for England, Scotland, and Wales, while Northern Ireland still follows EU rules.
Health claims rules
Only claims listed on the GB Register can be used in marketing or labeling. Claims implying disease prevention or treatment remain prohibited. The MHRA decides whether a product should be classified as a medicine if claims cross the line.
Notification and labeling requirements
The UK has no mandatory pre-market notification in England, but products must be registered with local Environmental Health or Trading Standards authorities. Labels must include:
- “Food supplement” designation
- UK-based address
- Nutrition information, allergens, recommended dose, and disclaimers
Brand owner responsibilities in the UK
- Appoint a UK-based Food Business Operator if manufacturing outside the UK.
- Ensure traceability and safety documentation is available.
- Manage product recalls and withdrawals when necessary.
Before launching a supplement brand, many owners wonder whether licenses or approvals are required in different markets. We’ve explained the essentials in our guide on what you need to know about licensing before selling vitamins and supplements.
Best practices for brand owners working with manufacturers
Even with expert manufacturers, you must stay proactive. Here’s how:
Manufacturer qualification
Before signing contracts, ensure your manufacturer:
- Holds GMP, NSF, or ISO certifications
- Provides audit reports and compliance documentation on request
- Agrees to clear responsibility divisions in contracts covering dietary supplement claims, testing, and labeling compliance
Documentation & traceability
Keep full records for every product, including:
- Product Information Files (PIFs) for EU and UK, and equivalent documentation for US.
- Ingredient traceability from supplier to finished product
Safety assessments and test reports for each batch
Claims management
Work with your manufacturer’s compliance team to:
- Approve only authorized claims from official registers.
- Avoid disease prevention or cure language.
- Schedule annual claim reviews as regulations evolve.
When choosing a manufacturing partner, it’s worth checking whether they hold the right quality and safety certifications. Our blog post on key certificates to look for when selecting a supplement manufacturer walks you through the most important ones.
Key takeaways on dietary supplement claims
Staying compliant across multiple markets doesn’t have to feel overwhelming. If there’s one thing to remember, it’s this: compliance is your responsibility as the brand owner—even if a manufacturer makes your products.
Here’s what to keep top of mind:
- Know the rules before you launch: Every market (EU, US, UK) has its own authorized claims lists, labeling rules, and notification processes.
- Use only approved health claims: Always cross-check dietary supplement claims against official registers and avoid disease prevention or cure wording.
- Work with the right partners: Choose certified manufacturers and demand full documentation and testing records.
- Stay proactive: Schedule regular claim reviews, monitor regulatory updates, and keep product documentation audit-ready.
- Own your responsibility: Manufacturers support compliance, but regulators hold brand owners accountable for claims, labeling, and safety.
If you’re looking for a manufacturing partner who not only produces high-quality supplements but also helps you navigate compliance, get in touch with our team. Together, we’ll make sure your products are launch-ready, safe, and compliant.