Have you ever browsed the internet or listened to popular US podcasts and gotten interested in a supplement promising incredible results—only to discover that finding it in Europe is nearly impossible? That’s no coincidence. It’s the result of two completely different approaches to consumer safety in the supplement industry.

This article offers a clear, simple explanation of the essential differences in how dietary supplements are regulated around the world.
We’ll explore why the European market is so strict, the US market is much more lenient, and why the road to market for new, innovative ingredients in Europe is so long and winding.

In short: the core differences

Two different philosophies

The European Union (EU) follows a “safety-first” principle. Any supplement or its ingredient must prove its safety and effectiveness before entering the market. In contrast, the US places more responsibility on the manufacturer, and government agencies only step in when consumers face problems.

Europe's "gatekeeper" vs. America's "supervisor"

Key institutions are the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA). EFSA acts like a strict gatekeeper, thoroughly verifying every health claim. Meanwhile, the FDA doesn’t strictly regulate supplements and acts more like a supervisor, responding to complaints.

The "novel food" rule

Europe enforces a tough rule for innovative ingredients: if an ingredient wasn't widely consumed before 1997, it's considered a novel food. To sell it as a supplement, one must go through a lengthy and expensive safety approval process.

Example: NMN

Nicotinamide mononucleotide (NMN), hyped in the US as a “longevity supplement,” is a perfect example. It’s freely sold in the US but banned in the EU as it’s considered an unapproved novel food.

The confusing world of regulation— made simple

Our goal is to explain complex legal rules in plain language. We want you to understand why certain products are on European shelves while others — often featured in shows like Huberman Lab or Joe Rogan Experience — are missing.

The EU: a strict bouncer at the club entrance

Imagine the supplement market as a nightclub. The EU is the strict bouncer at the door, carefully checking every ID. If there’s even the slightest doubt about someone’s age or documentation — they don’t get in.

That’s how EU supplement regulation works. Every health claim (e.g., “Vitamin C supports immune function”) must be approved by EFSA. To get a claim approved, manufacturers must submit serious scientific proof — often expensive human clinical trials. Only if the evidence is rock-solid does EFSA approve the claim. This process can take years and is usually only feasible for large corporations due to high costs.

The US approach: freedom and manufacturer responsibility

Using the same nightclub analogy, the US is the club that lets everyone in without much checking. Inside, security guards (the FDA) keep an eye on things. If someone causes trouble—they’re thrown out.

Under the 1994 DSHEA law, full responsibility for supplement safety lies with the manufacturer. The FDA does not pre-approve supplements or health claims. Manufacturers can claim that a product “supports digestive health” as long as they include a disclaimer that the FDA has not evaluated the statement. The FDA only intervenes if there are reports of safety concerns or false advertising.

EFSA vs. FDA: Two Different Guardians

Novel food status: why Europe has fewer innovations

Even stricter than claim regulation is the “novel food” rule.

In short: if your great-grandparents didn’t eat it, the EU wants proof it’s safe. Any ingredient not widely consumed in the EU before 1997 is considered a novel food. Such ingredients are banned from being sold.

Take NMN, for example — a compound of great interest to longevity enthusiasts. It cannot be sold as a supplement in the EU because it has novel food status.

To make a novel food legally available, manufacturers must go through an extensive and expensive authorization process to prove it’s safe. This discourages many companies from introducing innovations to the EU market.

Banned claims: what you can’t say in Europe

The EU strictly regulates marketing promises. If a claim isn’t on EFSA’s official approved list — it can’t be used. Examples of popular but illegal claims:

• “Anti-aging” or “longevity supplements” – science is still exploring this, but no supplements have been approved by EFSA for life-extension effects.

• “Boosts immunity” – the word “boost” is considered misleading. EFSA allows “supports normal immune function” for Vitamin C, but not unrealistic enhancements like “super immunity.”

• “Nootropics” or “brain boosters” – claims like “improves memory” or “increases focus” for healthy individuals are not approved, as existing studies are seen as insufficient.

• “Detox” or “cleansing” – “detox” is viewed as a medical claim. Healthy livers and kidneys already handle detoxification. EFSA has not approved any supplement that enhances this process.

Shipping from the US: why your iHerb package might get stuck in customs

Some consumers try to bypass EU rules by ordering from US platforms like iHerb. But this is risky.

Every non-EU shipment is considered an import and subject to customs checks. If it contains banned ingredients—like high-dose vitamins, unapproved novel foods (e.g., NMN, DHEA, huperzine A), or prescription-level substances like high-dose melatonin—the package may be confiscated, returned, or destroyed. You could lose your money and even face a fine.

Buying from EU-based shops or pharmacies ensures that the supplements you take are safe and legally compliant.

In summary: safety over innovation

The EU and US have chosen different regulatory paths.

• Europe prioritizes consumer safety, even if it slows down innovation.

• The US allows more freedom, giving consumers wider access—but with greater responsibility to discern what’s effective and safe.

Understanding these regulatory differences is key to making smart, safe decisions in the global supplement market.

Frequently Asked Questions

• Why does EU supplement approval take so long?
  Because EFSA requires serious scientific proof (often several human clinical trials) to ensure both safety and efficacy. Quality matters more than speed.
• Will my iHerb order always be stopped?
  Not always. Customs checks are random. But if you order a product that clearly breaks EU rules (e.g., 10 mg melatonin), the risk of it being stopped is high.
• What does “FDA approved” on a US supplement mean?
  It’s often misleading. The FDA doesn’t approve supplement efficacy, only manufacturing compliance. It doesn’t guarantee the product works.
• Are EU supplements better than US ones?
  Not necessarily. EU regulation ensures claims are science-backed and ingredients are safe. But that doesn’t mean the US lacks quality products. In both markets, consumer knowledge and choosing trustworthy manufacturers are essential.