Selling supplements in the US: DSHEA, the FDA and the dietary supplement model

The United States is the world's largest supplement market, and its regulatory model is fundamentally different from the EU's. Under DSHEA, dietary supplements are a distinct category with their own framework — a system any manufacturer expanding from Europe has to understand on its own terms rather than mapping from EU concepts.

How supplements are classified

In the US, dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994 as a category of food — not drugs. The framework defines what counts as a dietary ingredient, sets labelling requirements (including the Supplement Facts panel), and places the burden of safety and compliance on the manufacturer or distributor.

The regulator

In the US, the competent authority is the Food and Drug Administration (FDA). Knowing the regulator is the starting point: it determines how a product enters the market, who enforces the rules, and where to look for authoritative guidance.

Getting to market

There is no general pre-market approval for dietary supplements: products do not need FDA clearance before launch. However, a New Dietary Ingredient (NDI) — one not marketed in the US before 1994 — generally requires a pre-market NDI notification to the FDA. Facilities must register and follow cGMP (current Good Manufacturing Practice) requirements.

What makes the US distinct

The US model centres on the Supplement Facts panel (not the EU nutrition format), DSHEA-compliant structure/function claims with the required disclaimer, the NDI question for newer ingredients, and cGMP. Concepts like the EU's harmonised maximum levels do not map directly — the US approach to permitted ingredients and claims is its own system, and getting the label format and claims right is the core task.

Labelling and language

The label must be in English and use the US Supplement Facts panel format with US-compliant claims. Beyond language, the label has to carry the market-specific mandatory information — the right claim wording, the correct nutrition or supplement format, and any registration or licence identifiers the regime requires.

Because national requirements, registration procedures and permitted ingredients change and differ in detail, confirm the current rules for the US with the competent authority or a local regulatory expert rather than relying on a general summary.

One formula, many markets — the software argument

The deeper point is that the US is not the EU, and a market like this is exactly where a single source-of-truth formula proves its worth. The same underlying formula has to be expressed in a completely different way here — a different claims framework, a different label format, a different registration dossier, a different language — while still tracing back to the same recipe that serves Europe and every other market. Managing that as one structured formula with market-specific outputs, rather than rebuilding the product from scratch for each country, is what makes genuinely global expansion sustainable.

Where Lemoniq fits

Lemoniq holds each product as one structured formula and generates the market-specific outputs a US launch needs — the right label format and language, the ingredients and levels checked against local rules, and the documentation a registration or notification expects — from the same source that serves every other market. Expanding into the US becomes a configuration of an existing formula, not a fresh product.

The takeaway

Selling supplements in the US means working within its own classification, its own regulator and its own market-entry route — which look nothing like a simple copy of an EU launch. The manufacturers who expand globally without drowning in duplicated work are the ones whose one formula generates each market's label, ingredients check and documentation automatically.

Lemoniq turns one formula into compliant outputs for the US and markets worldwide at once. We solve this exact problem. See how it works