Supplement label requirements in the US and EU: a beginner checklist

This is a beginner checklist, not legal advice. Labels are regulated documents. Before you print or sell, have a qualified regulatory professional review your final artwork for each market.

The goal here is simple. You should finish this post knowing what goes on a US label, what goes on an EU label, and where the two differ. Then you can brief a designer or supplier with confidence.

Why labels matter before you launch

Your label is the first thing a regulator, a marketplace and a shopper will read. A mistake can mean relabelling stock or pulling a product page.

If you are still planning your brand, start with our guide on how to start a supplement brand. It shows where labelling fits in the overall launch order.

Two rule sets matter most for beginners:

• United States: FDA rules, including 21 CFR 101.36 for the Supplement Facts panel.
• European Union: Directive 2002/46/EC on food supplements, alongside general EU food labelling rules.

They share a logic. Both want shoppers to know what the product is, how much is inside, and who is responsible. But the details differ a lot.

US dietary supplement label requirements

FDA guidance says five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.^[1]

Placement matters too. You must place the statement of identity and the net quantity of contents statement on the principal display panel.^[1] That is the front panel shoppers see first.

For the business address, FDA guidance says you must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code.^[1]

The Supplement Facts panel

The regulation says the label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.^[2] In practice, that nutrition labeling appears as the Supplement Facts panel.

Key points from 21 CFR 101.36:

• The subheading "Serving Size" shall be placed under the heading "Supplement Facts" and aligned on the left side of the nutrition label.^[3]
• Serving size shall be expressed using a term that is appropriate for the form of the supplement, such as "tablets," "capsules," "packets," or "teaspoonfuls."^[2]
• Certain dietary ingredients must be declared when present above the amount that can be declared as zero: total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.^[3]
• A source ingredient may be shown in parentheses, preceded by the words "as" or "from", e.g., "Calcium (as calcium carbonate)."^[3]
• When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement placed outside and immediately below the nutrition label.^[3]
• Botanical listings shall specify the part of the plant from which the ingredient is derived.^[3]

Formatting rules designers often miss

The Supplement Facts panel has strict design rules. These trip up beginners who hand off artwork to a general designer.

• The title, "Supplement Facts," shall be set in a type size larger than all other print size in the nutrition label and, unless impractical, shall be set full width of the nutrition label.^[4]
• The nutrition information shall be enclosed in a box by using hairlines.^[4]
• Text uses a single easy-to-read type style, upper- and lowercase letters, at least one point leading, and letters that do not touch.^[4]
• Most information shall be in uniform type size no smaller than 8 point, with column headings and footnotes allowed down to 6 point.^[4]

Small bottles get some flexibility. For intermediate-sized packages, which have from 12 to 40 square inches of surface area available to bear labeling, information shall be in type size no smaller than 6 point.^[4] Small packages under 12 square inches can go to 4.5 point.^[4]

Tip: measure the real label area on your bottle before design starts. It decides your minimum font size.

EU food supplement labelling

The EU starts with a definition. Food supplements are foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect.^[5]

The sales name is fixed. The Directive says the name under which products covered by this Directive are sold shall be "food supplement".^[5]

Mandatory particulars under Directive 2002/46/EC

The Directive lists particulars the labelling shall bear:

1. The names of the categories of nutrients or substances that characterise the product, or an indication of their nature.^[6]
2. The portion of the product recommended for daily consumption.^[6]
3. A warning not to exceed the stated recommended daily dose.^[6]
4. A statement to the effect that food supplements should not be used as a substitute for a varied diet.^[7]
5. A statement to the effect that the products should be stored out of the reach of young children.^[7]

How amounts are declared

The EU approach to quantities differs from the US serving model. The amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form, and units for vitamins and minerals shall be those specified in Annex I.^[8]

Those amounts shall be those per portion of the product as recommended for daily consumption on the labelling.^[8] So EU labels anchor on the recommended daily portion.

What EU labels must not say

Two prohibitions matter for copywriting:

• The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.^[5]
• Labelling shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.^[9]

This applies to presentation and advertising too, not only the bottle.^[5] Your product page copy counts.

Side-by-side checklist: US vs EU

Use this table as a briefing sheet for your designer or supplier. It summarises the sources above. It is not a complete legal list.

A practical takeaway: one label rarely works in both markets. Plan for separate artwork per region from day one.

A simple pre-print checklist

Run through this before you approve any label proof.

• [ ] Correct region chosen (US, EU or both, with separate files)
• [ ] Product name meets the regional rule
• [ ] Quantity shown in the right place
• [ ] Nutrient amounts match the supplier's specification sheet
• [ ] US: Supplement Facts title, box and font sizes checked
• [ ] EU: dose warning, varied diet and children statements present
• [ ] Business name and address complete
• [ ] No disease or medical wording anywhere on the label
• [ ] Product page copy matches the label
• [ ] Final proof reviewed by a qualified regulatory professional

If you use a private-label supplier, ask what label support they provide. Our private label supplements guide explains how that relationship usually works for beginners.

Where Suplify fits in

Suplify does not replace a label review. But it reduces risk in the copy that sits next to your label.

In Suplify, shopper-facing supplement copy is checked against the EU register of authorised health claims. Disease and cure wording is blocked. US stores get structure/function phrasing plus the FDA disclaimer. That keeps your store pages consistent with the restrictions above.

Suplify also holds no inventory. Products are made and shipped per order. That matters for labels: if you need to fix artwork, you are not sitting on thousands of misprinted bottles.

Costs matter while you iterate. For example, using the Suplify profit calculator defaults, a $39 product with about $12 product and shipping cost leaves about $27 gross profit before card fees, the 0.85% platform fee and marketing. Run your own numbers in the supplement profit calculator.

Next steps

1. Decide your first market: US, EU, or both.
2. Use the table above to brief your designer or supplier.
3. Read how to start a supplement brand for the full launch order.
4. Compare supplier models in the private label supplements guide.
5. Check Suplify pricing: one Basic plan at $49/month with a 0.85% platform fee per order.

Get your label right first. Then launch your store, which takes about 8 minutes in Suplify.