Understanding supplement labeling requirements

Every dietary supplement sold in the US must carry a Supplement Facts panel in the FDA's prescribed format, make only substantiated structure/function claims with the required disclaimer, and be produced in an FDA-registered, GMP-certified facility. Canada is a separate system entirely: you need a Natural Product Number (NPN) and bilingual labelling.

Labelling is where most first-time supplement brands make their most expensive mistakes. A non-compliant label can mean product recalls, FDA warning letters, and months of delays while you redesign packaging you've already printed.

We've reviewed hundreds of labels for brands at every stage. Here's what you need to know.

The Supplement Facts panel

Every dietary supplement sold in the US needs a Supplement Facts panel. Not a Nutrition Facts panel (that's for food). Not a Drug Facts panel. Supplement Facts. The format is prescribed by the FDA down to the font size, line spacing, and order of nutrients.

Your panel must include:

• Serving size and servings per container — in household measures (e.g., "1 stick pack (7 g)")
• Each active ingredient — listed with the amount per serving and % Daily Value where established
• Other ingredients — listed below the panel in descending order by weight
• Allergen declarations — if your product contains or was manufactured in a facility that processes major allergens

The % Daily Value column matters. For nutrients with an established DV (vitamins, minerals, electrolytes), you must show the percentage. For ingredients without a DV (proprietary blends, botanicals), you show a dagger (†) and the note "Daily Value not established."

Claims: what you can and can't say

This is where brands get into trouble. There are three types of claims the FDA recognizes:

Structure/function claims are the most common for supplement brands. These describe how a nutrient affects the body's structure or function. "Supports hydration" is fine. "Helps maintain electrolyte balance" is fine. But "cures dehydration" is a drug claim, and the FDA will come after you for it.

Nutrient content claims describe the level of a nutrient. "High in potassium" or "good source of vitamin C." These have specific numerical thresholds defined by the FDA.

Health claims describe a relationship between a nutrient and a disease or health condition. These require significant scientific agreement and FDA pre-approval. Most supplement brands don't use them because the bar is extremely high.

The practical rule: never claim your product treats, cures, prevents, or diagnoses any disease. That makes it a drug in the FDA's eyes, and you'd need to go through the drug approval process.

Common mistakes we see

Copying claims from competitors. Just because another brand says "boosts immunity" on their website doesn't mean the claim is legal. They might have received a warning letter you don't know about. Or they might be flying under the radar temporarily. Don't use other brands' labels as your compliance template.

Wrong panel format. Some brands design their labels using nutrition panel generators that produce Nutrition Facts panels instead of Supplement Facts panels. These look similar but have different rules. Using the wrong one flags your product as non-compliant.

Missing the disclaimer. If you make any structure/function claim, you're required to include this disclaimer on your label: "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." Many brands forget it or bury it in illegibly small text.

Ignoring state requirements. California's Proposition 65 requires specific warnings for products containing ingredients above certain thresholds. Some states have their own labelling requirements on top of federal ones.

Canadian requirements are different

If you're selling in Canada, your product falls under the Natural Health Products Directorate (NHPD), not the FDA. You need a Natural Product Number (NPN) on your label. Bilingual labelling (English and French) is mandatory. The panel format, permitted claims, and regulatory pathway are all distinct from US requirements.

We manufacture for both markets. Our regulatory compliance team handles the requirements for each, so you don't need to become an expert in two regulatory systems.

How to get it right

Work with a manufacturer who builds compliant labels as part of the process. At Evo Hydration, our team creates your Supplement Facts panel from the actual batch formula, reviews all marketing claims before printing, and ensures your labels meet requirements for every market you're selling in.

This isn't an add-on service we upsell. It's built into how we work. A non-compliant label is a liability for both of us, so we'd rather catch issues before printing than deal with a recall after.

Have questions about labelling for a specific product? Get in touch and our regulatory team can walk you through the requirements.