Dietary Supplement Labeling Requirements, With a Checklist

A dietary supplement's label follows the food label's frame, the front panel and the information panel, with three things of its own. The statement of identity says "dietary supplement", or names the ingredient with "supplement", like "calcium supplement". Nutrition goes in a Supplement Facts panel instead of Nutrition Facts, with the serving size in capsules or scoops, each dietary ingredient and its amount, and a dagger where no Daily Value exists. And any structure/function claim, "supports a healthy immune system", carries FDA's disclaimer, can't claim to treat a disease, and has to be reported to FDA within 30 days of first sale. In the example below, a noni capsule maker works out its panel from the powder in a bottle and checks every line. Below are the rules, the panel, the claim, and a free checklist.

The short version

• Statement of identity: "dietary supplement", or the ingredient's name with "supplement".
• Net quantity on the front, which for capsules can be a count.
• Supplement Facts: serving size in the product's units, servings per container, each dietary ingredient and its amount.
• Ingredients with no Daily Value get a dagger and "Daily Value not established".
• Botanicals name the part of the plant; other ingredients, such as the capsule, go below the panel.
• A structure/function claim needs substantiation, FDA's disclaimer, and notice to FDA within 30 days of first sale.
• No claim to diagnose, treat, cure or prevent a disease.
• TaroStack keeps each encapsulating run's lot and the powder lot it used. More below.

The rules

The panel's serving size uses a unit that fits the product, "capsules", "tablets", "scoops". Each dietary ingredient without a Daily Value carries a symbol in the % Daily Value column, pointing to "Daily Value not established" at the bottom of the panel; the rest of the label follows the food rules in food labeling requirements for small business. Botanicals are named with the part of the plant they come from, and ingredients that aren't dietary ingredients, the capsule shell, a flow agent, are listed in an ingredient statement right below the panel. This is general information, not legal advice.

An example: a noni capsule

Noni Grove, a made-up supplement maker in Hawaiʻi I use in these examples, fills 90 capsules with 45 grams of noni fruit powder per bottle:

The front reads "Noni Fruit Powder, Dietary Supplement, 90 capsules". The back carries the panel, the other ingredients, Noni Grove's name and address, and one claim: "Supports a healthy immune system*", with the disclaimer below it. How a supplement maker keeps track of powder and capsule lots is in supplement inventory software.

Structure/function claims

A structure/function statement describes how an ingredient affects the body's structure or function, or general well-being. The maker has to have substantiation that it's truthful and not misleading, it can't claim to diagnose, mitigate, treat, cure or prevent a disease, and the maker notifies FDA no later than 30 days after first selling the supplement with that statement. Each statement carries, in bold: "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." It sits right next to the claim, or is linked to it by an asterisk. Noni Grove notified FDA on September 22, within 30 days of its first sale with the claim. A disease claim makes a supplement an unapproved drug, which is why "relieves arthritis" never goes on the label, a website or a market sign.

Get the checklist

Download the dietary supplement label checklist. Two sheets: Supplement Facts, where you type the powder in a bottle, the capsules in a bottle and the capsules in a serving, and the amount a capsule, a serving and the servings a bottle fill in with the panel's lines; and a label checklist, each item with its rule, a column for what your label says, and a tick. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.

Where this stops working

The label says 1,000 mg a serving. Whether each bottle holds it depends on the powder lot, the encapsulator's fill weight that morning, and the capsules counted into each bottle, and a supplement maker has to be able to show that, lot by lot, if a buyer or an inspector asks.

How TaroStack does it

TaroStack keeps each encapsulating run's lot and the powder lot it used.

Each run its lot. An encapsulating run takes its powder, capsules, bottles and labels off stock, records the lots it consumed, and gets a lot of its own, the code on the bottle. How to number lots is in how to create lot numbers.

Checks on the batch record. Fields of your own on the batch record hold the fill weight checks, the capsule count and who checked, and fields on each received lot hold the supplier's certificate or identity test number.

From run to customer. Each order records the lots each customer got as it ships, so one recall report shows where a run went and what's still on your shelves.

Lots, batches, batch records with fields of your own, and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.

Questions people also ask

What has to be on a supplement label?

A statement of identity with "dietary supplement", net quantity, a Supplement Facts panel, other ingredients, the maker's name and place of business, allergens, and the disclaimer with any structure/function claim.

What is the difference between Supplement Facts and Nutrition Facts?

Supplements use Supplement Facts, with servings in the product's own units and dietary ingredients that may have no Daily Value, marked with a dagger.

Do I have to tell FDA about a structure/function claim?

Yes, no later than 30 days after first selling the supplement with that claim.

What claims can't a supplement make?

Any claim to diagnose, mitigate, treat, cure or prevent a disease, such as "relieves arthritis" or "prevents colds".