Updated 2026-09-12. This page is not legal advice.
You sell a dietary supplement in the United States. FDA sets what the label must say, and you carry the responsibility for it, not your manufacturer. The main rule for the panel is 21 CFR 101.36. This page covers each part of the label, from the panel to the claims.
What must a dietary supplement label show?
Five things: a statement of identity, the net quantity of contents, a Supplement Facts panel, an ingredient list, and your address. The detail for each one follows.
- Statement of identity. The front of the package names the product and calls it a “dietary supplement”. You may replace the word “dietary” with the ingredient, such as “herbal supplement”.
- Net quantity of contents. Put the count or the weight in the lower third of the front panel, for example “60 capsules”. The net weight statement guide covers the wording and the type size.
- Supplement Facts panel. 21 CFR 101.36 sets the content, the order, and the layout.
- Other ingredients. Everything that is not a dietary ingredient goes on this line, under 21 CFR 101.4.
- Name and place of business. Give the name and address of the manufacturer, packer, or distributor. Write “Distributed by” before your name when you did not make the product.
Federal rules also require a domestic phone number or address, so a buyer can report a serious adverse event. Directions for use are not required, but buyers expect them.
What is the difference between Supplement Facts and Nutrition Facts?
The panel title is the difference that matters most. Conventional foods carry a Nutrition Facts panel. Dietary supplements carry a Supplement Facts panel under 21 CFR 101.36. The two layouts look alike, and the rules under them differ in four ways.
First, a Supplement Facts panel leaves out nutrients that are not in the product. A food panel declares the mandatory nutrients even at zero.
Second, a Supplement Facts panel lists dietary ingredients that have no Daily Value, such as botanicals and amino acids. A food panel has no place for them.
Third, a Supplement Facts panel names the plant part and may name the source ingredient. “Turmeric (Curcuma longa) root” is a supplement line.
Fourth, the ingredient list sits below the panel under the heading “Other ingredients”. On a food label the ingredient list stands alone.
Use the Nutrition Facts label maker for a food product and the Supplement Facts generator for a supplement. Never put a Nutrition Facts panel on a supplement.
How do I list ingredients in the Supplement Facts panel?
List the serving size first, then the dietary ingredients that have a Daily Value, then the ones that do not. 21 CFR 101.36 fixes that order.
Start with “Serving Size” and “Servings Per Container”. The serving size is the largest amount you recommend at one time, such as “2 capsules”. The serving size calculator helps when you split a bulk powder into scoops.
Vitamins and minerals with an established Daily Value come next. Give the amount per serving in metric units, then the percent Daily Value in the right column. Vitamin A, vitamin D, and vitamin E use micrograms or milligrams, not International Units. Folate uses micrograms DFE.
A heavy line then separates that block from the dietary ingredients with no Daily Value. Botanicals, amino acids, extracts, and probiotics go below the line. Name a botanical by its common name, its Latin name, and the plant part, for example “Ashwagandha (Withania somnifera) root”.
Every amount in the panel is a number you must be able to prove. Ask your manufacturer for a certificate of analysis that supports each one.
What is the dagger symbol, and when do I use it?
The dagger (†) marks a dietary ingredient that has no established Daily Value. It takes the place of the percent in the right column. A footnote under the panel then reads: † Daily Value not established.
FDA has set Daily Values for vitamins, minerals, protein, and a short list of other nutrients. Most botanicals, amino acids, enzymes, and probiotic strains have none. Those rows get the dagger.
Use one dagger symbol and print the footnote once, directly below the panel. Do not invent a percent for an ingredient with no Daily Value. Do not put a dagger on a vitamin or mineral that has one, because the percent belongs there. The Supplement Facts generator adds the dagger when you leave the Daily Value field blank.
How do I list a proprietary blend?
Name the blend and print its total weight. List the components under it in order by weight, heaviest first. You do not print the amount of each component. 21 CFR 101.36 allows this format.
A blend row looks like this:
Energy Blend 750 mg † Green tea leaf extract, guarana seed, ginseng root
Two limits apply. A vitamin or mineral with a Daily Value must appear on its own line, with its amount. That rule holds even when the nutrient also sits in the blend. The order inside the blend must still follow weight.
A blend hides the amount of each ingredient. Many buyers treat that as a reason to distrust the product, and some retailers reject it. Print the individual amounts when your formula allows it.
What goes in the “Other ingredients” line?
Everything in the product that is not a dietary ingredient. The line sits directly under the Supplement Facts panel. 21 CFR 101.4 sets the format: common or usual names, in order by weight, heaviest first.
Typical entries are the capsule shell, rice flour, microcrystalline cellulose, magnesium stearate, silicon dioxide, and any color or sweetener. A capsule shell is gelatin or hydroxypropyl methylcellulose. Certified colors carry their full names, such as FD&C Blue No. 1.
Allergens follow the same rules as food. The nine major allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Name the allergen inside the list, or add a “Contains:” line under it. See how to write an ingredient statement and how to write the allergen statement. The ingredient label maker puts the list in order by weight and builds the allergen line for you.
What claims can I make, and what disclaimer do they need?
You may make structure/function claims. You may not make disease claims. A structure/function claim says what an ingredient does in a healthy body, such as “supports joint comfort”. A disease claim says the product treats, prevents, or cures a condition, such as “relieves arthritis”. A disease claim turns your product into an unapproved drug.
DSHEA 1994 drew that line, and 21 CFR 101.93 sets what travels with the claim. Every structure/function claim carries this disclaimer, word for word:
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.
Print the disclaimer in bold type, inside a box, on every panel that carries a claim. Tie it to the claim with a symbol when the two sit apart. You must also notify FDA in writing within 30 days after you first market the claim.
Nutrient content claims, such as “high in vitamin C”, follow separate federal rules. Each one needs a Daily Value behind it.
Do I have to register with FDA or get approval?
FDA does not approve dietary supplements before sale. No agency reviews your formula, your panel, or your claims before the product ships. Three federal duties still apply.
Facility registration. Every facility that manufactures, packs, or holds your product must register with FDA under the Bioterrorism Act. The registration renews every two years. Your contract manufacturer normally holds it. Ask for the registration number.
Current good manufacturing practice. 21 CFR Part 111 sets the manufacturing rules for dietary supplements, including identity testing, written specifications, and batch records. It binds whoever manufactures, packages, labels, or holds the product.
New dietary ingredients. Some ingredients were not sold in the United States before October 1994. Such an ingredient needs a notification to FDA 75 days before you market it. Most private label formulas use known ingredients, so this rarely applies. Get the answer in writing anyway.
You remain the responsible party for the label. FDA acts after the fact, through warning letters, seizures, and recalls.
What should I ask a private label manufacturer about the label?
Ask these questions before the first production run, and keep the answers in writing.
- Who builds the label file, and who owns the artwork? Get the print-ready file under your name.
- Which facility makes the product, and what is its FDA registration number?
- Do you follow 21 CFR Part 111, and who audited you last?
- Will you send a certificate of analysis for every lot?
- Does the tested amount match the label amount, and how much overage goes into the batch?
- Which ingredients carry one of the nine major allergens, and what else runs on the same equipment?
- What is the shelf life, and what stability data sets the expiration date?
- Where do the lot code and the expiration date print on the bottle?
- Does the label carry my “Distributed by” line and my adverse event phone number?
- Will you print the structure/function disclaimer in a box on every panel that carries a claim?
Review a physical proof, not a screen image. Check the panel order, the dagger footnote, the “Other ingredients” line, and the disclaimer. For a short first run, the guide to printing labels at home covers stock and sizing. If you also sell food from your kitchen, the state cottage food rules cover those products separately.