Label Compliance
Verify the panel before it goes to print, because a labeling mistake ships on every bottle in the run.
Lesson Objective
Almost everything else in this business can be changed after launch: prices change, pages get rewritten, ads get pulled. A label is printed once, applied to every bottle in the run, and then sits in a warehouse for up to two years.
This module checks your artwork against federal labeling rules before it goes to press. A product with a wrong label is legally , whatever is actually in the bottle.
Your manufacturer prepares the and usually reviews the artwork, but that review isn't a guarantee. Responsibility sits with the company named on the label, which is yours.
Strategy
Artwork can contain everything it needs and still be wrong. Below are the three ways a label usually fails.
Wrong placement catches people out because it comes from the design process instead of carelessness. A designer tidying the back panel by spacing things out, adding a badge or moving a block of copy can break a compliant layout without changing a word.
Action Plan
Take the Panel From Your Manufacturer
Your manufacturer builds the Supplement Facts panel from the formula, including the calculations and rounding rules. They do this constantly, so let them.
Your job is to check that the panel matches the product you agreed to buy: the dose per serving, the , the servings per container and the form. Hold it against the specification you both signed.
Check the heading too. A dietary supplement carries a Supplement Facts panel. Nutrition Facts is the version for conventional food, and it has different rules about which ingredients appear, how zero amounts are handled and what can be listed. Artwork built from a food template, or from another company's file, arrives with the wrong heading more often than you'd expect.
Verify the Front Panel
Two things on the front panel have rules attached.
- The product name has to appear with the words Dietary Supplement, or a description that includes the word "supplement". Designers tend to shrink it, but it has to be prominent.
- The net quantity, such as "60 Capsules", has to sit in the bottom 30% of the panel.
Everything else on the front is your choice: the brand, the mechanism, the imagery and the one claim you lead with.
Check the Information Panel Runs Uninterrupted
The Supplement Facts panel, the other ingredients, the allergen statement, and the company name and address have to run together with nothing in between. Breaking up this block is the most common way well-designed artwork becomes non-compliant.
Read it top to bottom and confirm nothing has been dropped into it. Certification seals, QR codes, barcodes and brand copy are the usual culprits, because they're what a designer reaches for when a panel looks unbalanced. All of them belong above or below the required block.
Then check the type size. The minimum is one sixteenth of an inch, measured on a lowercase letter o.
Check Allergens Against the Full Formula
Nine allergens have to be declared: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Either name them in the ingredient list or add a "Contains" statement beside it.
The catch is that allergens arrive in things you didn't think of as ingredients. A flow agent, a capsule shell, a flavor system or a carrier blended into a raw material can each bring one in. Ask your manufacturer for a complete allergen declaration that covers incoming raw materials as well as your formula sheet.
Place the Disclaimer With the Claim
Any on the label needs the , in bold type at least one sixteenth of an inch tall, linked to the claim by a symbol such as an asterisk.
The regulation says the disclaimer has to appear on every panel that carries a claim. In December 2025 the told the industry it would no longer enforce that part and expects to propose changing the rule, so a front-panel claim ending in an asterisk can point to a disclaimer on the back. This is the line most likely to move, so check the FDA's current position before your artwork goes to print.
Run every word on the label through the compliance word bank while you're here, front panel included. The claim on your front panel is the most-read sentence you'll write, and once it's printed you can't edit it.
The claim also comes with a filing. Within 30 days of first marketing the product with a structure/function claim, you have to notify the FDA on Form FDA 3955 through its electronic submission portal. In it you certify four things: that it's a structure/function claim, that you have for it, that the disclaimer accompanies it, and that it doesn't claim to treat a disease.
The 30 days start when you begin marketing, so a live product page can start the clock before a bottle has shipped. The obligation sits with the company named on the label, which is yours.
Settle the California Warning
You decided this in the module: formulate and source under California's lead limit, or carry the warning. Either way, the artwork has to reflect it now.
If you're carrying the warning, its wording and format are set out in the regulations, so get them from your lawyer instead of copying another brand's bottle.
Have More Than One Person Check It
Artwork errors survive because everyone assumes someone else caught them, and because a bottle that looks right is easy to read past.
Give it to at least two people who didn't make it, each with a different job. One checks the panel against the signed specification line by line, reading the numbers aloud. The other reads it as a customer would, front to back, looking for anything confusing or missing.
Someone who has looked at your bottles for years is the least likely to spot a stale figure, so include someone who hasn't.
Proof It Physically Before the Run
Artwork approved on a large screen hasn't really been checked.
Print the label at actual size, on paper if that's all you have, and wrap it around a bottle of the right diameter. Then read the back panel at arm's length in ordinary light. Type that looked fine at 200% on a monitor is often unreadable curved around a 60-count bottle, and the required minimum size is only a floor.
Then ask someone who has never seen it to find the serving size and the allergen statement. If they struggle, the panel needs work even where it technically complies.

At the first supplement startup I worked at, I was redesigning labels constantly. We had a lot of bottles, and the deadline was always yesterday.
So I worked the way you do under that kind of pressure: pull the template file from an existing product, redo the art, update the facts to match the new supplement, and send it on.
One time I didn't update the facts. The label went to print with another product's Supplement Facts panel on it, and it cost five thousand dollars to redo.
That was my mistake, and I've never pretended otherwise. But there's a second half to it: nobody in the company checked my work before it went out. One person moving fast is normal in a growing business. One person moving fast with nothing between them and a printer is a decision somebody made.
Two lessons came out of it. Slow down on anything that can't be undone, and print is the clearest example of that. And get more than one set of eyes on artwork before it's released, ideally a few. When you've looked at the same bottles for years, you stop reading them. You see the shape of the label and your brain fills in the rest.
Asset
The Label Anatomy below shows every element the front and back panels have to carry, including the four that have to run together with nothing between them. Check your artwork against it before the file goes anywhere near a printer.
What Has to Be on the Label
Two elements on the front, eight on the back, and where each one belongs.
Principal Display Panel
The front, as a customer sees it on a shelf
- 1
Statement of identity
The name of the product, together with the words "Dietary Supplement". A descriptor such as "Herbal Supplement" can stand in for the word dietary. This has to be one of the most prominent things on the panel.
- 2
Net quantity of contents
The count or weight, placed in the lower 30% of the panel, at a type size set by the panel's area.
Information Panel
The back or side, immediately to the right of the front
- 3
Supplement Facts panel
Must run togetherServing size, servings per container, and every dietary ingredient with its amount per serving and percent daily value where one is established. The heading sets in type larger than anything else inside the panel.
- 4
Other ingredients
Must run togetherEverything not already named in the Supplement Facts panel, in descending order by weight. Capsule shells, flow agents, sweeteners and colors all belong here.
- 5
Allergen declaration
Must run togetherAny of the nine major allergens, either named inside the ingredient list or in a "Contains" statement placed beside it. Sesame became the ninth in 2023.
- 6
Name and place of business
Must run togetherThe manufacturer, packer or distributor, with a street address unless the firm is listed in a current directory.
- 7
Adverse event contact
A US address or phone number where a report of a serious adverse event can be received. This is the decision you made when forming the company, and it can be the same address as element six.
- 8
Directions for use
How much to take and how often, matching the serving size declared in the Supplement Facts panel.
- 9
FDA disclaimer
Required wherever you make a structure or function claim. Boldface, no smaller than one sixteenth of an inch, and linked to each claim by a symbol such as an asterisk. Since December 2025 the FDA has said it won't enforce the requirement that it sit on every panel carrying a claim, so it can live on the back.
- 10
Proposition 65 warning
ConditionalCarried only if your product exceeds California's levels and you chose to warn rather than reformulate. Wording and formatting are specified.
Two rules about placement
Elements 3-6 must not have anything placed between them. Often you will see a certification seal, a QR code, a barcode, or a block of brand copy dropped between the ingredient list and the company address, and any one of them breaks the required run.
Type on the information panel sets at a minimum of one sixteenth of an inch, measured on a lowercase letter o. Small packages get some relief, and a 60 count bottle generally does not qualify for it.
For a finished version, the product label example shows every element above on the Liver Detox Liquid label, at real size, numbered the same way.
Late Artwork Changes
The version your manufacturer reviewed and the version that goes to press are often different files.
The changes usually happen in the last week. The brand color is adjusted, a logo moves, or someone decides the back panel looks crowded and the designer tightens the spacing. None of these feel like compliance changes, but any of them can shrink the disclaimer below the minimum type size, push the "Contains" statement onto another panel, or break the required block with a badge moved up to fill a gap.
Nobody re-reviews it, because everyone remembers approving the label.
What prevents it: treat the reviewed file as locked. Put a version number on the file and on the printed label, so any later change becomes a new version that goes through the same check before it reaches the printer. The check is quick, while a relabeling run takes weeks and comes out of the same budget as your first month of advertising.
You now have artwork that carries everything it's required to, in the right places, in wording you can defend, which clears the last obstacle before a . Next, you build the images that sell it.
This is one module of The Foundry
The Foundry takes a supplement brand from formula to first reorder, with a working tool in every module and your numbers carried between them.