Custom Food Labels: FDA Requirements, Materials & Best Practices

The Two Halves of Food Label Compliance

A food label has to satisfy two separate sets of rules, and most buyers only think about the first one.

The first is what the label says — statement of identity, net quantity, ingredients, allergens, nutrition facts. This is the part governed by 21 CFR Part 101, and it's what everyone researches.

The second is what the label is made of. A label touches food packaging, and sometimes food directly. The adhesive, face stock, and ink are regulated as indirect food additives. This is the part that quietly fails audits — and the part a label supplier should be able to document.

This guide covers both, plus the material choices that determine whether your label survives a freezer, a chilled case, or an oily surface.

First, a Myth Worth Killing: FDA Does Not Approve Labels

There is no FDA label approval step. The agency does not review and sign off your artwork before printing. Compliance is the responsibility of the firm whose name is on the product.

This matters practically. If a supplier tells you "the FDA approved this label," that statement is wrong — and it's a signal they don't understand the regulatory landscape. What a competent supplier provides is different: a label built to your supplied content, plus documentation on the materials.

The corollary is uncomfortable but important: your printer cannot make your label compliant. They can print what you send correctly and supply compliant materials. The claims, ingredient list, and allergen statement are your responsibility — normally reviewed by a regulatory consultant or counsel, not a printer.

The Mandatory Elements

For most packaged foods sold in the US, the principal display panel and information panel carry six required elements:

Formatting details — type size minimums, bold requirements, contrast, and placement — are specified in 21 CFR Part 101, Subpart B. Those rules are numeric and unforgiving; a label can contain every required element and still be non-compliant because the net quantity is in the wrong type size for the panel area.

The Allergen Declaration: Nine, Not Eight

The US major food allergen list expanded to nine. Under the FASTER Act, sesame became the ninth major food allergen, effective January 1, 2023, joining milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

Two practical consequences that trip up small producers:

• "Contains" statements must be complete. If sesame is present — including as tahini, sesame oil, or a sesame-derived ingredient — it must be declared by its common name.
• Allergens cannot hide inside collective terms. An allergen present in a spice blend or natural flavor still has to be named. "Spices" does not cover a major allergen.

Sesame is also the allergen most often missed by producers reformulating an existing recipe, because it enters through suppliers rather than the recipe itself — a new bun supplier, a new seasoning blend. Confirm allergen status with every ingredient supplier, in writing, at every reformulation.

FDA reference: Sesame Added as a Major Food Allergen (FDA factsheet)

Nutrition Facts and the Small Business Exemptions

Nutrition labeling under 21 CFR 101.9 applies to most packaged foods, but there are exemptions — and the small business provisions are the ones most often misunderstood.

Section 101.9(j) contains, among others, a retail exemption tied to annual gross sales: a firm with annual gross sales to consumers of no more than $500,000, or annual gross sales in food sales to consumers of no more than $50,000, may qualify. There are also low-volume provisions and conditions attached — including that the exemption is forfeited if nutrition claims are made.

Three cautions:

1. Making a nutrient claim generally ends the exemption. Say "high in fiber" and you've typically invited the panel back.
2. Exemptions are fact-specific. Whether you qualify depends on your sales structure, not your size in headcount.
3. Verify before relying on it. This article is informational, not legal advice — confirm your position with FDA guidance or a regulatory professional. The current regulation text is available in the 21 CFR Part 101 compilation.

The Part Buyers Forget: Your Label Is a Food Contact Material

Label adhesives, face stocks, and inks are regulated as indirect food additives when they may reasonably become components of food. The relevant regulations are specific:

• 21 CFR 175.105 — adhesives. Lists substances cleared for use in adhesives for food packaging.
• 21 CFR 175.125 — pressure-sensitive adhesives. Directly relevant to labels.
• 21 CFR 176.170 — components of paper and paperboard in contact with aqueous and fatty foods.

What this means in practice depends on the contact scenario, which is why the question "is this food grade?" is close to meaningless on its own. "Food grade" is not a legally defined term in FDA regulation. What matters is the specific compliance route for the specific material in the specific contact condition.

Three contact scenarios

• Indirect contact (most common). The label sits on the outside of a package with an intact barrier — a glass jar, a sealed pouch, a lined carton. The adhesive and ink don't touch food. Compliance requirements are lighter, but still documented.
• Incidental contact. The label is on a wrapper where food may touch the inner surface, or the label is on a container rim. This needs materials cleared for the contact type.
• Direct contact. The label is applied to food itself or to a surface in direct contact. This is the strictest scenario and usually requires purpose-made food contact materials.

Ask your supplier which scenario they're certifying for. A supplier who answers "all of them" without asking you a question hasn't understood the request.

Material Selection by Food Application

Once your artwork is compliant, the label still has to physically survive the product's environment. This is where most reprints originate:

Material behaviour in depth: Sticker and label materials compared → and Waterproof vs vinyl →

What to Request From Your Label Supplier

Compliance is a paper trail as much as a product. Ask for these before the first production run:

1. A statement of compliance naming the specific regulations the adhesive and face stock meet — e.g. 21 CFR 175.105 and 175.125 — not a generic "FDA compliant" line.
2. The intended contact scenario the material is cleared for: indirect, incidental, or direct food contact.
3. The adhesive's temperature range, covering both application and storage, in writing.
4. Ink specification, and whether the ink system is suitable for the contact scenario.
5. Lot traceability — can they identify which material lot went into your run?
6. Change notification. Will they tell you before substituting an adhesive or liner? Undisclosed substitution is the most common way a compliant label quietly becomes non-compliant.
7. A physical sample on the exact final material, for you to test in your real storage conditions.

Supplier vetting in broader terms: Wholesale supplier checklist →

Common Compliance Failures

1. Treating "FDA approved" as a real status. It isn't. There is no pre-approval.
2. Missing sesame after a supplier or recipe change — the newest and most frequently missed allergen.
3. Allergens concealed in collective terms like "spices" or "natural flavor."
4. Claiming a nutrition exemption while making a nutrient claim.
5. Type size below the minimum for the panel area — compliant words, non-compliant formatting.
6. No written material documentation, then failing a retailer or co-packer audit.
7. Undisclosed adhesive substitution by the printer between runs.
8. Testing labels on dry glass and then shipping into a chilled, condensing case.

Frequently Asked Questions

Does the FDA approve food labels before printing?

No. The FDA does not pre-approve labels. The firm whose name appears on the product is responsible for compliance. A supplier claiming FDA approval of your artwork is misstating the process.

What are the required elements on a US food label?

Generally a statement of identity, net quantity of contents, ingredient list, major allergen declaration, Nutrition Facts panel (unless exempt), and the name and place of business of the manufacturer, packer, or distributor. Formatting rules are in 21 CFR Part 101, Subpart B.

How many major food allergens must be declared in the US?

Nine: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame was added as the ninth under the FASTER Act, effective January 1, 2023.

Is my small food business exempt from Nutrition Facts labeling?

Possibly. 21 CFR 101.9(j) includes small business provisions, including a retail exemption tied to annual gross sales thresholds of $500,000 to consumers or $50,000 in food sales to consumers. Conditions apply, and making a nutrient claim generally forfeits the exemption. Confirm your specific position with FDA guidance or a regulatory professional.

What does "food grade" mean for a label?

"Food grade" is not a legally defined term in FDA regulation. What matters is whether the specific adhesive, face stock, and ink comply with the applicable regulation for your contact scenario — for example 21 CFR 175.105 for adhesives or 175.125 for pressure-sensitive adhesives.

Do label adhesives need FDA compliance if the label doesn't touch food?

Requirements depend on the contact scenario. For indirect contact through an intact package barrier, requirements are lighter than for direct contact, but documentation is still expected — particularly by retailers and co-packers conducting supplier audits.

What label material works for frozen foods?

A freezer-grade adhesive rated below your actual storage temperature with margin, on a moisture-resistant face stock. Test on a surface with frost or condensation present, since application conditions matter as much as storage conditions.

Why do my labels lift in the refrigerated case?

Usually an adhesive that isn't rated for chilled, wet conditions, or application to a dry label on a bottle that then condensates. Water-resistant face stock with a chilled-grade adhesive, tested on a wet bottle, resolves most cases.

Compliance Is a Specification, Not a Sticker

Food label compliance splits cleanly in two: the content, which is your regulatory responsibility, and the material, which is your supplier's. Both need documentation, and neither is satisfied by the phrase "FDA approved."

Build the label to the required elements, declare all nine allergens, verify any nutrition exemption rather than assuming it, and specify materials against the actual contact scenario and storage conditions. Then test a sample where the product really lives.

This article is general information, not legal advice. Label compliance depends on your specific product, claims, and sales structure — confirm with FDA guidance or a qualified regulatory professional.

Jokeystickers has produced custom labels for 24 years for food, beverage, and retail accounts. Food-contact-compliant adhesive options with written documentation, freezer and chilled grades, free physical samples, and international certifications (ISO, FSC, UL, and more).

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