FDA Label Review Help
Why label review matters, what each category's label must include, and why claims — not formatting — are where labels most often go wrong.
Key Takeaways
- Review before you print — labeling is a top cause of recalls, warning letters, and detentions.
- Requirements differ by category — food, supplement, cosmetic, OTC drug, device.
- Claims are the highest-risk part — a disease claim makes a product an unapproved drug.
- "FDA approved" is almost never accurate — and for devices, implying it is prohibited.
- A misbranded product is unlawful to sell or import.
- A foreign-market label isn't automatically U.S.-compliant.
Labels Cause More Problems Than Almost Anything
Label issues are among the most common — and most avoidable — compliance failures:
- Undeclared allergens and mislabeling are leading causes of food recalls
- Non-compliant labels and claims trigger warning letters and marketplace takedowns
- A misbranded or adulterated product can't legally be sold or imported — and can be detained at the border
- Fixing a label after the print run (or after a detention) is far more expensive than a review beforehand
What Each Label Must Include
| Category | Required panel | Also required |
|---|---|---|
| Food | Nutrition Facts | Identity, net qty, ingredients, allergens (9), responsible party (21 CFR 101) |
| Dietary supplement | Supplement Facts | DSHEA disclaimer, no disease claims, ingredients, identity (21 CFR 101) |
| Cosmetic | — | Identity, net qty, INCI ingredients, warnings, MoCRA U.S. adverse-event contact (21 CFR 701) |
| OTC drug | Drug Facts | NDC, monograph-compliant actives/claims (21 CFR 201.66) |
| Medical device | — | Labeling & IFU (21 CFR 801) + UDI (21 CFR 830) |
Claims Are the Highest-Risk Part
A perfectly formatted label can still be misbranded — because of its claims. Claims determine classification, and can turn a compliant product into an illegal one:
- A disease claim ("treats," "cures," "prevents" a condition) on a food, cosmetic, or supplement makes it an unapproved drug
- A structure/function claim (or SPF) on a cosmetic makes it a drug
- Overstated device claims exceed the cleared/exempt intended use
- "FDA approved" is almost never accurate — most products are registered/listed, not approved (and for devices, implying approval via registration is prohibited)
Label Review by Product Type
Food labels
Nutrition Facts, ingredients, allergens.
Food →Supplement labels
Supplement Facts + DSHEA claims.
Supplements →Cosmetic labels
INCI, warnings, MoCRA contact.
Cosmetics →OTC drug labels
Drug Facts, NDC, monograph.
OTC drugs →Allergens
The 9 major allergens & declaration.
Allergens →Cosmetic or drug?
Classify before you label.
Classify →Common Label Mistakes
- Disease/illegal claims — the top one
- Missing or misformatted required panels — Nutrition/Supplement/Drug Facts
- Undeclared (or over-declared) allergens
- Missing the responsible-party contact — for cosmetics, the MoCRA adverse-event contact
- Wrong ingredient order or non-INCI names; missing UDI (devices)
- "FDA approved" language; using a foreign-market label unchanged for the U.S.
Get Your FDA Label Reviewed
FDA Registration Assistance reviews your label against the current FDA rules for its category — the required panel, statement of identity, net quantity, ingredient/INCI list, allergen declarations or warnings, responsible-party and any required contacts (like the MoCRA adverse-event contact), UDI where applicable, and — the critical part — that your claims are lawful and don't push you into a different classification. We flag misbranding risks before you print.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333 for a quote. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — FDA Label Review
1. What is FDA label review?
FDA label review is checking a product's label against the FDA rules for its category - before it's printed and sold. That means confirming the required panel (Nutrition Facts, Supplement Facts, Drug Facts, etc.), the statement of identity, net quantity, ingredient/INCI list, any allergen declarations or warnings, the responsible-party contact, and - most importantly - that the claims are lawful. It matters because labeling is a leading cause of FDA recalls, warning letters, and import detentions, and a misbranded product is unlawful to sell or import.
2. Why is label review so important?
Because label problems are among the most common - and most avoidable - compliance failures. Undeclared allergens and mislabeling are leading causes of food recalls; non-compliant labels and claims trigger warning letters, marketplace takedowns, and import detentions; and a misbranded or adulterated product can't legally be sold or imported. Fixing a label after printing (or after a detention) is far more expensive than a review before the print run. Label review is cheap insurance against costly problems.
3. What does a food label need?
Under 21 CFR Part 101: a statement of identity, net quantity of contents, a Nutrition Facts panel, an ingredient list (in descending order by weight), allergen declarations for the major food allergens (nine of them, including sesame), the name and place of business of the responsible party, and truthful claims. Dietary supplements follow a related but distinct format (Supplement Facts, DSHEA disclaimer). See our food labeling requirements and major food allergens pages.
4. What does a dietary supplement label need?
A Supplement Facts panel (not Nutrition Facts), an ingredient list, a statement of identity, net quantity, the responsible-party contact, allergen declarations, and - critically - claims that stay within DSHEA. Structure/function claims are allowed but must carry the disclaimer that the statements haven't been evaluated by FDA and the product isn't intended to diagnose, treat, cure, or prevent any disease. Disease claims are not allowed and turn the product into an unapproved drug. See our supplement label review page.
5. What does a cosmetic label need?
Under 21 CFR Part 701: a statement of identity, net quantity, an ingredient list (INCI names, in the required order), any necessary warnings, and the responsible-party information - plus, under MoCRA, a U.S. contact for adverse-event reports (required since December 29, 2024). And the claims must stay cosmetic: the moment a "cosmetic" claims to treat a condition or affect the body's structure/function (or adds SPF), it's a drug. See our cosmetic labeling mistakes guide.
6. What does an OTC drug label need?
A Drug Facts panel (21 CFR 201.66) with the active ingredient(s), uses, warnings, directions, and other required content, plus an NDC and compliant identity/net-quantity. The actives and claims must be monograph-compliant (or supported by an approved application). OTC drug labeling is more prescriptive than cosmetic or food labeling, and getting the Drug Facts format and content right is essential. See our OTC drug label review page.
7. What about medical device labeling?
Device labeling follows 21 CFR Part 801 (intended use, directions for use, warnings) plus Unique Device Identification (UDI, 21 CFR Part 830) where applicable, and instructions for use. Device claims must match the cleared/approved (or exempt) intended use - overstated claims are a common problem. And, as with all categories, don't imply "FDA approved" for a device that's actually 510(k)-cleared or exempt.
8. Why are claims the highest-risk part of a label?
Because claims determine classification - and can turn a compliant product into an illegal one. A disease claim ("treats," "cures," "prevents" a condition) on a food, cosmetic, or supplement makes it an unapproved drug. A structure/function claim on a cosmetic can make it a drug. Overstated device claims exceed the cleared intended use. So even a perfectly formatted label can be misbranded because of its claims - which is why claims review is the heart of a good label review, not an afterthought.
9. Can I say "FDA approved" on my label?
Almost never accurately. FDA doesn't approve most products (food, cosmetics, supplements, exempt devices) - those are registered/listed, not approved - and for devices, using registration to imply approval is specifically prohibited (21 CFR 807.39). Even for approved/cleared products, "FDA approved" claims on labeling are tightly restricted. As a rule, keep "FDA approved" (and "FDA registered" used as a badge) off your label unless it's genuinely accurate and permitted.
10. What's the difference between misbranded and adulterated?
Misbranded is mainly a labeling problem - the label is false or misleading, missing required information, or makes unlawful claims. Adulterated is mainly a product/quality problem - the product is contaminated, made under poor conditions, or contains something it shouldn't. A label review targets misbranding, but the two overlap (for example, an undeclared allergen can make a food both misbranded and adulterated). Both make a product unlawful to sell or import.
11. When should I get my label reviewed?
Before you print and before you list or ship - ideally at the artwork stage. A review after a large print run means costly reprints; a review after a detention or a marketplace takedown means lost sales and rushed fixes. The cheapest, lowest-risk moment is while the label is still a file. And if you're changing your formulation, claims, or entering a new market (like the U.S. for the first time), that's exactly when a fresh review pays off.
12. Does a label review guarantee I won't be flagged?
No one can guarantee an outcome, but a thorough review against the current rules removes the most common reasons labels get flagged - missing panels, undeclared allergens, non-compliant claims, missing required contacts, and "FDA approved" language. It materially reduces your risk of recalls, warning letters, detentions, and marketplace removals. Think of it as removing avoidable errors, not as an FDA sign-off (which a review isn't).
13. I sell the same product in multiple categories/markets — does the label change?
Often yes. The required label depends on the product's category (food vs supplement vs cosmetic vs drug) and, for imports, on U.S. rules that may differ from your home market - U.S. allergen rules, Nutrition/Supplement Facts formats, INCI naming, the MoCRA adverse-event contact, and English-language requirements. A label that's compliant abroad isn't automatically compliant for the U.S. Review the U.S. label specifically before importing.
14. Which label review page should I use?
Use the one that matches your product: food labeling requirements, supplement label review, cosmetic labeling mistakes, or OTC drug label review - each linked from this hub. If your issue is allergens, see the major food allergens page; if you're unsure whether your product is a cosmetic or an OTC drug (which changes the whole label), start with the cosmetic-vs-OTC-drug guide. Getting the category right comes before reviewing the label.
15. What are the most common label mistakes?
Disease/illegal claims (the top one); missing or misformatted required panels (Nutrition/Supplement/Drug Facts); undeclared or over-declared allergens; missing the responsible-party contact (for cosmetics, the MoCRA adverse-event contact); wrong ingredient order or non-INCI names; missing UDI (devices); "FDA approved" language; and using a foreign-market label unchanged for the U.S. Most are caught easily in a pre-print review and expensive to fix afterward.
16. How does FDA Registration Assistance do label review?
We review your label against the current FDA rules for its category - confirming the required panel, statement of identity, net quantity, ingredient/INCI list, allergen declarations or warnings, responsible-party and any required contacts (like the MoCRA adverse-event contact), UDI where applicable, and - the critical part - that your claims are lawful and don't push you into a different classification. We flag misbranding risks before you print. We're an independent compliance firm serving 1,000+ companies across 135+ countries with 15+ years of experience. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
