Supplement Label Review Before Customs
Don't let customs be the first to catch your mistake. We review, correct, and finalize your supplement label before it ever ships.
Key Takeaways
- FDA doesn't pre-approve labels — the label carries the legal weight, and the border is the worst place to find a problem.
- Disease claims are the #1 trap — they turn a supplement into an unapproved drug.
- Structure/function claims are allowed — with substantiation, a 30-day FDA notice, and the DSHEA disclaimer.
- The Supplement Facts panel (not "Nutrition Facts") has strict 101.36 formatting rules.
- A wrong label = misbranded = detention, refusal, re-export or destruction.
- We review it before you ship — claims, disclaimer, panel, required elements, allergens.
Claims: The Line Between Supplement and Drug
The most common — and most serious — labeling problem is a claim that crosses from structure/function into disease territory. Supplements may say how an ingredient supports the body's normal function; they may not say the product treats, cures, or prevents a disease. Cross that line and FDA treats your supplement as an unapproved drug.
| Compliant (structure/function) | Non-compliant (disease claim) |
|---|---|
| "Supports immune function" | "Prevents colds and flu" |
| "Helps maintain healthy blood sugar already in the normal range" | "Controls diabetes" |
| "Supports memory" | "Treats Alzheimer's" |
| "Calcium builds strong bones" | "Prevents osteoporosis" |
The DSHEA Disclaimer & the 30-Day Notice
If your label makes any structure/function claim, two obligations attach automatically:
The DSHEA disclaimer
The label must carry: "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." Under 21 CFR 101.93 it must be boxed, boldface, at least 1/16-inch type, and linked to each claim.
The 30-day notification
You must hold substantiation that the claim is truthful and not misleading, and notify FDA of the claim text within 30 days of first marketing. The claim isn't pre-approved — but skipping the notice is its own violation.
The Required Label Elements
Beyond claims, a supplement label is misbranded if it's missing any required element. A compliant label includes:
- Statement of identity — the name, including "dietary supplement"
- Net quantity of contents
- Supplement Facts panel — headed "Supplement Facts," not "Nutrition Facts" 101.36
- "Other ingredients" list, in descending order
- Allergen declaration for major allergens
- Manufacturer / packer / distributor name and address, with a U.S. contact for adverse-event reports
What Happens if the Label Is Wrong at Entry
| Stage | What happens |
|---|---|
| Detention | FDA holds the shipment and issues a notice citing the labeling violation |
| Response window | You must respond; storage and demurrage fees accrue while the container sits |
| Refusal | If unresolved, the product is refused — then re-exported or destroyed |
| Reconditioning | In some cases, relabeling is allowed under FDA supervision — slow and costly |
| Import Alert | Repeat problems can land the product on an Import Alert, causing detention without physical examination on future shipments |
How We Clear Your Label Before Customs
Review the claims first
Flag any disease claim; confirm structure/function claims are defensible.
Verify the DSHEA disclaimer
Present, correctly worded, boxed, boldface, linked to each claim.
Check the Supplement Facts panel
101.36 heading, serving size, %DV, and typography — done right.
Confirm the required elements
Identity, net quantity, other ingredients, allergens, U.S. contact.
Fix it before you print & ship
Every correction made while the label is still a file.
Keep registration & imports in order
Registration, U.S. Agent, prior notice, supplier verification.
Get Your Supplement Label Reviewed Before You Ship
FDA Registration Assistance performs a full pre-import label review — claims, DSHEA disclaimer, Supplement Facts panel, required elements, allergens, and ingredient compliance — and gives you clear, actionable corrections. We also handle facility registration, U.S. Agent, prior notice, and supplier verification, so no single gap stops your shipment.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Food Facility Registration is available starting at $858. Trusted by companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions
1. Why does FDA scrutinize supplement labels at import?
Because FDA doesn't pre-approve supplement labels, the label is where compliance is judged — and it's one of the first things reviewed at entry. If the label is misbranded (a disease claim, a missing disclaimer, an incorrect Supplement Facts panel), the shipment can be detained or refused even if the product is safe.
2. What's the single most common labeling problem?
Disease claims. Supplements may make structure/function claims ("supports immune function") but not claims to diagnose, treat, cure, or prevent disease ("treats hypertension," "prevents colds"). A disease claim makes the product an unapproved drug in FDA's eyes — a fast route to detention and refusal.
3. What's the difference between a structure/function claim and a disease claim?
A structure/function claim describes how an ingredient affects normal body structure or function ("calcium builds strong bones," "supports memory"). A disease claim says or implies the product treats or prevents a disease. The first is allowed on supplements with a disclaimer; the second is reserved for approved drugs. "Supports healthy blood sugar" is fine; "controls diabetes" is not.
4. What is the DSHEA disclaimer and when is it required?
When a label makes a structure/function claim, it must carry: "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." Under 21 CFR 101.93 it must be boxed, boldface, at least 1/16-inch type, and linked to each claim.
5. Do I also have to notify FDA about my claims?
Yes. For structure/function claims, you must have substantiation that the claim is truthful and not misleading, and notify FDA of the claim text within 30 days of first marketing. The claim isn't pre-approved, but the notification and the disclaimer are both required.
6. Has the DSHEA disclaimer rule changed recently?
In late 2025, FDA announced it would exercise enforcement discretion on the older requirement that the disclaimer appear on every panel of the label, while it considers amending that rule. Importantly, the disclaimer is still required and still must be linked to each structure/function claim — only the "every panel" placement is under enforcement discretion.
7. What must a compliant Supplement Facts panel include?
Under 21 CFR 101.36, the panel must be headed "Supplement Facts" (never "Nutrition Facts"), with serving size, servings per container, each dietary ingredient, and % Daily Value where established. The typography rules — heading size, boxing, type size — are specific and a frequent source of violations.
8. What other label elements are required?
A statement of identity (including "dietary supplement"), net quantity, the Supplement Facts panel, an "Other ingredients" list, an allergen declaration, and the manufacturer/packer/distributor name and address with a U.S. contact for adverse-event reports. Missing any of these can render the product misbranded.
9. What actually happens if my label is wrong at the border?
FDA can detain the shipment and issue a notice; you respond, and if unresolved the product is refused — then re-exported or destroyed, though relabeling (reconditioning) is sometimes allowed under supervision. Repeated problems can land your product on an Import Alert, triggering detention without physical examination on future shipments.
10. Can I just fix the label after it's flagged?
Sometimes, but it's the worst case. By then inventory is committed and in transit, storage and demurrage fees accrue, and your options narrow to reconditioning under supervision, re-export, or destruction. Catching the same issue in the design file costs a fraction.
11. My label looks professional — isn't that enough?
No. Labels often look correct because designers focus on aesthetics, brands copy competitors, or international (non-FDA) formats are used. Compliance issues are usually invisible to the eye and only surface during regulatory review — which is why a professional pre-import review exists.
12. Are Amazon takedowns related to these same issues?
Often, yes. The same non-compliant claims and labeling errors that trigger import problems can also cause marketplace listing removals. Getting the label right for FDA generally strengthens your standing on retail and e-commerce platforms too.
13. Does a label review replace registration and FSVP?
No — it complements them. Your facility still needs FDA registration and a U.S. Agent, imports still need prior notice, and importers still need supplier verification. A clean label clears one major hurdle; we handle the others so no single gap stops your shipment.
14. How does FDA Registration Assistance help?
We perform a full pre-import label review — claims, DSHEA disclaimer, Supplement Facts panel, required elements, allergens, and ingredient compliance — with clear, actionable corrections before you print and ship. We also handle facility registration, U.S. Agent, prior notice, and supplier verification. Starting at $858 for registration, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
