10 Things Every Food Brand Must Know Before Importing to the U.S.

Importing your product into the U.S. can open the door to Amazon sales, grocery buyers, and a much bigger market. But it is rarely as simple as shipping and selling.

U.S. label regulations are specific. If you try to bring your label over “as-is,” it is easy to lose money and end up with product held at port during import review. And the changes are usually not tiny if this happens. We are talking re-labeling at port (time and money), or destroying your product at port (ah!!!!).

Here are the 10 things I want every international food and supplement brand to know before your product lands at a U.S. port.

Need your label checked before it ships? Contact us here.

1) CBP vs FDA: two different gatekeepers

This gets misunderstood immediately. The FDA is not the only agency that reviews your product for entry to the United States.

CBP (Customs & Border Protection) handles entry, classification, duties, and documentation at the border.
FDA (Food & Drug Administration) reviews FDA-regulated products for compliance with U.S. laws, including labeling and product requirements. FDA-regulated entries are submitted to CBP and referred to FDA for review. ¹

You can clear one and still get stopped by the other. Even if you pass an FDA review, the CBP can still hold your shipment for missing or inconsistent paperwork. Even if the CBP clears you, the FDA can stop your product for labeling mistakes.

A smooth import needs both your paperwork and your product labeling to be aligned.

2) FDA does not “pre-approve” your label

Many brands assume FDA must approve an imported product before it ships, but that is not how it works.

The FDA states that importers can import foods without prior sanction by FDA, as long as the facilities are properly registered and prior notice is provided. ¹

Translation: it is on you to get it right before it ships, because “we’ll see what happens” is an expensive strategy.

3) EU (and most non-U.S.) labels will not pass U.S. review

This is not about translating language. It is about rebuilding to a different format and required elements.

Common differences include:

U.S. Nutrition Facts formatting and rules (different from EU-style nutrition tables). ⁵
Ingredient lists must follow U.S. rules, including descending order by weight and proper naming. ⁷
U.S. requires a name and place of business statement in a compliant format. ¹⁰
Net quantity placement and formatting must follow U.S. rules. ⁹

If your goal is Amazon or grocery, assume your packaging will be scrutinized. Retailers do not want compliance surprises.

Want a clear plan for rebuilding your label for the U.S.? Learn more here.

4) Allergens must be declared the U.S. way

The Big 9 allergens

In the U.S., sesame is the ninth major allergen, and it must be declared on packaged foods and dietary supplements. ⁸

“Contains” vs parentheses

U.S. allergen disclosure is not “bolding” or “highlighting.” Those are design choices which do not constitute proper allergen declaration. What matters is that the allergen is clearly declared in an accepted format.

Here’s a practical rule. Use either:

Parenthetical disclosure after the ingredient (example: whey (milk)), or
A clear Contains statement near the ingredient list

This is one of the fastest ways imported products get detained, because it is easy to get wrong and it is high priority for FDA. ⁸

Allergens are the fastest way to get held. Need to learn more? Sign up for a launchpad course here.

5) Added sugars trip up international brands

The U.S. requires added sugars on nutrition panels and international brands often underestimate how many ingredients count towards added sugars. ⁵

A few reminders that regularly surprise importers:

Sugars added during processing, including honey and syrups used as sweeteners, count as added sugars. ⁵
There are special nuances for single-ingredient honey/maple products, and FDA has specific guidance on how added sugars are handled for those. ⁵

If you cannot clearly support your numbers, you are inviting questions during review.

6) Serving sizes are not whatever you want

Foods use RACC

For foods, serving sizes are based on FDA’s Reference Amounts Customarily Consumed (RACC) and must be expressed properly in household measures and grams. ⁶ These values are recommended by FDA and assigned to specific product categories to help keep serving sizes consistent across similar foods.

Here are a few examples for foods:

Granola follows the ready-to-eat cereal category. FDA provides three weight-based options for this category: 15 g, 40 g, or 60 g per cup. The serving size is listed as: _ cup(s) (_ g) using the cup amount that aligns with the closest gram weight to your product.
Granola bars fall under snack bars, which have a RACC of 40 g. The serving size is listed as: _ piece(s) (_ g)

Supplements use intended use

For dietary supplements, serving size is tied to intended use (how and when the product is meant to be taken) and don’t forget that the supplement panel follows its own formatting rules. ¹³

This matters because serving size impacts everything: calories, %DV, “per serving” claims, and sometimes whether a claim is even allowed.

Here are a few examples for dietary supplements:

A dietary supplement in capsule form when the usage instructions state “Take 1 capsules, twice daily.” The correct serving would be1 capsule.
A dietary supplement in capsule form when the usage instructions state “Take 3 capsules.” The correct serving would be 3 capsules, as it does not specify different eating occasions to consume each capsule.

If you want to understand serving sizes without digging through CFR language, start with our label courses.

7) Claims are restricted in the U.S.

If you are importing into the U.S., it is safe to assume your claims will be evaluated under U.S. definitions, even if the claims are acceptable eslewhere.

You might be able to say “detox,” or “immune boosting,” overseas, but the U.S. plays by different rules. Claims must fit specific definitions, and you must be able to support every statement you make. Most brands do not realize how narrow these rules are until their label gets flagged. Even if your product is great, the U.S. draws a hard line between structure function style language and disease treatment style language. If the FDA thinks your label implies disease treatment or prevention, you can end up relabeling after the product already shipped.

When selling on Amazon, this matters even more because your product page copy tends to mirror your packaging claims, and inconsistency is a common trigger for takedowns and complaints.

If the FDA believes your claim overreaches in any way, the product can be pulled from shelves or held at a warehouse until the label is fixed. It is one of the fastest ways to delay a launch or lose a retail buyer. Three types of claims cause the most trouble:

1. Structure or function claims

These describe how a nutrient or ingredient supports normal body functions. You cannot imply treatment, prevention, or any change to the body beyond normal structure and function. ¹⁵

2. Nutrient content claims

These are tightly defined by FDA. Words like “low,” “high,” “good source,” or “excellent source” can only be used if the product meets the FDA’s exact criteria. If your vitamin C level does not hit the percentage threshold, you cannot say “high in vitamin C,” even if that language is acceptable in another country. ¹⁵

3. Drug claims

Anything that suggests your product can diagnose, cure, treat, or prevent a disease moves it into drug territory. This includes vague claims like “anti-inflammatory,” “antiviral,” or “helps with anxiety.” If a claim reads like a drug claim, the FDA can stop the product until it is corrected. ¹⁵

If you want a simple filter: if the claim sounds like it is fixing something abnormal, it probably needs a rewrite.

8) BE disclosure can apply even when your supplier says “non-GMO”

The National Bioengineered Food Disclosure Standard is not the same thing as marketing a “non-GMO” claim.

USDA maintains the List of Bioengineered Foods to help regulated entities determine when records and disclosure may be required. ¹¹

If your formula includes ingredients derived from common BE crops, you need documentation that supports your disclosure decision. Do not rely on casual supplier language. Build a file you can defend.

Current approved Bioengineered foods: ¹⁶

Sugarcane (Bt insect-resistant)
Alfalfa
Apple (Arctic varieties)
Canola
Corn
Cotton
Eggplant (BARI Bt Begun)
Papaya (ringspot virus-resistant)
Pineapple (pink-flesh)
Potato
Salmon (AquAdvantage)
Soybean
Squash (summer, virus-resistant)
Sugarbeet

“Non-GMO” is not regulated by the FDA. If you use “non-GMO” anywhere on your label, define what that claim means for your company and keep documentation to back it up.

9) Foreign manufacturing still has U.S. safety rules

Facility registration

Domestic and foreign facilities that manufacture/process, pack, or hold food for U.S. consumption are required to register with FDA and renew registration every other year (with specific renewal timing rules). ⁴

FSVP and food safety plans

Under FSMA, importers are required to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for each food and each supplier, unless an exemption applies. ¹²

Many facilities also fall under preventive controls expectations, including having a food safety plan with hazard analysis and risk-based preventive controls. ¹²

Supplements have Part 111

If you are importing dietary supplements, cGMPs are addressed under 21 CFR Part 111, and documentation expectations are not light. ¹³

Also, if you are importing liquid “food-like” supplements (shots, drink mixes, tonics), pay attention to the FDA’s factors for distinguishing liquid supplements from beverages. Classification mistakes can create labeling and compliance problems fast. ¹⁴

10) Label mistakes cause more delays than formulation

Common problems that cause real delays:

Missing or noncompliant name and place of business statement ¹⁰
Net quantity statement issues (placement, format, clarity) ⁹
Non-U.S. Nutrition Facts format or incorrect serving size basis ⁵ ⁶
Ingredient list not in descending order by weight or using non-U.S. naming conventions ⁷
Allergen declaration not in a compliant format (especially sesame) ⁸

Quick “before you print” import checklist

Confirm product category: food vs supplement (and liquid supplement vs beverage if relevant). ¹⁴
Confirm facility registration is current and renewed appropriately. ⁴
Confirm you can file Prior Notice and have the right importer support. ³
Confirm ingredient list order and naming conventions. ⁷
Confirm allergens are declared properly, including sesame. ⁸
Confirm serving size rules (RACC for foods). ⁶
Confirm Added Sugars calculations and documentation. ⁵
Confirm net quantity and business statement formatting. ⁹ ¹⁰
Confirm BE disclosure documentation decision. ¹¹
Confirm your claim language fits U.S. expectations.

FAQs

1) Do I need FDA approval before importing?

No, in fact the FDA states it does not approve individual products, labels, or shipments before import. ¹

2) What is Prior Notice and who files it?

The FDA must receive prior notification of food imported or offered for import into the U.S. ³

3) Who actually stops a shipment, CBP or FDA?

Entries go through CBP, and FDA-regulated products are referred to FDA for review. ²

4) If my label is compliant overseas, why can’t I just translate it?

U.S. regulations are different. It is illegal to sell products that are not labeled according to regulations in the U.S. ⁵ ⁷ ⁸ ⁹ ¹⁰

5) What are the “Big 9” allergens in the U.S.?

The major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. ⁸

6) What is the biggest sugar mistake on imported labels?

Not declaring added sugars correctly on the nutrition facts panel. ⁵

7) How do I know what serving size to use in the U.S.?

Foods use RACC-based serving size rule. ⁶
Supplements use intended use and must follow supplement facts requirements. ¹³

8) What is FSVP and does it apply to me?

If you are the importer, you generally must develop, maintain, and follow an FSVP for each food and each supplier unless exempt. ¹²

9) Are there extra requirements for dietary supplements?

Yes. Dietary supplement cGMPs are addressed under 21 CFR Part 111, and documentation expectations are significant. ¹³

10) What is one thing that prevents most import delays?

A pre-print label review plus a documentation check (serving size basis, allergens, added sugars support, facility status, and import filing readiness).

Final Thoughts

Importing to the U.S. is completely doable. It may seem scary, even daunting, but a little preparation saves money, time, and the headache of detained shipments.

If you need help translating your label to U.S. compliance, Proof & Panel is here to help you get it right before it ships.

You can work directly with us for your labeling needs, take an online course, or join our membership. We have what it takes to get your product to the U.S.

Happy labeling,
Lauren Rockteacher

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