Dietary supplement import clearance
Supplements attract more border attention than most food categories, and the usual reason is what the label says rather than what the product contains.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
Dietary supplement import clearance covers customs entries for vitamins, minerals, botanicals and other supplement products. Supplements are regulated as a category of food, so Prior Notice, facility registration, product codes and FSVP apply — but they also draw particular scrutiny over labelling claims and ingredient acceptability.
Key takeaways
- Supplements are regulated as food, so the food entry requirements all apply.
- Label claims are a common cause of border attention.
- Some ingredients acceptable elsewhere are not permitted in U.S. supplements.
- New dietary ingredients may carry notification obligations.
- The product code must reflect the actual formulation, not the marketing category.
Labelling is where the trouble starts
A supplement label that claims to treat, cure or prevent a disease is making a drug claim, and that changes how the product is treated entirely. Products developed for other markets frequently carry claims that are ordinary there and unacceptable here.
This is worth resolving before production. Relabelling an arrived container is possible but expensive, and in some cases the goods cannot be brought into compliance at all.
Ingredients and formulation
Some botanical and other ingredients permitted in other jurisdictions are not permitted in U.S. dietary supplements, and certain new dietary ingredients carry notification requirements before marketing. The formulation therefore needs reviewing against U.S. requirements rather than assumed to be acceptable because it sells elsewhere.
How it works
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01
Formulation reviewed
Full ingredient list assessed against U.S. requirements.
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02
Labelling checked
Claims, supplement facts panel and required statements reviewed before production.
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03
Facility registration verified
Manufacturer registration confirmed current.
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04
Product code matched
Reflecting the actual formulation and dosage form.
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05
Entry filed
With Prior Notice, FSVP and affirmations complete.
Common mistakes
- Importing a label written for another market. Claims acceptable there may not be here.
- Disease claims on the packaging. That reclassifies the product entirely.
- Assuming an ingredient is acceptable. Permitted elsewhere does not mean permitted here.
- A product code chosen by category. It should reflect the actual formulation.
- Leaving labelling until arrival. Relabelling a container is expensive and sometimes impossible.
Questions
Why are supplements held more often than other food?
Labelling claims are the usual reason. Supplements developed for other markets often carry claims that are unacceptable under U.S. rules, and the label is reviewed as part of admissibility.
What is a disease claim?
A statement that a product treats, prevents, cures or mitigates a disease. Such claims move a product out of the supplement category and into drug territory, with entirely different requirements.
Do supplements need Prior Notice?
Yes. Supplements are a category of food, so Prior Notice, facility registration, product codes and FSVP coordination all apply.
Can you review my label before production?
Yes, and it is by far the cheapest point to do it. Reviewing artwork before a production run avoids the situation where a compliant product arrives in non-compliant packaging.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.