Does FDA approve dietary supplements before sale?

No. Supplements are not approved before marketing. The responsibility sits with the firm to ensure the product is safe, properly labeled and lawfully claimed — which is why the consequences arrive after launch rather than before it.

What makes a claim a drug claim?

Language that names a disease or implies treatment, prevention or cure of one. The line is about what the claim asserts, not how carefully it is phrased.

Do we need to register our manufacturing facility?

Facilities manufacturing, processing, packing or holding food, including supplements, for U.S. consumption generally register with FDA and renew on a schedule. Foreign facilities also need a U.S. agent on file.

Is this legal advice?

No. These guides are educational and reflect how the requirements work in practice. Specific products and claims should be reviewed by qualified regulatory counsel, and we work alongside counsel rather than in place of it.

FDA Compliance — Topic Hub | TruLife Distribution

The pillar

Start here if you're new to the topic.

Pillar guide · 16 min · Updated Aug 2026

FDA compliance

Registration, the U.S. agent requirement, panel construction, claims classification, prior notice and the import pathway, for each of the main product categories.

Read the guide →

Supporting guides

Deeper on each stage.

Supporting guide
Building a U.S. Supplement Facts panel

Serving sizes, nutrient declarations, allergens and the domestic address requirement.
In production
Supporting guide
Structure-function claims in practice

What survives review, what doesn't, and where the line actually sits.
In production
Supporting guide
Prior notice and import entry

What has to be filed before a shipment arrives, and what happens when it isn't.
In production
Supporting guide
Personal care and cosmetics requirements

How the rules differ from supplements, and what MoCRA changed.
In production

Questions

Frequently asked.

Does FDA approve dietary supplements before sale?: No. Supplements are not approved before marketing. The responsibility sits with the firm to ensure the product is safe, properly labeled and lawfully claimed — which is why the consequences arrive after launch rather than before it.
What makes a claim a drug claim?: Language that names a disease or implies treatment, prevention or cure of one. The line is about what the claim asserts, not how carefully it is phrased.
Do we need to register our manufacturing facility?: Facilities manufacturing, processing, packing or holding food, including supplements, for U.S. consumption generally register with FDA and renew on a schedule. Foreign facilities also need a U.S. agent on file.
Is this legal advice?: No. These guides are educational and reflect how the requirements work in practice. Specific products and claims should be reviewed by qualified regulatory counsel, and we work alongside counsel rather than in place of it.

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