United States · Food Contact

US FDA Food Contact Notification

A practical guide to US FDA Food Contact Notification for food contact sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Food contact substances and articles such as packaging, coatings, and utensils; Components intended for repeated or single use with food

Authority

US Food and Drug Administration (FDA)

Legal basis

Federal Food, Drug, and Cosmetic Act section 409; 21 CFR Parts 174-178

Local representative

A US agent is required for foreign manufacturers

Timeline

Notification review typically takes several months; confirm current timing with FDA

Cost

Testing and consultant costs vary; not every submission carries an FDA fee

If you do not comply

Import detention, refusal of entry, and enforcement action

Who needs this

Food contact substances and articles such as packaging, coatings, and utensils
Components intended for repeated or single use with food

Documents you need

Food contact notification or evidence of an effective prior listing
Migration and extraction test data
Good manufacturing practice records
Statement of composition for each food contact layer

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Food contact notification or evidence of an effective prior listing
Migration and extraction test data
Good manufacturing practice records
Statement of composition for each food contact layer

How to comply

Determine the regulatory status of every food contact substance
Run migration testing where needed
File a food contact notification or rely on an existing listing
Retain supporting records for inspection

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: US FDA Food Contact Notification — United States
Product category: Food Contact
Authority: US Food and Drug Administration (FDA)
Legal basis: Federal Food, Drug, and Cosmetic Act section 409; 21 CFR Parts 174-178

Documents we already have:
  1. Food contact notification or evidence of an effective prior listing
  2. Migration and extraction test data
  3. Good manufacturing practice records
  4. Statement of composition for each food contact layer

Questions:
  1. Does our product fall under US FDA Food Contact Notification in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Notification review typically takes several months; confirm current timing with FDA.

Testing and consultant costs vary; not every submission carries an FDA fee.

Common rejection reasons

Substance has no regulatory status or listing
Migration data does not cover intended use conditions
Composition statement missing for a layer

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.