Last refresh: . 26,358 refusals since 2020-01-01.

FDA refusal charge LACK NOTIF: no premarket notification

← All charge codes Process and registration Dashboard

The LACK NOTIF charge appeared in 51 FDA import refusals between 2021 and 2026 — 0.2% of all 26,358 US import refusals. The charge is a process, registration or approval failure, not a contaminant or pathogen found in the product. The origins cited most often are Germany, Australia, Switzerland. The most-affected product category is Baby (Infant and Junior) Food Products. Volume in 2025 was up 800% on 2024.

Email me about new FDA import refusals involving the LACK NOTIF charge

One email a week, and only when something matches. We'll send a confirmation link first; unsubscribe any time from the footer of any email.

What FDA's charge says

LACK NOTIF is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.

Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).

Sections 301(s)

LACK NOTIF refusals by year

YearRefusalsYoY
20216—
202317—
20241-94.1%
20259+800.0%
202618—YTD
Total51

Origins most often refused under LACK NOTIF

#Origin countryRefusals
1Germany14
2Australia10
3Switzerland9
4New Zealand7
5Austria4
6Netherlands3
7France2
8Brazil1
9Spain1

Product categories refused under LACK NOTIF

#Product categoryRefusals
1Baby (Infant and Junior) Food Products51

Latest refusals citing LACK NOTIF

About LACK NOTIF

What does the FDA import refusal charge LACK NOTIF mean?

FDA uses LACK NOTIF for: no premarket notification. Its published charge language reads: “Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).”

Is LACK NOTIF a food safety finding?

No. LACK NOTIF is a process, registration or approval failure: the charge records a missing filing, registration, approval or process control, not a contaminant or pathogen found in the product. This site counts a refusal citing it alone with paperwork. It can still mean the product cannot lawfully be sold in the US.

What happens to a shipment refused under LACK NOTIF?

Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.