What does LACK NOTIF mean on an FDA refusal?

LACK NOTIF is the refusal charge “Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification…”. FDA's official statement for the charge 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).”

What law does LACK NOTIF cite?

FDA's refusal charge table cites section 301(s) of the FD&C Act for LACK NOTIF. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most LACK NOTIF refusals?

As of October 26, 2026, the countries with the most LACK NOTIF refusal lines are Germany (16), Switzerland (13) and Australia (10). The full list with links is in the table on this page.

Is there an FDA import alert for LACK NOTIF?

SupplierRadar found no food import alert whose charge section names LACK NOTIF. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge LACK NOTIF

Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification…

LACK NOTIF is the FDA import refusal charge for adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification…; it cites section 301(s) of the FD&C Act. FDA recorded it on 58 refused shipment lines between October 2016 and August 27, 2026, most often for baby food from Germany.

Data from FDA public records, last checked October 26, 2026.

58
refused shipment lines carry this charge: 10
countries of origin: 0
import alerts name this charge

What LACK NOTIF means

SupplierRadar has not written a plain-English version of LACK NOTIF yet. FDA's own statement is quoted below.

FD&C Act section: 301(s)

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

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).

LACK NOTIF · 301(s)FDA reference table (CSV)

Countries with the most LACK NOTIF refusals

Shipment lines carrying LACK NOTIF, by country of origin.

LACK NOTIF refusal lines by country
Country	Lines	Share of LACK NOTIF
Germany	16	28%
Switzerland	13	22%
Australia	10	17%
New Zealand	7	12%
Austria	4	7%
Netherlands	3	5%
France	2	3%
Brazil	1	2%
Spain	1	2%
Ghana	1	2%

Product categories with the most LACK NOTIF refusals

LACK NOTIF refusal lines by product category
Category	Lines	Share of LACK NOTIF
Baby (Infant and Junior) Food Products	58	100%

Latest LACK NOTIF refusals

The 20 most recent refused lines, through August 27, 2026, each with its FDA source.

Latest FDA refusals carrying LACK NOTIF
Date	Firm	Product	Charges
Aug 27, 2026	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU FALSE+1	Source
Aug 27, 2026	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU FALSE+1	Source
Aug 26, 2026	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF FALSE NO ENGLISH	Source
Jul 22, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), ready to feed	LACK NOTIF FALSE NO ENGLISH	Source
Jun 1, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF NO ENGLISH NUTRIT LBL	Source
Apr 17, 2026	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU NO ENGLISH+1	Source
Apr 7, 2026	Agrana Staerke GmbHVienna, Austria	Other formula products, n.e.c., ready to feed	LACK NOTIF	Source
Apr 2, 2026	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU NO ENGLISH+1	Source
Apr 2, 2026	Agrana Staerke GmbHWien, Australia	Toddler milk based formula/drink product (12-36 months), ready to feed	LACK NOTIF	Source
Mar 31, 2026	Agrana Staerke GmbHVienna, Austria	Other formula products, n.e.c., ready to feed	LACK NOTIF	Source
Mar 16, 2026	Agrana Staerke GmbHVienna, Austria	Goat milk infant based formula product (0-12 months), powder formula	LACK NOTIF	Source
Mar 16, 2026	Danone Ltda (Brazil) - SN Pocos de CaldasPocos De Caldas, Brazil	Other formula products, n.e.c., powder formula	LACK NOTIF	Source
Mar 16, 2026	Agrana Zucker GmbhVienna, Austria	Goat milk infant based formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU NO ENGLISH+2	Source
Mar 9, 2026	Holle Baby Food GmbHRiehen, Switzerland	Other formula products, n.e.c., powder formula	LACK NOTIF INCONSPICU FALSE+2	Source
Feb 27, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF INCONSPICU NO ENGLISH	Source
Feb 20, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Other formula products, n.e.c., ready to feed	LACK NOTIF FALSE	Source
Feb 13, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF FALSE	Source
Jan 28, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	LACK NOTIF FALSE NO ENGLISH	Source
Jan 13, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Whey base infant formula product (0-12 months), ready to feed	LACK NOTIF NO ENGLISH	Source
Dec 3, 2025	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Other formula products, n.e.c., ready to feed	LACK NOTIF INCONSPICU NO ENGLISH+1	Source

Questions about LACK NOTIF

What does LACK NOTIF mean on an FDA refusal?: LACK NOTIF is the refusal charge “Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification…”. FDA's official statement for the charge 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).”
What law does LACK NOTIF cite?: FDA's refusal charge table cites section 301(s) of the FD&C Act for LACK NOTIF. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most LACK NOTIF refusals?: As of October 26, 2026, the countries with the most LACK NOTIF refusal lines are Germany (16), Switzerland (13) and Australia (10). The full list with links is in the table on this page.
Is there an FDA import alert for LACK NOTIF?: SupplierRadar found no food import alert whose charge section names LACK NOTIF. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.