What does NUTR DEF mean on an FDA refusal?

NUTR DEF is the refusal charge “The infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100”

What law does NUTR DEF cite?

FDA's refusal charge table cites sections 412(a)(1) and 801(a)(3) of the FD&C Act (adulterated) for NUTR DEF, and classifies the charge as adulterated. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most NUTR DEF refusals?

As of October 26, 2026, the countries with the most NUTR DEF refusal lines are Switzerland (12), Germany (4) and United Kingdom (4). The full list with links is in the table on this page.

Is there an FDA import alert for NUTR DEF?

Yes. One FDA import alert names NUTR DEF as a charge code, including Import Alert 40-05 (Adulterated and misbranded infant formula). 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 NUTR DEF

The infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100

NUTR DEF is the FDA import refusal charge for the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100; it cites sections 412(a)(1) and 801(a)(3) of the FD&C Act (adulterated). FDA recorded it on 25 refused shipment lines from 6 countries between October 2016 and August 18, 2026, most often for baby food from Switzerland.

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

25
refused shipment lines carry this charge: 6
countries of origin: 1
import alert names this charge

What NUTR DEF means

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

FD&C Act section: 412(a)(1)801(a)(3)
Classification: adulterated

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100

NUTR DEF · 412(a)(1), 801(a)(3); AdulteratedFDA reference table (CSV)

Import alerts that name NUTR DEF

The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.

Import alerts naming NUTR DEF as a charge
Alert	Covers	Red	Green
40-05	Adulterated and misbranded infant formula	17

Countries with the most NUTR DEF refusals

Shipment lines carrying NUTR DEF, by country of origin.

NUTR DEF refusal lines by country
Country	Lines	Share of NUTR DEF
Switzerland	12	48%
Germany	4	16%
United Kingdom	4	16%
Ghana	2	8%
Netherlands	2	8%
Australia	1	4%

Product categories with the most NUTR DEF refusals

NUTR DEF refusal lines by product category
Category	Lines	Share of NUTR DEF
Baby (Infant and Junior) Food Products	24	96%
Filled Milk and Imitation Milk Products	1	4%

Latest NUTR DEF refusals

The 20 most recent refused lines, through August 18, 2026, each with its FDA source.

Latest FDA refusals carrying NUTR DEF
Date	Firm	Product	Charges
Aug 18, 2026	Kendal Nutricare Ltd.Kendal, United Kingdom	Milk base infant formula product (0-12 months), powder formula	NUTR DEF NUTR UNIT	Source
Jun 3, 2026	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	NO ENGLISH NUTR DEF NUTR UNIT	Source
Apr 6, 2026	Holle Baby Food GmbHRiehen, Switzerland	Other formula products, n.e.c., powder formula	NUTR DEF	Source
Apr 6, 2026	Holle Baby Food GmbHRiehen, Switzerland	Other formula products, n.e.c., powder formula	NUTR DEF	Source
Dec 5, 2025	Holle Baby Food GmbHRiehen, Switzerland	Other formula products, n.e.c., powder formula	NUTR DEF	Source
Dec 5, 2025	Holle Baby Food GmbHRiehen, Switzerland	Other formula products, n.e.c., powder formula	NUTR DEF	Source
Oct 27, 2025	Holle FoodRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	NO ENGLISH NUTR DEF	Source
Sep 4, 2025	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	NUTR DEF	Source
Jul 17, 2024	Holle Baby Food GmbHRiehen, Switzerland	Toddler goat milk based formula/drink product (12-36 months), powder formula	NUTR DEF	Source
Mar 26, 2024	Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany	Milk base infant formula product (0-12 months), powder formula	FALSE NO ENGLISH NUTR DEF+1	Source
Feb 21, 2024	Holle Baby Food GmbHRiehen, Switzerland	Other formula products for sample testing (not for sale), n.e.c	FALSE ALLERGEN NUTR DEF+1	Source
Jan 12, 2024	Holle Baby Food GmbHRiehen, Switzerland	Goat milk based infant formula product (0-12 months), ready to feed	LIST INGRE LACKS FIRM LACKS N/C+2	Source
Jan 10, 2024	Kendal Nutricare Ltd.Kendal, United Kingdom	Milk base infant formula product (0-12 months), powder formula	FALSE NUTR DEF	Source
Jan 8, 2024	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	NO ENGLISH NUTR DEF NUTR UNIT	Source
Jan 8, 2024	Holle Baby Food GmbHRiehen, Switzerland	Whey base infant formula product (0-12 months), powder formula	NO ENGLISH NUTR DEF NUTR UNIT	Source
Aug 1, 2023	HippHurst Grove, United Kingdom	Milk base infant formula product (0-12 months), powder formula	LIST INGRE FALSE LACKS FIRM+5	Source
Jul 31, 2023	The Littleoak Company Pty CoByron Bay, Australia	Other formula products, n.e.c., powder formula	NUTR DEF	Source
Dec 12, 2022	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	INCONSPICU LACKS FIRM LACKS N/C+2	Source
Dec 12, 2022	Holle Baby Food GmbHRiehen, Switzerland	Milk base infant formula product (0-12 months), powder formula	INCONSPICU LACKS FIRM LACKS N/C+2	Source
Jul 14, 2022	Lisa ScholtenIttervoort, Netherlands	Filled milk, dried milk type product	LIST INGRE FALSE LACKS FIRM+5	Source

Questions about NUTR DEF

What does NUTR DEF mean on an FDA refusal?: NUTR DEF is the refusal charge “The infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100”
What law does NUTR DEF cite?: FDA's refusal charge table cites sections 412(a)(1) and 801(a)(3) of the FD&C Act (adulterated) for NUTR DEF, and classifies the charge as adulterated. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most NUTR DEF refusals?: As of October 26, 2026, the countries with the most NUTR DEF refusal lines are Switzerland (12), Germany (4) and United Kingdom (4). The full list with links is in the table on this page.
Is there an FDA import alert for NUTR DEF?: Yes. One FDA import alert names NUTR DEF as a charge code, including Import Alert 40-05 (Adulterated and misbranded infant formula). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

Built for the person who signs the FSVP file

Look before you order.

Check up to five suppliers against every FDA record in one paste, no account needed. Watch the ones you buy from and get the source the day a record changes.

Check five suppliers free Watch a supplier free

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.