What does REGISTERED mean on an FDA refusal?

REGISTERED is the refusal charge “It appears the device is subject to listing under 510(j) and the initial distributor has not registered as…”. FDA's official statement for the charge reads: “It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).”

What law does REGISTERED cite?

FDA's refusal charge table cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding) for REGISTERED, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most REGISTERED refusals?

As of October 26, 2026, the countries with the most REGISTERED refusal lines are United Kingdom (1). The full list with links is in the table on this page.

Is there an FDA import alert for REGISTERED?

SupplierRadar found no food import alert whose charge section names REGISTERED. 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 REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as…

REGISTERED is the FDA import refusal charge for it appears the device is subject to listing under 510(j) and the initial distributor has not registered as…; it cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 1 refused shipment line from 1 country between October 2016 and April 15, 2026, most often for dietary supplements from United Kingdom.

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

1
refused shipment lines carry this charge: 1
countries of origin: 0
import alerts name this charge

What REGISTERED means

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

FD&C Act section: 502(o)801(a)(3)
Classification: misbranding

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

REGISTERED · 502(o), 801(a)(3); MISBRANDINGFDA reference table (CSV)

Countries with the most REGISTERED refusals

Shipment lines carrying REGISTERED, by country of origin.

REGISTERED refusal lines by country
Country	Lines	Share of REGISTERED
United Kingdom	1	100%

Product categories with the most REGISTERED refusals

REGISTERED refusal lines by product category
Category	Lines	Share of REGISTERED
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	1	100%

Latest REGISTERED refusals

The 1 most recent refused lines, through April 15, 2026, each with its FDA source.

Latest FDA refusals carrying REGISTERED
Date	Firm	Product	Charges
Apr 15, 2026	Live Wellness LimitedGlasgow, United Kingdom	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	NOT LISTED FRNMFGREG REGISTERED+1	Source

Questions about REGISTERED

What does REGISTERED mean on an FDA refusal?: REGISTERED is the refusal charge “It appears the device is subject to listing under 510(j) and the initial distributor has not registered as…”. FDA's official statement for the charge reads: “It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).”
What law does REGISTERED cite?: FDA's refusal charge table cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding) for REGISTERED, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most REGISTERED refusals?: As of October 26, 2026, the countries with the most REGISTERED refusal lines are United Kingdom (1). The full list with links is in the table on this page.
Is there an FDA import alert for REGISTERED?: SupplierRadar found no food import alert whose charge section names REGISTERED. 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.