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FDA refusal charge

FDA refusal charge 708NEWANIM

The article has been determined to be a new animal drug without an approved new animal drug application.

708NEWANIM is the FDA import refusal charge for the article has been determined to be a new animal drug without an approved new animal drug application.; it cites sections 501(a)(5) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 1 refused shipment line from 1 country between October 2016 and May 19, 2023, most often for dietary supplements from Argentina.

Data from FDA public records, last checked .

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

What 708NEWANIM means

SupplierRadar has not written a plain-English version of 708NEWANIM yet. FDA's own statement is quoted below.

FD&C Act section
501(a)(5)801(a)(3)
Classification
adulteration

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.
The article has been determined to be a new animal drug without an approved new animal drug application.
708NEWANIM · 501(a)(5), 801(a)(3); ADULTERATIONFDA reference table (CSV)

Countries with the most 708NEWANIM refusals

Shipment lines carrying 708NEWANIM, by country of origin.
708NEWANIM refusal lines by country
CountryLinesShare of 708NEWANIM
Argentina1100%

Product categories with the most 708NEWANIM refusals

708NEWANIM refusal lines by product category
CategoryLinesShare of 708NEWANIM
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties1100%

Latest 708NEWANIM refusals

The 1 most recent refused lines, through May 19, 2023, each with its FDA source.
Latest FDA refusals carrying 708NEWANIM
DateFirmProductCharges
Ec Labs SACordoba, ArgentinaArnica (herbal & botanicals, not teas)708NEWANIM708LISTINGNEW VET DR+1Source

Questions about 708NEWANIM

What does 708NEWANIM mean on an FDA refusal?
708NEWANIM is the refusal charge “The article has been determined to be a new animal drug without an approved new animal drug application.”. FDA's official statement for the charge reads: “The article has been determined to be a new animal drug without an approved new animal drug application.”
What law does 708NEWANIM cite?
FDA's refusal charge table cites sections 501(a)(5) and 801(a)(3) of the FD&C Act (adulteration) for 708NEWANIM, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most 708NEWANIM refusals?
As of October 26, 2026, the countries with the most 708NEWANIM refusal lines are Argentina (1). The full list with links is in the table on this page.
Is there an FDA import alert for 708NEWANIM?
SupplierRadar found no food import alert whose charge section names 708NEWANIM. 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.