What law does ADDDRUGBIO cite?

FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (301(ll)) for ADDDRUGBIO, and classifies the charge as 301(ll). The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most ADDDRUGBIO refusals?

As of October 25, 2026, the countries with the most ADDDRUGBIO refusal lines are Sri Lanka (5), India (3) and Kenya (3). The full list with links is in the table on this page.

Is there an FDA import alert for ADDDRUGBIO?

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

Appears to be a food to which has been added either a drug approved under section 505, a biological product…

ADDDRUGBIO is the FDA import refusal charge for appears to be a food to which has been added either a drug approved under section 505, a biological product…; it cites section 801(a)(3) of the FD&C Act (301(ll)). FDA recorded it on 22 refused shipment lines between October 2016 and October 6, 2026, most often for dietary supplements from Sri Lanka.

Data from FDA public records, last checked October 25, 2026.

22
refused shipment lines carry this charge: 12
countries of origin: 0
import alerts name this charge

What ADDDRUGBIO means

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

FD&C Act section: 801(a)(3)
Classification: 301(ll)

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 it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.

ADDDRUGBIO · 801(a)(3);301(ll); PROHIBITED ACTFDA reference table (CSV)

Countries with the most ADDDRUGBIO refusals

Shipment lines carrying ADDDRUGBIO, by country of origin.

ADDDRUGBIO refusal lines by country
Country	Lines	Share of ADDDRUGBIO
Sri Lanka	5	23%
India	3	14%
Kenya	3	14%
Italy	2	9%
Malaysia	2	9%
China	1	5%
Estonia	1	5%
Ghana	1	5%
Moldova	1	5%
Mexico	1	5%

Product categories with the most ADDDRUGBIO refusals

ADDDRUGBIO refusal lines by product category
Category	Lines	Share of ADDDRUGBIO
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	5	23%
Spices, Flavors, and Salts	4	18%
Candy without Chocolate, Candy Specialties, and Chewing Gum	3	14%
Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)	2	9%
Food Sweeteners (Nutritive)	2	9%
Whole Grains, Milled Grain Products, and Starch	1	5%
Nuts and Edible Seeds	1	5%
Vegetable Oils (Includes Olive Oil)	1	5%
Soft Drinks and Waters	1	5%
Coffee and Tea	1	5%

Latest ADDDRUGBIO refusals

The 20 most recent refused lines, through October 6, 2026, each with its FDA source.

Latest FDA refusals carrying ADDDRUGBIO
Date	Firm	Product	Charges
Oct 6, 2026	Dru Era (Pvt) LtdDehiwala, Sri Lanka	Cinnamon, cassia, ground, cracked (spice)	ADDDRUGBIO	Source
Oct 2, 2026	Dru Era (Pvt) LtdDehiwala, Sri Lanka	Cinnamon, cassia, ground, cracked (spice)	ADDDRUGBIO	Source
Oct 2, 2026	Dru Era (Pvt) LtdDehiwala, Sri Lanka	Cinnamon, cassia, ground, cracked (spice)	ADDDRUGBIO	Source
Oct 2, 2026	Dru Era (Pvt) LtdDehiwala, Sri Lanka	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	ADDDRUGBIO	Source
Sep 22, 2026	Omega NutritionHidalgo Del Parral, Mexico	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	ADDDRUGBIO	Source
Jan 20, 2026	societatea comerciala TAINET, SRLComrat, Moldova	Syrups and molasses, n.e.c	ADDDRUGBIO	Source
Oct 22, 2025	Dru Era (Pvt) LtdDehiwala, Sri Lanka	Cinnamon, cassia, ground, cracked (spice)	ADDDRUGBIO	Source
Jul 31, 2025	FUTURE360Tallinn, Estonia	Energy drink caffeine-free, noncarbonated, n.e.c	ADDDRUGBIO	Source
Jul 3, 2025	Silver Star Resources Co., Inc.Quezon City, Philippines	Barley, whole grain	ADDDRUGBIO	Source
Jun 11, 2025	Sk Mart TradingKuala Kelawang, Malaysia	Honey, n.e.c	ADDDRUGBIO	Source
Nov 13, 2024	Hego FulfilmentWeert, Netherlands	Other formula products for sample testing (not for sale), n.e.c	ADDDRUGBIO	Source
May 21, 2024	Patanjali Ayurved LimitedHaridwar, India	Leaf & stem vegetables, with sauce, n.e.c	ADDDRUGBIO	Source
May 21, 2024	Patanjali Ayurved LimitedHaridwar, India	Leaf & stem vegetables, with sauce, n.e.c	ADDDRUGBIO	Source
Apr 29, 2024	Amidzi Nuts and SeedsNairobi, Kenya	Olive oil with other vegetable oils, refined	ADDDRUGBIO	Source
Apr 29, 2024	Zutan FoodsNairobi, Kenya	Candy without chocolate n.e.c	ADDDRUGBIO	Source
Apr 29, 2024	Amidzi Nuts and SeedsNairobi, Kenya	Mixed nuts, in shell, n.e.c	ADDDRUGBIO	Source
Apr 14, 2021	Jiangmen Chuangkeqi Food TechGuangdong, China	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	LIST INGRE UNSAFE ADD LACKS FIRM+3	Source
Oct 20, 2020	Drs Secret Worldwide ManufacturiPulau Pinang, Malaysia	Herbal coffee (blend of herbs, grains, fruits and nuts)	ADDDRUGBIO	Source
Jul 2, 2020	Geo Medicore LimitedAccra, Ghana	Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c	ADDDRUGBIO	Source
Apr 20, 2020	Shalina Laboratories LimitedMumbai, India	Vitamin b1 (thiamine)	ADDDRUGBIO	Source

Questions about ADDDRUGBIO

What does ADDDRUGBIO mean on an FDA refusal?: ADDDRUGBIO is the refusal charge “Appears to be a food to which has been added either a drug approved under section 505, a biological product…”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.”
What law does ADDDRUGBIO cite?: FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (301(ll)) for ADDDRUGBIO, and classifies the charge as 301(ll). The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most ADDDRUGBIO refusals?: As of October 25, 2026, the countries with the most ADDDRUGBIO refusal lines are Sri Lanka (5), India (3) and Kenya (3). The full list with links is in the table on this page.
Is there an FDA import alert for ADDDRUGBIO?: SupplierRadar found no food import alert whose charge section names ADDDRUGBIO. 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.