India — Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans — Supplements

India received 316 FDA import refusals in Supplements, part of Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans between 2024-Q1 and 2026-Q4. Volume peaked at 60 in 2026-Q3, with the trend roughly flat year-on-year. The most-cited issues are unapproved new drug, establishment not listed, and false or misleading label. No trade baseline is published for this commodity from India, so no per-$1B rate is shown here.

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Key figures

If you import supplements from India

Hazard or paperwork: Of 327 refusals in the last 3 years, 21 were hazard findings and 306 paperwork alone — most were avoidable at the desk.
Where refusals happen: DSEI — Southeast (305); DNEI — Northeast (14); DNBI — North Border, the Canadian land border (5).
Riskiest months: September, July, August, by refusals since 2020.
Test for before shipping: unsafe color additive (13), E. coli O157:H7 (2), filth (2), insanitary plant (1), pesticide residue (1).
Paperwork to get right: unapproved new drug (259), establishment not listed (37), nutrition labeling (30).

FDA does not publish how many entries it examines, so no page can state a true probability of refusal; these are the figures that are published.

Quarterly refusals, last 12 quarters

hazard findings labelling & registration

Show the numbers

Quarter	Refusals	Hazard	Paperwork
2024-Q1	8	0	8
2024-Q2	12	3	9
2024-Q3	20	0	20
2024-Q4	22	0	22
2025-Q1	28	2	26
2025-Q2	39	5	34
2025-Q3	22	1	21
2025-Q4	37	4	33
2026-Q1	34	3	31
2026-Q2	24	2	22
2026-Q3	60	0	60
2026-Q4	10	0	10

Recent refusals

EJG-2602155-6 2026-10-22 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DNBI. false or misleading label
AEK-2058257-2 2026-10-21 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug
AEK-2027330-5 2026-10-21 VITAMIN, N.E.C. Import division DSEI. unapproved new drug
1FX-8631279-1 2026-10-21 CALCIUM (MINERAL) Import division DSEI. establishment not listedunapproved new drug
1FX-3489737-2 2026-10-08 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug
1FX-1129280-3 2026-10-08 COCCULUS Import division DSEI. unapproved new drug
1FX-3876690-4 2026-10-08 PROBIOTICS (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) Import division DSEI. unapproved new drug
AEK-0710428-3 2026-10-02 FOLIC ACID (VITAMIN) Import division DSEI. unapproved new drug
1FX-0754914-1 2026-10-02 ZINC (MINERAL) Import division DSEI. unapproved new drug
AEK-9616633-3 2026-10-02 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug
1FX-4836945-9 2026-09-30 VITAMIN, N.E.C. Import division DSEI. unapproved new drug
1FX-4841360-4 2026-09-30 MECOBALAMIN (VITAMIN) Import division DSEI. unapproved new drug
1FX-1847601-1 2026-09-28 VITAMIN D2 (CALCIFEROL) Import division DSEI. unapproved new drug
1FX-5695390-5 2026-09-25 BIOTIN (VITAMIN H, COENZYME R) Import division DSEI. unapproved new drug
1FX-5122163-9 2026-09-25 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug
1FX-3503980-0 2026-09-25 PROBIOTICS (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) Import division DSEI. unapproved new drug
1FX-8172370-2 2026-09-22 VITAMIN, N.E.C. Import division DSEI. establishment not listedforeign plant not registered
AEK-9743642-0 2026-09-22 L-ARGININE (PROTEIN) Import division DSEI. unapproved new drug
1FX-3165589-8 2026-09-18 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug
1FX-4833306-7 2026-09-18 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. Import division DSEI. unapproved new drug

Data and downloads

Download all 449 entries (CSV) — every refusal behind this page, with its import division, FDA product code, charges and whether it was a hazard finding or paperwork.

The file holds entries up to 2026-10-22. To get new ones for India by email, watch India.

India country report since 2020 — every refusal by year, charge and import division →