FDA import refusals
FDA import refusals: dietary supplements from Germany
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 9, 2026
FDA refused 167 dietary supplements shipment lines from Germany between October 2016 and October 9, 2026, 13 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 167
- dietary supplements lines refused since October 2016
- 13
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Germany by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 13 | |
| 2025 | 18 | -42% |
| 2024 | 31 | +520% |
| 2023 | 5 | -69% |
| 2022 | 16 | +23% |
| 2021 | 13 | +333% |
| 2020 | 3 | -57% |
| 2019 | 7 | -78% |
| 2018 | 32 | +300% |
| 2017 | 8 | |
| 2016 (from Oct) | 21 |
Vitamin refusals from Germany
FDA refused 108 vitamin lines from Germany between October 2016 and October 9, 2026, 65% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 92 | 55.1% |
| Vitamin, n.e.c. | 16 | 9.6% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Froximun AgSchlanstedt, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Biologische Heilmittel Heel GmbhBaden-Baden, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTED | Source | |
| Linden-Apotheke M. Spiegel E.K.Graefenhainichen, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Germany
FDA refused 14 herbals & botanicals lines from Germany between October 2016 and October 9, 2026, 8% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 14 | 8.4% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Purslane refusals from Germany
FDA refused 7 purslane lines from Germany between October 2016 and October 9, 2026, 4% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Purslane (herbal & botaniicals, not teas) | 7 | 4.2% |
Other dietary supplements products refused from Germany
| Product group | Lines | Share |
|---|---|---|
| Camomille | 5 | 3.0% |
| Magnesium | 5 | 3.0% |
| Vitamin d2 | 3 | 1.8% |
| Calcium | 2 | 1.2% |
| Kratom | 2 | 1.2% |
| Vitamin b1 | 2 | 1.2% |
Why FDA refused dietary supplements from Germany
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 49 | 19% |
| NUTRIT LBL | Nutrition information missing from label | 47 | 18% |
| NO ENGLISH | Required label information not in English | 45 | 17% |
| LABELING | Fair Packaging and Labeling Act | 33 | 13% |
| NCONTACT | No U.S. adverse event contact on supplement label | 32 | 12% |
| HEALTH C | Unauthorized nutrient content or health claim | 16 | 6% |
| LACKS FIRM | Manufacturer name and address missing | 11 | 4% |
| SUPPL GMP | Dietary supplement CGMP not met | 11 | 4% |
| DIETARYING | Dietary ingredients not listed | 10 | 4% |
| LIST INGRE | Ingredients not listed | 10 | 4% |
Import alerts for dietary supplements that list Germany firms
Germany dietary supplements firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Denk Pharma GmbH & Co. KG | Munich | 14 |
| SanPharma GmbH | Hamburg | 13 |
| vitOrgan Arzneimittel GmbH | Ostfildern | 12 |
| Cfs Gmbh Kempten | Kempten (Allgau) | 12 |
| Queisser Pharma Gmbh & Co. | Flensburg | 11 |
| Barbara Sturm Molecular Cosmetic Gmbh | Dusseldorf | 9 |
| Plantafood Medical GmbH | Leiningen | 8 |
| Froximun Ag | Schlanstedt | 7 |
| Dr. Reinwald Healthcare Gmbh + co kg | Altdorf B. Nurnberg | 7 |
| Martin Bauer Gmbh & Co. KG | Vestenbergsgreuth | 5 |
Latest dietary supplements refusals from Germany
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Froximun AgSchlanstedt, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Biologische Heilmittel Heel GmbhBaden-Baden, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTED | Source | |
| Linden-Apotheke M. Spiegel E.K.Graefenhainichen, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Merck Kommanditgesellschaft auf AktienDarmstadt, Germany | Vitamin b1 (thiamine) | UNAPPROVED | Source | |
| Merck Kommanditgesellschaft auf AktienDarmstadt, Germany | Vitamin b1 (thiamine) | UNAPPROVED | Source | |
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| SANUM-Kehlbeck GmbH & Co. KGHoya, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| Ursapharm Arzneimittel GmbHSaarbrucken, Germany | Omega-3 (fats and lipid substances) | UNAPPROVED | Source | |
| Froximun AgSchlanstedt, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| SANUM-Kehlbeck GmbH & Co. KGHoya, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | SUPPL GMP | Source | |
| Mucos Pharma GmbH & Co. KGBerlin, Germany | Vitamin, n.e.c | NO ENGLISH | Source | |
| Bio-Gen Milchserum Marketing GmbHMontabaur, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | SUPPL GMP | Source | |
| Bio-Gen Milchserum Marketing GmbHMontabaur, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | SUPPL GMP | Source | |
| Dm-Drogerie Markt GmbH + Co. KGKarlsruhe, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | INCONSPICUNO ENGLISHNUTRIT LBL | Source | |
| ABNOBA GmbHNiefern-Oschelbronn, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDFRNMFGREG | Source | |
| WALA Heilmittel GmbHBad Boll, Germany | Vitamin, n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Germany
- How many dietary supplements shipments from Germany did FDA refuse in 2026?
- FDA refused 13 shipment lines of dietary supplements from Germany in 2026 through October 9, 2026, compared with 18 in 2025.
- Why does FDA refuse dietary supplements from Germany?
- FDA records a charge code on every refused shipment line. For dietary supplements from Germany the most frequent are UNAPPROVED (unapproved new drug, 49 lines), NUTRIT LBL (nutrition information missing from label, 47 lines) and NO ENGLISH (required label information not in English, 45 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover dietary supplements from Germany?
- As of October 26, 2026, the FDA import alerts for this category that list Germany firms are Import Alert 54-14 (3 firms) and Import Alert 54-16 (2 firms). General food alerts numbered 99-xx can list Germany firms too; see the country page.
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