FDA refusal charge LACKS FIRM: no manufacturer name
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The LACKS FIRM charge appeared in 914 FDA import refusals between 2020 and 2026 — 3.5% of all 26,358 US import refusals. The charge is a labelling or registration failure, not a hazard found in the product. The origins cited most often are China, Mexico, India. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was down 7% on 2024.
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What FDA's charge says
LACKS FIRM is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LACKS FIRM refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 111 | — | |
| 2021 | 136 | +22.5% | |
| 2022 | 104 | -23.5% | |
| 2023 | 115 | +10.6% | |
| 2024 | 179 | +55.7% | |
| 2025 | 167 | -6.7% | |
| 2026 | 102 | — | YTD |
| Total | 914 |
Origins most often refused under LACKS FIRM
| # | Origin country | Refusals |
|---|---|---|
| 1 | China | 144 |
| 2 | Mexico | 108 |
| 3 | India | 89 |
| 4 | Canada | 32 |
| 5 | Nigeria | 32 |
| 6 | Turkey | 28 |
| 7 | United Kingdom | 24 |
| 8 | Indonesia | 23 |
| 9 | Japan | 22 |
| 10 | Switzerland | 21 |
| 11 | Honduras | 18 |
| 12 | Vietnam | 16 |
| 13 | Germany | 15 |
| 14 | Hong Kong | 15 |
| 15 | Malaysia | 15 |
| 16 | Tanzania | 14 |
| 17 | Thailand | 13 |
| 18 | Guatemala | 12 |
| 19 | South Korea | 12 |
| 20 | Ecuador | 11 |
| 21 | Ghana | 10 |
| 22 | Haiti | 10 |
| 23 | Jordan | 10 |
| 24 | Netherlands | 9 |
| 25 | Sweden | 9 |
| 26 | Bangladesh | 8 |
| 27 | France | 8 |
| 28 | Pakistan | 8 |
| 29 | Taiwan | 8 |
| 30 | Afghanistan | 7 |
Product categories refused under LACKS FIRM
| # | Product category | Refusals |
|---|---|---|
| 1 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 216 |
| 2 | Vegetables and Vegetable Products | 89 |
| 3 | Fishery/Seafood Products | 74 |
| 4 | Fruit and Fruit Products | 72 |
| 5 | Bakery Products, Doughs, Bakery Mixes, and Icings | 60 |
| 6 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 45 |
| 7 | Spices, Flavors, and Salts | 40 |
| 8 | Snack Food Items (Flour, Meal, or Vegetable Base) | 35 |
| 9 | Coffee and Tea | 34 |
| 10 | Dietary Conventional Foods and Meal Replacements | 33 |
| 11 | Soft Drinks and Waters | 30 |
| 12 | Chocolate and Cocoa Products | 24 |
| 13 | Nuts and Edible Seeds | 24 |
| 14 | Macaroni and Noodle Products | 21 |
| 15 | Baby (Infant and Junior) Food Products | 19 |
Latest refusals citing LACKS FIRM
- K09-0100953-8 SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C.From Turkey, Bakery Products, Doughs, Bakery Mixes, and Icings. label not conspicuousno net quantityno common namenutrition labeling+1 more
- SCS-5183735-7 SYRUPS AND MOLASSES, N.E.C.From Canada, Food Sweeteners (Nutritive). filthingredients not listedno process filingno manufacturer name+2 more
- U72-0540747-2 TORTILLASFrom Mexico, Bakery Products, Doughs, Bakery Mixes, and Icings. ingredients not listednot to standard of identityno manufacturer nameno net quantity+1 more
- FY4-0123977-4 CINNAMON, CASSIA, GROUND, CRACKED (SPICE)From India, Spices, Flavors, and Salts. false or misleading labelno manufacturer namenutrition labeling
- U72-0540776-1 TORTILLASFrom Mexico, Bakery Products, Doughs, Bakery Mixes, and Icings. ingredients not listednot to standard of identityno manufacturer nameno net quantity+2 more
- 1FX-5690254-8 LOLLIPOP (WITHOUT CHOCOLATE)From Honduras, Candy Without Chocolate, Candy Specialties, and Chewing Gum. no manufacturer namerxlabellabelingnutrition labeling+1 more
- FY4-0124081-4 CINNAMON, CASSIA, GROUND, CRACKED (SPICE)From India, Spices, Flavors, and Salts. false or misleading labelno manufacturer namenutrition labeling
- 1FX-5191937-2 JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)From Sweden, Candy Without Chocolate, Candy Specialties, and Chewing Gum. ingredients not listedlabel not conspicuouscolor not declaredno manufacturer name+6 more
- EEE-0104266-1 CHEWING GUM (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. unsafe color additiveingredients not listedlabel not conspicuouscolor not declared+5 more
- 9EH-0606019-0 FISH, N.E.C.From China, Fishery/Seafood Products. ingredients not listedno manufacturer nameno net quantitynot in English+2 more
- ANG-0099420-3 CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)From Mexico, Candy Without Chocolate, Candy Specialties, and Chewing Gum. ingredients not listedlabel not conspicuousno manufacturer name
- KM6-3683885-6 NOODLES, INSTANTFrom Bangladesh, Macaroni and Noodle Products. unsafe color additiveingredients not listedcolor not declaredno manufacturer name+4 more
- TXC-7508193-4 CANDY WITHOUT CHOCOLATE N.E.C.From Finland, Candy Without Chocolate, Candy Specialties, and Chewing Gum. no manufacturer nameno net quantitynutrition labelinglabel not conspicuous+3 more
- TXC-1506367-9 CANDY WITHOUT CHOCOLATE N.E.C.From Sweden, Candy Without Chocolate, Candy Specialties, and Chewing Gum. color not declaredno net quantitynutrition labelingnot in English+2 more
- AEK-0890916-9 VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.From China, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listedsupplement labelingno manufacturer namelabeling+1 more
- NUV-4010000-3 FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFrom Japan, Dietary Conventional Foods and Meal Replacements. ingredients not listedlabel not conspicuousno manufacturer namenutrition labeling
- KM6-1640199-8 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Pakistan, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. ingredients not listednot in Englishsupplement labelingno manufacturer name+2 more
- 8B4-0012673-4 MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.From Haiti, Vegetables and Vegetable Products. no manufacturer nameno net quantityno common name
- 1FX-8249756-1 OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULAFrom Switzerland, Baby (Infant and Junior) Food Products. ingredients not listedfalse or misleading labelno manufacturer nameno net quantity
- 8QB-0001362-6 CHEESE PRODUCTS, STANDARDIZED, N.E.C.From Honduras, Cheese and Cheese Products. ingredients not listedinsanitary conditionsno manufacturer nameno net quantity+3 more
About LACKS FIRM
What does the FDA import refusal charge LACKS FIRM mean?
FDA uses LACKS FIRM for: no manufacturer name. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.”
Is LACKS FIRM a food safety finding?
No. LACKS FIRM is a labelling or registration failure: the charge is about the label, the filing or the paperwork, not a hazard found in the product. A refusal citing it alone is counted as paperwork on this site.
What happens to a shipment refused under LACKS FIRM?
Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.