FDA refusal charge
FDA refusal charge LACKS FIRM
LACKS FIRM is the FDA import refusal charge for manufacturer name and address missing; it cites sections 403(e)(1) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 3,082 refused shipment lines between October 2016 and October 14, 2026, most often for dietary supplements from China.
Data from FDA public records, last checked .
- 3,082
- refused shipment lines carry this charge
- 105
- countries of origin
- 2
- import alerts name this charge
What LACKS FIRM means
The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 403(e)(1)801(a)(3)
- Classification
- misbranding
FDA's official statement
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.
Import alerts that name LACKS FIRM
Countries with the most LACKS FIRM refusals
Product categories with the most LACKS FIRM refusals
| Category | Lines | Share of LACKS FIRM |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 644 | 21% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 241 | 8% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 219 | 7% |
| Fishery/Seafood Products | 215 | 7% |
| Snack Food Items | 153 | 5% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 144 | 5% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 134 | 4% |
| Spices, Flavors, and Salts | 130 | 4% |
| Soft Drinks and Waters | 120 | 4% |
| Chocolate and Cocoa Products | 104 | 3% |
Latest LACKS FIRM refusals
Questions about LACKS FIRM
- What does LACKS FIRM mean on an FDA refusal?
- LACKS FIRM is the refusal charge “Manufacturer name and address missing”. The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.
- What law does LACKS FIRM cite?
- FDA's refusal charge table cites sections 403(e)(1) and 801(a)(3) of the FD&C Act (misbranding) for LACKS FIRM, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most LACKS FIRM refusals?
- As of October 26, 2026, the countries with the most LACKS FIRM refusal lines are China (508), Mexico (328) and India (232). The full list with links is in the table on this page.
- Is there an FDA import alert for LACKS FIRM?
- Yes. 2 FDA import alerts name LACKS FIRM as a charge code, including Import Alert 99-39 (Imported foods that appear to be misbranded) and Import Alert 40-05 (Adulterated and misbranded infant formula). 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.