FDA Import Alert 99-41: Importers Not Meeting FSVP
Import Alert 99-41 is different from most food alerts: it lists the U.S. importer, not the foreign factory. When FDA finds an importer has no adequate Foreign Supplier Verification Program for a food, that importer's shipments of the food can be detained without examination. The fix is a working FSVP, documented and shown to FDA.
Listed on 99-41? Send us your importer name, the foods and the FDA letter. We rebuild the FSVP records and prepare the removal request.
Get a 99-41 Case ReviewImport Alert 99-41 Basics
| Item | Import Alert 99-41 |
|---|---|
| Official title | DWPE of Foods Imported by Importers Not in Compliance With FSVP |
| Who is listed | The U.S. FSVP importer, for specific foods or all foods |
| Rule | 21 CFR part 1, subpart L (FD&C Act section 805) |
| Charge | Section 801(a)(3); OASIS code FSVP VIO |
| Red List | U.S. importers, organized under United States |
| Removal contact | The FDA compliance officer or office named in the regulatory letter |
Details follow the current text of Import Alert 99-41, published October 21, 2026.
Foods Most Often Named on 99-41 Listings
Snacks and bakery
Biscuits, snack mixes, chips, noodles and cereal products.
Fresh produce
Fruit, vegetables, herbs and fresh mushrooms such as enoki.
Nuts and seeds
Cashews, peanuts, sesame paste and tahini.
Spices and oils
Spice powders, condiments and vegetable oils.
Beverages
Soft drinks, rehydration drinks, coffee and tea.
Specialty foods
Candy, dairy, baby foods and edible insect products.
What the FSVP Importer Must Have
- A hazard analysis for each food and foreign supplier.
- An evaluation and approval of each foreign supplier.
- Supplier verification activities, such as audits, sampling and testing, or record review.
- Corrective actions when a supplier or food falls short.
- Your DUNS number in the FSVP field of each entry, and records kept in English or translated on request.
- Help setting this up through our FSVP service.
Foods 99-41 Does Not Cover
| Exempt food | Rule |
|---|---|
| Juice and seafood under HACCP (parts 120 and 123) | 21 CFR 1.501(b) |
| Food for research or evaluation | 1.501(c) |
| Food for personal consumption | 1.501(d) |
| Alcoholic beverages | 1.501(e) |
| Food transshipped or imported for processing and export | 1.501(f) |
| U.S. food returned; certain meat, poultry and egg products | 1.501(g) and (h) |
Two Tracks: Releasing a Shipment vs Leaving the List
Release one shipment
The alert gives no release testing route, because the problem is the importer's program, not the food. Testing a shipment does not cure an FSVP violation. FDA encourages listed importers to request removal before importing the food again; talk to the FDA Division compliance office named in the notice about any entry already held.
Removal from the Red List
Information showing the importer has resolved the FSVP violations described in the regulatory letter, in English, sent to the FDA compliance officer or office named in that letter. FDA may do a follow-up inspection. The foreign supplier is not responsible for this; FDA directs suppliers back to the importer.
What a Strong 99-41 Request Includes
- The regulatory letter and the FSVP observations behind the listing.
- A written FSVP for each listed food and foreign supplier, with the hazard analysis.
- Supplier evaluation and approval records.
- Verification records: audits, sampling and testing, or record review, matched to the hazards.
- Corrective actions, training and the person responsible for the FSVP going forward.
Our Import Alert 99-41 Process
FDA's framework is in RPM Chapter 9-8; FDA removal guidance explains what a request should include.
Import Alert Resources
Import Alert Removal
Removal help for food and supplements.
FSVP Service
Supplier verification for importers.
FSVP Refusal Help
When a shipment is refused for FSVP.
FSVP Gap Analysis
Find what your program is missing.
Hire an FSVP Agent
When a foreign seller needs an FSVP importer.
Release a Held Shipment
FDA hold statuses and release steps.
Get Help With Import Alert 99-41
We review the FDA letter, rebuild the FSVP records for each listed food and prepare the response to the compliance officer. We are an independent compliance firm, not FDA or a law firm, and no one can guarantee FDA's decision.
- Custom-scoped quote based on your listing and products.
- Exporters, manufacturers and U.S. importers.
- Agree the scope and pricing before any paid work begins.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Import alert removal · Food services · Contact.
Get a 99-41 Case ReviewFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — Import Alert 99-41
What is FDA Import Alert 99-41?
Import Alert 99-41 is titled "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation." It lets FDA detain listed foods offered by listed importers without examining each shipment.
Who gets listed on Import Alert 99-41, the importer or the supplier?
The importer. The Red List names U.S. FSVP importers, organized under United States. The listing covers the specific food, sometimes from a specific foreign supplier, when imported by that importer. It does not cover all food from the supplier or the same food brought in by other importers.
Who is the FSVP importer?
Under 21 CFR 1.500, the FSVP importer is the U.S. owner or consignee of the food at entry. If there is none, it is the U.S. agent or representative of the foreign owner or consignee, confirmed by a signed statement of consent. The FSVP importer may or may not be the importer of record.
Can all of an importer's food be put on 99-41?
Yes. In some cases FDA lists all food imported by an importer, when the importer appears to violate FSVP requirements for every food it brings in.
What is the charge under Import Alert 99-41?
The article is subject to refusal under section 801(a)(3) because it appears the importer, as defined in section 805, is in violation of section 805. The OASIS charge code is FSVP VIO.
Which foods are exempt from 99-41?
Foods exempt from FSVP under 21 CFR 1.501: juice and seafood covered by HACCP parts 120 and 123, food for research or evaluation, food for personal consumption, alcoholic beverages, food transshipped or imported for processing and export, U.S. food returned, and certain meat, poultry and egg products.
How do I know if my firm is on Import Alert 99-41?
Open Import Alert 99-41 and search the Red List by country and firm name. Each entry shows the product and the date it was added. Check before every shipment season, since the alert is updated often.
Does 99-41 cover animal food?
Yes. It covers human and animal food. Human food listings are recommended to the Human Foods Program Imports Enforcement Branch, and animal food listings to the Center for Veterinary Medicine's Division of Food Compliance.
Can a 99-41 shipment be released by lab testing?
No release testing route is given. The violation is the importer's missing or inadequate program, so a clean test result does not fix it. Ask the FDA Division compliance office named in the notice about entries already held, and request removal before importing the food again.
How do I get removed from Import Alert 99-41?
Send the FDA compliance officer or office named in the regulatory letter information showing you have resolved the conditions behind the FSVP violation, in English. It can respond directly to the violations in the letter. FDA may do a follow-up inspection before deciding.
Is there a set number of clean shipments for 99-41 removal?
No. The alert sets no shipment count. Removal depends on showing that your FSVP now meets the rule for the listed food and supplier.
Can the foreign supplier ask FDA to remove the listing?
No. The alert says the foreign supplier is not responsible for showing the importer's violations are resolved. If a supplier contacts FDA, FDA directs it to the importer.
What does a complete FSVP include?
A hazard analysis, evaluation and approval of each foreign supplier, verification activities matched to the hazards, corrective actions, importer identification at entry and records. See our FSVP service and FSVP gap analysis.
Who do I contact at FDA about Import Alert 99-41?
The compliance officer named in your regulatory letter handles removal. For import operations, the alert lists the Division of Import Operations at (301) 796-0356 or Imports@fda.hhs.gov.
Can you guarantee removal from Import Alert 99-41?
No. FDA makes every removal decision. We are an independent compliance firm, not FDA or a law firm. We help you build a complete, well-documented request.
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