Food importers seeking the release of shipments detained for toxic-element concerns will face a new laboratory requirement beginning October 23, 2026.
On and after that date, food testing used to support the admission of an article detained under Section 801(a) of the Federal Food, Drug, and Cosmetic Act for specified toxic elements must be conducted by a laboratory accredited under FDA’s Laboratory Accreditation for Analyses of Foods (LAAF) program, as required by 21 CFR 1.1107.
The requirement applies to testing for:
- Arsenic
- Lead
- Cadmium
- Mercury
FDA has stated that its compliance officers will include this LAAF requirement in the Notices of Action they send to firms.
Toxic elements are the latest analyte group phased into the LAAF program. FDA first required LAAF-accredited testing for mycotoxins beginning December 1, 2024. Under FDA’s 2024 implementation notice, each new analyte group takes effect six months after FDA posts it to the LAAF Dashboard.
Importers with products subject to FDA Import Alert 99-42 should confirm their laboratory arrangements before submitting samples for analysis.
What Is Import Alert 99-42?
FDA Import Alert 99-42 authorizes detention without physical examination of identified foods from listed firms due to heavy-metal or toxic-element contamination.
Detention without physical examination, commonly called DWPE, allows FDA to detain covered merchandise based on the appearance of a violation without first examining or sampling every shipment.
To obtain the release of an individual shipment, the owner, consignee or other responsible party may submit evidence showing that the product does not contain toxic-element levels that would make it injurious to health. That evidence can include a private laboratory analysis of representative samples from the detained merchandise.
Beginning October 23, qualifying analyses for arsenic, lead, cadmium and mercury must be performed by a LAAF-accredited laboratory.
Not Every Laboratory Will Qualify
A laboratory’s general accreditation (such as ISO/IEC 17025), technical experience or prior work on FDA import matters does not necessarily mean it holds LAAF accreditation. LAAF builds on ISO/IEC 17025 and adds further requirements, including passing a proficiency test within the last 12 months for each method the laboratory is LAAF-accredited to perform.
Importers should verify that the laboratory:
- Appears on FDA’s LAAF Dashboard as accredited for toxic-element testing
- Has the specific analytical method within its scope of LAAF accreditation (LAAF accreditation is granted method by method)
- Can apply that method appropriately to the specific food product
- Can meet the shipment’s sampling and testing timeline
- Is prepared to submit the full analytical report and supporting documentation directly to FDA
- Understands FDA’s requirements for detained import shipments
Importers should complete that review before authorizing testing. If the laboratory is not properly accredited, FDA may decline to rely on its results to support admission.
That could force the importer to arrange new sampling and testing while the shipment continues to incur storage, demurrage or detention costs.
Sampling, Chain of Custody and Reporting Still Matter
Using an accredited laboratory does not guarantee that FDA will release a shipment.
Under LAAF, the laboratory that analyzes the sample, not the importer, is responsible for submitting test results directly to FDA. The submission must identify the owner or consignee and, as appropriate, the CBP entry and line numbers. It must also include the sampling plan, sample collection reports, documentation of the sampler’s qualifications and a certification from laboratory management that the results are true and accurate. If required information is missing, FDA may consider the testing invalid. Importers should still coordinate with the FDA compliance officer identified in the detention notice.
Samples generally must be collected after the shipment arrives in the United States. Testing a sample taken before arrival requires written FDA approval that the sample is, or would be, representative of the shipment.
FDA may review the laboratory’s methods, documentation and sample integrity. The agency may also collect and analyze audit samples before making an admissibility decision.
Because the laboratory must obtain sampling records before it can analyze a sample, importers should coordinate sampling carefully and make sure the sampler or sampling firm documents:
- The sampler’s qualifications and the identity of the sampling firm
- A written sampling plan explaining how the sample will represent the detained shipment
- The product code, lot number, sample size and quantity
- Where and when the samples were collected
- Collection procedures and any sample preparation
- How the samples were sealed, stored and transported, and who maintained custody at each stage
- The CBP entry and line numbers the results cover
A testing plan developed after detention may be difficult to execute quickly, particularly when the product is stored at a port, bonded facility or refrigerated warehouse.
Which Importers Should Pay Particular Attention?
The requirement is relevant to any food shipment detained for the four specified toxic elements, but it may be especially important for importers handling products that have historically received greater toxic-element scrutiny.
These can include:
- Spices and seasonings
- Candy and confectionery products
- Dietary supplements
- Botanicals and herbal products
- Fruit products and juices
- Cocoa products
- Seafood
- Foods intended for infants and children
Importers should review both the foreign manufacturer and the specific product because FDA Import Alert coverage is often firm- and product-specific.
What Food Importers Should Do Before October 23
Food importers should:
- Screen suppliers and products against the current Import Alert 99-42 Red List.
- Identify any shipments already detained for arsenic, lead, cadmium or mercury concerns.
- Confirm that the selected laboratory appears on FDA’s LAAF Dashboard for toxic-element testing.
- Verify that the analytical method for the specific product is within the laboratory’s scope of LAAF accreditation.
- Establish written sampling plans and chain-of-custody procedures that meet LAAF documentation requirements.
- Clarify laboratory turnaround times and confirm the laboratory will submit results directly to FDA.
- Coordinate with FDA before testing when the detention notice or sampling circumstances are unclear, including any plan to sample before arrival.
- Maintain supplier corrective-action and preventive-control records.
- Evaluate whether recurring detentions require a petition for removal from the Red List. Toxic-element testing used to support removal from an import alert through consecutive testing is also covered by the LAAF regulation.
The October 23 change does not create a general testing mandate for every imported food. It applies when testing is used to support admission of food detained under Section 801(a) for arsenic, lead, cadmium or mercury concerns, or to support removal from an import alert through consecutive testing.
For more information, review FDA Import Alert 99-42 and FDA’s LAAF Dashboard, which lists LAAF-accredited laboratories by analyte and method.
ASK Alba™: Contact the Alba team for assistance reviewing Import Alert exposure, coordinating a detention response or preparing documentation for FDA.
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References
- U.S. Food and Drug Administration, Import Alert 99-42: Detention Without Physical Examination of Foods Due to Heavy Metal (Toxic Element) Contamination
- U.S. Food and Drug Administration, Laboratory Accreditation for Analyses of Foods (LAAF) Dashboard
- Electronic Code of Federal Regulations, 21 CFR Part 1, Subpart R: Laboratory Accreditation for Analyses of Foods (see §§ 1.1107, 1.1138, 1.1149, 1.1152)
- Federal Register, Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation, June 3, 2024 (Doc. 2024-12027)
- Federal Register, Laboratory Accreditation for Analyses of Foods final rule, 86 FR 68817, December 3, 2021
- U.S. Food and Drug Administration, FDA Announces Sufficient Capacity to Test for Mycotoxins Under FSMA Laboratory Accreditation for Analyses of Foods
