What is FDA Detention Testing?
To provide some context, the United States’s Food and Drug Administration (FDA) has reported that 15% of the overall food supply in the United States is imported from other countries, including 55% of fresh fruit and 32% fresh vegetables consumed domestically. Both federal agencies, the USDA focuses on meat, poultry, and dairy products while the FDA assumes control of most of the rest, including fresh produce.
With food constantly streaming across the borders, the FDA has a big role in ensuring that produce entering the country is safe. So, the FDA performs regular inspections to make sure imported food adheres to US standards, testing for pesticides, pathogens, and additives.
When a product is found to contain pesticides exceeding the tolerance levels or MRL (maximum residue limit), the importer is placed on “Import Alert”. When a shipper is on the Import Alert list, the FDA requires additional evidence that each future shipment is suitable for entrance into the US. Each shipment is put on hold until the importer can prove it meets US standards.
The FDA calls this “detention without physical examination” (DWPE). In an effort to free up agency resources, this evidence can be submitted in the form of a third-party private laboratory report (conducted by a laboratory unaffiliated with the FDA). If your company finds itself in such a position, firstly, we’re sorry to hear that. Being on Import Alert is hardly ever a fun experience. However, PrimusLabs’ Residue and Microbiological labs are ready to help you.
We can help you get your product moving to its destinations quickly and efficiently.
PrimusLabs offers comprehensive services to assist in this process, including sampling, analysis, and submission of a final analytical packet directly to the FDA. The FDA requires 10 subsamples be taken from each shipment from the shipper’s premises, completed by a trained and qualified PrimusLabs sampler. Our samplers fully document the sampling with pictures, rush the samples to a nearby PrimusLabs laboratory for processing.
These ten subsamples are homogenized in a large grinder and concentrated/extracted for analysis, typically using the Quechers AOAC 2007.01 extraction method. Our chemists will then analyze the samples using GC-MS/MS or LC-MS/MS technology while adhering to the FDA’s stringent protocols. If the samples require microbiological testing, our microbiologists use Hygenia technology to conduct pathogen testing. After our analysis, an analytical packet (often approaching or exceeding 100 pages) is submitted directly to the FDA on your behalf.
The packet will then be reviewed by the FDA and the shipment released for distribution if found to be in compliance. After five consecutive passing submissions, the shipper will be removed from the Import Alert list and free to resume normal operations! With over 30 years of FDA detention experience, PrimusLabs is knowledgeable and skilled in quickly and efficiently assisting shippers working through the Import Alert process.
Have you ever had shipments held by the FDA in the importing process? Let us know in the comments!