Written by Thomas Jones, Senior Director of Analytical Services and Pam Cooper, Quality Assurance Manager for Safe Food Alliance
Detention; a word associated with childhood pranks, the principal’s office, guilt, and remorse. In a similar fashion, receiving notice from the United States (US) government that your facility’s products have been detained can also trigger those negative childhood emotions.
FDA Detention Explained
Detention occurs when products entering the US are refused entry; either by the US Food & Drug Administration (FDA) or the US Customs and Border Patrol, acting on the FDA’s behalf. These detentions occur because the FDA has reason to believe that the products do not conform to US laws and regulations. The specific issues that can cause detention include:
- adulteration/contamination
- mislabeled or misbranded product
- manufacturing
- processing or packing under unsanitary conditions
- importing products that are forbidden for sale
Some of these detentions are the result of the FDA’s Import Alert List. This list is based upon FDA surveillance of imported products and detected patterns of noncompliance. Most listings take the form of a Red List Import Alert, in which specific firms from a certain country have a pattern of non-compliance and thus are added to the Alert. Once listed, any future products imported from that firm will be detained without physical examination (DWPE). Such products will be detained by the FDA until it can be shown that they are safe and meet pre-approved standards.
In Action
In some cases, Red List Import Alerts apply to products from an entire country. In 2007, the FDA traced pet deaths in the US to melamine contamination of wheat gluten and rice protein concentrate from China. During the investigation, more than 150 brands of pet food were recalled as a result of the mislabeled ingredient. Melamine, a molecule used as an industrial binding agent, flame retardant, and fertilizer, caused over 17,000 consumer complaints, 1950 deaths of cats and 2200 deaths of dogs. The devastating mistake resulted in Import Alert # 99-29 “Detention without Physical Examination of All Vegetable Protein Products from China for Animal or Human Food Use Due to the Presence of Melamine and/or Undeclared Colors”. Districts were directed to detain all shipments with vegetable protein products to prevent the products from continuing to contaminate pet foods. Since this import alert was issued, over twenty Chinese firms producing these products have been added to the Green List, meaning they have met the compliance requirements of the FDA and are no longer subject to DWPE.
Applying The Rule
Any firm importing food products from abroad is strongly encouraged to familiarize themselves with the FDA Import Alert List. The list can be searched by country, industry, alert number and last published date. Within each alert, the details of the product types, firms subject to DWPE, and the specific product violations related to the alert are listed. Notices may indicate DWPE with surveillance, meaning that the FDA will be doing spot inspection and testing of those products.
Key Alerts for Detention without Physical Examination are:
- aflatoxin in food products (#23-14)
- pesticides in raw agricultural commodities (#99-05)
- and in processed foods (#99-15)
- Salmonella in food products (#99-19)
- sulfites in food products (#99-21)
Reviewing this list allows you to make an informed choice of which firms to do business with and what types of product testing or evaluations to require from the seller prior to shipment. This can prevent the headache associated with a detained shipment, saving you time and money.
At Safe Food Alliance, we have been handling FDA product detentions for over a decade. Product detention in our facility primarily involves adulteration and contamination. In terms of specific issues cited in the detentions that have been examined by Safe Food Alliance, aflatoxin has been the most common (45%), followed by pesticides (19%), pathogens (16%), quality/filth (16%) and claims of organoleptic issues/rancidity (2%). The remaining 2% of cases have involved mislabeling due to sulfite residues. Tree nuts, dried fruits, and seeds/seed pastes are the commodities which having the most violations.
The most common example we encounter is tree nuts that fail to pass the importing nations’ aflatoxin limits and are returned to California. The FDA will typically notify the “responsible parties” of the violation by issuing a Notice of FDA Action. In our tree nut example, this is usually the handler or broker who originally shipped the load and to whom it has been returned.
How To Handle An FDA Notice
Step 1: If you receive a notice read it immediately and carefully!
Step 2: Understand the terminology
Hearing – A hearing is your opportunity to present evidence, or testimony, to overcome the appearance of a violation and to give FDA confidence that the product is in compliance. The hearing will vary from a series of email or telephone conversations to a more formal meeting. The hearing officer is generally the FDA compliance officer listed on the Notice of Detention and Hearing.
Testimony – Testimony is any information you wish to submit to overcome the appearance of the violation, or to otherwise support the release of your product. Testimony should be provided to the contact that is listed on the Notice of FDA Action, usually a compliance officer.
Charges – Charges are the reason the shipment has been detained by the FDA. Reasons include adulteration, misbranding, and restricted for sale.
Respond by Date – The “respond by” date is the amount of time to provide testimony. If the FDA does not receive a response to the detention within the specified timeframe, the compliance officer can issue a refusal of admission.
Definitions from https://www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/ucm459476.htm
Step 3: Create a plan
The Notice of FDA Action will cite the specific laws and regulations that appear to have been violated and are known as the charges. The FDA allows the responsible party the chance to either submit evidence to overcome the charges or submit a request to recondition the product to correct the violation. If you choose to submit evidence, known as testimony, it must be provided by the specific date listed on the Notice. This respond by date is typically 10 business days/20 calendar days from the detention date. Such testimony is typically provided in emails, telephone calls and/or hard copies and is addressed to the FDA Compliance Officer listed on the Notice. This process is known as the hearing.
In the case of our ill-fated tree nut shipment, the testimony will typically take the form of product sampling and testing, to show that the products meet US limits for aflatoxin and can be allowed entry. In this case, it is critical that our laboratory is notified immediately so that we can begin the process of getting the products cleared.
Step 4: Get your product tested
It is of critical importance to work with a laboratory that has experience with FDA detention. If the analytical package is not prepared according to the FDA’s strict protocol and does not meet their standards for sampling and testing it will be rejected, delaying the process even further. Choosing to work with Safe Food Alliance provides you with everything you need to be successful. The testimony that Safe Food Alliance provides is more than a typical laboratory result. In addition to the regular results, you receive details about quality assurance, methods validations, technician training, and sampling plans.
Note: It may not be possible to have your lab report completed by the initial response date given by FDA, in which case a request for extension must be made by the responsible party.
What if the product fails to pass the testing process? The responsible party can submit a request to recondition the product to bring it into compliance. In our example, that might involve resorting the product to remove any moldy/damaged nuts. This would then be followed by the same sampling, testing and reporting process we described above. If the product still fails to pass, then your options are either to work with FDA and Customs/Border Protection to export the product from the US or destroy it. This product disposition must be completed within 90 days.
Step 5: Submit Your Testimony
If the testimony shows that the product is in compliance (in our example, the aflatoxin is below 20 parts per billion), then the data package is submitted for review and the wait begins for FDA to clear the product. This process can take several weeks; FDA may also request additional information from the responsible party and the laboratory.
If this seems like a bureaucratic maze, you are right! The most important thing to remember is to read the notice immediately and gather all the facts you can about the detention. Next, reach out to the FDA Compliance Officer and determine exactly what is expected from you and when.
Safe Food Alliance laboratories should be your next contact. The most common problem we encounter is that we are not contacted soon enough when our client receives their FDA Notice, resulting in insufficient time to assemble all of the evidence and triggering a panicked request for an extension. Tell us exactly what you have found out from the FDA and we can plan the next steps of sampling, testing and reporting the results that will clear your product. Remember, it is critical that the correct steps are taking when sampling and testing or the data will be rejected. Count on us to walk you through the process, and stop worrying about the principal’s office!
