I have been asked to give a lecture to a university in Lebanon on US labeling and nutrition compliance for the food industry and food safety graduates. I did a presentation concerning many of the same issues in January 2020 at another university and it was well received and has continued to have relevance for many in the food industry. During the last preparation zoom meeting I was asked to address the rejection of products for Detention Without Physical Examination (DWPE). They are looking for an accurate application of this process and what is required to not get on the list and how to be removed from the list.
I have gone through the FDA information, but I still have some questions regarding the specific applications that are required. I have requested clatification from the FDA but have yet to receive an answer. I have put the FDA statement in parentheses and my questions below regarding the statements. Could you please address my questions as you understand the rules/regulations and feel free to add any other pertinent information? I am curious if this process has raised any questions internationally of trade restrictions and how different countries have reacted to the new procedures.
I hope that this blog will be ongoing with information from people within the food industry, food safety professionals, academia, and those dealing with litigation of food laws and regulations. What is your experience, knowledge, or understanding regarding DWPE?
“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. Before importing into the United States, importers should know if their products are subject to DWPE. DWPE allows the agency to detain a product without physically examining it at the time of entry.” Import Alerts | FDA
- What and how much evidence leads to DWPE?
“Import alerts go through an FDA approval process before implementation.”
- What is the FDA approval process?
“If a firm/product is on the red list of an import alert, it means they are subject to DWPE.”
- How should a company respond and prepare with the fact that their product might be subject to DWPE?
“If your product is detained without physical examination, you have the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to the FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States.” Removal from Import Alert | FDA
- What evidence is necessary for attempting to overcome the appearance of the violation?
“products imported by the firms or manufactured/shipped by the firms on the Yellow List will continue to be subject to DWPE and require a private laboratory analysis until the FDA has confidence the firm’s products are in compliance.” “Food products under FDA import Alert and Detention without Physical Examination (DWPE) must be sampled and tested by qualified independent sampling and laboratory companies.”
- Is the private laboratory analysis to be done before shipment of the product or is this to be done upon arrival to the US? Is there a list of qualified independent sampling and laboratory companies? Who is certifying these laboratories, are these US or international labs?
“The entry process is reliant upon data provided by parties outside of the FDA, such as customs brokers (entry filers) who submit entry information to the FDA on behalf of importers.”
- Do all importers need a custom broker/entry filer?
“To determine the quality and accuracy of data that customs brokers (entry filers) are submitting, the FDA conducts periodic filer evaluations. These evaluations inform the FDA’s confidence about the overall performance of the customs brokers (entry filers).”
“The FDA’s filer evaluation outcomes are available to the public. They are posted on line and can be found in the document FDA Filer Evaluation Outcomes. The list is updated monthly and gives the most recent outcome for each customs broker (entry filer). Because this list is prospective and updated monthly, interested parties should not make any inferences with regard to the status of customs brokers (entry filers) who do not have filer evaluation outcomes posted on this site.”
- What considerations should an overseas company utilize when considering a customs broker? Is this relevant for a small overseas company?
“In order for FDA to consider removing a product and/or firm from DWPE, FDA must have evidence that the conditions that gave rise to the apparent violation have been resolved and that gives FDA confidence future entries will be in compliance with FDA laws and regulations.“
“You may submit a petition to DIO for removal from DWPE for most import alerts. There is no particular form to complete when petitioning for removal from detention without physical examination. In your petition you should outline the corrective actions and steps taken by the firm to prevent the problem which led the firm to be placed on the import alert.”
- Are there guidelines that should be followed in submitting a petition? Is corrective action based on the companies HACCP plan?
“For most import alerts, you are also expected to supply information relating to a minimum of five entries shipped to the U.S. and subsequently analyzed or examined and found to no longer be in violation. Submit the following documents for each entry you supply in support of your petition.
- Packing List
- Bill of Lading
- US Customs Form 3461 or US Customs Form 7501 (Required for manual/paper entries only)
*Please note you do not need to submit the actual private laboratory results with your removal petition.”
- When are the minimum of five entries shipped to the US to have taken place, before or after being placed on the import alert list? If you are on the DWPE how could a company continue to import product?