Without question, one of the most challenging aspects of doing business in the U.S. is navigating the many and varied regulatory requirements of U.S. agencies. When working with food imports overseen by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), that means compliance with not only U.S. Customs and Border Protection requirements (CBP) but those related to FDA and USDA imports, a well as other federal agencies. Avoiding FDA and USDA detention as well as Import Alert Lists are key to expediting entry.
The Certified Group of companies (Certified Laboratories, FSNS and EAS Consulting Group) work with food imports daily, helping ensure products are safe through laboratory testing and compliant with U.S. laws and regulations through regulatory consulting. Our expert, Angel Suarez, an EAS regulatory consultant, weighs in on some of the most frequent challenges food importers face.
Food Import Challenges: Failure to Conduct Premarket Research
“FDA and USDA have specific requirements for importers, from agricultural permits, canning regulations, drugs & device registrations, wildlife permits, labeling regulations, etc.,” says Suarez. “A lack of knowledge on FDA and USDA import regulations and policies can cause major problems when attempting to bring products into the U.S. marketplace.”
LACF and Acidified Foods
Low acid (LACF) and acidified canned food in hermetically sealed containers is an excellent example of a complicated application and permit system that challenges food importers. These challenges are many, including…
- Inactive Food Canning Establishment (FCE) registration numbers for corresponding shipments
- Missing or inaccurate Scheduled Process Identification (SID) numbers on customs paperwork
- Failure to accurately obtain, maintain or report either of these will result in detention or refusal of admission.
Suarez explains, “Prior to importing, manufacturers must first obtain from FDA a unique FCE Code, then submit to FDA, along with the FCE registration, its scheduled process filings for all commercially sterile, acidified and low-acid canned foods. FDA will then provide an FCE and SID number. The SID number is required for each specific canned food import and aseptic or acidified food, and the manufacturer’s scheduled process must be reviewed by FDA before any canned food import is permitted to enter the U.S. If a manufacturer modifies the manufacturing process, the type of container, acidification or aseptic processing equipment, the manufacturer is required to submit an updated SID filing.”
Food Import Challenges: Incomplete Documentation Filed with FDA
Import documentation submitted to the CBP is electronically screened by FDA – and documentation errors are among the most frequently cited justifications for FDA detention.
FDA and USDA Prior Notice Submissions
Advance notice of food import shipments allows FDA and CBP to target import inspections for the protection of the nation’s food supply, including bulk food shipments for further processing. Even importers of live animals intended for food use and subject to inspection by USDA’s Animal and Plant Health Inspection Service (APHIS) are required to give prior notice of food imports before importing.
Two common problems with import entry submissions include accurately completing the Affirmation of Compliance (AofC), which affirms the product meets requirements specific to the product being imported, and incorrectly completing the manufacturer information, which includes the site-specific location where the product is made, produced or grown.
Required information as part of import entry submission may differ between FDA, USDA and CBP. Examples include FDA’s Country of Production and CBP’s Country of Origin. Additionally, the FDA’s required Port of Entry may differ from CBP’s Port of Arrival. Understanding the nomenclature of each U.S. entity and how to accurately and completely file documentation can be a challenge to those working with FDA and USDA imports of food.
Of course, of significant concern are import alert lists: Red, Green and Yellow. Having a diligent understanding of products being imported, their regulatory requirements and origins can help avoid the Red List where firms, products and/or countries are subject to Detention Without Physical Examination (DWPE) under an import alert. To the extent possible, meeting criteria for exemption from DWPE under an import alert will move your products to the Green List, expediting import into the U.S. When products are detained, or are subject to a Yellow or Red list, an independent third-party laboratory can conduct product-sample testing to verify integrity of the goods. Certified Laboratories is frequently called upon for their testing expertise to help companies navigate FDA detention and help move your shipment from the Red list or Yellow to the Green list.
(Get an FDA Notice of Action? Here’s how to respond.)
Food Import Challenges: Emerging Problems in the Supply Chain
The onus is on manufacturers to ensure all suppliers are appropriately vetted. This includes suppliers of raw materials and packaging materials to identify the possibility of emerging problems and resolve them. Emerging supplier problems may be issues of safety or, as was seen during the COVID-19 health emergency, availability.
In some cases, manufacturers were forced to consider using alternative ingredients to meet consumer demand. That became problematic because in the U.S., any changes to approved food additives and formulations may require FDA approval. FDA developed a guidance document with provisions to temporarily help manufacturers through the supplier availability challenges; however, vigilant oversight of the safety of food via the Foreign Supplier Verification Programs (FSVP) is and will continue to be a top priority.
FSVP for Foods
Enhancement of supply chain protection through FSVP is mandated under the Food Safety Modernization Act (FSMA). Each importer of FDA-regulated foods must have a documented and on-going FSVP that is overseen by a Qualified Individual (or team) with the training, education or experience (or some combination) necessary to undertake the FSVP activities.
“For example,” explains Suarez, “the importer must establish, sustain and adhere to an FSVP that adequately documents and affirms that the foreign supplier is producing the ‘food in compliance with processes and procedures that provide at least the same level of public health protection’ as those in the Hazard Analysis and risk-based preventive controls (HARPC/Preventive Control Rule) and the new Standards for Produce Safety. 21 C.F.R. 1.502(a). food importers must also verify that the imported food is not adulterated or misbranded because it fails to disclose the presence of major food allergens in compliance with the Federal Food, Drug and Cosmetic Act (FD&C).”
The specific food-safety protocols in any given FSVP plan will depend upon a variety of factors, including inherent risks associated with the food or the processing steps, the region or country of origin of the food, the ingredients used, the number of manufacturing parties involved in making the food, etc. Not having an FSVP is the number-one FDA citation for U.S. food importers leading into a DWPE of Human and Animal Foods imported from foreign suppliers who are not in compliance with the requirements of FSVP.
Working with FDA and USDA imports into the U.S. is complicated. Do your homework and enlist the assistance of a qualified regulatory expert who can help you understand specific requirements by Agency, product type and country of origin. They will know how and in what order permits should be filed, and work with you to develop compliance strategies for products on FDA or USDA’s import alert lists and/or from countries on detention Red lists. Their knowledge and guidance will save you time and money in the long run.
- Development of regulatory import strategies
- Filing of FDA documentation
- Expedited testing of detained products to confirm safety