Import Refusals – “Don’t Panic”

By Mark Moen, EAS Consulting Group Senior Regulatory Consultant

Products imported into the US may be assessed and inspected by US Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and US Consumer Products Safety Commission (CPSC).

US Customs and Border Protection (CBP) is the unified border agency that falls under the Department of Homeland Security and is charged with the comprehensive management, control and protection of our nation’s borders, combining US Customs, immigration, border security and agricultural protection at and between ports of entry. CBP also protects the American consumer and the environment against the introduction of hazardous, toxic or noxious products into the United States, and protecting industry and labor against unfair foreign competition; and detecting, interdicting, and investigating smuggling and other illegal practices aimed at illegally entering narcotics, drugs, contraband, and other prohibited articles into the US.

The Food and Drug Administration (FDA) is tasked with protecting the public health by assuring the safety, efficacy, and security human ad veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The U.S. Consumer Products Safety Commission (CPSC, or Commission) was established by Congress in 1972, as an independent federal regulatory agency charged with reducing unreasonable risks of injury and death associated with consumer products. The CPSC achieves that goal through education, safety standards, regulation, and enforcement of the statutes and implementing regulations.

In 2021 – 2024, there were 53,597 refusals for all FDA regulated products, of which 23,960 (45%) of these refusals were for human foods. This number may seem high, it represents an extremely low percentage of an estimated 39 million entries at US borders for all product types in a single year.

My Shipment is Refused. What Happens Next?

The FDA may detain and imported shipment whenever it finds a violation of the Food, Drug and Cosmetic Act during an Import exam. Similarly, products regulated by CPSC, and other agencies may be detained if they do not meet regulations, have defects (substantial product hazard), or are missing required paperwork.

When the FDA detains a shipment, they will notify the importer and their Customs broker/filer advising the importer of the refusal and the next steps to take. In some situations, an importer may overcome the detention by providing documentation, such as a private laboratory report.

FDA May Refuse a Shipment When:

• The importer fails to respond to the detention date.
• The entry is from a firm or country that is on an Import Alert
• The importer fails to submit all necessary paperwork before the expiration of the detention period.
• The importer fails to submit an adequate reconditioning proposal.

CBP may issue an Emergency Action Notification (EAN), requiring immediate export of products. CBP issues EAN’s when there is an imminent hazard found, such as infestation of harmful insects. In this case, the importer may export the goods to another country, if they comply with the laws of that country. However, the exportation requirement cannot simply be met by delivering the goods to a foreign trade zone. If the importer decides to destroy the product, FDA regulations do not require any specific methods of destroying or disposing of refused goods. FDA does, however, require that the goods be rendered unusable or unsalvageable.

What are the Likely Reasons for a Refusal?

From 2005 to 2013, adulteration (57%) and misbranding (41%) accounted for all Import violations. Product may be found as adulterated for several reasons such as filth, unallowed ingredients, and laboratory indications of unsafe products such as histamines, infestations from insects or evidence of pests, pesticides, or pathogens.

Strategies to Avoid Detentions into the United States?

The top strategy to avoid product detentions and refusals is to proactively prevent the reasons for refusals. History indicates that approximately one-third of the reasons for food recalls are in the category of undeclared allergens and the top reason for allergen issues is related to labelling. Importers should seek to prevent allergen and labelling-related non-compliance by:

1. Monitor for changing regulations. The US recently added sesame to the list of allergens required to be on the label. Implement an allergen labeling and country specific label checks.
2. Implement procedures to ensure products are made with approved ingredients.
3. Ensure your products are produced and shipped in conditions that support good manufacturing practices (GMP) and shipping conditions meet or exceed the US standards.
4. Develop a robust food safety / HACCP program.
5. Ensure your suppliers consistently supply your organization with ingredients and packaging that will support US compliance standards.
6. Ensure shipment practices meet the CBP and FDA expectations regarding notification and providing the required information about the shipment before it arrives at the US border.
7. Practice special care regarding anti-counterfeit measures such as ensuring the destruction of labels and packaging from being reused.
8. Ensure products meet US safety standards such as those to prevent CPSC regulated (or California Proposition 65) product being found to have choking, fire or the presence of chemical hazards such as lead, phthalates, and cadmium.
9. Join Customs Trade Partnership Against Terrorism (CTPAT). When an entity joins CTPAT, an agreement is made to work with CBP to protect the supply chain, identify security gaps, and implement specific security measures and best practices. Applicants must address a broad range of security topics and present security profiles that list action plans throughout the supply chain. CTPAT members are low risk, and therefore less likely to have their product examined at a US port of entry.
10. Implement a continuous improvement and a strong culture of quality and compliance to support proactive compliance and learning to prevent occurrences of detentions and refusals.