For those exporting food to the U.S., two more companies got hit this week.
On September 29, a company in Lu'an, Anhui, had its frozen cooked whole shrimp and frozen cooked vacuum-packed crayfish placed under FDA automatic detention for "failure to comply with HACCP requirements."
On September 19, a company in Jiangsu had its egg custard/cream-filled cake refused entry by the FDA for "improper labeling."
Two cases—one tripped up by HACCP, the other by labeling. Both are high-frequency detention reasons, and both deserve a closer look.
The company detained is Anhui Lu'an Hongyuan Food Co., Ltd., with products including frozen cooked whole shrimp and frozen cooked vacuum-packed crayfish, under Import Alert 16-120.
What is 16-120? It's an import alert specifically targeting foreign processors that fail to comply with seafood HACCP regulations. In plain terms, if your seafood processing facility hasn't established a HACCP system that meets U.S. requirements, the FDA can place you under automatic detention.
For seafood exporters, HACCP isn't a "bonus"—it's the "entry ticket."
Under 21 CFR Part 123, all processors exporting seafood to the U.S. must establish and implement a HACCP plan. Importers must, at the time of importation, verify through "verification procedures" that the foreign processor meets HACCP requirements.
What does the importer need to do? Under 21 CFR 123.12, U.S. importers must complete at least one of the following "affirmative steps":
Obtain the foreign processor's HACCP and sanitation monitoring records for the specific lot
Obtain a certificate from a foreign government inspection agency or qualified third party confirming the product was processed in accordance with U.S. HACCP regulations
Periodically inspect the foreign processor's facility to ensure HACCP requirements are being met
Retain a copy of the processor's HACCP plan (in English) and a written guarantee
If your company has been detained, what should you do? Automatic detention doesn't mean the product is unsafe—but the shipment must be inspected and found compliant by the FDA or an FDA-accredited lab, and cleared by the FDA, before Customs will release it. The core of the correction is: proving your HACCP system complies with 21 CFR Part 123.
The company flagged is HAOYOULI FOOD (JIANGSU), with products described as egg custard or cream-filled cakes.
The FDA's reason for refusal: under Section 801(a)(3) of the FD&C Act, the product is a "misbranded" product under Section 403(i)(2)—the product is made from two or more ingredients, but the label fails to state the common or usual name of each ingredient.
In plain English: your cake has several ingredients, but the label doesn't list all of them by name.
This sounds like a "minor issue," but in the FDA's eyes, it's a hard defect that directly triggers refusal of entry. Section 403(i)(2) of the FD&C Act requires food labels to state the common name of every ingredient. Miss one ingredient, and it's "misbranded."
Why are labeling issues so common? Because many exporters think "as long as the product is fine, it's fine"—and just grab a template for the label. But the FDA's logic is: Labeling error = consumer misled = illegal. Whether you intended it or not.
Action One: Seafood exporters—check your HACCP system.
If your products are shrimp, fish, crab, shellfish, or other seafood, confirm whether your processing facility has established a HACCP plan compliant with 21 CFR Part 123. If you're a U.S. importer, confirm whether you've completed the "affirmative steps" required under 123.12—a supplier's letter of guarantee alone isn't enough. You need specific lot records or third-party certificates.
Action Two: All food exporters—check your ingredient list.
The ingredient list must state the common name of every ingredient. Composite ingredients (such as cream, sugar, and emulsifiers in a "cream filling") must be broken out individually. This is a mandatory requirement under 403(i)(2)—not a "suggestion."
Action Three: Confirm whether your products fall under "high-risk import alert numbers."
16-120 (seafood HACCP) and 99-19 (Salmonella) are among the high-frequency alerts relevant this week. Seafood companies should focus on the 16 series; food companies should watch the 99 series.
The FDA's detention logic is simple: either your system complies, or your label complies. If you have neither, your goods won't make it ashore. Anhui's shrimp lacked the system; Jiangsu's cake lacked the label—what about yours?
