<p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Warning letters target violations of “regulatory significance” and include a threat of legal action if you don't comply. While all are serious (some provide damaging evidence to competitors and for criminal prosecutions and class-action lawsuits), others have more immediate consequences. Foreign facilities, for example, face the prospect of refusals under an Import Alert.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Because these letters are a surrogate measure of FDA's enforcement activities, any significant change in their number should raise questions about what's going on - and a significant change has occurred.</span></span><span style="font-family: 'Arial','sans-serif'; color: black; font-size: 10pt"><o:p></o:p></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><strong style="mso-bidi-font-weight: normal"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">What Happened?<o:p></o:p></span></strong></span></p> <div style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Starting in late 2009, the number of seafood letters began to increase significantly, rising 42 percent between 2009 and 2010, and then another 43 percent between 2010 and 2011. Here's the trend:<o:p></o:p></span></span></div> <div style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="center"> <div align="center"><img border="0" alt="" width="508" height="341" src="/uploads/Graphic_1_BT07.JPG" /></div> </div> <div style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="left"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Increases were particularly significant for domestic seafood processors, which received most of the letters during this period.<o:p></o:p></span> <div> </div> </span></div> <div style="text-align: justify; line-height: 12pt; margin: 0in 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="left"><span style="font-family: 'Arial','sans-serif'; color: black; font-size: 10pt"><span class="story1"><span style="font-family: 'Arial','sans-serif'; mso-ansi-font-size: 10.0pt; mso-bidi-font-size: 10.0pt">Type of Seafood Firm Receiving a Warning Letter 2009 – 2011<o:p></o:p></span></span></span></div> <div style="text-align: justify; line-height: 12pt; margin: 0in 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal" align="left"> </div> <div> <div align="center"><img border="0" alt="" width="484" height="310" src="/uploads/Graphic_2_BT07.JPG" /></div> </div> <div style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">No seafood firm engaged solely in warehousing, transportation or retail was warned. But a broad range of processors and importers --- both small and large --- were, including a few to sophisticated processors of breaded, smoked and canned seafood. In recent months, however, more letters appear to be going to smaller firms --- making products like tuna sandwiches and salads. Typically, FDA cited a firm for a seafood HACCP violation and then added on other violations. </span></span></div> <div style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA"> <div align="center"><img border="0" alt="" width="437" height="235" src="/uploads/Graphic_3_BT07.JPG" /></div> </span></span></div> <div> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">The three most frequently cited deficiencies were ---<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• Inadequate temperature controls - especially for histamine-forming species, pasteurized crabmeat, chilled vacuum-packed fish and ready-to-eat products;<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• Lack of HACCP planning - especially for tuna sandwiches and sushi;<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• Importers - lacking product specifications and verification steps.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">There also appears to be more testing for Listeria during FDA inspections, which prompted more FDA comment about controlling it.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Most letters only reference the Seafood HACCP Guide and a FDA rule --- so they don't break new legal ground. However, every now and then a letter reveals a new or little known FDA enforcement policy. High-profile examples were two warning letters in 2009-2010, which cited the inclusion of ice glaze or frozen marinade in the net-weight label for shrimp. They were prompted in part by tests conducted by state weights and measures inspectors in 17 states that found glazing on frozen seafood wrongly included as part of the labeled net weight.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Nothing like that occurred in 2011 that but there were a few letters that caught my eye.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• A letter to an importer acknowledging that it could fulfill its HACCP verification requirement by sourcing from firms on the "List of Canadian Establishments Approved for Export" on the FDA website, but then warning that the importer “should maintain copies of that list demonstrating that, at the time of importation, the firm was listed as approved” --- something it had not been doing. (There's no FDA guidance referring to this policy.)<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• Another importer gave FDA a copy of his foreign supplier's HACCP plan as its affirmative step, which FDA then reviewed and said was inadequate. (Having a copy of your supplier's HACCP plan is a common “affirmative step” --- but, as this letter illustrates, it exposes your supplier to violations that can be avoided if you chose another alternative.) <o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• A letter saying the Chesapeake Bay posed a reasonable risk of environmental contamination, requiring a primary processor to have HACCP controls when buying Croaker and Spot. <o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• A letter to a crab processor acknowledging that while it was “obtaining a certificate accompanying the live crab that indicates the area the crab was obtained from”, it was “not correlating the area information to information that identifies areas closed to harvesting or under consumption advisories.”<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">• A letter to a processor who was labeling and advertising fish as being low fat and useful in reducing body weight, leading to allegations of more than 20 misbranding violations. (Be careful about nutritional claims and what you say on your website.)<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><strong style="mso-bidi-font-weight: normal"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Looking Ahead<o:p></o:p></span></strong></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Changes in FDA enforcement policies (including an expansion of the authority of FDA Districts to issue letters) and increases in the number FDA inspectors and inspections are part of the reason why more Warning Letters were issued.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">FDA reports that its inspections of “high-risk” food facilities rose 13 percent between FY 2009 and FY 2010. The FDA target for last year was 7,800 “high risk” facilities and the number of FDA inspections of foreign food facilities jumped from 171 to 438 between FY 2010 and FY 2011. (Statistics on seafood inspections are not available.)<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">The target for “high risk” facilities increased again this year to 8,850 and additional Congressional directives about inspections in the Food Safety Modernization Act (FSMA) are likely to further increase the number of letters in the future.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">In the past, FDA was hesitant give foreign firms a Form FDA-483 (Inspectional Observations form) at the close-out of an inspection, and to send them Warning Letters. This clearly is changing --- although there has been no significant surge so far in the letters issued to foreign seafood processors.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">The FSMA, however, directs the agency to inspect at least 1,200 foreign food facilities by this October --- an increase of more than 100% percent over last year --- which FDA told Congress “may be attainable”. FDA also plans to increase its assessments of the foreign regulatory programs from five to nine this year.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">If these additional inspections do occur, there may be a corresponding increase in warning letters --- and import detentions.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><strong style="mso-bidi-font-weight: normal"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Additional Help <o:p></o:p></span></strong></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">While you can search the word “seafood” on the FDA website and find the warning letters alleging a seafood HACCP violation, you'll miss many other letters concerning seafood --- and there's no single word, or easy way to find them other than by reading the letters as they are posted each week on the FDA website.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">So --- to help you find what FDA has said about seafood in the past, I'm posting my 2009-2011 tables for FTD subscribers. You also can search for company names or specific products or violations using the “search” feature on our website.<o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Your email comments to me on this issue are welcome. <o:p></o:p></span></span></p> <p style="text-align: justify; line-height: 15pt; margin: 6pt 0in 0pt; mso-line-height-rule: exactly" class="MsoNormal"><span class="story1"><span style="font-family: 'Arial','sans-serif'; font-size: 10pt">Richard E. Gutting, Jr. regutting@rpb-law.com</span></span><span style="font-family: 'Arial','sans-serif'; font-size: 10pt"><o:p></o:p></span></p> </div>
(seafood.vasep.com.vn) The “Moringa Noodles Salad” product by Sa Giang Import-Export Corporation was honored as one of the “Top 10 Winning Products” at the THAIFEX – Anuga taste Innovation Show 2026, held as part of THAIFEX – Anuga Asia 2026 in Bangkok.
(seafood.vasep.com.vn) After a fairly strong upward trend in 2025, Vietnam’s clam exports entered 2026 with a mixed picture: strong growth at the beginning of the year, followed by a slowdown from March onward. According to Vietnam Customs data, Vietnam’s clam export turnover in the first four months of 2026 reached more than USD 38 million, up 2% compared to the same period in 2025.
(seafood.vasep.com.vn) Vietnam’s pangasius industry is facing new opportunities to expand its development space as many localities and businesses begin promoting marine farming models aimed at diversifying farming areas and adapting to climate change. However, for pangasius to truly “go offshore” and develop into a large-scale industry segment, significant challenges related to technology, broodstock, and markets still need to be addressed.
(seafood.vasep.com.vn) Vietnam’s tilapia exports in April 2026 reached USD 11 million, up 92% compared to the same period in 2025. This strong growth indicates that Vietnamese tilapia products are continuing to penetrate and expand rapidly in international markets. Cumulative export turnover in the first four months of 2026 reached USD 49 million, up 151% year-on-year.
(seafood.vasep.com) At VietShrimp Asia 2026, disease management trends in shrimp farming are shifting strongly from treatment-based approaches toward proactive prevention through environmental and pond ecosystem control.
(vasep.com.vn) After a period of strong growth, with export turnover reaching USD 38 million in Q1/2026 — up 174% year-on-year — the sector’s rapid expansion clearly reflects growing market opportunities.
(vasep.com.vn) In the first quarter of 2026, Vietnam’s pangasius exports to the ASEAN bloc reached USD 44 million, up 7% compared to the same period in 2025. After falling to the lowest level of the quarter at USD 9 million in February — reflecting the seasonal slowdown in orders after the festive period — exports recovered strongly to USD 18 million in March, the highest monthly value of the quarter. This development shows that import demand for pangasius in ASEAN remains relatively stable despite short-term fluctuations.
(seafood.vasep.com.vn) On May 11, 2026, the US National Oceanic and Atmospheric Administration (NOAA) announced a positive comparability finding for Vietnam’s swimming crab fisheries, along with those of Indonesia and Sri Lanka, under the Marine Mammal Protection Act (MMPA). With this decision, seafood and seafood products harvested from Vietnam’s swimming crab fisheries will continue to be eligible for import into the US market.
(seafood.vasep.com.vn) After a slowdown in 2025, Vietnam’s tuna exports to Germany showed more positive signs in the first quarter of 2026. However, the recovery remains uncertain as consumer demand in Germany is still cautious, while market competition is increasingly driven by pricing and supply stability.
(seafood.vasep.com.vn) After a sharp decline in 2025, Vietnam’s tuna exports to Israel are showing positive signs of recovery in the early months of 2026. According to Vietnam Customs data, export turnover to this market grew steadily month by month in Q1/2026, reaching nearly USD 10 million, up 33% compared to the same period in 2025. However, compared to Q1/2024, this level remains significantly lower, indicating that the recovery is still in its early stage following last year’s strong adjustment.
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