This started out to be a news story about how the FDA and DOJ did that thing they do this week — protect the public interest — when they closed down a smoked fish company in New York that had been endangering people’s lives for at least six years.
But we brought you that story Wednesday: “Feds target smoked fish operation once on Oprah’s favorite list.”
So when the Department of Justice and Food and the Drug Administration finally got around to officially announcing their actions against The Smokehouse of New York late Thursday and midday Friday, respectively, it seemed like a fresh approach was in order. I pondered what the readers of Food Safety News would want to know, what questions they would post in the comments section on our website or send us through the “Contact Us” email link.
Let me know if I’ve missed something you’re interested in:
Question 1 — If FDA got positive results for Listeria monocytogenes when they tested a vacuum-packed, ready-to-eat, cold-smoked salmon collected at the production facility in Mamaroneck, NY, during an inspection from Feb. 23-March 11, 2011;
And, if FDA got six positive results for Listeria monocytogenes out of an environmental sample consisting of 100 subsamples collected at the facility from March 29-April 1, 2011;
And, if FDA got 25 positive results for Listeria monocytogenes out of an environmental sample consisting of 94 subsamples collected from Nov. 12-21, 2011;
Why wasn’t The Smokehouse of New York and its owner Panagiota Soublis and her husband and company director of operations Brett Portier stopped from producing and distributing food from the facility in 2011?
Question 2 — If FDA got 10 positive test results for Listeria monocytogenes out of an environmental sample consisting of 100 subsamples collected from Dec. 3-12, 2013;
And, if FDA got 21 positive test results for Listeria monocytogenes out of an environmental sample consisting of 99 subsamples collected from Nov. 18-Dec. 2, 2015;
Why wasn’t the food company shut down?
Question 3 — If FDA got 37 positive rest results for Listeria monocytogenes out of an environmental sample consisting of 99 subsamples collected from March 8-April 5 this year when inspectors noted the company had not corrected multiple repeat violations of the federal Food, Drug & Cosmetic Act, why wasn’t the facility immediately closed.
Rest assured I’m asking those questions and I’ll keep you posted, either in Beach Beat or a news story on www.FoodSafetyNews.com.
In the meantime, here are a few highlights from the news releases from FDA and the U.S. Attorney’s Office in the Southern District of New York, as well as some choice tidbits from the federal court complaint against the smokehouse and its principals and the consent decree they signed this week.
“The Smokehouse of NY had several opportunities to come into compliance with the law,” FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said in the agency’s news release Friday. “Through the use of modern technology, the FDA was able to establish that the company has resident strains of L. mono in its facility that it has consistently failed to eradicate. Conditions like these are unacceptable and the FDA took action to protect Americans.”
And from acting U.S. Attorney Joon H. Kim: “We will not let businesses put profits over public health. Smokehouse, Portier and Soublis have repeatedly put their customers at risk of severe illness. Our complaint and today’s consent decree hold them accountable and require them to clean up their operations and protect the public.”
In one section of the 19-page consent decree, signed Thursday by federal officials, Portier and Soublis, the couple “admit, acknowledge and accept responsibility for” 10 points, including:
- The location of the production, distribution and retail operation at 434 Waverly Avenue, Mamaroneck, NY;
- Their titles with the business;
- The fact that their business and products are subject to the Food, Drug and Cosmetic Act; and
- The fact that they “repeatedly prepared, packed or held food under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health, and failed to manufacture, package and store food under conditions and controls necessary to minimize the potential for microorganisms.”
Before you pass go …
The consent decree also details specifically what Soublis and Portier must do before they can even ask for FDA to reconsider allowing them to resume operations. All of the actions, including the FDA’s reinspection and testing, must be paid for by the business operators.
Among the first requirements, due in the first 10 days, is the posting of the consent decree for employees to read in English and Spanish. The company also must provide a hard copy of the decree to all officers and employees.
Soublis and Portier must recall all fish products distributed since May 3, 2017, at their own expense and certify to FDA in writing that they have completed the recall. They must also hire an expert and develop a plan, to be approved by FDA, for the destruction of all foods on hand at the facility and recalled from distributors, retailers and consumers.
The expert is also required to help the food company operators analyze their facility and develop food safety preventive controls and protocols, subject to FDA approval. After cleaning, sanitizing and testing of the facility, and training and testing employees on food safety practices and protocols, the owners can seek FDA’s permission to resume operations.
The government included a strict inspection schedule, with frequent testing of the facility and products, in the consent decree, which gives FDA the right to conduct unannounced inspections.
Listeriosis can take 70 days to develop
As of Friday, the FDA reported, there had not been any illnesses reported in connection with products from The Smokehouse of New York.
Anyone who has eaten any fish products from the company and developed symptoms of listeriosis, the infection caused by the bacteria Listeria monocytogenes, should seek medical attention. Possible food poisoning victims should tell their doctors about the possible exposure so the proper diagnostic tests can be performed.
Also, anyone who has recently eaten any of the smokehouse fish products should monitor themselves for symptoms of Listeria infection for the coming weeks. It can take up to 70 days after exposure for symptoms to develop, according to the Centers for Disease Control and Prevention.
Symptoms of Listeria infection can include high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Healthy adults may suffer only short-term symptoms, but serious and sometimes fatal infections can easily develop in young children, frail or elderly people, and others with weakened immune systems. Listeria infection can cause miscarriages and stillbirths among pregnant women.
Consumers are encouraged to contact the FDA to report problems with FDA-regulated products.
(To sign up for a free subscription to Food Safety News, click here.)© Food Safety News