So, why not use the authority granted under the FSMA and use the FDA’s mandatory recall authority?
According to the FDA, before the FSMA (Food Safety Modernization Act) was enacted, the FDA relied on responsible parties to voluntarily recall violative food products — except infant formula recalls which are described under section 412 of the FD&C Act – Food, Drug and Cosmetic Act.
The FDA continues to rely on responsible parties to voluntarily recall violative food products; however, FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met.
The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA ( Serious Adverse Health Consequences or Death to Humans or Animals).
See, Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff
On August 27, 2021, the FDA advised consumers not to purchase or eat any seafood products sold or processed by Felix Custom Smoking due to possible Listeria monocytogenes contamination. See, Advisory
Listeria monocytogenes is a species of disease-causing bacteria, which can cause an infection called listeriosis. Listeria monocytogenes is generally transmitted when food is harvested, processed, prepared, packed, transported or stored in environments contaminated with Listeria monocytogenes. A listeriosis infection can have serious adverse effects for women who are or may become pregnant, the elderly, and persons with weakened immune systems. There are a range of symptoms for listeriosis. Depending on the severity of the illness, symptoms may last from days to several weeks. Mild symptoms may include a fever, muscle aches, nausea, vomiting, and diarrhea. If a more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions. For the very young, the elderly, and the immune-compromised listeriosis can result in death.
Summary of Problem and Scope
The FDA detected the pathogen Listeria monocytogenes and other strains of Listeria during an inspection at Felix Custom Smoking that began on July 19, 2021 and is still ongoing.
As part of the inspection, on July 19, 2021, the FDA collected environmental samples from the firm which consisted of 104 samples from direct food contact surfaces and areas near direct food contact surfaces. Laboratory analysis shows that of the 104 samples collected, 19 tested positive for the pathogen Listeria monocytogenes and four tested positive for other strains of Listeria. Of the 19 samples that were positive for Listeria monocytogenes, five were collected from food contact surfaces.
“The FDA has notified Felix of its findings, but the company has declined to initiate a recall of its products and is still processing seafood at this time.”
The FDA is issuing this alert to notify consumers, companies, and fishermen who may have received product from Felix because the agency is concerned about the presence of Listeria monocytogenes at the firm and the safety of its products. The FDA is continuing its efforts with Felix and its customers to remove these products from the market.
The U.S. Food and Drug Administration is alerting consumers who have purchased Felix Custom Smoking branded products directly from the firm, as well as companies and commercial and sports fishermen who have used Felix to process, package, and/or label their seafood.
The FDA is advising consumers not to eat any of Felix’s products or products processed by Felix and to discard any remaining products they may have purchased in the past due to possible Listeria monocytogenes contamination.
The FDA is advising companies and commercial fishermen not to sell or further distribute any products processed by Felix. They also should discard any of their remaining products that were processed by Felix due to possible Listeria monocytogenes contamination.
Felix Custom Smoking of Monroe, Washington, is a processor of a variety of ready-to-eat salmon, squid jerky, and frozen, hot smoked and cold smoked seafood. The firm also processes seafood products for companies that distribute these products independently.
Some of Felix’s products include:
Felix Northwest Blend Smoked Wild King Salmon
Felix Northwest Blend Smoked Wild Sockeye Salmon
Felix Northwest Blend Smoked Wild Tuna
Felix Pepper Smoked Wild Mixed Salmon Jerky
Felix Wild Keta Teriyaki Smoked Salmon Jerky
One of Felix’s customers, Loki Fish Company, issued its own product recall on August 23, 2021.
So, what’s up FDA?