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Mandatory vs. voluntary recalls and FSMA

TAGS: News
As the first change in foodsafety laws since the 1930s FSMA gave the FDA the authority to recall unsafe products It quickly knocked performanceenhancing ingredient DMAA off store shelves It also shifted the requirement that facilities register with the agency from oneanddone to a requalification once every two years Theres also a foreign supplier verification program where the importer has to verify that the person is in compliance with product and process verification The higher costs assoc
USDA/FSIS’s “voluntary” method of encouraging the plants to initiate recalls is better than FDA’s mandatory recall authority.

I think most, if not all, readers of my blogs for Feedstuffs know that the Food Safety & Inspection System (FSIS) at the U.S. Department of Agriculture does not have the authority to mandate a company to issue a recall. All meat and poultry and egg product recalls are voluntary, even if the recall is the largest meat recall in U.S. history, as was the Westland-Hallmark recall.

That recall was the subject of a four-plus hour hearing by the House Oversight Committee in 2008.

Then chair of the committee, Bart Stupak (D., Mich.), seemed stunned that the plant ownership would issue a recall just hours after we asked them to do so. He asked me what I knew that he didn’t that would force them to make the move.

I responded that there were no “smoking guns,” just indisputable evidence that animals were entering the plant for slaughter and processing without proper inspection for over two years, and therefore the product was “unfit for human consumption.”

His response was something like “you mean it was not just the cow in the video we just showed.”

Of course, if the plant had not responded positively we could have detained product and pulled the inspectors. No inspectors, no plant operations. That is a pretty powerful hammer that has seldom needed to be used.

On the other hand, the Food & Drug Administration, at the same time, had no hammer because daily inspection of FDA-regulated foods is not mandatory.

In May of 2007, the Chief Medical Officer of the Center for Food Safety & Nutrition at FDA was Dr. David Acheson. In the middle of a widespread pet food contamination event, Acheson was named the first ever assistant commissioner for food protection.

One of his first moves was to ask me to join him in petitioning the Office of Management & Budget (OMB) for mandatory recall authority for both FDA and USDA.

I asked Acheson if any company had ever refused to recall a product when asked to do so. He replied they (FDA) had one pet food company that refused a recall of salmonella-contaminated pet food.

I asked why that was a human health issue and the answer was a toddler may think it looked appetizing and sample it.

I thought to myself that if a parent allowed a toddler access to pet food that child probably had other issues even more threatening to its safety and well-being than contaminated cat food.

We turned down the request, of course, because the proposal was to allow a company to voluntarily recall within a stated time period and if they did not comply, they would be able to request an informal hearing that was to be held no more than two days down the road.

When USDA/FSIA asks a plant to recall a product, the plant may talk lawyer talk for a few hours but that is usually it. They move fast, or FSIS moves even faster to shut them down.

FSIS leadership felt a possible three-day delay in initiating a recall was an unnecessary risk to the public’s health and we were opposed to the language.

But that language, including a possible three-day delay, made it into the Food Safety Modernization Act (FSMA) signed into law on Jan. 5, 2011.

The latest on the FDA’s authority to mandate a recall is dated Nov. 15, 2018, nearly eight years after FSMA became the law of the land and is titled “Guidance on Mandatory Recall Authority.” It can be found at: www.fda.gov/downloads/Food/GuuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM445437.pdf.

The interesting thing about this guidance that was first made available for public comment in 2015 is that the very top of the first page states:

“Contains Nonbinding Recommendations”

In the body of the first paragraph is the statement that the guidance does “not establish legally enforceable responsibilities” and is not “binding on the FDA or the public.”

Somehow my understanding of mandatory is quite a bit different than a guidance that is not binding.

When FSMA was passed, this new mandatory authority, which can also be found in Section 423 of the Federal Food, Drug & Cosmetics Act, was ballyhooed by FDA and consumer groups as a great improvement to food safety and our health, and comments often repeated that USDA/FSIS should ask for the same.

FDA has issued a mandatory recall order of a food product only once, that being on April 3, 2018. The recall was for kratom contaminated with salmonella discovered in the investigation of a multi-state Salmonella outbreak.

Kratom is grown in Thailand, Malaysia and Indonesia and the recalled product was packaged and dispensed by Triangle Pharmanaturals LLC located in Las Vegas, Nev.

Kratom has an opioid effect when consumed and comes in powdered form and in capsules.

Triangle was asked to voluntarily recall certain kratom containing products within 24 hours on March 30, 2018.

Nothing happened.

In the mandatory recall notice FDA stated that “Triangle Pharmanaturals LLC refused to cooperate with FDA after repeated attempts to encourage voluntary recalls.”

So four days passed, in the middle of a multi-state salmonella outbreak, before FDA could man-up enough to invoke its mandatory recall authority that supporters of FSMA thought was the best thing since sliced bread.

FDA’s guidance also states, “In two other instances, FDA started down the path of using its mandatory recall authority under FSMA until the companies ultimately chose to voluntarily recall their product.” Therefore, more delays in protecting our health.

I like the USDA/FSIS’s “voluntary” method of encouraging the plants to initiate recalls better than FDA’s mandatory recall authority for all the above reasons.

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