Sued by the FDA
Even in the Trumpian dystopia of 2020, I’m not sure there is a more frightening phrase than “sued by the FDA”. You know you ain’t coming back from that.
And so it goes for Washington State juice processor Valley Processing Inc, who received the lawsuit on Nov 6 for inadequate hazard analysis, inadequate controls, arsenic exceeding the defect action level, patulin being diluted with new juice, and then some garden-variety grossness (such as live & dead critters & feces throughout the facility).
They supplied bottled apple, pear, and grape juices to school districts as part of the federal lunch program (3 million servings per year!), and sold juice to household names like Jamba Juice, Kroger (Fry’s, Smith’s, Harris Teeter, Dillons, etc), and Safeway stores.
I’m not sure which side of the line Valley Processing falls on: willful ignorance or bad actor? Reading a bit further, it’s not like they sat on their hands after the first FDA investigation in 2015; Valley Processing revised their HACCP plan to include the hazards of patulin, arsenic, and physical metal contamination (presumably from grinding/juicing/mixing), but failed to enact controls for those hazards (metal detection “pending” is not, ahem, a control!).
Perhaps Valley Processing was being a bit flip when they included in their hazard analysis such justifications as “FDA regulated” and, as a preventive measure, “Letter of Guarantee”.
Anemic responses to the FDA don’t hold up as assurances for the control of food safety hazards.
But maybe Valley Processing was doing the best it could. The instructional Juice HACCP binder I received from my course at Cornell is almost 4 inches thick, contains about 600-odd pages, including guidance I later cherry-picked from the Journal of Food Protection for such things as controlling patulin, arsenic, and screening for metal contamination. Gosh, that stuff could’ve been helpful to Valley.
Which brings me to my point:
HACCP and food safety plans have become their own discipline, about a hundred miles removed from daily food production. Oh sure you always have GMPs and pest control in the mix… these are part of the daily hustle for any manufacturing facility or processing plant, and not to be taken lightly.
The detour comes in the form of record keeping, lab testing, identification of what needs to be tested, implementation of controls to prevent contamination, and inevitable verification & validation. All part of the esoteric world of HACCP. It’s not easy to marry these concepts & practices to your day-to-day of production. Maybe it should be easier. I’ll loan you my 600 page binder for a little breezy reading (not!) and then you can decide.
So when was the last time you revised or reanalyzed your food safety, preventive controls, or HACCP plan? How relevant is it to your process? How far off the mark are you?
When was the last time you set foot on HACCP World and wrangled your paperwork so that, five years after the FDA visits, you don’t end up in court entering a consent decree?
Therein we find the value of a good consultant, the value of an expert in food safety & FSMA. A good consultant can be a bulwark between your daily production & overwhelming regulations, maybe even prevent your business being sued by the FDA. Maybe.
Consultants can’t do it all for you, but they can streamline things and make the right science- and regulation-based decisions about your unique process.
This, in turn, frees you up to make amazing product without fear or worry about compliance.
Cheers!