I recently subscribed to a weekly FDA recalled products report. It’s interesting.
Eighteen of the 139 recalls for the week of April 22 are in the category of “biologics.” They are all recalls, from seven different providers, of blood plasma, blood cells and platelets, or “blood or blood products” – 35 batches with separate product numbers. Except for one case, in which “quality control and distribution of products did not meet specifications,” the reason for the recalls is that there were problems with donors. Three of the recalls evidently stemmed from one incident, in which a donor may have been HIV-positive. The rest are based on a failure in the vetting of donors. This is one of half a dozen different “reasons for recall”:
Blood products, in which Donor Deferral/Donor missing or incorrectly identified on deferral list and/or donor should have been previously deferred due to history, were distributed.
Forty-eight recalls are categorized as “devices.” They range from a screw (which “provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries”) which was a different color from what it was said to be in the instruction manual, to catheters which could burst, to dental implants which were packed in a something which made them sticky.
Only five of the recalls were for drugs. The reasons: incorrect labelling; test procedure failure; prolonged exposure to high temperatures; aluminum dust on capsules; subpotency.
One category – Veterinary – had no recalls.
Sixty-eight of the recalls were for food. Except for three products in which shards of metal or glass were found, a brand of gutted haddock, sold in 100 pound bags, which customers claimed “smelled like diesel fuel,” and ceramic spoons (food?) from Shanghai which leached lead and cadmium, food was recalled because of the presence, or possible presence of allergens.
Thirty-nine were for products made with cumin powder which was found to contain peanuts. (The report for the previous week also contained twenty or thirty recalls based on, evidently, the same batch of cumin powder.) Then there were foods labeled gluten-free which were found to contain wheat, some Korean candy which contained “undeclared milk,” and some cheese ravioli in which two customers had found “undeclared lobster” and “undeclared shrimp,” but the prime culprits were beans (which technically includes peanuts) and “tree nuts.”
Eleven recalls were for various varieties of Trader Joe’s pita breads which “may contain undeclared soy.” The recalled pita breads all had “sell-by” dates of February 3-5, 2015.
Here’s (today’s) Wikipedia on soybean allergy:
Soybean allergy is one of the more common food allergies, especially among babies and children. Approximately 0.4 percent of children are allergic to soy. Studies indicate that an allergy to soy generally occurs early in childhood and often is outgrown by age three. Research indicates that the majority of children with soy allergy will outgrow the allergy by the age of 10.
Allergic reactions to soy are typically mild; however, although rare, severe reactions can occur.
It’s downright heartwarming to see the FDA being so staunch in protecting – how many children? Let’s see:
Fifty million Americans are under the age of twelve, half of those under the age of six.
So, as a rough estimate, 200,000 children are allergic to soy.
Of those 200,000 children, how many would have been served the Trader Joe’s pita bread perhaps containing soy, if it had not been recalled?
A website called Good Guide rates 93 different pita breads made by 26 different companies, but Trader Joe’s are not included. Calculating very conservatively (assuming, that is, that Trader Joe’s eleven types of pita bread are the only pita bread omitted from the Good Guide list), consumers can choose from 104 different kinds of pita bread made by 27 different companies.
Giving equal weight to each manufacturer – which is being very generous, since it can be assumed that, Trader Joe’s not being mentioned by Good Guide, it is not a popular brand of pita bread – then approximately 10% of those 200,000 soy-allergic kids might have eaten Trader Joe’s pita bread.
Evidently only one batch of Trader Joe’s pita bread was possibly “contaminated” with soy (only one sell-by date is referenced for each type recalled).
To make a seat-of-the-pants calculation, from complete ignorance of Trader Joe’s pita bread manufacturing and dating routine, let’s say that Trader Joe’s bakes pita bread once a week and that its sell-by date is one week after baking. That would mean that the perhaps soy-containing pita was baked in the last week of January and would have been removed from shelves by the end of the first week of February.
Thus, of the 20,000 soy-allergic children who were served Trader Joe’s pita bread over a period of, let’s say one year – I’m totally lost here, being no statistician – 400 would have been served the one week’s batch that “may” have contained soy.
But wait a moment. The sell-by date was in February. All that pita bread was long gone, off the shelves, by the time of the recall last week. Most of those kids will already have eaten the bread that might have contained soy and have had their allergic reaction (“typically mild,” according to Wikipedia). Those who suffered severe reactions (“rare,” according to Wikipedia) would already have died or survived by the time of the FDA recall.
Of course, some of the perhaps soy-containing Trader Joe’s pita might still be sitting in freezers; there still might be a few kids at risk. Let’s estimate that 10% of the risky pita bread is still in the freezer. At least the FDA is protecting those 40 kids (4 of whom might suffer a severe reaction) is it not? Yes – if the kids’ parents subscribe to the FDA’s recall report service, or have some other way of learning of the FDA recall. If not, then who’s going to warn them?
I suppose if the life is saved of even the one child who would have had a severe reaction (and not have been able to make it to an emergency room) whose care-giver became aware last week that the Trader Joe’s pita in their freezer may contain soy, all the FDA’s bureaucratic recall rigmarole is worth it. I would congratulate the FDA on its diligence, if it weren’t for the thousands and thousands of asthma-prone kids whose parents are unable to afford albuterol inhalers thanks to big-pharma successfully lobbying the FDA to ban generic inhalers – because they used a propellant (non-proprietary, presumably) that was deemed harmful to the atmosphere.
Evidently these are two of the FDA’s priorities: 1) Save one hypothetical child (remember, the pita “may contain soy”) by recalling a product two months past its sell-by date. 2) Let a significant number of real children suffer respiratory damage from asthma, and some of them be hospitalized, rather than allowing them to spray something into their lungs which, when they come to exhale whatever remains of it, will deplete the ozone layer a wee bit more than it is already being depleted by whatever else is being spewed into the air by unregulated refrigerants and propellants.
From a position of total ignorance, here’s my reaction to the FDA’s recall program.
Good work on blood recalls; at least some providers are practicing due diligence.
Crazy, knee-jerk bureaucratic panic when it comes to food recalls – too much, too late, and mostly unnecessary.
Drug recalls: suspiciously few in number. Why do food companies seem to cringe and over-comply, with 68 recalls in one week, while drug companies breeze by with five recalls? Might it have something to do with the fact that the pharmaceutical interest spends more money lobbying Washington than any other industry? Pharmaceutical lobbyists spent $231,000,000 in 2014; food processors and retailers spent $27,000,000.
Eighteen of the 139 recalls for the week of April 22 are in the category of “biologics.” They are all recalls, from seven different providers, of blood plasma, blood cells and platelets, or “blood or blood products” – 35 batches with separate product numbers. Except for one case, in which “quality control and distribution of products did not meet specifications,” the reason for the recalls is that there were problems with donors. Three of the recalls evidently stemmed from one incident, in which a donor may have been HIV-positive. The rest are based on a failure in the vetting of donors. This is one of half a dozen different “reasons for recall”:
Blood products, in which Donor Deferral/Donor missing or incorrectly identified on deferral list and/or donor should have been previously deferred due to history, were distributed.
Forty-eight recalls are categorized as “devices.” They range from a screw (which “provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries”) which was a different color from what it was said to be in the instruction manual, to catheters which could burst, to dental implants which were packed in a something which made them sticky.
Only five of the recalls were for drugs. The reasons: incorrect labelling; test procedure failure; prolonged exposure to high temperatures; aluminum dust on capsules; subpotency.
One category – Veterinary – had no recalls.
Sixty-eight of the recalls were for food. Except for three products in which shards of metal or glass were found, a brand of gutted haddock, sold in 100 pound bags, which customers claimed “smelled like diesel fuel,” and ceramic spoons (food?) from Shanghai which leached lead and cadmium, food was recalled because of the presence, or possible presence of allergens.
Thirty-nine were for products made with cumin powder which was found to contain peanuts. (The report for the previous week also contained twenty or thirty recalls based on, evidently, the same batch of cumin powder.) Then there were foods labeled gluten-free which were found to contain wheat, some Korean candy which contained “undeclared milk,” and some cheese ravioli in which two customers had found “undeclared lobster” and “undeclared shrimp,” but the prime culprits were beans (which technically includes peanuts) and “tree nuts.”
Eleven recalls were for various varieties of Trader Joe’s pita breads which “may contain undeclared soy.” The recalled pita breads all had “sell-by” dates of February 3-5, 2015.
Here’s (today’s) Wikipedia on soybean allergy:
Soybean allergy is one of the more common food allergies, especially among babies and children. Approximately 0.4 percent of children are allergic to soy. Studies indicate that an allergy to soy generally occurs early in childhood and often is outgrown by age three. Research indicates that the majority of children with soy allergy will outgrow the allergy by the age of 10.
Allergic reactions to soy are typically mild; however, although rare, severe reactions can occur.
It’s downright heartwarming to see the FDA being so staunch in protecting – how many children? Let’s see:
Fifty million Americans are under the age of twelve, half of those under the age of six.
So, as a rough estimate, 200,000 children are allergic to soy.
Of those 200,000 children, how many would have been served the Trader Joe’s pita bread perhaps containing soy, if it had not been recalled?
A website called Good Guide rates 93 different pita breads made by 26 different companies, but Trader Joe’s are not included. Calculating very conservatively (assuming, that is, that Trader Joe’s eleven types of pita bread are the only pita bread omitted from the Good Guide list), consumers can choose from 104 different kinds of pita bread made by 27 different companies.
Giving equal weight to each manufacturer – which is being very generous, since it can be assumed that, Trader Joe’s not being mentioned by Good Guide, it is not a popular brand of pita bread – then approximately 10% of those 200,000 soy-allergic kids might have eaten Trader Joe’s pita bread.
Evidently only one batch of Trader Joe’s pita bread was possibly “contaminated” with soy (only one sell-by date is referenced for each type recalled).
To make a seat-of-the-pants calculation, from complete ignorance of Trader Joe’s pita bread manufacturing and dating routine, let’s say that Trader Joe’s bakes pita bread once a week and that its sell-by date is one week after baking. That would mean that the perhaps soy-containing pita was baked in the last week of January and would have been removed from shelves by the end of the first week of February.
Thus, of the 20,000 soy-allergic children who were served Trader Joe’s pita bread over a period of, let’s say one year – I’m totally lost here, being no statistician – 400 would have been served the one week’s batch that “may” have contained soy.
But wait a moment. The sell-by date was in February. All that pita bread was long gone, off the shelves, by the time of the recall last week. Most of those kids will already have eaten the bread that might have contained soy and have had their allergic reaction (“typically mild,” according to Wikipedia). Those who suffered severe reactions (“rare,” according to Wikipedia) would already have died or survived by the time of the FDA recall.
Of course, some of the perhaps soy-containing Trader Joe’s pita might still be sitting in freezers; there still might be a few kids at risk. Let’s estimate that 10% of the risky pita bread is still in the freezer. At least the FDA is protecting those 40 kids (4 of whom might suffer a severe reaction) is it not? Yes – if the kids’ parents subscribe to the FDA’s recall report service, or have some other way of learning of the FDA recall. If not, then who’s going to warn them?
I suppose if the life is saved of even the one child who would have had a severe reaction (and not have been able to make it to an emergency room) whose care-giver became aware last week that the Trader Joe’s pita in their freezer may contain soy, all the FDA’s bureaucratic recall rigmarole is worth it. I would congratulate the FDA on its diligence, if it weren’t for the thousands and thousands of asthma-prone kids whose parents are unable to afford albuterol inhalers thanks to big-pharma successfully lobbying the FDA to ban generic inhalers – because they used a propellant (non-proprietary, presumably) that was deemed harmful to the atmosphere.
Evidently these are two of the FDA’s priorities: 1) Save one hypothetical child (remember, the pita “may contain soy”) by recalling a product two months past its sell-by date. 2) Let a significant number of real children suffer respiratory damage from asthma, and some of them be hospitalized, rather than allowing them to spray something into their lungs which, when they come to exhale whatever remains of it, will deplete the ozone layer a wee bit more than it is already being depleted by whatever else is being spewed into the air by unregulated refrigerants and propellants.
From a position of total ignorance, here’s my reaction to the FDA’s recall program.
Good work on blood recalls; at least some providers are practicing due diligence.
Crazy, knee-jerk bureaucratic panic when it comes to food recalls – too much, too late, and mostly unnecessary.
Drug recalls: suspiciously few in number. Why do food companies seem to cringe and over-comply, with 68 recalls in one week, while drug companies breeze by with five recalls? Might it have something to do with the fact that the pharmaceutical interest spends more money lobbying Washington than any other industry? Pharmaceutical lobbyists spent $231,000,000 in 2014; food processors and retailers spent $27,000,000.