Applesauce pouches may have been contaminated on purpose, FDA foods chief says
politico.com
politico.com
The Economist, how to stop turmeric from killing people: https://www.economist.com/leaders/2023/11/02/how-to-stop-tur...
Hacker News post: https://news.ycombinator.com/item?id=38139011
The FDA deputy commissioner’s statement on the adulterated cinnamon is very interesting.
“My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”
In fact, the regulatory process failed to prevent the lead poisoning of the children involved. The goalposts the statement erects are to stop a poisoning that’s underway once children already have high levels of lead in their blood, rather than to prevent lead poisoning to begin with. And it suggests that the supply chain issue was a mixup that was only possible due to the failure of other countries to reject lead-laced cinnamon, seemingly an attempt to scapegoat other countries for the agency’s failure at preventing the poisoning of children within the United States.
Unless they just wanted to bulk up the weight
EDIT: Indeed ethylene glycol has been the culprit in the poisoning of children who consumed cough syrup in Indonesia https://www.aljazeera.com/news/2022/10/22/indonesia-says-chi...
Even red lead is "only" 8.3g/mm³, so it's not like you can get a noticeable bump in mass before your product is way up there in ppm. 10000pm (pretty enormous!) would increase the mass by only about 70 grams per litre.
Of course, this assumes the lead is free, which isn't the case, but that actually makes adulterating cinnamon even more profitable by comparison. For instance if lead costs $5/kg, then you'd make $5/kg of profit on the applesauce vs $25/kg on the cinnamon, making it 5x as profitable.
And then but in order to bulk it up by even a percent, you're quickly into "holy shit" concentrations. 500ppm is above the highest level detected by the Stanford turmeric study and would only get you 3 or 4 grams of extra mass per litre (say 0.5% change). I don't know where the Equadorian standards are but Indian food standards, in the news for similar scandals, are 2.5ppm for some spices and the EU version for bark spices is 2.0ppm. To get to a percent in mass change, that's like 3 orders of magnitude more.
I don't doubt you can increase the density. I do doubt you can do it at a macroscopic level and not expect someone to notice at some point that a percent of the product is now pure lead. Maybe they're just that stupid, or they only had lead compounds in the building, but cutting food with multiple grams/kg an easily-detected, insoluble neurotoxin, harmful in the low microgram/dl ranges, for the sake of a percent ish mass increase seems completely mad even by criminal standards. Why not just add sawdust (which is what cinnamon basically is) and sell 101 kg rather than 100? Even if you have to adulterate for density, there are plenty of fairly inert heavy things, purchasable in bulk, that you could use that won't set of alarms the moment a lead testing strip comes out of a packet (not that that happened, early enough, apparently).
Maybe it's for colour in which case it makes sense: you don't get that with sawdust or iron oxide, >5g/cm³, nearly as dense, or whatever. But I can't imagine they're deliberately making an appreciable change in the bulk density of the cinnamon.
https://inspection.canada.ca/food-safety-for-industry/food-c...
And the regulatory controls elsewhere leave much to be desired.
It took the FDA years to figure out that widely used blood pressure medications were being contaminated with a carcinogen.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-u...
But I doubt this will work reliably with pharmaceuticals. These are complex chemicals. A slight variation in composition can be the difference between medicine and carcinogen.
To reliably automate testing for every possible variation would be virtually impossible without producing so many false positives as to be essentially useless.
> Our patented solution combines two integrated technological components, the revolutionary SCiO Sensor, and our powerful cloud. Together these disruptive technologies provide a comprehensive end to end solution that gives you everything your business needs for instant material analysis.[1]
A consumer product no longer exists, even though one was originally delivered. This could be an issue of going up-market first, scaling issues, or if I believed in conspiracies like "killer acquisitions,"[2] then I might imagine that this technology would be inconvenient for many industries if end consumers had the spectrographic data in hand. This inconvenience might be a bunch of people complaining about compounds which were not dangerous, or it might democratize the testing that the FDA should be doing, and show dangerous contamination in many consumer products, especially in the food category.
[0] https://theindexproject.org/post/scio
[1] https://www.consumerphysics.com/
[2] https://www.google.com/search?q=%22killer+acquisition%22
https://www.timesofisrael.com/scanner-identifyng-foods-calor...
The US FDA has an on-site presence in every major exporting country to the US [0]
If I have a line of generic drugs I manufactured in India or China that I want to sell in the US, they will have to be tested by the FDA office in those countries in order to get past customs.
If those companies do not comply or break FDA regulations, they face US level fines and can even see valuations collapse [1]
[0] - https://www.fda.gov/about-fda/office-global-policy-and-strat...
[1] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
> They’ve saved taxpayers and consumers hundreds of billions of dollars a year. But recalls related to drug manufacturing quality doubled in the US from 2018 to 2022. With almost 80% of FDA-registered generic production facilities located overseas, years can pass between inspections. Profit margins on generics are so thin that there are often only one or two suppliers of vital medications. As a result, quality issues are fueling shocking shortfalls in supply, which a US Senate committee will examine on Tuesday. Shortages in the US reached near-record highs this year and left cancer patients, among others, waiting for life-saving treatments. Generics are supposed to be affordable and safe. Instead, they’re cheap — but sometimes dangerous.
> Concern about the nation's drug supply has reached the point that big hospitals, the Defense Department and Congress are raising questions about the FDA's ability to monitor it. The Pentagon in August chose an independent lab with which the FDA has publicly feuded, Valisure LLC, to test some of the generics available to millions of military personnel and their families, two years after Kaiser Permanente, a health system serving 12.7 million in the US, started a similar program with the lab.
> The efforts have run headlong into a major roadblock: the FDA itself. One might assume the US drug regulator, which dates to the 19th century Division of Chemistry, leads the mission of testing drugs. In fact, the FDA resists the idea of grading drugs by quality and rarely conducts tests of its own. Agency officials sought to block the Pentagon's nascent study, cast doubt on Valisure's methods and, according to multiple government officials, soured a Biden administration effort this year to introduce third-party testing more widely.
I would be wary about trusting current FDA oversight and governance implementations overseas, especially in India due to geopolitical concerns (prioritizing the relationship over robust testing). The above piece dives into detail.
I have family that work in the Pharma Manufacturing Industry in India. If you've ever taken a generic drug, it's likely manufactured in a factory within 20 miles of my ancestral village.
The US FDA does NOT compromise on testing in India and China. They will send US FDA inspectors to factories on random audits.
There is stuff to complain about w/ regards to the US, but the US FDA is pretty good at safety globally. The only better regulatory agencies I can think of is the EU's EMA and SK's KFDA.
It's regulated by the "Food Safety" division of the FDA.
The FDA as an organization over-specializes on Biologics and Drug regulation at the expense of Food Regulation [0][1] and due to the "Food Safety" division's overlap with USDA.
[0] - https://www.fda.gov/about-fda/fda-organization/fda-organizat...
[1] - https://www.politico.com/interactives/2022/fda-fails-regulat...
I am talking about drug and biologics regulation. Not food safety.
I don't know why you're talking about food safety.
Basically, they are making more profit by selling a placebo. This is often the case with low cost generics.
When the low cost generics are ineffective, doctors prescribe more expensive alternatives produced by the same manufacturer --- again they generate more profit.
Counterpoint: https://web.archive.org/web/20130815013650/http://features.b...
They compromise quite a bit, considering a multi-billion dollar company was found, many years down the line, to be completely fraudulent.
The article you linked was the icing on the cake before the Ranbaxy scandal.
In fact, it was Ranbaxy's massive shitshow that caused the US to open an FDA Field Office in India (specifically in our hick ass area of Himachal)
[0] - https://www.biospectrumasia.com/opinion/25/3716/ranbaxys-fal...
Your link [0] doesn't actually support that claim, for the obvious reason that it isn't true. Ranbaxy didn't experience failures with the FDA. They had a stream of neverending successes punctuated by a years-long investigation that was triggered when a whistleblower emailed the FDA to reveal that Ranbaxy's data, and products, were all fraudulent.
Note that despite the whistleblower's accusations proving to be completely correct, the company did not collapse. It was acquired for a significant price.
> Well before the final resolution, in November 2011, the FDA gave its final blessing for Ranbaxy’s version of Lipitor. Asked about the decision to allow Ranbaxy to make Lipitor after its misconduct at two plants was revealed, an FDA spokesman asserts that the agency is required to evaluate a drug application on a “facility-specific basis.” The company’s “data integrity problems,” he says, occurred at facilities different from where its generic Lipitor is manufactured.
> That’s true — but it leaves out the fact that Ranbaxy originally applied to make Lipitor at one of its Indian facilities, which was then blacklisted by the FDA. The agency permitted the company to make a significant shift in its application: to switch the plant at which it would make the generic Lipitor. Ranbaxy now proposed making the drug in the U.S. at a facility that was not under FDA investigation.
> Last November [2012], Ranbaxy was back in the headlines with some very unwelcome news — the company had detected tiny glass particles in its Lipitor. It had to recall millions of pills and temporarily halt production. Says the FDA spokesperson, “The fact that there were some quality problems that led to a limited recall of the generic product was not a result of the approval process or how it was handled.”
I would not call the FDA a model of efficiency, competence, basic common sense, or honesty.
But then again, maybe the problem was the lack of an FDA Field Office in the US.
2009, Daiichi to post $3 bln in losses on Ranbaxy - https://reuters.com/article/idUST336466/
2009, Ranbaxy slumps 16 pct as FDA says data falsified - https://www.reuters.com/article/idUSDEL443078/
2013, Ranbaxy falls over 30 pct after FDA import alert; stock downgrade - https://www.reuters.com/article/idUSI8N0CZ00W/
2014, Ranbaxy sale shows risk in Japanese M&A adventures - https://www.reuters.com/article/idUS1614191930/
2013, Ranbaxy: The Fall of an Icon - https://www.thehindubusinessline.com/news/variety/ranbaxy-fa...
2019, Former Ranbaxy owners arrested for fraud - https://www.chemistryworld.com/news/former-ranbaxy-owners-ar...
This was a massive scandal in India at the time. It was the equivalent of if Pfizer collapsed. And it had actual ramifications in how drug regulation works in the FDA
Ohhh scary !!!
They circumvent this by simply setting up a privately held front company in New Jersey to be the importer of record.
If the fines are minimal, they just pay them and continue business as usual.
If the fines are too much or they run into PR issues that affect their business, they simply shut the front company down and start up a new one.
In one particular case I have seen, the name of new company was the same as the old one but spelled backwards.
This is for Food, Supplements, Cosmetics, and other products that fall under the "Food Safety" Division
For drugs and biologics, the regulations are much stricter after the fallout from the Ranbaxy scandal in 2013.
And yet 10 years later, problems found with adulterated generic drugs and recalls are only increasing.
January 2023 saw a significant increase in the number of
drug recalls and units recalled compared to the Q4 2022
monthly average.
From the article quoting an FDA spokesperson: "We have limited authority over foreign ingredient suppliers that do not directly ship product to the US because their food undergoes further manufacturing/processing prior to export."
https://www.washingtonpost.com/opinions/2023/01/10/baby-form...
https://abcnews.go.com/Business/story?id=3944507&page=1 (2007)
Related: https://undark.org/2023/02/01/for-a-host-of-vital-lab-tests-...
If you aren't a drug or biologic, you will be regulated by the "Center for Food Safety and Applied Nutrition", which regulates food, ingredients, supplements, cosmetics, additives, etc.
It is also the least funded part of the FDA.
Drug and Biologics regulation is much stricter due to the aftermath of the Ranbaxy Scandal.
Ranbaxy was one of the largest generic manufacturers in the world, and a major Japanese pharma company invested billions in them in the 2000s. It turns out Ranbaxy had been fudging numbers since the 2000s, and they faced serious DoJ charges in 2013 [1] where they had to pay almost 15% of their entire capital on hand in fines. This whole scandal also lead the US FDA's Drug Division to begin on site testing in India and China.
Ranbaxy was always a shitshow, given their origins [2]
[0] - https://www.fda.gov/about-fda/fda-organization/fda-organizat...
[1] - https://www.justice.gov/opa/pr/generic-drug-manufacturer-ran...
[2] - https://www.cnbctv18.com/business/companies/backstory-bhai-m...
There are cases where lead has been used as a food coloring ingredient for curcumin and it's also possible something like that could have happened. The intention is not specifically to add lead, but the fact that lead is being added for some other purpose is being ignored.
There's a lot of minor lead contamination going on with these kinds of mechanisms. What happened in this case is that for some unknown reason the lead contamination was major rather than minor.
Lead salts taste sweet. I'm with the FDA; I doubt this is inadvertent contamination from machinery. This looks to me like deliberate adulteration.
Also: those sachets are made from metallized plastic, and cannot be recycled. They are pure pollution, and should be banned.
Plastic and glass recycling is also a source of lead contamination! You are starting to take materials of unknown origin in a way where it is really difficult to assume any consistency from testing. If they are turned into a glass or plastic bottle and in particular if someone puts acid in them you have lead leeching.
Plastic recycling is mostly a fantasy anyways. Much of the plastic that goes into a recycling stream is just thrown away. If it is recycled that's only at most for one more use.
We could be making returnable, washable jars, but probably someone will say we can't because it's not safe because someone could have intentionally poisoned a jar with lead before they returned it!
Sorry. My implication was that either the manufacturer was using apples that weren't sweet enough, or that the added sweetness made them more palatable than they could achieve using just fruit (and who knows how many legal additives).
[Edit] Glass isn't made with lead, unless it's lead crystal (and even that doesn't use lead nowadays).
I'm with you on plastic bottles, and packaging generally; even if it's "recyclable", you can only really recycle virgin plastic, not recycled plastic. And most of it isn't recycled anyway. The only legitimate use for plastic nowadays is to make things that are meant to survive basically forever.
A lot of clear glass has lead in the paint or markings, even in baby bottles. Here’s various test results: https://tamararubin.com/2020/04/this-post-is-linked-to-all-o...
[1] https://tamararubin.com/2021/02/the-heavy-metals-in-baby-foo...
https://duckduckgo.com/?q=peanut+corporation+of+america+blak...
https://www.theguardian.com/us-news/2015/sep/22/peanut-corp-...
In an EU vs US showdown, a manufacturer will sell the "inferior" product to US, but US and EU product safety regulations are miles beyond other large markets (China, India, Brazil, Russia, ASEAN, etc).
Manufacturers will absolutely create different SKUs of the exact same brand for different export markets. Try out P&G products in Thailand versus the US for example. Or the Indian Cough Syrup scandal where Indian companies exported cough syrups that wouldn't pass Indian regulatory muster to Africa, Central Asia, and poorer parts of India
We're talking hundreds of times every month.
https://www.accessdata.fda.gov/scripts/ImportRefusals/index....
Not all of these are refused for being dangerous, of course. Some just have inaccurate labels or suchlike. But still hundreds of times each and every month.
Not because I think capital punishment deters such reprehensible behavior, but because it's ridiculous tax payers shelter and feed animals willing to do such horrible things. Those tax dollars are better spent on virtually anything else.
Corruption is a huge problem, worldwide. We have plenty of it, in the US, but other nations almost have it in their constitution. Everyone just expects a little silver to cross their palms.
I had family that was very big on fighting corruption.
It seems safe to say that there is a deterrent effect.
From the title it sounded like there was a supervillain poisoning children for the funsies.
A killer doing it for fun wouldn't have his incentives aligned with the company and wouldn't have all their resources available to hide and facilitate it continuing. Potential killers also know that they wouldn't be able to get away with it for long and would be viciously punished, whereas company leadership know they will be able diffuse responsibility and be minimally punished, if at all.
When purchased by weight, adding lead equates to more money because the product is heavier.
This is not new. Paprika has been found to be intentionally contaminated with lead oxide which is red in color. Ground turmeric has been found to be intentionally contaminated with lead chromate which is yellow in color.
In that case, the idea isn't that the lead chromate is yellow so that it can increase the weight of the spice while being safely camouflaged.
The idea is that it is visually distinct and consumers prefer the brighter yellow of turmeric-with-lead to the duller yellow of non-poisonous turmeric.
They chose lead chromate because it is yellow and it increases the weight.
They weren't just trying to bulk up the products with inert ingredients. Their "bulk up" (to increase profit) resulted in as much a 500x the limit of lead contamination.
Very much supervillain poisoning kids for profit.
Anyway, the executives involved deserve the death penalty (see: 2008 Chinese milk scandal)