The Fifth Circuit, whose judges never hesitate to play doctor and cause harm, has just ruled that the FDA overstepped its authority in reminding people what species we are.
I have criticized the #FDA in recent years when there was evidence of inappropriate relationships with industry (cough cough Aduhelm) but today I am re-posting their solid words of wisdom in their support.
me: Time to to re-order my 30-day supply of #ADHD drug #Vyvanse (lisdexamfetamine). I can’t get refills or larger prescriptions because it’s an #FDA Schedule II controlled substance
my #pharmacy: We only have the 50mg name-brand in stock, no generic.
my doctor: You were on 60mg last month, is it OK to go down to 50?
me: My dosage is supposed to be 50 but they only had the 60 last month. And both are better for me than zero.
Hundreds of American children were poisoned last year. Records show how, time and again, the contamination went unnoticed across borders.
by Will FitzgibbonandChristina Jewett
February 27, 2024
"Cinnamon-flavored applesauce pouches sold in grocery and dollar stores last year poisoned hundreds of American children with extremely high doses of lead, leaving anxious parents to watch for signs of brain damage, developmental delays and seizures.
"The U.S. Food and Drug Administration, citing Ecuadorian investigators, said a spice grinder was likely responsible for the contamination and said the quick recall of three million applesauce pouches protected the food supply.
"But hundreds of pages of documents obtained by The Examination, in collaborations with The New York Times and El Universo, along with interviews with government and company officials in multiple countries, show that in the weeks and months before the recall, the tainted applesauce sailed through a series of checkpoints in a food safety system meant to protect American consumers.
"The documents and interviews offer the clearest accounting to date of the most widespread toxic exposure in food marketed to young children in decades. Children in 44 states ate the tainted applesauce, some of which contained lead at extraordinarily high levels.
"Time and again, the tainted #cinnamon went untested and undiscovered, the result of an overstretched FDA and a food safety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test.
"'It’s amazing in a bad sense what a catastrophic failure this was,' said Neal Fortin, director of the Institute for Food Laws and Regulations at Michigan State University. 'Largely, the food supply regulatory system is based on an honor system.'
"The cinnamon originated in #SriLanka and was shipped to #Ecuador, where it was ground into a powder. It was probably there, the FDA has said, that the cinnamon was likely contaminated with #LeadChromate, a powder that is sometimes illegally used to tint or bulk up spices.
"The ground cinnamon was then sold, bagged and sold again to a company called #Austrofood, which blended it into applesauce and shipped pouches to the United States. It was sold under the brand name #WanaBana and various generic store labels.
"Austrofood never tested the cinnamon or its tainted applesauce before shipping it to the United States. The company said it relied on a certificate from a supplier saying the cinnamon was virtually lead free, records show. In a statement, the supplier, Negasmart, did not discuss that certification but said it had complied with all regulations and quality standards.
"The FDA can inspect overseas food companies that ship to the United States, but even as food imports soared to record levels in 2022, international inspections fell far short of targets set by law.
"American inspectors had not visited Austrofood in five years, records show.
"'Companies have the responsibility to take steps to assure that the products they manufacture are not contaminated with unsafe levels of heavy metals,' Jim Jones, the top FDA food official, said in a statement. 'The agency’s job is to help the industry comply and hold those who evade these requirements accountable, as appropriate.'
"The FDA says it has no authority to investigate far down the international supply chain. Records show that the Ecuadorian government had the authority but not the capacity. Ecuadorian regulators had never before tested cinnamon for toxins and, when the FDA called looking for help, nearly half of the government’s lab equipment was out of service, said Daniel Sánchez, the head of Ecuador’s food safety agency.
"Private safety audits commissioned by American importers are supposed to provide another layer of protection. But audits typically look only for the hazards that the importers themselves have identified.
"None of the importers would say whether they considered lead a risk or tested for it and it is unclear what, if any, steps they took. But none blocked the applesauce. Records show one auditor gave the applesauce maker an A+ safety rating in December, as American children were being poisoned.
"The FDA has the power to test food arriving at the border. There is no indication that anyone tested the applesauce when it arrived at ports in Miami and Baltimore. Inspectors conduct about half as many such tests as they did a decade ago.
"The FDA said it planned to analyze the incident and whether it needs to seek new powers from Congress to prevent future outbreaks."
#FDA approves 1st-of-its-kind treatment for severe food allergies
Many food allergies are driven by IgE, including those to milk, eggs, soy, peanuts, tree nuts, fish, shellfish and wheat. New med grabs hold of (IgE), the type of body-made antibody primarily responsible for allergic reactions