In a special report today in the New York Times, it was revealed that the FDA’s failure in the New England Compounding Center meningitis outbreak was “ineffective” and “halting“.
I found the reveal particularly interesting, because I admit to letting the FDA off the proverbial hook by telling myself that they must have more important things to do than worrying about chicken jerky treats for dogs. When considering their limited resources and the enormous volume of products they are responsible for monitoring; it is natural to assume that they are burdened with making difficult decisions based on their workload.
That was before I read this article. Now, I am convinced that the FDA deserves no slack whatsoever. None.
For example, in today’s NYT piece, “Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection“. Wait a minute – 684 days? That is absurd.
When the warning letter from the agency eventually arrived, the New England Compounding Center said it was no longer relevant; as some changes had already been made during the 684 days since the FDA visited them.
The agency said in a statement Wednesday, in response to the oversight, that it, “was not the timeline we strive for”. How about, “we realize that we screwed up royally and we are as sorry as Hell about it, because had we had our sh*t together maybe none of this would have ever happened” instead?
You think 685 days is something? I got news for you, check out this timeline:
- The total number of days between the first FDA warning notice about chicken jerky treats posted on Thursday, September 27th, 2007 and today, Thursday, November 22nd, 2012 is 1,884 days.
- This is equal to exactly 5 years, 1 month, and 27 days.
- The total time span from 2007-09-27 to 2012-11-22 is 45,216 hours.
Which brings me to a bone I want to pick with the FDA: You know that part in the Food Safety Modernization Act (FSMA), the section about improving the safety imported goods? In it, there is a section that allows for inspection of foreign food facilities, which is a really good thing these days.
So, with that in mind, FDA inspectors went off to China in March to inspect five of the Chinese food facilities that make the treats the agency had received the most complaints for. But all did not go well in China, the agency inspectors were prevented from completing their investigation by the Chinese government.
What? They weren’t? Why, of all the nerve, you say.
According to inspection report documents, the Chinese government would not allow the FDA to take samples for testing in accredited laboratories in the U.S.
Slam dunk, right? Section 306 of the FSMA, inspection of foreign food facilities, allows FDA to deny entry of food if the foreign facility inspection is denied. In the agency’s Investigations Operations Manual it states that, ‘If the refusal is such you cannot conduct a satisfactory inspection, discuss with your supervisor if a Warrant for Inspection should be requested’. Did that ever happen? Nope.
Did the FDA issue an import alert on the products made at those Chinese facilities? Nope.
Eight months after the agency’s visit to China we are still scratching our heads wondering what in the world could be taking them so long?
A formal letter was sent to FDA commissioner Dr. Margaret Hamburg on August 24, 2012 demanding the answer to this question. Fast forward to today – what was her answer? Um, well…nothing – so far. For all we know, the letter, citing the relevant sections of the FSMA which gives the FDA full authority to act in this case, is gathering a thick layer of dust on Margaret’s desk.
In a scathing statement, Wenonah Hauter, Food & Water Watch’s executive director, blasted the FDA’s handling of the investigation, “Although the China investigation took place in April, it took the FDA four months to admit that they were denied permission from collecting samples from the Chinese facilities. As the FDA dragged its feet, the suspect treats remained on store shelves and put thousands of dogs at risk,” Hauter said, adding, “What’s more disgraceful than the FDA’s dawdling is the fact that it has full authority under Section 306 of the Food Safety Modernization Act to refuse shipments of these treats from China now.”
Sound familiar? It should. Read today’s piece in the New York Times: Oversight Failures Documented in Meningitis Outbreak.
You have to ask yourself, if the FDA can’t get their shit together when it comes to shutting down a filthy compounding pharmacy operation responsible for killing 50+ people and leaving thousands of others with a possible death sentence hanging over their heads that has been under investigation since 2002, where does that leave people with pets?
The FDA has a choice: They can issue an import alert on all the pet treats manufactured in China before more animals and the humans that love them suffer needlessly — or — they can wait.
How many more days must Americans wait for an answer? How many more pets have to become ill and die from the tainted treats, treats that even Dr. Dan McChesney, director of the Office of Surveillance and Compliance at the FDA Center for Veterinary Medicine, concedes there is clearly an apparent issue with chicken jerky treats.
After reading today’s piece in the NYT, my hope of receiving action (prompt or otherwise) from the agency has withered even more than before. In fact, it was that waning hope that eventually led to the formation of the Black Friday for Pets campaign. At one point, both Susan Thixton of Truth About Pet Food and I realized we needed ask retailers to step in where the FDA had dropped the ball.
It is our hope that retailers will take a more active role in protecting consumer health, just as Wal-Mart did last December when a product they carried was voluntarily removed from the market by them “out of an abundance of caution“.
We hope that you will stand with us, and all American families with pets, in urging retailers to do the right thing, “out of an abundance of caution”, by joining us on Black Friday for Pets at Wal-Mart stores nationwide.
People and their pets deserve more; Demand more of retailers, because when wallets speak, retailers listen. It’s time they heard from us.
To find out more about the campaign, please visit Black Friday for Pets and read the articles introducing the campaign here: Black Friday for Pets and here: Black Friday for Pets, a Protest to Stop the Sale of Deadly Pet Treats.
SOURCE: Oversight Failures Documented in Meningitis Outbreak (NYT)
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