Posts Tagged Agency
June 28, 2012
By their very website their charter clearly states:
“FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”1
Some would surmise that since the FDA – with the above maxim to boot – is a Government Agency, then it must be doing its’ job. However, nothing could be further from the truth.
A few glaring instances of their failure to follow their very adage will be presented below. These examples implicitly dissolve the FDA’s very dictum.
Let’s now take a gander at an excerpt from the unparalleled book 63 Documents The Government Dosn’t Want You To Read by Jesse Ventura & Dick Russell.
Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming contaminated foods and beverages. Recent high-profile outbreaks of foodborne illness have raised serious questions about FDA’s inspections process and its ability to protect the Nation’s food supply. The Senate Committee on Agriculture, Nutrition, and Forestry requested that the Office of Inspector General [OIG] review the extent to which FDA conducts food facility inspections and identifies violations.
FDA inspects food facilities to ensure food safety and compliance with regulations. During an inspection, FDA inspectors may identify potential violations of the Food, Drug, and Cosmetic Act as well as other applicable laws and regulations. Based on the outcome of the inspection, FDA assigns a facility one of three classifications: official action indicated [OAI], voluntary action indicated [VAI], or no action indicated [NAI]. In addition, FDA may choose to change a facility’s initial classification to another classification under certain circumstances.
FDA relies on several approaches to determine whether a facility corrected the violations found by inspectors. FDA may review evidence provided by a food facility describing any completed corrective actions. FDA may also reinspect a facility to verify that corrections were made.
On average, FDA inspects less than a quarter of food facilities each year, and the number of facilities inspected has declined over time. Between the fiscal years [FY] 2004 & 2008, FDA inspected annually an average of 24 percent of the food facilities subject to its inspection. Except for a few instances, there are no specific guidelines that govern the frequency with which inspections should occur. Further, the number of food facilities that FDA inspected declined between FY’s 2004 & 2008, even as the number of food facilities increased. In addition, the number of inspections of facilities that have been desginated by FDA as “high risk” has also declined. FDA officials noted the overall decline in FDA inspections was largely due to a decline in staffing levels.
Fifty-six percent of food facilities have gone 5 or more years without an FDA inspection. FDA identified 51,229 food facilities that were subject to inspection and were in business from the start of FY 2004 until the end of FY 2008. Of these, 56 percent were not inspected at all, 14 percent were inspected a single time, and the remaining 30 percent were inspected two or more times. If FDA does not routinely inspect food facilities, it is unable to guarantee that these facilities are complying with applicable laws and regulations.
The number of facilities that received OAI classifications has declined over time. The number of inspected facilities that received OAI classsficiations decreased from 614 in FY 204 to 283 in FY 2008. The percentage of facilities that received OAI classifications also dropped from nearly 4 percent to nearly 2 percent during this 5-year period. In addition, nearly three-quarters of the facilities that received OAI classifications in FY 2008 had a history of violations. Two percent of facilities that received OAI classifications refused to grant FDA officials access to their records.
FDA took regulatory action againts 46 percent of the facilities with initial OAI classifications; for the remainder, FDA either lowered the classification or took no regulatory action. In FY 2007, a total of 446 facilities initialy received OAI classifications. FDA took regulatory action against 46 percent of these facilities. For the remainder, FDA lowered the OAI classification for 29 percent and took no regulatory action for 25 percent.
For 36 percent of the facilities with OAI classifications in FY 2007, FDA took no additional steps to ensure that the violations were corrected. In FY 2007, 280 facilities received OAI classifications that were not lowered by FDA. For 36 percent of these facilities, FDA did not reinspect them within a year of the inspection or review other evidence provided by facilities to ensure that the violations were corrected.2
As can be gathered by the information above, the FDA has had an extremely questionable modus operandi for starters. Their failure to act in many circumstances against violating facilities not only shows their lack of initiative to tackle issues that are imperative, but in addition also showcases the downright negligence to carry out their charter, which poses a great threat to the American public’s health.
The fact that the FDA does not also have the manpower to conduct its much needed operations is no excuse for the poor inspection performance either.
In addition to their lassitude in face of violations, the FDA has also undertaken a censorship operation in attacking walnuts, not only claiming they pose no health benefits, but also stating them to be “unapproved drugs.”3 In fact there is plentiful evidence that points to the contrary.4 Not only have walnuts been shown to help againts osteoporosis, but its also been shown to safeguard againts cancer.5
Now why would the FDA undertake a campaign againts a food that helps fight cancer? Was that just one case in which they attacked by ‘coincidence’ a benificial food, or are there other examples of this? Do they have an agenda we do not know about? Is there additional evidence of this? If there is evidence, how deep does this dilemma go? We will attempt to tackle many of these questions in the next segment that touches deeper upon the FDA’s hazardous track record.
For now, always remember, healthy skepticism never hurt anybody. And always make sure to do your research irrespective of topic – it can only be benificial.
Sources for this article:
 63 Document’s The Government Does Not Want You To Read. Jesse Ventura & Dick Russell. Skyhorse Publishing. New York. 2011. p.146, 147, 148.
By: Tyler Durden
June 25, 2012
While everyone’s attention was focused on details surrounding the household sector in the recently released Q1 Flow of Funds report (ours included), something much more important happened in the US economy from a flow perspective, something which, in fact, has not happened since December of 1995, when liabilities in the deposit-free US Shadow Banking system for the first time ever became larger than liabilities held by traditional financial institutions, or those whose funding comes primarily from deposits. As a reminder, Zero Hedge has been covering the topic of Shadow Banking for over two years, as it is our contention that this massive, and virtually undiscussed component of the US real economy (that which is never covered by hobby economists’ three letter economic theories used to validate socialism, or even any version of (neo-)Keynesianism as shadow banking in its proper, virulent form did not exist until the late 1990s and yet is the same size as total US GDP!), is, on the margin, the most important one:in fact one that defines, or at least should, monetary policy more than most imagine, and also explains why despite trillions in new money having been created out of thin air, the flow through into the general economy has been negligible.
Before we get into the nuances, here, courtesy of Zoltan Pozsar is a reminder of the nebulous entity under discussion which is the definition of “baffle them with bullshit.” We recommend only Intel chip technicians try to make any sense of this schematic.