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Sunday, December 29, 2013

MooPig Government Regulations Department :: "What doesn't FDA regulate?

Transparency in the FDA
mashed articles by Pat Darnell |  Dec 29, 2013  |  Bryan TX

[Picture LINK unknown]

I am doing the right thing this morning. I am sorting through the FDA Gov site, and trying to wrap my mind around it.

Everything today seems like it is a Federal Case. We at MooPig Government Regulations Department are inundated with reports by whistle-blowers from within Government Regulatory Offices. Who to believe? Where do we draw the line to the cynicism that all this mess causes, until the American people just throw their hands up in surrender?

This is a good question. Our FDA does not regulate everything you think it would.

FDA Basics :: What doesn’t FDA regulate? How do I contact the agencies that do?: "What doesn't FDA regulate? How do I contact the agencies that do?

FDA does not regulate:
  • advertising (except for prescription drugs, medical devices, and tobacco products)
  • some consumer products, such as paint, child-resistant packages, baby toys, and household appliances (except for those that give off radiation)
  • illegal drugs of abuse, such as heroin and marijuana
  • health insurance meat and poultry (except for game meats, such as venison, ostrich, and snake) 
  • restaurants and grocery stores 
  • vaccines for infectious animal diseases
FDA shares the responsibility for regulating these products with other government agencies:
  • pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency regulate these)
  • water (FDA regulates the labeling and safety of bottled water, while the Environmental Protection Agency develops national standards for drinking water from municipal water supplies)"
'via Blog this'

Let's look at one product line, shall we? Advertising in Tobacco. From FDA Transparency files we have this slide show:
Tobacco is the leading cause of preventable death and disease in the U.S.
  • Tobacco dependence is a life-threatening condition There are 45 million smokers in the
  • U.S. and 440,000 people die every year Each day in the United States
  • 3,600 kids under 18 years of age smoke their first cigarette, and over 700 kids become regular smokers (Slide 3)
Are you already bored with bullet presentations? I am. Let's push on:
FDA’s ability to enact science-based regulation has the true potential to reduce the death and disease toll from the most harmful products
  • A main goal is to have a country free of tobacco related disease and death
  • Passage of the Tobacco Control Act means that FDA has many tools to help meet that goal
  • FDA regulates an extremely addictive and toxic product
  • But people smoke for the nicotine while dying from the tar
  • Ongoing debate about how to regulate products based upon where they fit on a “continuum of risk” given their toxicities and how they are used (Slide 12)
[Picture LINK] Narcoti-Cure, Cures the Tobacco Habit - Vintage Drug Pharmaceutical Advertising Art Nouveau Poster

It's a mess. I could spend a whole school term on this FDA web site. What stands out is their commitment to transparency. However, I cannot find any tidbits concerning "in-house whistle-blowers at the FDA." For those we must travel Google source maps, such as Former FDA reviewer speaks out about intimidation, retaliation and marginalizing of safety (By Martha Rosenberg Posted on August 22, 2012).
" ... The agency, [FDA], using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show. (ERIC LICHTBLAU and SCOTT SHANE. Published: July 14, 2012. LINK ) ..."
For instnace: looking for guidance on the site is going to be a tough search for anyone trying to figure out how to guard against youth using tobacco products. Smokers' smoke for the nicotine, and die from the tar, that is a fact. But, does transparency refer to this type of searching, or to its internal investigations of its employees and their governmental contacts all over the world?

" ... Government agencies cannot discourage whistle-blowing and reporting of wrongdoing by monitoring employees, echoed a White House memo sent to all government agencies about the FDA spy program. (ibid. Martha Rosenberg. LINK ) ... "

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