FDA’s Lethal Regulations

FDA's Lethal Regulations
FDA’s Lethal Regulations

As with all regulatory agencies when left unchecked, the FDA causes great harm through its hyper-authoritarian stances and rules as well as preventing harm through other rules. It’s why such agencies, operating outside of legislation but having the force of law, need to be regularly checked and forced to defend their actions by properly elected officials.

A perfect case in point is the FDA’s lethal regulations that categorically and absolutely forbid drug manufacturers engaging in any form of speech which can be construed as describing or promoting a use of their drug(s) for any use other than an the FDA approved on-label use, even if the information about this other use is entirely truthful, totally non-misleading, and could help physicians better treat their patients.

As a result of the FDAโ€™s interpretation of the Federal Food, Drug and Cosmetic Act (FDCA), manufacturers of pharmaceuticals may face severe penalties for disseminating truthful and non-misleading information about off-label uses before those uses are approved by the FDA. Indeed, some companies have paid settlements of hundreds of millions or billions of dollars in the face of threatened prosecution or trial in civil false claims cases. Governments and other private actors do not suffer the same burdens on their speech, even though the pharmaceutical manufacturer likely has the most complete, up-to-date, and useful information about the product. Moreover, even when it makes economic sense for a pharmaceutical manufacturer to seek FDA approval for a new use, the FDA can take many months or even years to approve such new uses. Patients โ€” especially those with life-threatening conditions โ€” cannot wait for the agency to act. Even with recent changes in the FDCA, if a new use concerns a rare disease โ€” or the drug is off-patent โ€” it may not be economical for the pharmaceutical manufacturer to seek approval of a new use.

Regulatory Transparency Project

And, sadly, this is lethal regulatory intransigence and tyranny. It has killed, is killing, and will continue to kill people. And all for no valid purposes other than keeping the manufacturers of pharmaceuticals on their proverbial knees before the Deep State and maintaining the perceived relevance – and budget appropriations – of the FDA.

With the FDA censoring what drug makers can publish – even when it’s true, simply presented, and efficacious – many doctors aren’t able to know that there are alternative, off-label, treatment options available for their patients. Similarly, this censorship makes it functionally and legally impossible for health insurance providers to cover the costs of those prescriptions. That has, can, and will kill people – all for the sake of the powermongers of the FDA.

This seems to be no longer be true, but in my day, if you wanted to try CHANTIX to aid you in stopping smoking, insurance wouldn’t cover it because it was an off-label use of the medication.

And, if we’re to even begin to believe the current, #Woke sorts, this is systemic racism since non-Whites, especially the Blacks, are less likely to be able to afford medications that aren’t covered by health insurance. Hence, they’re “disproportionately impacted” by the FDA’s lethal regulations upon free speech involving medicines’ uses.

Honestly, American or Democrat, everyone should be calling for a end to the FDA’s lethal regulation and censorship and calling upon the organization to account for and defend its regulations – which aren’t laws but carry the weight thereof without Legislative oversight – or be forced to abandon them.

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Feeding The Hordes

The FLOTUS, Michelle Obama and her husband’s FDA have decide that the long-serving Food Guide Pyramid was just too damn difficult for her husband’s constituency to understand. Hence, they replaced it with a plate divided into sections with very simplistic labels.

Choose My Plate
So…What’s a Potato? Or Spinach?

Normally I would ignore the politically correct sop thrown to the vegans by using “protein” as opposed to “meat, fish, and eggs,” but it’s part of the problem with this new program. Four general classes of food and a nutrient?

You want to make it understandable? Then pick a freaking metric and stick with it, you valueless idiots! Mixing them for sake of the votes of a few strident fringe dwellers will just cause harm.

And where are the fats and oils? Is everyone expected to go on a raw foods diets or don’t cooking methods and saucing matter anymore?

How about strawberry cheesecake? Since sweets aren’t mentioned at all, does that imply that it shouldn’t be eaten or is it one fruit and one dairy?

For the Obamas and those toadies and donors they’ve appointment to the federal government’s bureaucracy it’s gets even worse. Their core constituency and the only one left solidly behind them, the Obama Zombies, need a slightly different diet in order to stay vigorous and, hence, need a different Food Guide… ๐Ÿ˜›

Zombie Food Pyramid
OooooobaaAAAmmaaa! We’re Entitled To Their Brains

Sadly the shambling, yet still dangerous, hordes of zombies that support Obama aren’t quite as teachable as the average flatworm. No matter how many Americans’ brains they devour, they still won’t learn anything.

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Selling Fear & Loathing

As I’ve posted before, if Obama’s FDA and HHS were really trying to curtail smoking by Americans, the ads they’ve chosen will fail just as every previous attempt at social engineering of people’s habit through fear-mongering have failed.

Anti-Smoking Ad
Eeeeeeewwwwww!

On the other hand, disgust and loathing work better than fear in almost all cases. It’s just a matter of marketing. ๐Ÿ˜‰

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Graphic Propaganda

Americans need to put a stop, by any and means necessary, to the encroachment of the Nanny StateBeginning September 2012, Obama’s FDA will require larger, more prominent cigarette health warnings on all cigarette packaging. They claim that the introduction of these warnings is expected to lower medical costs, a necessity if ObamaCare is not undone by the American courts and/or Congress.

It’s a just another of Obama’s many lies though.

It strains rational credulity to believe that this bit of fear-mongering will work any better than any of the plethora of such campaigns have worked in the past. It strains rational credulity past the breaking point to think that Obama and his appointees in the FDA and HHS don’t know this fact.

Obama’s Nanny State Fear-Mongering
Because This Has Worked So Well Before…

It well might meet Obama’s and his Liberals’ true goals though – the further destruction of the economy of the South where the vast majority of America’s tobacco is grown and processed. After all, these are historically red states and the Liberals’ best hope is to crush their economies in order to either cause people to leave or be shackled by government subsistence level hand-outs.

The placement requirements for this propaganda make their goal of brand destruction and impeding sales quite clear:

  1. On the top 50 percent of both the front and rear panels of each cigarette package.
  2. In the upper portion of each cigarette advertisement, occupying at least 20 percent of the area of the advertisement.

The actual, and I believe planned, effect of Obama’s FDA’s new cigarette label regulations will be to make it harder for smokers and retailers to swiftly identify brands and types of cigarettes at the time of sale.

FDA Approved Cigarette Display
Now Where’s My Cigarettes?

Such backhanded tactics by Obama and his sort don’t actually sink to the legal definition of a prior restraint, but they do certainly approach the functional level of such due to the added aggravation and time such labeling regulations will cause both shoppers and retailers.

These delays will also aggravate others waiting in the check-out lines, a bit of social engineering designed to further vilify and isolate American smokers that I’m sure is part and parcel of the Liberals’ plan.

Of course, if this goes like ObamaCare has so far, Newports and Kools will be given exemptions due to the “disproportion impact” upon Blacks, i.e., trusted Democrat sharecroppers voters.

The warning ads are useless, graphic propaganda that will be, like all other such things, ignored by the majority. The placement requirements, however, will do much to further Obama’s real goals, which is something for every man and woman in the southern states to remember as we approach the 2012 elections.

~*~

Keep your eyes open. Travel light but load heavy, and always put another round in the enemy after theyโ€™re down. ๐Ÿ˜‰

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Regulating Your Diet

The Obama regime is, once again, expanding its power at the expense of the personal liberty of each and every American citizen. They are of course doing this for our own good – or so they will continue to claim just as all titularly beneficent tyrants do, often even as the People place a well-earned noose around their necks.

The latest excess of Obama’s nanny state is his regime’s burgeoning war on what Americans are allowed to eat and drink – specifically how much salt we’re allowed to have ready access to.

Naturally Obama’s and his Liberals’ pet media stayed largely silent on this latest intrusion into Americans’ personal lives by the regime, which is why, almost a month after the announcement, I finally found out about it. A few outlets, mostly print, did report on it though.

As reported on April 20, 2010 by the Washington Post:

The Food and Drug Administration is planning an unprecedented effort to gradually reduce the salt consumed each day by Americans, saying that less sodium in everything from soup to nuts would prevent thousands of deaths from hypertension and heart disease. The initiative, to be launched this year, would eventually lead to the first legal limits on the amount of salt allowed in food products.
This Story

The government intends to work with the food industry and health experts to reduce sodium gradually over a period of years to adjust the American palate to a less salty diet, according to FDA sources, who spoke on condition of anonymity because the initiative had not been formally announced.

Officials have not determined the salt limits. In a complicated undertaking, the FDA would analyze the salt in spaghetti sauces, breads and thousands of other products that make up the $600 billion food and beverage market, sources said. Working with food manufacturers, the government would set limits for salt in these categories, designed to gradually ratchet down sodium consumption. The changes would be calibrated so that consumers barely notice the modification.

The legal limits would be open to public comment, but administration officials do not think they need additional authority from Congress.

“This is a 10-year program,” one source said. “This is not rolling off a log. We’re talking about a comprehensive phase-down of a widely used ingredient. We’re talking about embedded tastes in a whole generation of people.”

The FDA, which regulates most processed foods, would be joined in the effort by the U.S. Department of Agriculture, which oversees meat and poultry.

Currently, manufacturers can use as much salt as they like in products because under federal standards, it falls into the category deemed “generally recognized as safe.” Foodmakers are merely required to report the amount on nutrition labels.

But for the past 30 years, health officials have grown increasingly alarmed as salt intake has increased with the explosion in processed foods and restaurant meals. Most adults consume about twice the government’s daily recommended limit, according to the Centers for Disease Control and Prevention.
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Until now, the government has pushed the food industry to voluntarily reduce salt and tried to educate consumers about the dangers of excessive sodium. But in a study to be released Wednesday, an expert panel convened by the Institute of Medicine concludes that those measures have failed. The panel will recommend that the government take action, according to sources familiar with the findings.

Although the specifics of the government’s plans have not been made public, the food industry has been bracing for a federal initiative.

The facts of this report have also been independently confirmed on April 21, 2010 by the Los Angeles Times.

Such an action by Obama’s “Food Police” is in no way surprising. After lying, cheating, bribing, and bludgeoning their way into inflicting Obamacare unto a largely unwilling citizenry it became in the federal government’s interest to regulate and strictly control any and all actions that the formerly free citizens of our country might take which would affect their overall health index. The federal government’s doing so became, instantly upon Obamacare’s passage into law, an economic requirement.

Oh yes! You and I need not even bother being our brothers’ keeper; Big Brother will be the keeper of us all and ensure that we remain healthy and appropriately fed – if we let them do so.

To paraphrase from Charlton Heston’s character, George Taylor in Planet of the Apes, “Take your stinking paws off my food, you damn dirty apes!”

The question before the American people is whether or not we have the conviction and the will to do whatever is necessary to put a stop to them.

Keep your eyes open. Travel light but load heavy, and always put another round in the enemy after theyโ€™re down. ;-)

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