This is why people are morons.
OK, so I'm updating my myspace page and I accidentally see a bulletin someone on my "friends" list posted. Since it's the Miss Poly Manners site, these people aren't actually my friends, they're followers of MPM, so I take no responsibility for the level of stupidity I'm about to reveal.
The headline of the bulletin reads:
FDA THREATENS CHEERIOS! says it's a drug - WTF??! Now, I get the FDA recall notices directly from the government, in my inbox daily. I don't recall seeing any notice like this, nor seeing any headlines anywhere else. So I was curious because it sounded so far-fetched. I clicked on it.
This moron starts out with a rant about how the FDA needs to be dismantled completely. He is completely unaware of all the protections the FDA has placed on corporations and food producers (not to mention those greedy pharmaceutical companies) to prevent them from trying to slip something harmful into our marketplace or make baseless claims to rip off unknowing consumers. It's always amazing to me how uninformed and ignorant people are of how our government actually works, and how much is taken for granted.
Of course the government isn't perfect, and the FDA doesn't have a spotless record. One of the things that's so great about this country (in theory) is that we can and are supposed to be keeping an eye on the government, y'know, watching the watchmen. But you GOTTA have some idea of what you're looking at before you can make reasonable claims about what is going on. And the point is that for every drug that slips through the cracks, there are several thousand other drugs that are caught and prevented from being released onto the shelves that are harmful or that do not work as advertised. And
BECAUSE the FDA does its job as well as it does, we have the luxury of being complete idiots who can't see how we're being protected.
In my business, we have a saying: "If they notice you, you aren't doing it right". This means that if we did our jobs properly, no one will see us or see how we did it. If someone *does* notice us, it's because we fucked up somewhere and brought the audience member's attention to us or our screw-up. There's a reason why our job is a thankless one. We're supposed to go unnoticed. And our government is the same way in a lot of ways. I have lamented on several occasions, and a friend just did so very recently, that it's incredibly sad how excited I am to have a president make pro-science statements. It's coming to our attention because the last 12 years were such a monstrous clusterfuck of anti-intellectualism. These statements *
should* go completely unnoticed and unremarked because it should be so commonplace that we don't even hear them.
And that's what the FDA is like. When they do their job right, we don't hear anything from them. We don't think about the hours of scrutiny and research and evaluation that went into each and every bite of food we put in our mouths, or the YEARS of testing that resulted in our over-the-counter bottles of ibuprofin. We only hear about the FDA when they do something we don't like. And if we do not understand the processes used by the FDA, then we make stupid accusations like the government intentionally wanting to piss off consumers with their fancy-schmancy technical talk. That sound familiar?
Here, I'll just let ya'll read what he thinks of the FDA:
Oo I think it's time to dismantle the FDA entirely. This is taking anal retentive bullshit way too far. Who exactly hires these obviously retarded people in the FDA anyways?
Cheerios is not a drug. It's food. Shut the fuck up and leave my fucking Cheerios along you fucking FDA morons.
I'd laugh if bullshit laws, regulations, and rules collapsed America under their oppressive overbearing mass and cause our nation to implode in on itself like a neutron star.
This is just another example of people in the system being too damn controlling and spending too much time fapping to the idea of pissing off us consumers with their senseless technical jargon.
They remind me of fucking Vogons.
What the FDA is
ACTUALLY doing is responding to a specific health claim that General Mills makes about Cheerios ... exactly as they're supposed to.
You see, GM claims that eating Cheerios can lower cholesterol, which is a risk factor for coronary heart disease and they cite a clinical study. This indicates that GM is making a
specific health claim that is
intended to treat a disease. Since Cheerios has not been submitted to the FDA for approval of these claims, that makes it, technically and by definition, a "new drug".
Let me repeat that.
GM claims that their product can prevent or treat coronary heart disease.
This falls under the classification of a drug by the FDA. If GM wants to go back to saying "Cheerios is part of a balanced breakfast" and doesn't reference any specific disease that it can treat, then it's considered a food product. But as long as it claims to treat or prevent a specific disease, it must be regulated as a drug by the FDA.
The FDA sent a letter to GM saying they can either submit their claims for approval or change their marketing. That's Standard Operating Procedure, and the one that works to keep false and harmful drugs off our store shelves.
GM responded by saying their heart-benefit statement was approved by the FDA 12 years ago and the cholesterol message has been on the box for 2 years. If that's true, well, then yeah, someone at the FDA needs to explain what they think they're doing. Maybe they restructured the regulations or definitions or something or maybe it has been in violation all these years and no one did anything about it until now.
But, as the regulations stand as of today, making a claim that your product can prevent or treat a specific disease marks your product as a drug to be regulated by the FDA. Period. This is why we have so much crap on the shelves claiming to "boost your immune system" and "give you energy". These are not treating any diseases, and they are addressing non-specific symptoms that are notoriously susceptible to placebos and suggestion and are also completely undetectable from psychosomatic symptoms in most cases.
Which means that if the company gets the packaging and commercials right, they *will* actually do these things, in a totally untestable, unfalsifiable, unmeasurable way. Therefore, they are not subject to the FDA drug-approval process. If you eat apples, chances are you'll get an energy boost too. And, as the old saying goes, an apple a day will keep the doctor away. In other words, it's food that doesn't actively harm anyone who isn't allergic to it, and not a drug.
But as soon as apple growers slap a label on their apples that says "eating 2 of these a day will cure cancer", then the FDA steps in to make sure that claim is valid and the apple isn't harmful and the apple becomes labeled a "drug". Just as they're supposed to.
Oh yeah, here's the actual article:
Cheerios Are a Drug? FDA's Surprising Letter to General Mills
By , Agence France Presse
Posted on May 13, 2009, Printed on May 13, 2009
http://www.alternet.org/story/139990/ Popular US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.
"Based on claims made on your product's label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.
Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks.
Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.
Those claims indicate that Cheerios -- said by General Mills to be the best-selling cereal in the United States -- is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholestero
lemia, and to treat and prevent coronary heart disease.
"Because of these intended uses, the product is a drug," the FDA concluded in its letter.
Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholestero
lemia or coronary heart disease," the FDA said.
That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-
shaped cereal, the FDA said.
General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.
The FDA's quibble is not about whether Cheerios cereal is good for you but over "how the Cheerios cholesterol-
lowering information is presented on the Cheerios package and website," said General Mills.
"We look forward to discussing this with FDA and to reaching a resolution."
Meanwhile, the FDA warned in its letter that if General Mills fails to "correct the violations" on its labels, boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action.
According to General Mills, one in eight boxes of cereal sold in the United States is a box of Cheerios. The cereal debuted on the US market in 1941.
© 2009 Agence France Presse All rights reserved.
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