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To: exDemMom

As I read the bill, it strengthens the need to prove willful and knowing intent to cause harm AND it disarms the agency. It allows an oat cereal to state that studies show oat fiber can reduce cholesterol or that prune juice can be laxative. That is not wholesale allowing of snake oil. Oat fiber or prune juice will not kill or even injure you and if you want to drink raw milk, that is not the purview of government. Yes, the individual drinking the milk _could_ become ill, but they aren’t going to cause an epidemic. Millions of us have ingested clean milk direct from a bulk tank or from a cow and lived to tell the tale. I am one of those.

And, as I understand it, it did not pass.

OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.

Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.

A government bureaucracy is not eliminating threats by regulating around the edges of the problem. They appear to go after relatively innocent practices while not being able to address the serious problems.


10 posted on 05/28/2012 5:46:07 AM PDT by reformedliberal
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To: reformedliberal
As I read the bill, it strengthens the need to prove willful and knowing intent to cause harm AND it disarms the agency. It allows an oat cereal to state that studies show oat fiber can reduce cholesterol or that prune juice can be laxative. That is not wholesale allowing of snake oil. Oat fiber or prune juice will not kill or even injure you and if you want to drink raw milk, that is not the purview of government. Yes, the individual drinking the milk _could_ become ill, but they aren’t going to cause an epidemic. Millions of us have ingested clean milk direct from a bulk tank or from a cow and lived to tell the tale. I am one of those.

As things are, the FDA only steps in when the claims are not supported by solid published scientific studies. And the language of the claims is limited: my box of Quaker Oats says that "3 grams of soluble fiber...may reduce the risk of heart disease" (emphasis mine). Without those limitations, we'd see all kinds of fantastic, scientifically unsupported claims made about various foods.

As for drinking raw milk without ever getting ill from it, that is just a matter of chance. The reason for the heavy regulation of raw milk in the ~20 states that even allow its sale is that, relative to the amount consumed, raw milk is associated with more food poisoning outbreaks than any other food product.

OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.

The nature of clinical trials means that adverse effects that occur at a rate of ~1/1000 or less probably won't be picked up during a clinical trial. For that reason, a fourth clinical trial is conducted after drug/device approval, which is meant to catch those rarer adverse effects. Plus, there are reporting mechanisms that alert the FDA to the need for specific investigations. Another consideration would be the risk/benefit ratio. The FDA isn't perfect, but it is still the best mechanism we have for ensuring that the benefits of any drug/device sufficiently outweigh its risks. I hate to think what would happen if we didn't have the FDA acting as a central regulatory agency for these things. Trying to prove that a drug is harmful would be nearly impossible without having accessible data on side effects and so forth. Trying to prove that a drug does or doesn't have the claimed effect would also be nearly impossible without scientific data. The Libertarian notion that such adverse effects would be adequately addressed by the free market may be romantic, but it never actually happened (which is why the FDA was created). You only have to look at China to see what happens in an unregulated environment.

Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.

Are those failures the fault of the inspectors who check whether the farm/factory/stores/restaurants are storing and processing food products in accordance with the scientifically developed regulations? Or are those failures the fault of farmers/manufacturers/grocers/restaurateurs who flout the regulations and basically ignore food safety? The regulations are written to reflect the latest scientific information on food safety. The USDA and FDA inspectors can only do so much to ensure that the regulations are being followed. And then, when they are trying to ensure basic food safety, they're accused of "attacking innocent practices."

I've been to several American Society of Microbiology meetings. After going to those meetings and seeing presentations discussing various challenges of food safety, I've come to realize that it takes a HUGE effort to provide a safe food supply. A single small mistake anywhere within the production/distribution chain can negate the efforts of everyone else involved in that particular chain, which could be hundreds of individuals. Food safety is not a trivial matter!

14 posted on 05/28/2012 7:02:56 AM PDT by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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