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!
I am not arguing against food or drug safety. I know several producers, a former veterinarian meat inspector and a couple of registered food scientists who work in quality control. I have relatives who are medical clinicians and scientists working for pharmaceutical companies.
The fault(s) are shared. Unfortunately, any regulatory scheme only deals with things after the fact, after the contamination has been discovered, either by the QA person or after an outbreak.Notifying the public during or after an outbreak is preferable to no notification at all, but can only work to close down the source after the fact. Further injury may be prevented, but injury has still occurred.
I believe that the push from the public for local sources and basic foods(not processed) has come about because of a distrust of large conglomerate producers and processors. Everyone understands the economics of scale,however, there are many steps in the chain of production and processing that appear vulnerable to contamination, regardless of an FDA.
If I understand you correctly, drugs, supplements, devices and treatment protocols are approved prior to large scale real world *testing* via distribution to the public (Stage Four). This perhaps needs to be rethought. I have taken one undergraduate course in microbiology, over 50 years ago, but I do remember that even there, there was a time lag between culturing and getting the results. Perhaps that has changed w/technology. However, it does appear that much of this regulation depends upon reacting after the fact. Certainly, this can be improved upon.
It has been over 35 years since I consumed bulk tank milk. My family drank it for 4 years or so, until the rules changed. We checked out each producer with local vets, with other dairy farmers and other consumers. We visually inspected the premises. We brought out own sterilized containers. I was aware, as are all such consumers, of the inherent dangers. The responsibility was mine. As I recall, there was never a hint of food-borne illness back then from responsible producers.
Accidents happen, even with a massive regulatory bureaucracy. Arming these bureaucrats seems excessive. I see no problem with the law requiring proof of willful intent and disarming of the regulatory inspectors/enforcers.
Life is full of risks. Everyone needs to be responsible. Armed intimidation stops no outbreak, no side effect nor defective device. Much of the regulatory process appears to be theater. I still must be a savvy consumer. I will not purchase those huge tubes of ground beef from huge processors. In my kitchen, I assume chicken is contaminated before cooking. I do not consume raw eggs, although, growing up in the 40s and 50s, everyone occasionally did so. People ate steak tartare regularly, as well.No one ever feared fresh greens until well after this regulatory agency came into existence. I do not purchase or consume drugs with extensive black box warnings. I have done so in the past and was less than satisfied with my clinician’s response to my adverse experiences. I examine all information available on supplements and have still had adverse, individualistic reactions. I do not expect some massive bureaucracy to keep me safe. I do not presume that a gun in the hands of people who want to limit the average citizen’s access to firearms will keep anyone safe.
“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.”
You have immense and misplaced trust in the FDA. There are so many studies and commentaries on how the FDA is riddled with conflicts of interest. The board members of FDA are mostly former employees of pharmaceutical companies.
Look how the drug companies are allowed to leave out studies which show side effects and non-efficacy. FDA approval has become a complete joke.
Look at how many drugs were introduced after approval and later turned out to be deadly under normal use. Then it turns out that the negative information was known before approval.
The FDA needs serious reform. At least Rand Paul understands that.