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The Sad Truth About FDA Approval History

Most Americans trust that the food their family eats and the medications their doctors prescribe are safe and free of unwanted contaminates. This wide-scope view may be true, but when brought under the microscope of scrutiny, the guidelines that the FDA (Food and Drug Administration) uses may surprise and even scare you.

fda approvals 01America has some of the most rigid guidelines for food and drug production in the world, and yet, these rules are far from perfect. In fact, in examining the FDA approval history, many claim that the FDA leans in the direction of the Big Pharma and Food Conglomerates when implementing these guidelines, instead of the American consumer.

For example, in a recent CBS report on food production, it was discovered that the FDA has percentage tolerances for various foreign particles in US food products.

These particles include rat hair often found in peanuts and processed along with the nuts into peanut butter. Roach and other insect feces might be found in spices such as cinnamon. But wait, you may also find fly eggs in canned tomatoes since tomatoes seem to be a fruit fly’s favorite reproduction medium.

If these aren’t enough to churn your stomach, consider the FDA’s allowance of up to 12% mold in apples for applesauce and other canned apple products. Other insects and parasites often find their way into shelf products, but perhaps the most disconcerting particulates are non-animal, such as cigarette butts, sand, stones and even sticks.

FDA Approval History and Foreign Particles in Food

While it may seem outrageous to allow any foreign particle in the country’s foods, realistically, it’s considered nearly impossible to eliminate all foreign matter.

According to the FDA, the percentages allowed are so miniscule in comparison to the volume of food, it’s believed to impose little to no health risk. Still, many people contend that any percentage of containment is too much.

The term Defect Levels refers to the percentage of acceptable foreign particles in foods. While some naturally occurring particles such as insects are deemed acceptable, others aren’t. For example, the FDA Defect Level Handbook defines mold found in whole Allspice that is more than 5% of the berry weight to be a “potential health hazard – may contain mycotoxin producing fungi”.

The handbook guidelines evaluate contaminants based on two categories. The first is considered to be a potential health hazard and the second is aesthetic. The latter means that the percentage allowed will have no known health risk, but could present more of an aesthetic issue with consumers.

FDA Role in Medical Advances

fda approvals 02In addition to food regulation, the FDA plays a determining role in medicine. Many medical professionals believe the FDA has overstepped its purpose and thwarted advances in the field of medicine.

According to, prior to the FDA regulation of the pharmaceutical industry, consumers made these determinations of drug effectiveness and value. Could such a system survive in the twenty-first century burdened with endless lawsuits?

Even the FDA doesn’t serve as a buffer against such costly legal actions, but more importantly, the agency doesn’t seem to alleviate some of the highest risks many drugs pose to the human population.

Consumers often learn of class action lawsuit or drug recalls after detrimental side effects that often include death. In the face of such happenings, many people wonder why clinical trials don’t reveal such health risks. In fact, many have begun to scrutinize the FDA and its policies.

In this closer examination of the FDA approval history, many consumer advocates point fingers at the agency, claiming it places more allegiance with drug manufacturers than with consumers. According to techdirt, “the data from most clinical trials is totally hidden away.”

As a federal agency, it’s only expected that citizens have a right to absolute transparency for all clinical trial results. Fingers also point at the FDA’s responsibility to curtail the over-abundance of drug availability.

While the FDA is not responsible for the abuse of drugs, many claim that it plays a governing role in which drugs are available to consumers. The ease of availability and abundance of various drugs for every human ailment has resulted in a pill-dependent society. According to the article, Drugs: The Good, the Bad, and the Ugly by Mark Thornton:

We have been lulled into substituting prescription drugs for healthy lifestyles.

Thornton also points out that in other instances the FDA has slapped fines and taken legal action against pharmaceutical companies for marketing drugs for illnesses not approved by the FDA.

…such fines are just part of the cost of doing business with the FDA. No people have actually been punished…

Thornton concludes that third-party oversight is needed in order to remedy the FDA’s alliance with Big-Pharma.

Changes in bureaucracies don’t happen overnight, if at all. Several watch-dog organizations are vigilant in their quest to monitor the FDA. According to, in 2012 the FDA was sued for failure to disclose information about antibiotics used on animals that were later sold as food.

The lawsuit maintains that the FDA is in violation of the FOIA (Freedom Of Information Act) that ensures public disclosure, but the FDA cited that the documents “contain confidential commercial information”.

Consumer advocates argue this and similar lawsuits are evidence that the FDA’s allegiance is with the Big-Pharma and Food companies and not the American citizens it was created to protect.



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