Facts that Everyone Should [Know About] Fda Regulation

[Adam Fleming]

The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these areas.

For the average American consumer, the FDA is a protective agency that ensures that the foods and medicines consumed by Americans is of world class standards of quality and hygiene. It is also perceived as the agency that stalls bioterrorism by ensuring strict vigilance over this nefarious activity. All these make the FDA a source of comfort for many consumers in the US. After all, when Europe was shaken by the thalidomide scandal of the 1960’s, the FDA, under the stewardship of Frances Oldham Kelsey, showed exemplary alertness and diligence by not allowing it to be sold in the US because it failed to convince this woman of the extent of its standards into this product. The result: prevention of birth defects in potentially thousands or even hundreds of thousands of children, a malady that affected an entire generation in Europe.

To the manufacturers of the products that the FDA regulates, however, it is a stringent regulatory body that is highly adamantine in its approach and is unsparing of anyone. It is often seen as an arm chair critic who doesn’t have to get to the thick of action and just sits on a high pedestal, dictating terms without allowing for the slightest latitude in its strict regulatory requirements.

What is the truth about the FDA? Well, somewhere between. Let us get down to understanding a few facts about the FDA which will help us understand why it is so stern in setting out standards for regulations and implementing them.

It only does its duty as a health watchdog

The FDA’s primary goal is to ensure public health and to foster innovation and cost-effectiveness in the production of health products. It leaves no stone unturned in its quest to ensure this. This is why, many times, it gets down to hairsplitting details about the processes or composition of many products. It is also not easily convinced about the processes and methods adapted by companies, which is why it has its set of standards that are common to everyone in the respective industry.

Only companies that strictly adhere to the requirements can expect to have their products approved for marketing. When companies fail to meet the requirements of the FDA, they have to carry out a series of often painful and tedious corrective measures. If organizations fail to do this to the FDA’s satisfaction, they can face strict consequences. Many organizations have been penalized to an extent where it has impacted the business. Companies having to shut down their business also has not been unheard of.

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