Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.
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.
Other facts everyone should know about FDA regulation
If all these are an overview of the functioning of the FDA, then, there are many other facts everyone should know about FDA regulation. Let us start with a bit of history to understand how regulation is inbuilt into the FDA:
Although created in 1906, it gained more legislative teeth with the passage of the Federal Food, Drug and Cosmetic Act of 1938. This legislation came into being after a tonic, although legally marketed, killed over a hundred people, including many children. This was when the FDA’s system underwent an overhaul with added emphasis on regulation.
Among the other facts everyone should know about FDA regulation, there is the financial aspect of the FDA: With a budgetary allocation of well over $ five billion a year, the FDA has oversight of the consumption by the general American public of medical products, food and tobacco, whose value runs to over $2.5 trillion.
Some of the other facts everyone should know about FDA regulation
Now, some of the other facts everyone should know about FDA regulation:
- With the exception of some items such as meat, poultry and a few egg products, the FDA directly regulates nearly three fourths of the U.S. food supply
- The FDA approves close to 20,000 different varieties of prescription drug products for The number is over a third of that, more than 6,000, for medical device product categories. When it comes to animal drug products, the FDA has a hand in the approval of around 1600 varieties. With relation to biological products, the number is around 340
- Products whose worth adds to about a fifth of all the money Americans spend are regulated by the FDA
- Although the FDA oversees more than a humungous number of tobacco products-85,000; e-liquids are not included in this list
- The FDA attaches extreme importance to labeling of medical and other products it regulates. The labeling requirements are very strict and companies that make false claims are hauled up seriously and heavy penalties are slapped on them. Yet, it is estimated that there is a margin of error of as much as 20 percent when it comes to nutritional facts provided on labels.
The FDA and the touchy area of food supplements
The FDA does not regulate food supplements. This is among the facts everyone should know about FDA regulation. It is because of the subjective nature of many food supplements. Many supplements sold in the US and consumed by Americans as food supplements could be put to different uses in the country of their origin. Mood altering drugs are a prime example. Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.
However, the FDA’s stringent approval process could prevent some products from being labelled purely as drugs because of the effect on the human mind or body and because of the process employed in their production. The FDA has no say in the way these products are prepared, which is another reason for which the FDA may not regulate food products.
The matter with food supplements is that consumers can use them at their own risk. The FDA does not take responsibility for the safety of these products and leave it to the consumer. It is left to the individual consumer. If she has a high comfort level in using these, it is left to the user.