Have you ever taken any prescription medicine or been treated in any hospital in the United States?
Have you ever eaten any type of food in the United States?
If you answered “Yes” to any of these questions then you have engaged the FDA (Food and Drug Administration) in one way or another!
According to the organization, their main responsibility is to protect the public from substandard Food and drugs by regulating biologics, human drugs, food, cosmetics, tobacco products and medical devices.
The agency essentially works to make sure that all drugs including prescription meds, allergy shorts, vaccines as well as medical devices are not only safe but also effective.
Also, they supervise the security and safety of the United States food supply and other related factors.
How the FDA came to be Passage of the food and drug safety bill (Pure Food and Drug Act) in 1906, gave way to the FDA.
This was as a result of a decades’ long fight for the country to regulate drugs and food.
Now, as effects the Industrial Revolution continued to take charge, production of medicine and food become a huge business.
Inventions such as canning meant food could last long enough to be transported from one state to another or sit on shelves for long periods.
Additionally, patent medications started being distributed in catalogs for various conditions.
This eventually ended up masking drugs and foods.
Thousands of hyped slogans and artful labels made it very hard to know what the products actually contained.
And gradually, some producers started exploiting this opaqueness.
Using additives and spices, manufactures would change the taste of expired foods and other low quality ingredients.
What’s more, most patent medicines ended up relying heavily on cocaine and morphine to give patients a high instead of countering their ailments.
And to make matters worse, both the federal and state governments hugely took a passive approach to the problem during this time.
Manufacturers also had a considerable impact on congress through intrusive lobbying.
However, there are some who wanted things to change.
Harvey Wiley (Bureau of chemistry) a powerful advocate for drug and food regulation never relented in his quest to make medicines and foods in the United Safe.
Together with Alice Lakey (activist) and other like-minded women, they formed a powerful crusade of activists.
Their efforts received a major boost in 1906 after the publication of “the Jungle” by Upton Sinclair.
The expose documented the unhygienic and inhumane labor environments in most factories which ended up also exposing the unsanitary and horrific production of processed foods.
It was only after this that President Roosevelt signed the Food and Drug safety bill into law.
Further laws and amendments reorganized and expanded the agency into what we know today as FDA.
What it does
Makes sure prescription drugs are effective and safe Before any prescription drug can be sold, it has to be approved by the FDA.
The manufacturer of the drug will have to test the drug extensively even on human beings to determine if it is safe and effective.
Then they will submit the results as well the manufacturing information to the FDA for approval.
FDA’s scientists and physicians will review the application and ensure that the benefits of the drug outweigh the risks.
If everything is okay the organization will approve the drug and then the company can start selling it.
Makes sure all vaccines are safe for human consumption
As mentioned earlier, the agency also regulates vaccines (biological products).
According to FDA’s requirements, all new vaccines must undergo thorough testing by the respective drug companies.
Every vaccine is tested on human beings in 3 stages of clinical tests.
FDA also tracks its effects once it is released to the public.
Approves some ingredients and additives in foods
Food additives are ingredients that are added to food to help enhance the food’s value, stay fresh, or amp up the texture or taste.
And before any food additive is released into the market, the parent company must seek approval from the FDA.
The agency will evaluate the safety of the ingredient before giving the company the green-light to sale it.
It can also limit the types of food the ingredient can be added to or the amount that can be used.
This ensures that they don’t harm consumers who use them.
Makes sure labels have the correct nutritional data
According to FDA guidelines, nutritional data must appear accurately on most processed foods like drinks, cereals and breads.
The data must include calorie count, serving sizes as well as the added sugars.
This is to help users make healthier decisions when buying the products.
Notifies you when a drug or food product poses a risk
Works to alert the public about any drug or food recalls .This includes things such as food contamination, a listeria contamination or a recent discovery about an approved drug.
A good example is when studies showed that yeast infection medications could enhance the risk of miscarriage in pregnant women.
How does the organization enforce its regulations? Unlike the Police that essentially respond to 911 calls after a problem arises, the FDA’s main objective is to predict problems beforehand.
This usually requires perpetual testing, massive labor force and mandatory requirements of food and drug producers to participate in oversight.
Now, failure to comply with any of the agency’s rules can result in seizure of the goods in question, fines, criminal charges and civil liability.
Success stories FDA has helped Americans stay safe for over century.
One notable accomplishment of the organization is the rejection of thalidomide, a popular medication used in Germany in the 1950s that was later on discovered to cause various birth defects.
Most doctors thought it could not affect the fetus and hence never bothered to test it.
But when the manufacturers of the drug sought approval in the USA, FDA halted the process requesting the firm to conduct further research.
While they were still conducting the research, cases of babies being with birth defects began to popping up.!
This discovery earned the FDA tremendous praise from President Kennedy and helped accelerate passage of amendments that enhanced the agency’s drug approval process.
Although the organization makes lifer healthier and safer for consumers, it is not perfect.
Critics have specifically castigated its drug approval process for being very quick but very slow at getting new products on the market.
Also, most people take the caloric data on product labels very serious, when in reality it is just a guideline and not a hard fact.
They usually have a 20 percent margin of error.