A very renowned branch of government, known as the FDA, is the U.S. Food and Drug Administration which works to ensure the products consumed by the general public are safe, authentic and effective.
From making sure foods, medicines, and other products are secured to keeping the public very categorically informed when the products used are contaminated and unhealthy, this federal agency serves as a huge part of the Department of Health and Human Services.
1. Role of the FDA
From taking control of aspects such as food, medicine, and certain technological resources, to regulating how the products are brought into existence, the FDA has the authority to look over the above with scrutiny.
Not only the aforementioned, but the managing authority is also responsible for ensuring that the said products and the manufacturers of the same follow appropriate protocols and fit in the laws created for safety.
Adding to the list of the FDA’s duties is the fact that they also make sure, the general public is aware of the consequences or risks of consuming certain products such as cigarettes.
Diving deeper into understanding how the FDA functions, it is essential to take into consideration that not only does it monitor the safety and security of the product from the initiation of its development till its declining period, but the agency is required to give its assent to a product before it is set out to be used by the consumers.
Apart from the above stated, the responsibility of the FDA also comprises the aspect that they have the authority to place facilities under scrutiny that is in charge of bringing to existence foods and drugs as well as ensuring such manufacturers are adhering to the specified laws.
The FDA, from promoting the security of the product put out before the consumers by having them properly labelled to owning such power to have new medications and drugs processed immediately under certain special circumstances, such as during the pandemic of 2020, as an agency of security, has been made highly essential for regulating the development of food, drugs, medicines etc.
1.1 The Mission of the FDA
Health is the prime aspect of the regulation of the FDA, their mission lies as follows:
“To be responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”
Not only has the FDA encompassed a team with strong leaders who aim to work for the security of public health but also has been proactive in accomplishing and establishing the safety of approved drugs, biologics, and devices by making sure proper criteria for design, development and scrutinization of registrational trials are met thoroughly. Apart from the aforementioned, the agency has also:
A. Pushed for level-by-level clinical growth.
B. Ensured proper measures are taken in registrational trials through the process of randomization.
C. Analysed the essence of blinding when it boils down to outcome measures being subjective.
D. Indulged in preparing proper guidelines for designing non-inferiority trials.
E. Made sure very categorically, that the clinical trials are planned and executed in such a way that it ensures the safety of the study participants and the ethicality of the experiment.
F. Bettered the quality of the trials by making sure there is adherence to time, inculcation of real-time experimental and control regimens, maximization of the process of retention and sustainability of data while the trials are in session in terms of the aforesaid being confidential as well as efficient.
G. Made aware of the fact that analyses that are exploratory in nature should be categorized as generating hypotheses.
1.2 Scope of the FDA
Termed to be highly extensive, the authority of the FDA in terms of regulation of rules and extending responsibilities are interrelated with several other branches of the federal government agencies.
To ease the confusion of consumers as to what aspects fall under the jurisdiction of the FDA, the following list has been created however it is essential to keep in mind, that the said sequential positioning of items is not exhaustive.
Speaking in a general sense, the FDA regulates:
1.2.1. The Foods Such As:
- dietary supplements
- bottled water
- infant formulas
- other food products (meat, poultry, and egg products)
- food additives
The Food Additives in food
Though the authority to perform premarket approval of food products is off the table, the FDA, however, is bestowed with the power to allow certain ingredients to be involved in the process of food making. These ingredients comprise food additives and colour additives in other words, known as artificial flavourings.
Food additives or flavourings are those substances that are not only added to food items by will but also that transfer from food contact items to food, an illustration of which would be food packaging.
It is essential to highlight the fact that any agency or organization wanting to use food additives to their food items must come up with substantial evidence to prove to the FDA that the substances they desire to add are clinically safe and secure.
The FDA, post the receiving the evidence, performs a process of scrutinization of the tests instilled by the said company on how they termed the additive to be used, as safe. The additive can be said as approved, only if it is in compliance with its approved uses, specifications, and restrictions.
1.2.2 Drugs Such As:
- prescription drugs- branded or general
- non-prescription that is over the counter drugs.
1.2.3 Biologics Such As:
- vaccines for humans
- blood and blood products
- cellular and gene therapy products
- tissue and tissue products
1.2.4 Medical Devices Such As:
- simple items like tongue depressors and bedpans
- complex technologies such as heart pacemakers
- dental devices
- surgical implants and prosthetics
1.2.5 Electronic Products that Emit Radiation Such As:
- microwave ovens
- x-ray equipment
- laser products
- ultrasonic therapy equipment
- Mercury vapour lamps
1.2.6 Cosmetics Such As:
- colour additives that are found in makeup and other personal care brand products
- skin moisturizers and cleansers
- nail polish and perfume
1.2.7 Veterinary Products Such As:
- livestock feeds
- pet foods
- veterinary drugs and devices
1.2.8 Tobacco Products Such As:
- cigarette tobacco
- roll-your-own tobacco
- smokeless tobacco
- E-cigarettes- tobacco and non-tobacco-derived nicotine
2. Agencies Interlinked With The FDA
There are many branches of government that assist in the regulation of different products which are interlinked with the functions of the FDA. The following states such agencies:
2.1 The Advertising Department
The agency that regulates the functioning of all aspects of advertising is the Federal Trade Commission, or the FTC, the sole of which lies in the delivering utmost safety and security to consumers from acts such as unfair, deceptive, or fraudulent practices in the marketplace.
2.2 The Liquor Department
Overseeing the arenas of production, importation, wholesale distribution, classification, and advertising of any and all kinds of liquor or alcohol is the function of The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau or the TTB.
2.3 The Consumer Products Department
From toys, cribs, power tools, cigarette lighters, and household chemicals to any other product that is susceptible to a fire, electrical or chemical outbreak, all the consumer products fall under the jurisdiction of The Consumer Product Safety Commission or the CPSC to regulate, oversee and maintain the safety and efficiency of such products for its users.
2.4 The Drugs Abuse Department
To maintain, supervise, and administer the use of controlled substances in terms of having them follow the rules and regulations curated by the United States that comprise the divisions of manufacture, distribution, and usage of these legally produced controlled substances, is the duty of the Department of Justice’s Drug Enforcement Administration also known as the DEA.
2.5 The Meat and Poultry Department
Regulating the arenas of food such as traditional meats, poultry, and certain egg products, from maintaining its safety to executing the labelling of the aforementioned, is what the U.S. Department of Agriculture’s Food Safety and Inspection Service is known for.
2.6 The Pesticides Department
Known for managing the environment, when complemented with the FDA, The Environmental Protection Agency also known as the EPA focuses on regulating the aspect of pesticides.
From controlling the number of pesticides used in the processing and growth of food to set limits on how much the aforementioned is allowed to sustain in the food materials bought by consumers, it is the responsibility of the aforesaid branch to manage and secure.
2.7 The Department of Vaccines against Animal Diseases’
Be it veterinary vaccines or any kind of veterinary biologics, it is the duty of the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service also known as APHIS, The Centre for Veterinary Biologics to manage any and all kinds of services pertaining to the field of veterinary science.
2.8 The Water Department
From curating standards that all drinking water sources must follow to put ahead the limits that control the impurity levels found in the aforesaid, the EPA leads this section as well with ease.
3. Sectors not regulated by the FDA
As it is been stated above, though various, but not all aspects are supervised, managed or regulated by the FDA, and those divisions are stated below:
3.1 The Cosmetics Department
Though products such as makeup, lotions, perfumes, shampoos, hair dyes, and other such items do not fall under the jurisdiction of regulation of the FDA, if the above-stated products have any kind of colour additive added to them, then the aspect of such addition is due for an assent of the FDA.
As it is clear that once the product is in the market, the FDA holds no power to manage it which is why it deems it essential for all the ingredients used in the products to be securely labelled, the failure of which can lead to the implementation of federal law by the branch.
3.2 The Medical Foods Department
To treat a condition or a disease, generally with medicines, sometimes a medical food is prescribed for consumption. Such foods are barred from the supervision of the FDA.
Though there are certain guidelines that must be adhered to in the development, growth, and processing of such foods, it falls outside the regulation of the branch.
3.3 The Dietary Supplements Department
Though medicinal items such as multivitamins are managed by the FDA, regulating dietary supplements is an aspect that FDA deals with a tad differently.
With regards to the supplements, the FDA supervises the finished item not the process of it, that is the branch does not give its assent to the aforesaid before they are in the market.
What the branch does, in terms of this supplements arena, is that it makes sure the ingredients employed in the product match the text on its label. If the process of matching fails, the branch has the authority to institute legal action.
3.4 The Baby Formula Department
All types of products that fall under the arena of baby formulae are not obligated for assent from the FDA, however, the company selling such products is responsible for adhering to the rules and regulations pertaining to fulfilling the federal nutrient requirements and other aspects.
As an illustration, it can be said that a company curating such a product must have registered with the FDA following by submitting the formula.
From placing the manufacturing facilities under scrutiny every year to collecting the samples for analysis, the duty of the FDA ranges till the aforesaid.
4. FDA’s Role in the Drug Approval Process
The FDA plays a huge role in approving the drugs curated for various reasons.
From analysing how the drug proves to be of effect on adults as well as children to understanding the proper dosage that is to be given to children, determining the best method of administration as well as providing a way of testing all kinds of drug interactions, the FDA serves to be highly crucial in the process of drug approval.
The steps of the Drug approval process by the FDA:
Any company when curates and develops a new drug needs to have the assent of the FDA to have it go live in the market, and for the same, the following steps need to be adhered to:
- The IND Application: Post the first step, where the drugs are tested on various beings for them to be non-toxic, the result of the same is submitted to the FDA as an Investigational New Drug (IND) application. From the mentioned composition, development, and manufacturing of the drug to prepare a detailed plan on how the drug will be tested on people, the application sent to FDA must contain the aforesaid.
- Clinical Trials: Following the approval of the FDA on the IND application submitted by the company for the drug, testing on human beings take place which is known as clinical trials. Having comprised 4 stages in this procedure, ranging from small-scale trials to large-scale trials, it is only after such testing, the researchers are authorized to send a detailed report of the analysis to the FDA.
- NDA Application: Only after the evidence of the fact that the said drug is safe and efficient to be consumed is submitted by the developer of the drug, the company stand in a position to file for a New Drug Application also known as an NDA. Post the revision of the NDA, does the FDA decide whether to process the drug ahead or not.
- Drug Labelling: From reviewing and analysing the labelling as well as the packaging of the drug to making sure valid information is passed on to healthcare professionals and consumers, the FDA ensures the drug is authentic, safe and useful.
- Inspection of the Facility: The FDA is authorized to place the manufacturing facility of the drug under scrutiny to ensure proper methods are followed in the development of the aforesaid.
- The Decision for the Drug: Post the above steps, the FDA either approves the NDA or provides a response letter.
- Post-Marketing Supervision: Only if the drug receives the assent of the FDA, the company is allowed to submit a periodic safety update pertaining to the same.
The U.S. Food and Drug Administration or the FDA is a branch of the government that plays a highly essential role in the regulation of food, drugs and several other health-centric aspects to ensure that consumers are using products that are safe, authentic and efficient.
From understanding the mission and vision of the FDA, aspects managed by the FDA, and the arenas that do not fall under the ambit of the branch to comprehending the process of approving the drugs, the FDA serves as a shield for all the consumers in the United States.