What is the importance of FDA Approval?

What is the importance of FDA Approval?

What is the importance of FDA Approval?


You may have heard most medical professionals talk about FDA-approved drugs. But why do they keep mentioning the term? Is it to add value to the medication prescribed? In a way – yes, because the FDA or Food and Drug Administration is a body that protects the public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices, among other categories.


This means that FDA-approved drugs are different from Over-The-Counter or OTC drugs.


Today’s post will reveal the mystery of prescribed drugs, their efficacy, and their difference from OTC pills.


The importance of FDA-approved drugs

The FDA is responsible for helping the public health sector progress with innovations in a manner that is ethical, effective, safe, and affordable for the public. This body helps the consumer get accurate, scientific information needed to use medical products and foods to maintain and improve their health. They ensure the security of the food supply.


Their role is to meet with researchers and perform inspections of clinical trials. This process helps to verify the quality and integrity of the data and protect patients’ rights. In addition, they foster the development of medical products to respond to emerging public health threats.


The difference between FDA and OTC pills

Both prescription and OTC drugs related to weight loss are meant to reduce your appetite, increase the ability to burn body fat, and inhibit fat absorption.


However, there are differences that you must know:


FDA-approved drugs are:

  • Drugs that cannot be sold without a doctor’s prescription
  • Proved to be safe and effective
  • The drug meets federal quality standards
  • The benefits outweigh the risks


OTC drugs are:

  • Drugs that can be sold without a doctor’s prescription
  • Not reviewed for safety or efficacy
  • Not verified by the FDA regarding the claims made by the seller


OTC diet pills and herbal weight loss supplements are purchased without a prescription. At the same time, some weight loss pills may contain ingredients not listed on their labels. These ingredients have invariably not been approved by the FDA.


How OTC may work differently from FDA-approved drugs

There is a range of prescription weight loss diet pills approved by the FDA. These pills act differently and may only be appropriate for certain people.


Therefore, it is advisable to consult your healthcare provider, who can offer reliable information regarding weight loss pills, prescribed or OTC. They will also tell you how the diet pill might interact with your other medications and advise you regarding the safety of certain products.


Based on OTC and prescription-based pills, let’s look at the efficacy, benefits, and risks associated with weight loss drugs.


We’ll take Phentermine 37.5 results as a case in point.


How it works: Phentermine is marketed under names, including Suprenza, Adipex-P, and Lomaira. It works by decreasing your overall appetite.


Efficacy: A study published in 2021[1] compared the effects of different weight loss drugs in obese patients. Among the lists of effective drugs was Phentermine.

There was another long-term study from 1968 in the only controlled trial of Phentermine [2]. In this 36-week study, 64 patients were randomized to two groups that included a placebo with Phentermine 30 mg daily or intermittent Phentermine 30 mg daily (4 weeks on, 4 weeks off). Both the phentermine groups lost approximately 13% of their initial weight. The placebo group lost only 5%.


Side effects: The side effects may include insomnia, diarrhea or constipation, vomiting, a dry mouth, and an unpleasant taste. That is why you may consult your doctor, who will prescribe Phentermine based on your case history and other medications you may be taking at the time.


Who may benefit: Phentermine is designed for people with a BMI of 30 or higher. It is also designed for those with a BMI of 27 who have other weight-related medical conditions. However, you may consult our online weight loss doctor to understand whether or not this drug will help you lose weight effectively. You can also check some phentermine 37.5 mg reviews to understand the effectiveness of this drug better.


Risks: A small percentage of people cannot handle taking Phentermine, or it may not suit them. This drug is not recommended during pregnancy or nursing or for those with cardiovascular disease, hyperthyroidism, glaucoma, or a history of drug abuse.


Phentermine is an FDA-approved drug and has all the information to help the doctor identify whether or not it suits you.


Now, let’s look at an example for an OTC-based medication – Garcinia cambogia.


It’s important to know that weight loss supplements are not FDA-approved.


How it works: Garcinia cambogia is derived from a fruit that grows in warmer climates. It is said to assist in reducing appetite, thereby aiding in weight loss.


Efficacy: Research does not support the sellers’ claims, so there is little evidence to support its effectiveness. A review published in 2015 reports mixed results, wherein some people lost weight with this substance while others did not lose significant weight.[3]


Side effects: There are adverse effects associated with taking this drug. It may include headache, nausea, diarrhea, and other gastrointestinal issues.


Who may benefit: Some studies have found Garcinia Cambogia effective for weight loss such that the effects are the same regardless of age, sex, or any other weight-related issues. It may be more effective at reducing belly fat than some other substances.


Risks: While rare, the use of this drug may result in liver damage. It is unclear whether pregnant women or breastfeeding mothers can take this drug.


So, as you can see, medications, FDA-approved or not, require that you seek advice on consumption. You must consult your doctor before taking any pills for weight loss. If the drug suits you, you will be prescribed a proper dose with lifestyle modifications and behavioral changes.


Reference to study links:

[1] – Nader Salari, Samira Jafari, Niloofar Darvishi, Elahe Valipour, Masoud Mohammadi, Kamran Mansouri & Shamarina Shohaimi. The best drug supplement for obesity treatment: a systematic review and network meta-analysis. Diabetology & Metabolic Syndrome volume 13, Article number: 110 (2021) https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-021-00733-5


[2] – Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Comparison of continuous and intermittent anorectic therapy in obesity. Br Med J. 1968;1(5588):352–354. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1984840/


[3] – Wharton S, Bonder R, Jeffery A, Christensen RAG. The safety and effectiveness of commonly-marketed natural supplements for weight loss in populations with obesity: A critical review of the literature from 2006 to 2016. Crit Rev Food Sci Nutr. 2020;60(10):1614-1630. doi:10.1080/10408398.2019.1584873 https://www.tandfonline.com/doi/abs/10.1080/10408398.2019.1584873?journalCode=bfsn20


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