The FDA approval process is based on scientific evidence, but it does not guarantee complete safety. FDA approval means that the benefits of a drug or device outweigh the risks when used as directed. However, many side effects may only become clear after a product is widely used in the real world. This is why post-market surveillance is very important. Some FDA-approved drugs have later been recalled due to unexpected risks, which shows that the system is not perfect. On the other hand, non-FDA products are not always unsafe, but they often lack strong scientific testing and quality control. In my opinion, FDA approval increases confidence in safety, but it should not be seen as an absolute guarantee. Continuous monitoring and reporting of adverse events are necessary to protect patients.

Regarding the FDA's responsibility in "ensuring safety" as opposed to "guaranteeing safety," I believe you raise a very significant distinction. A medicine or device's FDA approval is predicated on the best available evidence at the time of evaluation, but this does not guarantee that problems won't arise later. Accutane is an excellent example since, although it can be quite successful for severe acne, there are serious hazards associated with it, such as birth deformities and adverse effects on mental health. This explains why, although being available on the market, it is so strictly regulated. However, non-FDA-regulated goods such as vitamins, supplements, and gym performance enhancers are allowed to be marketed without undergoing the same stringent testing, which raises questions over their efficacy and safety. Many people use them on a daily basis without realizing that they are not subject to the same scrutiny as prescription drugs. Therefore, FDA approval indicates that the risks and benefits have been thoroughly examined, even though it does not ensure that a product is completely safe. I want to know if the FDA should impose more stringent regulations on supplements and over-the-counter enhancers, or if doing so would significantly restrict consumer freedom.

This is a very thought provoking question! I do not believe that products that are FDA approved are 100% safe. The FDA is trying to minimize any risks as much as possible, but I definitely don't think every single product is 100% safe. It's true that the FDA determines if a product is safe and easy to use, but there can be issues even when the product gained FDA approval and is now on the market. Also, I don't necessarily think that any non FDA approved products are automatically unsafe. Just because a product isn't FDA approved doesn't mean it's necessarily harmful or causes any risks. However, without FDA approval, you don't know how safe this product is compared to FDA approved products on the market. The bottom line is the FDA does not guarantee the safety of any products because not every product is going to be safe and every product is not going to be marketed the same way. There is of course a higher risk of using a non FDA approved product compared to using an FDA approved product, but I don't necessarily think every non FDA approved product is harmful and doesn't present any risks to consumers.

This is a good question that is difficult to answer. I do not think that FDA approval means a drug or device is risk free. There have been many drugs that have been approved and put out on market but have been recalled. I do not think everything is up to the FDA it is also on the manufacturers to ensure safety because they are the ones making the drug. Just because something is FDA approved does not mean safety if the correct precautions are not taken. I don't think non FDA products are unsafe but I do think the manufacturers have to pay extra attention to the process to ensure safety for the public.

In medical device development, the FDA does not fully guarantee safety but rather ensures that devices meet established standards of safety and effectiveness before reaching the market. The FDA reviews clinical data, quality systems, and manufacturing processes to minimize risks, but it cannot eliminate them entirely. Devices may still have rare side effects or unforeseen issues that only become apparent after widespread use. Post-market surveillance systems, such as adverse event reporting and recalls, are in place to catch problems that surface later. This means the FDA’s role is more about risk management than absolute guarantees. Manufacturers also carry significant responsibility for continuous monitoring and compliance with safety standards. Patients and healthcare providers should understand that FDA clearance or approval reflects a balance between benefits and risks. Ultimately, the FDA helps safeguard public health, but no regulatory system can offer a 100% safety guarantee.