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.

I think the biggest aspect of the safe vs unsafe aspects of any medical device or product depends on the testing done, the science behind it, the public knowledge of it (papers or studies done on it), and then your own experience or bodily condition. The FDA cannot ensure that a product is 100% safe, that is definitely not possible. Every person is different and has different conditions, reactions, genetics, etc. Everyone reacts to everything differently (although we say generally most people react to certain things the same, there is a miniscule difference that is ignored since it is insignificant). This factor alone guarantees that nothing can 100% be safe. Now considering the FDA's job, it helps to reduce the risk and expose the risk of using a product or medical device to the user/public. It also causes the producer of the product to go through, at times, vigorous testing to ensure no significant adverse effects would occur (although in some cases it is unavoidable). What it comes down to is how much a person trusts the science behind the device, if scientists and researchers have done enough research on it to consider it effective, and then finally your own opinion. For example, there is a lot of skepticism around fat-loss drugs and what they do and the risks they have with them (like Eli-Lilly, who just recently got approved for one in the past couple months/year). If the FDA approves this drug, it would in reality come down to the user of the drug to decide whether it is safe for them because there are clear indications of lots of negative side effects.

When it comes to non-fda products like supplements, there is an even less guarantee of safety, a lot of the time significantly less. However, there are lots of products that have been tested, and data is out online about them. In addition, there are products like this that have thousands or even millions of reviews by users so in this type of case, by your own judgement and most people's general judgement, a product can be considered "safe" even if its not FDA approved.

The FDA plays a critical role in safeguarding public health, but I don’t think FDA approval equates to an absolute guarantee of safety. Approval means that, based on current evidence, the benefits of a product outweigh its risks for the intended population. However, medicine is never risk free, safety can never be 100% guaranteed, and side effects can emerge over time as more people use a drug or device in broader, real world settings. That is why post market surveillance, adverse event reporting, and even recalls are part of the regulatory process. Safety must be compromised during the approval process. 

I think the FDA does a good job overall, but approval does not mean a drug is perfectly safe. It really means that the benefits outweigh the risks for most patients. When I think about Accutane, for example, I understand why dermatologists still prescribe it despite the long list of side effects. For people with severe acne, the drug can be life changing, even if it comes with risks. I almost went on it myself, but the potential side effects felt overwhelming, and that personal hesitation made me realize that safety is not just about statistics, it is about how comfortable an individual feels with the trade-off.

That is why I personally place more trust in FDA-approved products than in non-FDA ones. At least with FDA drugs, there is transparency and data I can review to make an informed decision, even if the risks are not zero. With non-FDA products like supplements or performance enhancers, you do not always know what you are getting, and there is little accountability if something goes wrong. So for me, the FDA does not guarantee safety, but it does provide reassurance. Should the FDA place more emphasis on long-term monitoring after approval rather than focusing so heavily on pre-approval trials?

Sometimes I get surprised by how the FDA works as approval doesn't mean a drug is completely safe, it just means the benefits outweigh the risks for most people. Accutane is a good example to bring up, as it works really well for acne but the side effects can be really serious so its not for everyone. On the other hand just because supplements like protein powders or even some vitamins don't go through the same kind of testing that doesn't automatically mean they're unsafe, but it does mean we don't always know exactly how effective they are until there are reviews. Personally, i trust FDA-approved products for the most part because at least they've been studied, but I don't think that makes all non-FDA products automatically untrustworthy. I do believe supplements should have stricter testing especially if they have major claims.

While one would hope that the FDA does guarantee safety, I don't believe that to be the case. I think instead, the FDA, with as much scientific evidence and proof that is both gathered and tested, weighs a benefit to risk balance based on the product and need. This is one of the reasons that post market observation/surveillance is such a necessity which can include updates or recalls of drugs. I had also always wondered this every time I was up late and would see these commercials pop up and I'd always ask myself the same questions. In reality though, along with what I had mentioned before, they are carefully reviewing all clinical and trial data to determine the risk and benefits of whatever is being pushed.

In terms of supplements, while they are not unsafe from the get go, they do not ho through the same rigorous pre market tests as FDA monitored drugs or items do. They do step in if there are safety concerns that can come up from such supplements, which might cause questions to arise.

That's a very interesting observation. When I read this prompt what immediately came to my mind was the 99.99% effective GermEx. While 99.99% seems like a large success rate, it still has a 0.01% failure rate. When it comes to a bacteria colony with a population of 100,000,000 cells, applying the GermEx is inneffective for 1,000,000 of this population. We can easily jump to the conclusion that yes GermEx is safe, but there is also the angle that perhaps it's not safe enough or even unsafe.

I bring this up because in 2021 there were about 500,000 users of accutane or similar generic products with about 95% not seeing negative side effects. That leaves about 5% of the population or 25,000 individuals who faced negative effects compared to 475,000 individuals who found the product helpful. 

So considering something like GermEx could be unsafe and another product like accutane - which has been proven to be unsafe were approved by the FDA, perhaps it could be framed that their role isn't to deem what is safe and unsafe, but rather what is safe enough for general consumption. Let me know your thoughts.

FDA approval is not a guarantee of absolute safety, but rather an assurance that a product's scientifically-proven benefits for its intended use outweigh its known risks. The extensive list of side effects in drug commercials is a direct result of the FDA's mission to "provide the public accurate, science-based information needed regarding medicines", which allows patients and doctors to make informed decisions. Your example with Accutane is perfect; it has serious risks, but for a specific condition, a dermatologist may determine the benefits are worth it. On your second point, "non-FDA approved" does not automatically mean "unsafe." It typically means the product, such as a dietary supplement, falls into a different regulatory category that does not require the same pre-market demonstration of safety and efficacy that drugs do. For those products, the responsibility for safety falls much more on the manufacturer and the consumer, as they haven't been subjected to the same level of rigorous government review.