I see the point you are making that often times FDA approval comes with a briefcases of exceptions and side effects which ultimately make the drug look like there is one problem that they are fixing but give you 10 additional problems and side effects. However, like everything in this world, nothing is perfect. I believe the FDA does as best they can do to regulate what goes on in the market and to properly scrutinize each and every product that may come out. The fact that companies are obligated to state any and every side effects that may happen is a feat of the FDA so that users are fully informed with what they are getting into. I believe if any company who is selling such item, would opt not to make any side effects so apparent and cloud their product out of fear of missed sales at the potential expense of human safety. I also believe the system that the USA has with the FDA dosent guarantee that everything will be safe, but gives a certain element of approval, that a drug or device was looked over meticulously and deemed to be safe and effective. And often times the FDA does catch products that may be dangerous to people and have blocked the sale of such devices until they could prove its safe. Ultimately, I believe, it isn't perfect but it is able to minimize the need for any call backs, and safety issues.

While FDA approvals have their benefits in maintaining public health and safety, I do not believe it guarantees product safety nor do I believe that non-FDA approved products are guaranteed unsafe. As you mentioned, we have seen products that were once approved by the FDA be recalled and cause many health issues in consumers. We have also seen products once approved lose approval and people continue to use the product. This question is very interesting as I have recently been questioning how products that were once deemed safe are now known to cause so many problems, and what is the actual role of the FDA if it cannot identify these possible issues upon approval? On the other hand, I do believe that the FDA has kept a lot of harmful products off the market as well. Some people say that the FDA is too strict and takes too long to approve products; however, I think that may be more of an industry perspective because as a consumer, I would want to know that the products that I am using are safe in that moment as well as in the future. If it is possible to have safe products without FDA approval, I wonder if the approval will have less of an impact on company’s decisions to seek FDA approval as well as people's decision to use FDA approved products.

Great question! I have debated this throughout my research on supplements. It is a difficult position to be in, not knowing if you can trust what you are consuming. However, I find that the average ten-year FDA approval process can offer some assurance. There are special cases, which include products with expedited approval due to demand and the lack of other treatments. These cases are the riskiest in my opinion because they increase the risk of adverse effects. As for products that have not been approved by the FDA, they do pose greater risks to the general public. Because these products have not been reviewed for safety and efficacy, it can be detrimental to the health of consumers. 

Nothing is guaranteed and that includes the official stamp of approval from the FDA. Having the FDA approval does lessen the burden of concerns, but it is up to the consumer to do their due diligence in terms of their health and safety. There are also many products that consumers take such as vitamins, sleep aids, etc. that are not FDA approved; yet, many people trust and expect these products to function as advertised. It does raise concerns about public health and safety, but as medicine and diagnostics become more tailored to each individual, consumers will have to weigh the cost vs. the benefits of using Non-FDA and FDA approve products. Regardless of a products' approval, anyone would still be taking a chance and each person's body could respond differently to a product. You never really know it the product is consumed or not. Again, this is why it is important to do the necessary research about products and your health. It doesn't hurt to ask your primary care physician detailed questions, your health is important and they should be prepared to outline how said products could affect you.

@ljatta I agree with you, the FDA absolutely cannot guarantee anything as evidenced by what is allowed to be called food in America. Not to mention the pharmaceuticals that have been on the market for years just to be taken off the market, renamed, then placed back on the market with no significant changes. At times I see it as a money game and that there is no real approval process that occurs. I question if the research and clinical trials conducted are substantial or if the results were manufactured because how can the trials be done on humans only to show significant harmful effects on humans years later. I question if perhaps the approval process should have better standards and parameters. I know the FDA was created to protect the consumers but if they are no longer able to ensure safety, maybe there should be improvements to the department, their function, and how to best re-establish the trust between them and the consumers. I would like to ask those in the industry what types of improvements do you think the FDA could follow to better ensure safety among consumers?

@ljatta I think you worded that perfectly, there are many drugs that are FDA approved and suggested by physicians that contain A heap of side effects. I don't think there is ever going to be a 100% chance of certainty in anything, especially concerning the consumption of drugs.  I agree with consulting your primary care physician when it comes to taking certain medication but also making sure your primary care physician is one that you feel comfortable and compatible with. A few years ago I switched my PCP because I wasn’t comfortable with her consistently prescribing medication for minor issues and through research I was able to find a new physician elsewhere who focussed on different therapeutic approaches rather than prescribed medication.  Like you stated, many people feel comfortable taking vitamins that are not FDA approved and may see the benefits. I think overall, although it is important to use the FDA as a resource of information individuals should do their own research when it comes to the compounds they are ingesting.

The FDA does a fair job at regulating the safety of marketed products, but I do feel that they can not always regulate everything as far as the effects of the product well after the study or in regard to a specific person. Individual medical issues and genes can give different outcomes to the same product such as someone who has autoimmune deficiencies and taking a product such as accutane and developing adverse effects or having kidney issues prior and taking the medication could acquire adverse affects especially if those effects run genetically.

By assuring safety, the FDA prevents diseases or wrong treatments that may be caused by drugs in the long term. This is a good thing and perhaps the best way to avoid possible disasters. But on the other hand, being so strict has negative consequences. Being so strict can cause drugs (possible treatments) to be on the market late and spread late. This causes patients who need that medicine and treatments to wait desperately. but when I think about both sides, it seems more logical to do the work in this way and to proceed with sure steps, albeit with a delay.

I believe the FDA has ensured that most of the approved devices or drugs have been well tested. These non-FDA guarantee supplements or products seem risky, but I think most have passed some tests, even not by the FDA. Drugs and supplements with side effects that sell on the market must have clear notifications or warnings under the government's regulation. They must claim what kind of people should avoid them. However, nobody can give a hundred percent guarantee that there will be no accidents. Patients with diseases or undergoing some therapies might have unpredictable consequences even if they have taken these things for a while. In conclusion, I believe that FDA approval is the safest certification most time, the drug approved by FDA has passed tons of examinations after all. But I will ask the doctor when I need to take medicine or supplement with lots of side effects.

The FDA does not guarantee the safety of products. People think that FDA-approved drugs or product is totally safe. The fact is that despite FDA approval, a device or drug can be dangerous due to faulty manufacture, improper labeling, inadequate warnings, etc., all of which are within the responsibility and control of the manufacturer and not the FDA. But still, I think FDA approved products can have fewer issues than Non-FDA approved products.

This is definitely one of the more interesting topics in relation to regulatory and FDA. I think that as most people would agree with, there is no 100% "guarantee" on any products being completely harmless, the products are obviously evaluated for possible risks and cleared to be sold if deemed appropriate. An interesting idea that came to my mind was that products that have been available to the public for long period of times (products that have been on the market for decades, products like lotion, toothpaste, or shampoo) have proven amongst PUBLIC use that they are not dangerous overall. There are always some exceptions or claims that even shampoo can be harmful depending on the ingredients, but the overall population use is its own data that shows that the item is overall harmless. 

The first thing that came to my mind when the initial coronavirus vaccine was being developed was the time that it would take to develop it. I remember thinking that "this vaccine is so important to save potentially millions of lives but I wonder how long it will take for the FDA to approve it. As we all know, the approval of the vaccine was definitely a little rushed to get it released to the public and the vaccine even had some claimed dangerous affects. This is a perfect example of all the things taken into consideration for claiming a product safe and also the importance of the "public data" once the product is released into the market. 

FDA follows simple scientific method to review any of product that they come across. In its constitution it mentions FDA is responsible for protecting, promoting public health by supervision of substances. Nowhere it says what FDA approved means safe, it is impossible for FDA to guarantee safety since it is not feasible to predict everyones immune responses for different drugs and biologics.

This is a very good question. In my opinion, an important point to keep in mind is that while the FDA's purpose is to keep people safe from harmful products, there are products that can be sold without going through the FDA's approval process. FDA approval merely shows consumers that the product's claims are supported by scientific evidence and that testing has been done to determine what the side effects are. For products that haven't gone through the process, their claims may not be accurate and could actually have harmful effects. Therefore, while you're right that the FDA approved drugs that are supposed to be safe may still have several harmful side effects, you have to keep in mind that the FDA approval process is meant to provide the consumer with all the relevant information about the drug so they can make an informed decision. 

This is a very tricky question. I personally believe it does not always guarantee safety of the device or drug that has gained approval. There have been countess devices and drugs that have been approved by the FDA but have still been recalled for many reasons such as improper labeling. The FDA also does not do its own testing. In order for FDA approval, the manufacturer must submit all documentation of testing. If a device and drug is similar to one thats already been approved, it could get approval without having to conduct testing.