Forum

Notifications
Clear all

Does the FDA guarantee safety?

28 Posts
28 Users
0 Reactions
1,084 Views
(@ag2265)
Posts: 70
Trusted Member
 

To answer your question of does the FDA guarantee safety - I don't think it is appropriate to look at this topic in absolutes simply because at the end of the day there will always be human error. Additionally, as time progresses knowledge becomes greater and the human race is able to learn more about different molecules and chemicals and its effects on the human body which will then change certain conclusions about substances. For example, I recall that Coca Cola used to contain cocaine in the drink and at the time cocaine was seen as a medicine in small amounts. However, with further research people found out that cocaine is actually an addictive and harmful drug for humans. When looking at the FDA drug recall website recently I found that there were a few drugs recalled due to containing tadalafil which is a substance used for erectile dysfunction which was approved on its own as a supplement. However, products containing tadalafil with other substances requires a separate route of testing because tadalafil was found to have adverse effects when combined with certain substances which resulted in applicants to requiring further testing. With this new knowledge about tadalafil the FDA's responsibility is to correct its wrongs through recalling these drugs - it is not as if the FDA knew that this would be a problem. Furthermore, I would not say that all non FDA approved drugs can be safer than FDA approved drugs due to recalls simply because the non FDA approved drugs are non regulated. However, as @sseal98 mentioned, if the drugs have all their data publicly available along with all their methods and procedures I believe that it is up to the use to conduct their due diligence to determine what would and would not be safe for them dependent on the information given. 

 
Posted : 02/10/2022 11:25 pm
(@lwarejohnsonmsm-edu)
Posts: 12
Active Member
 

The purpose of the FDA is to “protect the public health by assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” (“What We Do,” 2023). While the FDA does indicate on their website that they “assure safety,” I nor the FDA can affirm that they guarantee safety. The act of guaranteeing something is very much definite. The FDA takes measures to identify any possible adverse event and prevent them. However, they also make it public knowledge of adverse or hazardous events that may potentially happen as a result of using the product (i.e. side effects). So, being that adverse events are reported to the FDA everyday it can be confirmed that realistically the FDA does not guarantee safety. It can also be noted that any product registered and regulated by the FDA must be manufactured under a complaint quality management system which is intended to help assure the safety of the products made thereby.

 

Reference:

 

What We Do. (2023). Retrieved from https://www.fda.gov/about-fda/what-we-do.

 
Posted : 15/03/2023 8:09 pm
(@magan-rhodes)
Posts: 24
Eminent Member
 

The FDA doesn't guarantee safety. To guarantee safety would be impossible. Every person on this Earth is different, and we all have different needs. The FDA does a great job at minimizing the overall negative impact of a device or drug. 

The FDA is in charge of safeguarding the public's health by enforcing laws governing medical equipment, food, cosmetics, tobacco products, human and animal pharmaceuticals and biological products, as well as animal drugs. Even if the procedure for licensing a new treatment may appear exhaustive on paper, some claim it makes the world out to be an idealized setting. Clinical trials are also time-constrained and unable to fully assess safety. 

The true question is not whether the FDA provides a "guarantee" of safety; the real question is whether a drug's side effects outweigh the harms caused by a disease.

 
Posted : 15/03/2023 10:26 pm
(@gsanniezmsm-edu)
Posts: 21
Eminent Member
 

From a consumer standpoint I do not believe that FDA approval is finally or always right. The people that work at the FDA are scientific experts, however they are still human beings. Making mistakes as well as situations where information has not been presented while the drug or item is undergoing the approval process. While on the other hand their are natural remedies not approved by the FDA how exhibit therapeutic effects.  

 
Posted : 17/03/2023 3:51 pm
(@kacey143)
Posts: 25
Eminent Member
 

In my opinion, the FDA does not guarantee safety but does take proper procedure and protocol to maximize the chances for things to be safe. This is why they have a very extensive and intensive procedure to get things approved and has a plethora of information on different products. To answer the second question, I do not believe that non-FDA products are unsafe but does cause skepticism within those products because why would they not take procedure to get it FDA approved. Personally, as a trainer and a person in the fitness industry, I understand that a lot of the products that are taken are not FDA approved but they do contain substances that increase enhancement in the gym which is very important to my field. the person must assume the risk if it's not FDA approved and take that chance with no support from the FDA since the company did not go through the steps to get FDA approved.

 
Posted : 18/03/2023 12:08 pm
(@raymond18)
Posts: 15
Active Member
 

The FDA (U.S. Food and Drug Administration) is responsible for regulating and ensuring the safety and efficacy of food, drugs, and medical devices in the United States. However, while the FDA plays a crucial role in regulating products, it cannot guarantee that every product on the market is completely safe. The FDA's role is to evaluate and approve products for safety and effectiveness based on scientific data submitted by manufacturers. However, this evaluation is not perfect and there have been cases where FDA-approved products were later found to have unexpected side effects. On the other hand, just because a product is not approved by the FDA does not necessarily mean it is unsafe. There may be legitimate reasons why a product is not approved, such as a lack of scientific data, but this does not automatically mean the product is unsafe. It is important to note that non-FDA approved products, especially those marketed as dietary supplements, may not have undergone the same level of rigorous testing and evaluation as FDA-approved drugs and medical devices. This can increase the risk of potential side effects or interactions with other medications, and consumers should be cautious when using these products. Overall, while the FDA plays an important role in ensuring the safety and efficacy of products, it is not a guarantee of complete safety, and non-FDA products are not necessarily guaranteed to be unsafe. Consumers should do their own research, consult with healthcare professionals, and use products as directed to minimize potential risks.

 
Posted : 18/03/2023 4:38 pm
(@danieshat1)
Posts: 22
Eminent Member
 

Great question. I do not believe that all FDA approved products are guaranteed safe. One Everyone's body reacts differently to a drug. Some people may react perfectly fine to a drug while others may have serious side effects. The FDA does research of drug quality, effectiveness, and safety versus conducting their own testing. People depend on FDA approval as comfort that what they take will always benefit them, but it is important to understand and accept that just because the FDA approves does not always mean his or her body will approve. Do you think the FDA should consider their conducting their own test for high risk drugs or medical devices?

 
Posted : 18/03/2023 7:36 pm
(@akilia23)
Posts: 22
Eminent Member
 

I think the FDA does guarantee safety of the products in which they approve. Yes, there are an endless list of side effects when it comes to most prescription drugs, but I think the word safety, as described by the FDA, is more in terms of life and death, in relation to treating the condition at hand. For example, the acne drug you mentioned, has its side effects, but it treats its target, acne, and it doesn't kill the patient. I think that is the FDAs main concern. On the other hand, I do not think non-fda regulated drugs are not safe. This is basic statist, a lot of non-fda regulated drugs are out there that may even be better than the regulated ones

 
Posted : 18/03/2023 10:00 pm
(@anywilliamsmsm-edu)
Posts: 26
Eminent Member
 

I don't think the FDA guarantees safety, however, I do believe that the organization tries its best to ensure safety. With both FDA-approved and Non-FDA improved, one should use their best judgement. Our bodies are different, we react differently to products. Some side effects may occur and some may not. The FDA regulates drug products by ensuring that clinical trials are conducted and if necessary, issues recall on products that pose risks to the public. The FDA is operated by well-trained scientists and health professionals that use their expertise to provide safety measures. We, the public, have autonomy over ourselves to make the ultimate decision on safety for ourselves. 

 
Posted : 19/03/2023 12:12 am
(@rbetz)
Posts: 27
Eminent Member
 

I too used to take Accutane. I was lucky and received none of the side affects.  The FDA cant guarantee safety ever.  I feel when you are using products for such a variety of things and for a variety of different types of humans, you never know how everyone is going to react to something.  I feel the FDA is there to make sure all the things that are obvious, and that are avoidable in harming someone is covered, but then they set a list of side affects that are given to the consumer and then the consumer can determine if they want to take the risk

 
Posted : 19/03/2023 1:56 pm
(@mme54)
Posts: 48
Trusted Member
 

I used to think that FDA-approved drugs were completely safe, but after seeing the endless lists of side effects in drug commercials and hearing about FDA-approved drugs that were later recalled, I'm not so sure.

This raises the question: Does FDA approval guarantee safety? And are non-FDA products guaranteed unsafe?

I'm not sure about the answer to the second question, but I know that non-FDA approved products are not subject to the same rigorous safety testing and regulation as FDA-approved products. This means that there may be more uncertainty about the safety and effectiveness of non-FDA approved products.

However, it's important to note that not all non-FDA approved products are unsafe. Some non-FDA approved products may be just as safe and effective as FDA-approved products. But it's important to do your research and talk to your doctor before taking any non-FDA approved product.

Here are some tips for staying safe when taking non-FDA approved products:

  • Talk to your doctor before taking any non-FDA approved product. Your doctor can help you assess the potential risks and benefits of the product.
  • Buy non-FDA approved products from reputable retailers. Avoid buying non-FDA approved products from online retailers that you do not trust.
  • Read the label carefully and follow the instructions. Be aware of the potential side effects of the product and stop taking it if you experience any adverse reactions.

I'm still learning about the safety and effectiveness of both FDA-approved and non-FDA approved products, but I'm committed to doing my research and making informed decisions about my health.

 
Posted : 25/09/2023 11:00 pm
 jj52
(@jj52)
Posts: 75
Estimable Member
 

As someone who is interested in the scientific field, I always feel like a hypocrite when I say that I don't think the FDA does an efficient job of regulating products, especially medicine. To answer your question I don't think being approved by the FDA automatically means that the drug or device is 100% safe and even though a product is not FDA approved doesn't mean it isn't safe. When comparing what the FDA allows compared to other agencies such as the EU, it was discovered that the FDA approves medicine in a shorter amount of time  versus European countries. It's also always a topic of discussion of how the United States is allowed to have so many additional additives in our food compared to European countries that use more natural ingredients. Overall I believe that just because something is FDA approved doesn't mean caution shouldn't be used with new medicines or devices. 

 
Posted : 27/09/2023 11:43 pm
(@31450849)
Posts: 70
Trusted Member
 

I think the FDA does a good job of making sure medical products are as safe as possible. In general, drugs are chemical mixtures and will necessarily have different effects on the human body. The FDA ensures that the medical product helps cure a disease and has as few harmful side effects as possible. In short, the positive effect we get from medication far outweighs any side effects a medication may cause. Also, an important point is that not every metabolism responds properly to a medicinal product. For example, when people received the Covid-19 vaccines, there were many people who had side effects from receiving them, but the benefit received by the majority of the population was very beneficial by reducing the spread and strength of the virus.

 
Posted : 29/09/2023 9:04 pm
Page 2 / 2
Share: