In the world of healthcare, FDA approval is a hot topic. The Food and Drug Administration handles the approval of everything from baby formula to cancer treatments and everything in between. While they have far-reaching power, not everything sold to the public for health care requires this approval. Herbal supplements, 
for example, can be sold without FDA approval which is why it’s so important for people to research their supplement options before they choose one. Other products, such as medical devices, often seek out FDA approval, though it isn’t mandatory, as a way to enhance a product’s retail value.
Penis Enlargement and the FDA
Simply put, there is not currently any device or product which has received FDA approval for the purpose of penis enlargement. The reason for this is that the FDA does not get involved with this type of self-care device. They are treated in the same way weight loss devices are treated – companies are expected to make reasonable and honest claims about what the products can do. Many companies go as far as to launch their own studies in order to prove the efficacy of a device, but they cannot claim it has federal approval.
The loophole in this system crops up when a penis extender is used for a medical condition. Peyrione’s disease is such a condition. Peyrione’s disease is characterized by a build-up of scar tissue or plaque in the penis which results in lumps and a change in the angle of the penis itself. Treatment options for this condition vary widely but many patients find that using a penis extender helps to realign the penis and straighten out mild to moderate curvatures.
When a penis extender is used in this way, it is often marketed as a medical device. In some cases, companies do seek out FDA approval so that their device is more marketable. In order to achieve FDA approval, a medical device must meet a number of different criteria. Everything from the packaging and labelling of the product to its safety must be evaluated and approved. This process can be lengthy which is understandably off-putting to some companies but for those who want their products to be seen as medical devices instead of products for self-improvement, the process can be worth it.
Is FDA Approval Important For Everyone?
The regulations the FDA puts in place are there to help protect consumers both physically and financially. But that does not mean that FDA approval is vital to every man looking into buying a traction device. In fact, many reputable and high-end enlargement devices have never been submitted for this approval process but have performed well in both private and clinical studies. What the approval offers is reassurance of a device’s safety and the company that stands behind it, which can be of great comfort for men who opt to use an enlargement device in order to address mild to moderate Peyrione’s disease or any similar condition.
While hallmarks of quality such as FDA approval can be useful when evaluating any personal care product, it’s important not to rule out products that don’t carry such a seal. Considering how many studies have already been conducted on these types of products as well as the privately funded research continuing, men can easily do a bit of research to learn about the efficacy of a penis extender regardless of whether or not it has an FDA seal. Even with such a seal, enlargement devices should always be checked out via online reviews in order to get a clear picture of how well it works over time. At the end of the day, a government stamp of approval may be reassuring but it’s no guarantee.
