While reading up on plastic surgery, you might notice some products or procedures that are touted as FDA approved. Clearly, those two words are meant to be reassuring, but is FDA approval all it’s cracked up to be? How does the FDA decide which products are safe, and should unapproved products send you running for the hills?
What is the FDA’s job?
Imagine walking through a grocery store. Try to picture all the products on the shelves. Now imagine turning into the pharmacy section. Try to picture all of the products sitting on those shelves. As you can tell, the good people at the “Food and Drug Administration” have their work cut out for them!
The FDA regulates food, medications for animals and humans, tobacco products, cosmetics and medical devices. Biologists, chemists, pharmacists, and attorneys at the FDA review the literature about each product that applies for their approval to make a decision about the product’s value. If they are satisfied that product testing was thorough and the results were positive, they will “approve” the product. But remember, FDA approval always comes with limits. They might approve a product only up to a certain dosage, or they might approve a product only for certain uses.
After a product has been approved, the FDA will make regular visits to the facility where it is manufactured to make sure that quality standards are being met. They may also take random samples of products on the market for quality testing.
If the FDA finds that a product is unsafe for the public (or that it makes unrealistic claims about its effectiveness, like gummy worms claiming to cure migraine headaches), the administration will issue a public warning to advise consumers not to buy the product. Usually, these warnings prompt the manufacturer to “recall” the product and improve it until it meets FDA standards again. In extreme cases, the FDA is authorized to seize property from uncooperative manufacturers and launch criminal prosecution.
How do manufacturers get FDA approval?
FDA approval is a long process. When a drug or vaccine is in critical need, the FDA might be able to crank out an approval in 6 months. Most products have to wait a year or more to get FDA approval.
To begin the approval process, manufacturers schedule an interview with the FDA. During the interview, the manufacturer shares the purpose of their product and their manufacturing process with an FDA agent. The FDA agent will then suggest tests for the product. Usually, testing begins in animals and advances through clinical trials before the results are handed in to the FDA for review. After the FDA has reviewed the product, they will issue manufacturing, marketing, and usage guidelines for the product. In order to keep the FDA’s approval, the manufacturer will have to follow these guidelines.
What can I expect from FDA approved products?
Simply put, you can expect that it’s safe and it works! You will also have access to literature about the product, so you can form your own educated opinion about the product and decide if it’s right for you. You will be able to read about the possible side effects of the product, for example, and decide if they’re worth the risk. Or you can verify that a food doesn’t have a certain additive that you are trying to avoid.
What if a product is not FDA approved?
As we’ve mentioned, FDA approval takes a long time. Some safe and effective products lack FDA approval simply because they haven’t accumulated enough data to support their application or because their application is still in the FDA’s waiting list. Likewise, some products that are FDA approved for one use might have other, unapproved uses. Botox is a great example. The FDA had already approved Botox for wrinkle reduction in between your brows and your crows feet for years but just approved Botox in October 2017 for the forehead. Plastic surgeons have been using it for forehead wrinkles for years. For products that are not FDA approved, you must use your own judgment–unless the FDA has issued a public warning about the product. In that case, steer clear!
If you’re still curious about FDA approval, or you’d like to learn more about the safety and effectiveness of a specific procedure, call one of our professionals at Associated Plastic Surgeons. We are always happy to lay out the facts for you!