What Does It Mean to Be 'FDA Approved,' Exactly?
Prescription drugs and medical devices for specific medical conditions have to go through an arduous approval process before getting to market. The average time it takes for a drug to hit the pharmacy is 12 years, and hundreds of millions of dollars are spent on research, development, and trials. Note that the FDA does not actually test these drugs; it simply reviews the testing processes.
, even if that happened years before. So an FDA-cleared product is likely safe, but it won’t necessarily work for everyone.This category is the most troublesome. Devices and drugs that make claims related to wellness and fitness rather than treatment of a specific medical condition don’t need to go through premarket evaluation. For example, a device that claims to tighten thebut markets itself as treating incontinence would need to be FDA cleared.
For FDA-registered products, the company determines what language is used on the packaging and what a device claims to do. Since scientific studies are very expensive and aren’t required at this point in the process, they’re not performed, since it’s not in a company’s best interest to do so . In 2019, the FDA sent warning letters to 17 companies illegally selling products that claimed to prevent or cureThousands of products pop up online and bombard desperate people with sketchy promises. For example, in 2019 the FDA sent warning letters to 17 companies illegally selling products that claimed to prevent or cure. The FDA stated, “These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.
If you’re confused about all these categories, you’re not alone. It doesn’t help that a product’s packaging might state that it’s FDA approved when it’s actually FDA listed—so some healthy skepticism is appropriate. When in doubt, visit the
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