A Physician Explains What It Actually Means to Be "FDA Approved"
You grab a health product off the shelf—maybe it promises to leakproof your bladder or erase your wrinkles or enhance your sex life. And look, there’s an FDA logo right on the product’s package! So you feel hopeful that it might actually work.
Surprise: Many products with an FDA logo haven’t gone through any kind of testing process to make sure their claims are legitimate. When you look more closely at that reassuring blue FDA logo, there’s a good chance you’ll see that it says FDA listed or FDA registered rather than FDA cleared or FDA approved. So what’s the difference?
What does it mean to be "FDA approved"?
Prescription drugs and medical devices for specific medical conditions have to go through an arduous approval process (showing that they work and that their benefits outweigh their risks) 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.
"FDA Cleared" is a step down.
Three classes of devices require FDA clearance, from no-risk products needing no premarket review (such as dental floss) to devices for medical use (like heart valves) that are potentially high-risk and seek full FDA approval. Keep in mind that some devices are eligible for FDA clearance if they’re similar to one that the FDA already deemed safe and more effective than a placebo, even if that happened years before. So an FDA-cleared product is likely safe, but it won’t necessarily work for everyone.
"FDA Registered" or "FDA Listed" have even squishier designations.
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 the pelvic floor but markets itself as treating incontinence (a medical condition) would need to be FDA cleared. A similar device that claims to “enhance intimacy” needs only to be registered.
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 (why spend millions on a study that might prove that a product doesn’t, say, eliminate wrinkles?).
In 2019, the FDA sent warning letters to 17 companies illegally selling products that claimed to prevent or cure Alzheimer’s disease.
Thousands 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 Alzheimer’s disease. 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 FDA’s website for more information.
This article originally appeared in the June 2020 issue of Prevention.
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