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Frequent Contributor
Posts: 93
Registered: ‎03-27-2010

Just a tidbit of info for everyone. Especially regarding an upcoming TSV. FDA Approval does not mean the FDA has proven something does what it says it will do, it simply means that FDA approves said item to be non-harmful if used as directed. My hubs is a pharmacist and gets really wacked when people assume "FDA Approved" means something is guaranteed to provide the results a vendor claims. I just thought for those who are unaware of this that it may be helpful to your decision making in the future. Smile

Super Contributor
Posts: 368
Registered: ‎03-09-2010

Good reminder for us all. Thanks.

Honored Contributor
Posts: 32,639
Registered: ‎05-10-2010

It's a good reminder but I'm pretty sure most adults know that.

Frequent Contributor
Posts: 93
Registered: ‎03-27-2010

Chrystaltree, one would think! But he works with 300+ people a day and roughly 5% of them ask him questions on a daily basis that require him to explain what FDA approval means.

Valued Contributor
Posts: 622
Registered: ‎03-09-2010
On 3/27/2014 Kiminator said:

Chrystaltree, one would think! But he works with 300+ people a day and roughly 5% of them ask him questions on a daily basis that require him to explain what FDA approval means.

Doesn't surprise me. I've realized that many posters on these boards think that the FDA has all kinds of oversight and authority over cosmetic companies. They don't. (Although that may change - but the cosmetic industry is not happy about the prospect!)

"Behold! We are not bound forever to the circles of the world, and beyond them is more than memory." J.R.R. Tolkien
Honored Contributor
Posts: 21,733
Registered: ‎03-09-2010
On 3/27/2014 chrystaltree said:

It's a good reminder but I'm pretty sure most adults know that.

I'd bet that if you did a scientific survey quizzing people on their knowledge of the FDA, the first thing you'd find out is that many don't even know what the letters stand for let alone what it is and what it does and doesn't do.

You underestimate the depth of our ignorance at your own peril. {#emotions_dlg.scared}


~Who in the world am I? Ah, that's the great puzzle~ Lewis Carroll, Alice in Wonderland
Frequent Contributor
Posts: 149
Registered: ‎10-10-2012

Thank you for the clarification. I thought FDA Approved meant the Food and Drug Administration did thorough research on the product, and that it is not only safe for human consumption or for use topically, but that the product does what it claims to do.

Super Contributor
Posts: 1,139
Registered: ‎10-01-2012
On 3/27/2014 RunnerMom said:

Thank you for the clarification. I thought FDA Approved meant the Food and Drug Administration did thorough research on the product, and that it is not only safe for human consumption or for use topically, but that the product does what it claims to do.

I believe the "does what it claims to do" is the responsibility of the FTC. And they go after as seen on TV very hard.

Trusted Contributor
Posts: 1,560
Registered: ‎12-31-2013

I am certainly not an expert on this topic, but if you look at the FDA website (fda.gov), there is a lot of information regarding approval of medical devices (some require presecription and some don't).

The following statement was taken directly from the FDA website (the PMA mentioned is the name of the type of application filed to get approval of a medical device).

"To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness."

It would seem to me that the part of their statement of reasonable assurance of EFFECTIVENESS implies that the device does what the marketer says it does. It hasn't been tested by FDA but apparently they don't approve unless they receive some assurance that it is both safe and does what the application says it does.

Honored Contributor
Posts: 20,570
Registered: ‎06-13-2012

Excellent points, OP! It is like when products say "dermatologist tested"- that does not mean a dermatologist approves of or recommends it, it simply means exactly what it says, that a dermatologist tested it and it has shown some level of "safety". Statements like that mean little and there are no real industry standards that claims like that are based on.

"According to the Food and Drug Administration (FDA), manufacturers are not required to perform any tests or provide supporting evidence to demonstrate that products labeled “dermatologist-tested” were actually tested by a doctor and produced fewer allergic reactions than other products. The FDA also states that nearly all cosmetics are likely to cause an allergic reaction in certain sensitive people."