topic Re: Facts on FDA Approval in Beauty

Facts on FDA Approval

Kiminator — Thu, 27 Mar 2014 20:55:53 GMT

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.

Re: Facts on FDA Approval

peace6576 — Thu, 27 Mar 2014 20:58:10 GMT

Good reminder for us all. Thanks.

Re: Facts on FDA Approval

chrystaltree — Thu, 27 Mar 2014 21:22:37 GMT

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

Re: Facts on FDA Approval

Kiminator — Thu, 27 Mar 2014 21:45:26 GMT

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.

Re: Facts on FDA Approval

sharlee — Thu, 27 Mar 2014 21:48:28 GMT

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!)

Re: Facts on FDA Approval

suzyQ3 — Thu, 27 Mar 2014 22:15:09 GMT

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.

Re: Facts on FDA Approval

RunnerMom — Thu, 27 Mar 2014 22:27:03 GMT

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.

Re: Facts on FDA Approval

Happy Elizabeth — Thu, 27 Mar 2014 22:29:01 GMT

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.

Re: Facts on FDA Approval

scotnovel — Thu, 27 Mar 2014 22:44:07 GMT

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.

Re: Facts on FDA Approval

HappyDaze — Thu, 27 Mar 2014 22:50:34 GMT

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."

Re: Facts on FDA Approval

sharlee — Thu, 27 Mar 2014 22:53:39 GMT

On 3/27/2014 Scotnovel said:
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.

True, medical devices are in a different class from cosmetics, which don't require pre-marketing approval at all.

Re: Facts on FDA Approval

scotnovel — Thu, 27 Mar 2014 23:13:14 GMT

On 3/27/2014 sharlee said:
On 3/27/2014 Scotnovel said:
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.

True, medical devices are in a different class from cosmetics, which don't require pre-marketing approval at all.

From FDA FAQ's, if it is a combination of a cosmetic and a drug, then other rules apply.

Is it permitted to label cosmetics "FDA Approved"?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].

Re: Facts on FDA Approval

Porcelain — Thu, 27 Mar 2014 23:38:27 GMT

The other day I noticed a host refer to some sort of device, maybe it was a facial LED light thingy, as being FDA cleared. She repeated that term, so it seemed deliberate. Wonder if that's different than approved. I'd expect a lower threshold for cleared than approved.

Re: Facts on FDA Approval

scotnovel — Thu, 27 Mar 2014 23:54:42 GMT

On 3/27/2014 Porcelain said:
The other day I noticed a host refer to some sort of device, maybe it was a facial LED light thingy, as being FDA cleared. She repeated that term, so it seemed deliberate. Wonder if that's different than approved. I'd expect a lower threshold for cleared than approved.

I found this on FDA website and from other info on the site cleared is not the same as approved. Also if you go to the FDA website and search NuFace you can find the actual FDA documents associated with the device you mentioned.

"To acquire clearance to market a device, the submitter must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use."

Re: Facts on FDA Approval

MarenSeattle — Fri, 28 Mar 2014 01:14:41 GMT

I used to work for a Biotec and we were conducting clinical approvals for FDA approval. I honestly think they just went over our trial results - certainly didn't do any testing on their own. You'd think I would remember more because I was involved in the FDA submission process, but it was a LONG time ago!

But essentially, the FDA is not telling me that the new Tria Age Defying Laser will REALLY get rid of my wrinkles, it's telling me that Tria's submission numbers (with supporting trial evidence) backs up Tria's claim, and that Tria isn't out and out scamming us. If Tria's clinical trials didn't support their claims, they wouldn't have received approval.

I'm using Tria just as an example because I've been talking about it all day. :-)

Re: Facts on FDA Approval

LuluOnBeauty — Fri, 28 Mar 2014 01:19:45 GMT

I think you mean FDA cleared if you are referring to beauty devices.