Makining Claims on Products

[sarahmarah]

What steps must be taken in order to make claims on cosmetic products?

For example if I wanted to create a lotion and I wanted to market it as  'a soothing skin cream that may benefit eczema'  how are you able to word it without having an issue with the FDA ?

I know it can vary by state but its something that I see small companies do all the time and its confusing....

[TallTayl]

short answer, no claims unless your product has been tested and verified by the FDA. Anecdotal evidence is not proof a product "works", and more importantly that it does not cause unintentional harm. 

 

Companies that do make claims, and try to skirt the law are often just lucky to not be caught or turned in. A soaping friend was surprise investigated by the good old FDA for including the words, "smells medicinal" to describe her eucalyptus essential oils used in cold process soap.  She got two follow up visits to ensure her manufacturing facility ( garage) met with all FDA health and safety requirements, and hefty fines for things like boxes not safely stowed 6" or more above the floor.

 

With so many people out of work looking for something to do, why chance it? Kim from Essential Depot got on someone's radar a few years back and was turned in to the FDA for medical claims on hot process soap.  What a cluster that turned into. An entire rabid facebook group made it their mission to take her down. 

[sarahmarah]

Thanks TallTayl, I'm not looking to sell anything for a good long while.  but I want to make sure that I approach it from a responsible position. 

 

[BusyBee]

If I am not mistaken, I believe costmetics & massage candles are already under FDA regulations with or without medical claims.  I suggest you to take a look at FDA regulations.

[NightLight]

Etsy is filled with medical claims on salves and balms. Don’t even go there. If you say this cures eczema set you up for trouble.

Even saying something is antibacterial because it uses xx essential oils is setting you up for trouble

[cmzaha]

We we first started out believe it or not but we we received a large order from a FDA inspector. and never actually knew if it was for personal or inspection. It was very weird but the order actually went to the FDA facility, and my daughter was a nervous wreck. Fortunately we never heard a word back. So I assumed she received a free inspection and passed muster. We just never knew. This was over 10 yrs ago. They can find you.

 

It takes thousands of dollars and years of testing to get a product certified and most of use small producers simply cannot afford such. I have a soap and a fantastic balm I always wanted to have certified but it will never happen in my lifetime. 

[TallTayl]

1 hour ago, cmzaha said:

We we first started out believe it or not but we we received a large order from a FDA inspector. and never actually knew if it was for personal or inspection. It was very weird but the order actually went to the FDA facility, and my daughter was a nervous wreck. Fortunately we never heard a word back. So I assumed she received a free inspection and passed muster. We just never knew. This was over 10 yrs ago. They can find you.

 

It takes thousands of dollars and years of testing to get a product certified and most of use small producers simply cannot afford such. I have a soap and a fantastic balm I always wanted to have certified but it will never happen in my lifetime. 

the big product du jour for FDA attention is hand sanitizer. Loads of recalls for dangerous product out there right now.