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Teach Soap • View topic - Lip Balm is now a drug according to the FDA

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PostPosted: Fri May 16, 2014 10:50 am 
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Googled "Lip Balm FDA Regulations" and that's what came up . . . This is a new change as of April 2014. So we can no longer call our lip balms "lip balms". I am at a loss on what to call mine.

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PostPosted: Fri May 16, 2014 12:31 pm 

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Oh, Good! I was soooo worried that the FDA didn't have enough to do already!!! :x

I read the FDA's Code of Federal Regulation. It appears that they consider lip balm to be a "skin protectant", thereby implying some medical benefit, and so now it is a drug.

Wow, Irena - we are drug dealers!!! Maybe we can get matching bedding ensembles for our prison cell!


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PostPosted: Fri May 16, 2014 12:36 pm 
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:lol: Matching jammies too Anakiya!
I wonder how many people would buy if I call it Lip Lube?

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PostPosted: Fri May 16, 2014 6:11 pm 
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Well that stinks, but clever soapbuddy, we could call them lip butters or lip wax(does that even make sense tho)..... maybe?

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PostPosted: Fri May 16, 2014 6:57 pm 
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PostPosted: Sat May 17, 2014 2:09 am 
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Our lip balms are safe: http://indiebusinessnetwork.net/forum/t ... d-fda-drug

This makes sense. They wrote badly on the FDA web site.

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PostPosted: Tue May 20, 2014 7:40 am 
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PostPosted: Tue May 20, 2014 9:43 am 
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PostPosted: Tue May 20, 2014 12:57 pm 
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This is the response I got yesterday from the FDA when I asked them if it was the word "balm" that made lip balm a drug or if lip balm is a drug when drug claims are made when selling it.

From FDA
"Several factors that can cause a product to be considered a drug; containing active ingredients and making certain claims. For information related to drugs as well as the factors (names) that cause a product to be considered a drug, please contact FDA’s Center for Drug Evaluation and Research (CDER) regulates drug (active ingredient) products."

Clear as mud, right? So now I've contacted the CDER and am waiting on a response.

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PostPosted: Tue May 20, 2014 1:38 pm 
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PostPosted: Tue May 20, 2014 2:03 pm 
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Thanks Genny. I wonder what they consider "active ingredients".

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PostPosted: Wed May 21, 2014 7:50 am 
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PostPosted: Thu May 22, 2014 12:13 pm 
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Zinc oxide, probably.

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PostPosted: Sat Jun 14, 2014 10:35 am 

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PostPosted: Sun Nov 09, 2014 6:47 pm 

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Is there any updates to this yet? on what it should be called or anything?


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