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Lip Balm is now a drug according to the FDA

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soapbuddy

Post subject: Lip Balm is now a drug according to the FDA

Posted: Fri May 16, 2014 10:50 am

Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather

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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Irena
Closed minds are like faulty parachutes; they refuse to open.

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Anakiya

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Fri May 16, 2014 12:31 pm

Joined: Thu May 16, 2013 2:57 pm
Posts: 238

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

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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soapbuddy

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Fri May 16, 2014 12:36 pm

Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather

Matching jammies too Anakiya!
I wonder how many people would buy if I call it Lip Lube?

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Irena
Closed minds are like faulty parachutes; they refuse to open.

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rosie99

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Fri May 16, 2014 6:11 pm

Joined: Mon Feb 04, 2013 8:21 pm
Posts: 360
Location: middle of nowhere VA

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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Anna Rose @-}--
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soapbuddy

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Fri May 16, 2014 6:57 pm

Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather

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Irena
Closed minds are like faulty parachutes; they refuse to open.

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Mellifera

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Sat May 17, 2014 2:09 am

Joined: Mon Oct 31, 2011 10:39 am
Posts: 731
Location: New York

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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Lesli Sagan
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StokedTopHat

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Tue May 20, 2014 7:40 am

Joined: Thu Feb 13, 2014 2:04 pm
Posts: 451

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Olivia :)

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soapbuddy

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Tue May 20, 2014 9:43 am

Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather

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Irena
Closed minds are like faulty parachutes; they refuse to open.

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Genny

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Tue May 20, 2014 12:57 pm

Joined: Mon Jan 30, 2012 7:42 am
Posts: 1621
Location: Western WI

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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Genny

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rosie99

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Tue May 20, 2014 1:38 pm

Joined: Mon Feb 04, 2013 8:21 pm
Posts: 360
Location: middle of nowhere VA

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Anna Rose @-}--
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soapbuddy

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Tue May 20, 2014 2:03 pm

Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather

Thanks Genny. I wonder what they consider "active ingredients".

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Irena
Closed minds are like faulty parachutes; they refuse to open.

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Genny

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Wed May 21, 2014 7:50 am

Joined: Mon Jan 30, 2012 7:42 am
Posts: 1621
Location: Western WI

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Genny

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Mellifera

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Thu May 22, 2014 12:13 pm

Joined: Mon Oct 31, 2011 10:39 am
Posts: 731
Location: New York

Zinc oxide, probably.

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Lesli Sagan
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ldashner

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Sat Jun 14, 2014 10:35 am

Joined: Sun Jun 01, 2014 10:20 pm
Posts: 5

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Leilani

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hubahubister

Post subject: Re: Lip Balm is now a drug according to the FDA

Posted: Sun Nov 09, 2014 6:47 pm

Joined: Mon Jun 03, 2013 4:37 pm
Posts: 17

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

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