FDA Questions & Answers

[PippiL]

Couldn't find the thread anymore.But I found this by looking around and wanted to share this.Because I thought to myself,no way do I give my address away and compromise the safety of my family.
I googled this from the sage forum

Ok so I went to a craft fair this weekend and I noticed that next to no one put a physical address on their labels. One even told me that as long as I put my website address and have a contact method on there (even e-mail) that it'd be fine.

So that didn't help the matter. So I decided to grab the bull by the horns and just call the FDA. I asked a few questions while on the phone with them and thought I'd post them so you would know as well. (I've noticed most posts that don't get answers are because no one is sure how to answer it..)

1. the address has to be some sort of mailing address. I spoke with Alexander Roy in the office of cosmetics and colors (at the phone number (301) 436-1130 4:30 EST 4/4/11) and he said that listing a website would not qualify as a address. He said a physical address (like your house address) would be fine or a PO box would work. So I will be getting a PO Box

today. I have small children and I'd hate to have anyone think of coming here that I didn't know.

2. Common name of ingredients is fine. I asked "Do I have to list the INCI listing or can I call it by the common name such as coconut oil, olive oil, etc" and he said that the Coconut oil, olive oil, etc was just fine.

3. Making claims of moisturizing and hydrating are not considered drug claims. (I didn't think they were, however, I wanted to be absolutely certain so I'd not have any issues.)

 

[Deda]

OMG, you are my new hero!

I love that you took the initiative and 15 minutes of your time and got the correct answer from the correct source!

It scares the beegeesus out of me when I see incorrect answers, half truths and other faulty information passed around like a bong at a frat party.

Well done, Pippi! Thank you for taking the time to get the correct answer and for sharing that answer, along with the source.

You earned your Gold Star!

 

[Deda]

Well, seems I speed readered through your post.

I thought you had called the FDA.

Still, good job. Thank you for sharing.

Me, being me and not taking anyone's word for anything (except Carebear and Tabitha) I would have called him myself and grilled him.

Cause I'm mean like that, ya know?

 

[PippiL]

I will call them next week,since it is driving me crazy.I will post again...promise.This is very important to me
I'm the same way...I have to do my own research, can't just believe everything.Sorry Deda for misleading you, I tried to type in bold letters to make sure people don't think, this is my own little thing I did.

 

[Deda]

You absolutely didn't mislead me, I was so excited that I raced through and didn't read everything.

You know I already know everything and don't have to read every.single.word.

 

[Hazel]

I think it's wonderful that you're checking into this info. I read somewhere that if your business is listed in the phone book then only a website and contact info is acceptable. You might want to ask if this is correct.

I don't think it would cost much to add your business in the white pages and it might be cheaper than a PO box. However, a PO box would provide more anonymity.

BTW, I can confirm that Deda knows everything and doesn't need to read every word. She's omniscient. :wink:

 

[carebear]

Aaaah, so that was a quote from The Sage? If so, I can modify the post to make it more clear.

Anyway, that's not what the cosmetics labeling manual says...

(d) The statement of the place of business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including the invoice).

(e) If a person manufactures, packs, or distributes a cosmetic at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such cosmetic was manufactured or packed or is to be distributed, unless such statement would be misleading.

http://ecfr.gpoaccess.gov/cgi/t/text/te ... .3&idno=21
so color me confused

I'd love to hear it from the horse's mouth myself!

 

[PippiL]

?

 

[PippiL]

so confusing :shock:

 

[carebear]

Apparently you are DOUBLE confused, Ms Longstocking!

 

[PippiL]

the question in the original post was I believe,too,if we need to put our home address on the label when selling soap?
But again I will find out either way, for soaps and cosmetics

 

[PippiL]

Oh no how did that happen ???
I will edit one

 

[Hazel]

Oh no how did that happen ???

Finger spasm?

 

[Deda]

Ok. So the $64000 question is "Does the FDA allow the use of a PO box in place of a physical street address in cases where the business is not listed in the local phone book?".

When I worked for TRE I contacted the FDA with a very similar question. I was told that using a PO box was allowed. We knew the physical location of the business would change within a short period and wanted to purchase a large run of labels. The subtle, yet important difference is that the business I worked for was listed in the phone book.

FWIW - my physical address (home) along with my business phone number (571)306-DEDA is printed on everything. So far no crazies knocking in my door, at least not because of my business.

I volunteer to contact the FDA on Tuesday.

 

[carebear]

Thank you, Deda.

 

[PippiL]

OK you twisted my arm Deda...I'm looking forward to your answer.

 

[Maythorn]

I have a post office box and recently the post office informed me that I can use their street address if I want to. Not sure if that includes the box number, too, or not though.

 

[carebear]

Anyone else listening in on the Indie phone call with the FDA guy? Maybe we'll get an answer.

 

[krissy]

....waiting..... so what did they say??

 

[carebear]

oh, sorry - the call is tomorrow at 1:00pm my time. I'll let you know - I hope I can stay on it, I'm supposed to be working LOL.