# FDA Questions & Answers



## PippiL (Feb 18, 2012)

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..)
> 
> ...


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## Deda (Feb 18, 2012)

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!


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## Deda (Feb 18, 2012)

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?


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## PippiL (Feb 18, 2012)

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.


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## Deda (Feb 18, 2012)

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.


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## Hazel (Feb 18, 2012)

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:


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## carebear (Feb 18, 2012)

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!


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## PippiL (Feb 18, 2012)

?


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## PippiL (Feb 18, 2012)

so confusing :shock:


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## carebear (Feb 18, 2012)

Apparently you are DOUBLE confused, Ms Longstocking!


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## PippiL (Feb 18, 2012)

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


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## PippiL (Feb 18, 2012)

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


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## Hazel (Feb 18, 2012)

PippiL said:
			
		

> Oh no how did that happen ???



Finger spasm?


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## Deda (Feb 18, 2012)

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.


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## carebear (Feb 18, 2012)

Thank you, Deda.


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## PippiL (Feb 18, 2012)

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


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## Maythorn (Feb 21, 2012)

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.


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## carebear (Feb 21, 2012)

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


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## krissy (Feb 21, 2012)

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


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## carebear (Feb 21, 2012)

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.


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## PippiL (Feb 21, 2012)

It is getting so suspenseful.I'm battling tooth extraction problems,that is why I have not called,but I will soon,because no way will I use my street address.


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## carebear (Feb 22, 2012)

woo hoo!  Don Havery of the FDA who is on the conference call said that a web site or a PO box are just fine!!!  That the customer just needs a way to reach us!


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## carebear (Feb 22, 2012)

regarding INCI names...

The point of the regulations is to tell consumers what is in there - clarity is everything.  So...

1 - Common name (with INCI name in parens) = good, OR
2 - Common name only = good
but just INCI names... not really good because most consumers don't speak Latin...

NOTE:  US only.  If you want to go outside the US you need to follow their rules...


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## carebear (Feb 22, 2012)

"The safety of this product has not been demonstrated" does not to be put on labels.  

I'll come back and tell you why after the conf call break.


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## IrishLass (Feb 22, 2012)

I wonder if we could get this in writing?

IrishLass


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## carebear (Feb 22, 2012)

members can get access to the recording, which should be good enough, I imagine.
and we can send Debbie questions she will put to him for a response in writing.


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## PippiL (Feb 22, 2012)

That Elmo is dancing  Thanks for the info and doing the work.


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## carebear (Feb 22, 2012)

Other things - your web site is considered part of the labeling!  it's called collateral labeling.  so you have to be careful what you say there re: claims.  AND TESTIMONIALS COUNT TOO!!

(I will pull these together and post as a sticky somewhere but whatn to get it out now).


LIP BALM - the word "balm" is ok - it's not going to be considered a drug claim unless there is other content which takes it in a drug direction.

(DON just offered to answer all questions by email  --  [email protected]).


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## carebear (Feb 22, 2012)

OK - 

FIRST AND FOREMOST - SOAP IS NOT A COSMETIC.  But as soon as you go past soap=soap then you move into cosmetic.

COSMETICS cleanse,  moisturize, or change the APPEARANCE of skin.  If you say it changes the skin physically - it's a drug; if it treats or prevents or protects - it's a drug! If you talk about any specific disease (rosacea or acne, for example) it's a drug.

Any product that even hints or suggests that it provides some protection (even naturally occurring in ingredients) is a DRUG.

Ingredients that impart color MUST be approved for that use by the FDA - some colorants also need certification (mfg of the colorant gets that).


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## Tegan (Feb 22, 2012)

Oh thank god!  I'm gonna go yank my street address off those labels ASAP!


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## Deda (Feb 22, 2012)

Still haven't received a call back from Mary Toro with the Consumer Product Safety Commission.  They are the ones who regulate SOAP.  

So far, what I've been told is that a PO Box will only suffice if you have a "Commercial Business" address.  

Hopefully, she will have the answers.

As for Cosmetics (FDA), the answers have been conflicting.  

Either way, an address is required on all products.  FDA or CPSC.  

I suppose we (homebased businesses) are a small enough demographic that the question isn't raised that often?  

As I stated before, I will continue to use my home/business address.  It's why I have a home occupation license.


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## Tegan (Feb 22, 2012)

Poo.....I thought it wasn't required per Carebear's post.  But I guess I'm wrong.  Thankfully I got busy and didn't have time to change my labels lol.  I'll just suck it up for now.  I haven't had any psychos yet thankfully!


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## carebear (Feb 22, 2012)

yes, soap isn't a cosmetic.

BUT I think I heard that. according to the FDA dude, if you add color it becomes a cosmetic. It was a little confusing at that point, so I'd like to clarify that so will send him an email.


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## rileylite (Mar 1, 2012)

Is that guy good with anyone contacting him? Because I have an insane amount of questions. I feel like this is one of those things where issues are dealt with by individual agents who all have different opinions.


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## PippiL (Mar 1, 2012)

I got my PO Box...6 Dollars a month,don't need a business license in my town,waiting for my state tax id have to study the labeling book.....


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## MarieGale (Mar 5, 2012)

*Labeling Clarifications*

Hi -

This thread was brought to my attention and I thought maybe I could help clarify some of the labeling points.

Name and address ARE required.  The regulations say "physical address", so technically a PO box doesn't qualify.  Website definitely doesn't qualify.

IF the name on the label is listed in a PRINT phone or city directory (not just directory assistance or online), then the street address can be omitted, but the city, state and zip code still need to be on the label.

Ingredients are required on all cosmetics.  Soap is classed as a cosmetic if there are any claims made other than "cleansing" and "soap".  So if you say it's moisturizing, soothing, exfoliating or anything other than "it cleans" and "it's soap", and ingredients are required.

Ingredients need to be in INCI format.  HOWEVER, the regulations specify the 2nd edition of INCI, which uses common names.  Subsequent editions  changed to include the Latin names --- so technically, either common, common with Latin in parenthesis (7th edition) or Latin with common names in parenthesis (current) are acceptable.

I think that covers most of the issues brought up ... I've created a Quick Labeling FAQ (http://www.mariegale.com/labeling-faq) on my website which addresses these points and a few others.  Check it out and if you have other questions that aren't addressed, email me and I'll add them.

I set this to notify me if there is a response, so if you have any additional questions and post them here, I'll answer.

Marie


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## Hazel (Mar 5, 2012)

Off topic here but I want to say welcome to the forum to Marie Gale. I'm thrilled that you've come onto the forum to clarify labeling info.  It's been a topic that has been extremely confusing and frustrating for many members.


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## MarieGale (Mar 6, 2012)

*Welcome - thanks!*

Thanks for the welcome. 

I'll be glad to answer any questions that come up.

Marie


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## carebear (Mar 7, 2012)

*Re: Labeling Clarifications*



			
				MarieGale said:
			
		

> Name and address ARE required.  The regulations say "physical address", so technically a PO box doesn't qualify.  Website definitely doesn't qualify.


Marie, in the recent conference call with Don Havery of the FDA (through the Indie Network), he told us that as long as the contact information was there, it was ok.  He said PO Box, email, or web site (as long as web site has contact info) are all acceptable and that a physical address is not required, despite the way it was currently written.


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## PippiL (Mar 7, 2012)

I have a PO Box and the rest of my label states my town,zip code and state.
There is no way I would give away my home address. 
This is something everybody should think about how dangerous this could be having your private home address on a label !
Why don't I attach my house keys with the label, too
If I would get in trouble with the FDA,bring it on.

There are a lot of sick people out and about, I think a PO Box is enough,since they have all the info about where you live etc.....


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## MarieGale (Mar 7, 2012)

*PO Box*

I know the issue of putting a physical address on the labels is a big one - for security, privacy and other reasons.  

I reviewed the regulations and legislation.  The terms used are "place of business" and "street address".  Technically, (and unfortunately) a PO Box doesn't qualify as either the "place of business" or the "street address".

Of course, that doesn't mean that tracking down anyone who puts a PO Box on their label is going to be very high on the FDA enforcement list!

I do know of one person in Michigan (I think - maybe Wisconsin) who was shut down by her LOCAL inspector because she didn't have the actual street address on her label ... even though her business had a dedicated phone in the business name, it wasn't listed in a PRINT directory.  She had to redo all of her labels and couldn't do anything until she passed a new inspection.

I haven't been able to find any documentation that backs up  what Mr. Havery said, but I've got some calls and emails in and will post what I find out.

Marie


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## carebear (Mar 7, 2012)

thank you.


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## PippiL (Mar 7, 2012)

Thank you very much for your help 
I have your book and love it....
I just payed for my PO Box  :cry: 
I will just play dumb for right now....and take my chance.
Everything else on my labels are a 100 % correct.
I wish this could be changed and I'm sure there is a way ???


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## MarieGale (Mar 7, 2012)

*Excellent News*

I just spoke with Mr. Havery and explained the concerns of about having street address on the labels.  He was very understanding (in fact, it sounds like he took some of the comments about the issues of putting a home address on the labels made during the interview to heart).

He doesn't have an official position of the FDA on the matter, but is getting clarification from the legal folks and has told me he should have an official answer within a couple of weeks.

I'll let you know as soon as I hear anything!

Marie


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## Hazel (Mar 7, 2012)

Thank you for your help.


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## carebear (Mar 7, 2012)

fantastic


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## MarieGale (Mar 16, 2012)

*FDA Statement - use of PO Boxes*

I heard back from Mr. Havery at the FDA about the use of a PO Box on a label.  This is what he wrote:



> I have posed the question about the use of a post office box on a cosmetics label in place of a street address to a lawyer in FDA’s Office of Compliance. While she understood the reason why a small business wouldn’t want to include a street address, it was her opinion that the regulation at 21 CFR 701.12 was very clear. There are only two options: 1) put their name in the local phone book so that they don’t have to put it on the product label; 2) put it on the product label. There is also no provision for replacing the street address with a website address.



So, it must be a street address OR the name listed must be in a local phone book.

Not such good news, but it is at least official.

Marie


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## Hazel (Mar 16, 2012)

Thank you for taking the time to get this clarified. It's greatly appreciated.


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## carebear (Mar 16, 2012)

Seems that conference call with him was a total waste - nothing but misinformation.

Oh, except that he said he lacks the resources to enforce anyway...


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## PippiL (Mar 16, 2012)

thank you very much here,too. I guess I got my PO BOX for nothing...
stupid regulation, I think.Something maybe has to happen to somebody before they realize.....


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## Dremma (Apr 14, 2012)

Guys I have a question.

We are moving in about 6 months (out of town to the wilderness, on a 160 acre area on a mountain, literally).  

What this means is...

1) I am closing the physical store and continuing to ship to local stores, as well as do online, which I have been doing in the past alongside my physical store.

2) My workshop is being built now (on our land and seperate building from the house) and county says I have no issue working from there.

3) I need new labels as per the address issue part only (and already working on them, need them ready to go by then).  And this is my problem.  I have no street address and will have no street address.  I do have a 911 address linked to the local EMS via GPS location, so they can get there for a 911 call.  However, the city on that address is over 100 miles away.  So obviously, that's not where I am working.

So, don't want to post my full future home address in public - we don't even have a street, only a private ranch road going through an easement on the other ranches land.  So should I just put...

'business name'
'our ranch name, city, state, zip'

We are not within 100 miles of town, so the business directory option isn't relevant for me.


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## MegaSoap (Apr 17, 2012)

Dremma, what will you use as your mailing address, the ranch name and RR#?  i'd assume that is what you'd use for your soap (mailing address).  but i'm just guessing!  someone else who knows more should chime in...


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## Dremma (Apr 17, 2012)

MegaSoap...

Thanks for the reply.  I don't have a RR # (as they don't deliver mail there, they give us all a free PO Box).

Since the entire community is on PO boxes system only, maybe something like...

'business name'
'ranch name, #1234, city, state, zip'


With the #1234 being a substitution for physically writing PO Box 1234?

That kind if seems like cheating but I don't really know what else to do to get both a required physical location on there and a mailing address.  Granted without the box number (as I said, very rurul and low population) they still know where to get your mail to you.  They even drop the UPS & FedEx off at the post office.   Apparently they have a contract to do so because of the remote mountain location and a lot of 4 wheel drive only roads.

Another option is that I could put the name of the mountain that we are on maybe?


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## VanessaP (Apr 17, 2012)

I work the front desk of a motel, and a lot of people who live in rural areas like that can only put the road name down on their drivers licenses so states accept that some people just don't have full street addresses. 

John Doe
Whatever Ave (no number at all, just the road)
City, State Zip

If that is all the state/county/town gives you to go on, then that's all you can do. I would put the ranch name down and then the street/road name and the town name.


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## Dremma (Apr 18, 2012)

VanessaP,

Thank you.  Thank you all for the replies, this is so darn complicated just for a label address and I don't want to do it incorrectly.  

Currently I still have this home address on my drivers liscense.  I will stop by the DPS/Drivers liscense office and just tell them where in the county that I am moving to and ask how it will read on my new one.

You are right, if it's on the main form of state ID, then it must (along with the ranch name) count as an official location.


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## judymoody (May 5, 2012)

Deda said:
			
		

> Still haven't received a call back from Mary Toro with the Consumer Product Safety Commission.  They are the ones who regulate SOAP.
> 
> So far, what I've been told is that a PO Box will only suffice if you have a "Commercial Business" address.
> 
> ...



Deda, did you ever hear back from Mary Toro?  The response that Marie Gale copied in this thread speaks specifically to "cosmetic" labeling, not soap.  If I read this correctly, I think the jury is still out on this question if we're dealing only with soap.  The FDA doesn't regulate soap.  The Consumer Products Safety Commission does, as you have indicated in your post.

Of course if you make lip balms, lotions, hair products, etc. then FDA mandated cosmetics regulations apply.


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## thefarmerdaughter (Oct 27, 2012)

Sorry to bump an old thread. But this one's a cliff hanger. Does anyone know what happened? Did anyone get ahold of someone at the CPSC? Did they contradict the FDA? and does one office supersede the other?


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## SimplyMadison (Nov 3, 2012)

Ive read this backwards and forwards and still have labeling questions!

So, if I list my BUSINESS NAME AND PHONE NUMBER within the community directory, I can omit my physical address from my labels?


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## ErikWeaver (Nov 22, 2012)

SimplyMadison said:
			
		

> Ive read this backwards and forwards and still have labeling questions!
> 
> So, if I list my BUSINESS NAME AND PHONE NUMBER within the community directory, I can omit my physical address from my labels?



This is how I read the thread. Not putting your street address on the soap label is permitted *if* a person can look up your business name in a printed telephone directory. The logic being, I assume, they can then obtain your street address from the telephone directory, which is easy once one knows the city, state, and business name to look up.


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## ErikWeaver (Nov 22, 2012)

ErikWeaver said:
			
		

> SimplyMadison said:
> 
> 
> 
> ...



Follow-up: 

I also noted on my Secretary of State web site another reason a physical address is required: being served!   The gov't wants to know where to serve process should that be required.


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## Lindy (Nov 23, 2012)

Here in Canada we have to be registered with Health Canada even if only making MP soap.  They then know where to serve you LOL   We do have to have something on the label that allows contact be it your web site address (not Etsy) plus a phone number.....


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## Seifenblasen (Nov 23, 2012)

This may be of interest to those in the US.  I have written a letter of support and commented on the FDA website.  The main point is, even with just a post office box, the "authorities" can still trace back to your actual street address if they need to serve you, but it keeps meth heads from breaking into your soap making place trying to steal NaOH.

http://www.soapqueen.com/business/produ ... ion-filed/


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## ErikWeaver (Nov 24, 2012)

Seifenblasen said:
			
		

> This may be of interest to those in the US.  I have written a letter of support and commented on the FDA website.  The main point is, even with just a post office box, the "authorities" can still trace back to your actual street address if they need to serve you, but it keeps meth heads from breaking into your soap making place trying to steal NaOH.
> 
> http://www.soapqueen.com/business/produ ... ion-filed/



If you could post the URL for the page, others could make a similar comment. I for one would do so. I suspect others may as well. The FDA web site is large and confusing enough having the URL would be greatly appreciated


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## Seifenblasen (Nov 24, 2012)

Here you go!

http://www.regulations.gov/#!submitComm ... -0872-0001


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## ErikWeaver (Nov 26, 2012)

Seifenblasen said:
			
		

> Here you go!
> 
> http://www.regulations.gov/#!submitComm ... -0872-0001




Done and done. Thank you for the link and notice of the comment period!


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