FDA Questions & Answers

[MarieGale]

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

 

[carebear]

thank you.

 

[PippiL]

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 ???

 

[MarieGale]

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

 

[Hazel]

Thank you for your help.

 

[carebear]

fantastic

 

[MarieGale]

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

 

[Hazel]

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

 

[carebear]

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...

 

[PippiL]

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.....

 

[Dremma]

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.

 

[MegaSoap]

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...

 

[Dremma]

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?

 

[VanessaP]

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.

 

[Dremma]

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.

 

[judymoody]

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.

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.

 

[thefarmerdaughter]

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?

 

[SimplyMadison]

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?

 

[ErikWeaver]

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.

 

[ErikWeaver]

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.

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.