FDA responds to PO Box Petition

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Cindy2428

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I received this e-mail from the Guild this morning. Thought I would pass it along.

FDA Responds to PO Box Petition

Posted by Executive Director on 8 January 2015, 4:00 am
In August of 2012, the HSCG wrote a Citizen Petition to the FDA – Department of Health & Human Services, regarding the use of a PO Box in the place of a street address on a cosmetic label. We did this mainly for the safety of the small businesses that make up the handcrafted soap and cosmetic industry as many of them operate out of their primary residence. In February of 2013, we received an interim response from FDA stating that they were still reviewing the request and had not reached a decision. The original petition as well as the supporting documentation can be viewed online at regulations.gov.
In November of 2014, we decided to send in a supplement letter to the petition to update FDA with our new name (the association changed from The Handcrafted Soapmakers Guild to The Handcrafted Soap & Cosmetic Guild in February of 2013) and our significant increase in membership (182% since the first petition). We again requested that a PO Box be allowed in the place of a street address on a cosmetic label.
We received a final response letter from FDA denying our request to change the current regulation. You can read the full letter here.
Even though the request was denied and the regulation will not change, there was some clarification on what constitutes a “telephone or city directory”. You need to pay close attention to this…
Under current regulation, the business name and address (full street address) of the person or business responsible for the product must be on every cosmetic label. The business address must include the street address, city, state and the ZIP code unless the business is listed in a current city or telephone directory under the business name. In the response letter from FDA dated November 14, 2014, they defined “city directory or current telephone directory” as both print AND online and that either would satisfy the option under the current regulation if the street address is not listed on a cosmetic label. They further offer the following examples of acceptable online directories that are “no cost or nominal cost” annually:

What this means for a small handcrafted soap and cosmetic business is that in order to meet the requirement under the regulation, to omit your street address, you would only need to list your business in one of these directories annually. It would be important to keep the listing up to date with current information.
On the one hand, we were disappointed that a PO Box was not accepted but it was nice to see that the FDA is taking advantage of the non-traditional directory options offered by the internet. On the whole, this is great news for our industry.
 
This is wonderful news and was happy when I saw this email this morning as well. The hubby is always concerned that our address is on my products so I am definitely going to look in to getting a listing with the yellow pages.
 
My understanding is that it can be either - as long as it is published by a recognized entity which lists the address along with the phone number. So basically your home address is still available, but it makes for additional work for someone to find. Hopefully some drug whackoo doesn't know how to use the reverse listing feature in the white-yellow pages. It's not full protection, but better. Lionprincess, I'm not selling yet but I would definitely have a separate phone line for business. In my previous life as a traveling manager, I used to get calls, faxes at all hours. I added a second phone line and it made all the difference.
 
Thx Cindy! I don't sell either, but I am storing all tidbits of information and making sure if I do sell one day, the startup goes smoothly. This is great info to have for the future, thank you!
 
Thank you for sharing the information, I noticed that in the beginning of the letter it said "cosmetic" and wonder if there is any difference since plain soap isn't considered a cosmetic? Maybe just hoping, because I really do not like my home address out there. If they are not going to accept a p.o. box guess they won't accept an email address either? I had a previous business listed with the yellow pages, and at that time an ad was required, and it was crazy expensive. Will have to check out an online only listing, since that was back when people actually used the yellow book.
 
I don't know which is worse though. An easy online search to find my address, or on the physical label. The label could have much less exposure.
 
Thank you for sharing the information, I noticed that in the beginning of the letter it said "cosmetic" and wonder if there is any difference since plain soap isn't considered a cosmetic? Maybe just hoping, because I really do not like my home address out there. If they are not going to accept a p.o. box guess they won't accept an email address either? I had a previous business listed with the yellow pages, and at that time an ad was required, and it was crazy expensive. Will have to check out an online only listing, since that was back when people actually used the yellow book.

Soap using no "cosmetic" phraseology is free from this law. How you label and market your soap determines if it is a cosmetic or soap.

See the FDA site for information -USA Only (click here).
 
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Thank you for sharing the information, I noticed that in the beginning of the letter it said "cosmetic" and wonder if there is any difference since plain soap isn't considered a cosmetic? Maybe just hoping, because I really do not like my home address out there. If they are not going to accept a p.o. box guess they won't accept an email address either? I had a previous business listed with the yellow pages, and at that time an ad was required, and it was crazy expensive. Will have to check out an online only listing, since that was back when people actually used the yellow book.

US only -
Plain soap is not a cosmetic, you're right. Anything that we make here for use on the body that is intended for anything other than cleaning (creams, balms, soaps with certain tag words, shaving soaps etc) are cosmetics.
 
Quote"Under current regulation, the business name and address (full street address) of the person or business responsible for the product must be on every cosmetic label. The business address must include the street address, city, state and the ZIP code unless the business is listed in a current city or telephone directory under the business name."

If the business is now listed, (I did the Yellow Pages). Does this mean that no address at all is needed?
 
Quote"Under current regulation, the business name and address (full street address) of the person or business responsible for the product must be on every cosmetic label. The business address must include the street address, city, state and the ZIP code unless the business is listed in a current city or telephone directory under the business name."

If the business is now listed, (I did the Yellow Pages). Does this mean that no address at all is needed?

Correct
 
This is awesome. I not only have an very long street name, but also a long town/state. I will now be able to increase the font size for ingredients etc on my smaller labels with the extra space.
 
Hello! I was raised not to be a conformist to everything the government bureaucrats say to do - especially when it comes to my family and home security.

When I began my soapmaking business I asked the lawyer who helped form my business LLC about having my home business address on my soap labels and other materials including my website. I was very concerned about this based upon what the FDA stated. According to him home craftmaking businesses should never include their home address. Otherwise you have the potential to have weird people stopping by at all hours to sample products, sniff the soap, ask for samples, ask if you have kids, dogs, etc. I think you get the general idea. All it takes is one very determined person. Also, your home insurance may not allow you to showcase your home like this. The lawyer recommended to obtain a PO Box number for communication purposes. The same precaution goes with not adding your home telephone number. You should have a separate business phone. Your home is strictly your home. Allow customer business elsewhere.

So, what about this new ruling? I say forget about it. Oh it sounds nice to use these online directories BUT that personal information is still right there for people to EASILY find. NO, I would want it to be difficult to find this info. Although I sell soap as soap I still have contact information. I have a PO Box number (but the post office has my home address listed in their records and it is not available to the public). I have a business cell phone, I have an email account, on my website I have a form page so people can contact me. All these various methods for someone to contact me.

I had asked my lawyer about the (now older) FDA rules and he said - don't worry about it. If a FDA representative presses about why you don't have that "necessary" home address info listed just ask the FDA person where he or she lives and home address, their home phone number and all other personal information. YOU can also play their game. Have to go to court about it? Just ask the judge and jury the same questions. The case would be dismissed in a minute. This is what my lawyer told me and he belongs with a top-notch law firm.

PLEASE, don't lose sleep over this. Make your products as safe as possible and have other communication methods available so people can contact you. The big companies never post their employees or owners personal information do they? So ask yourself - why do I really have to?

Am I wrong about this? Maybe I am but I am not going to change my mind. I am doing it for the safety of my family and home. And I haven't lost any sleep over it. I am off the soapbox now.
 
I own my own business and my labels for baked and canned goods are inspected by my state. I don't want my address listed, but unfortunately I will lose my license if I don't list it. I tried the po box, but couldn't continue since I can't lose my license.
 
Mx6, have you checked your cottage laws in your area? I can only speak for Texas, and while I would have to put my address, Im not held under the same FDA regs and they dont have authority to inspect anything..only thing they can do is keep a record of any complaints filed against me.

As for soap, as long as I label it as 'soap' I don't have to put my address...just the weight {not even ingredients, altho I do}

ETA: Here is a link that may help you..not an exhaustive list but you can find links from here to the food production areas in your state maybe..

http://www.mariegale.com/soap-and-cosmetic-labeling/labeling-state.html
 
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I'm sorry, moody glen, but that is a little bit extreme.

Asking the FDA chap for his address doesn't compare to you putting yours on a label. You are selling something that could do damage to someone. In fact, even if your soap is generally fine, there could be an issue with one particular batch. Having the ability to actually contact someone is jolly important.

While email, mobiles and so on are fine and dandy, there is a reason why companies have registered addresses - so there is a sure fire way to contact them when all else fails. If you are called to court, I'm pretty certain that a court official can't do that over the phone or email.

When you start selling you stuff to the public, you stop being 'you, private person' and start being a company. Just because you choose to live in the same place as your company location does not mean that you shouldn't abide by the laws. Your feelings on federal government should have nothing to do with how you stand legally as a company.

Of course, some states (eg Texas) give protection in the form of cottage laws. Others won't let you make certain products at home (I'm thinking Florida here) - but if your state doesn't, you should abide by the law or, if you don't like the law, get another location to make your soaps in.

"But that'll cost more!" Well, too bad. Your customers deserve the ability to have a sure fire way to get hold of you in case they need to. Don't forget that some people might well ignore an email or phone calls from a customer seeking damages - so the solution is a physical location.

It sounds like the PO box offer from the FDA is a great compromise. It shows they are taking the soapers concerns on board but still protecting your customers.
 
Mx6, have you checked your cottage laws in your area? I can only speak for Texas, and while I would have to put my address, Im not held under the same FDA regs and they dont have authority to inspect anything..only thing they can do is keep a record of any complaints filed against me.

TX, CA, NV and a few others have wonderful cottage laws. I'm in PA and we do not. In fact, myself and a number of other vendors at our local farmers market have spent the last 3 years fighting with our local and state authorities about it and TX cottage laws were what we based our requests for change on. Our market has been in business for 40 years and I think this year will probably be the last. The regs were made more stringent 3 years ago and we have dropped from 25-30 vendors to 10 or less.
 
Taken from: http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm#clgi

"Name and Place of Business
Corporate name
Manufactured for...
Distributed by...
Address
Principal place of business

21 CFR 701.12

The name and business address appearing on the label may be those of the manufacturer, packer or distributor.

If the name and address is not that of the manufacturer, the name must be preceded by phrases such as "Manufactured for ...", "Distributed by ...", or other appropriate wording.

The name of the firm must be the corporate name, and the address may be that of the principal place of business. Stating also the name of a corporation's particular division is optional.

The business address must include the street address, name of the city and state, and the ZIP code. The street address may be omitted if the firm is listed in a current city or telephone directory.

The Tariff Act of 1930 requires that imported products state on the label the English Name of the country of origin."

end quote

--------

I refuse to have my home address on my products. But I do not want to be harassed by feds so I complied. The way I go about it is packaging my soap at my father in laws business. I have: Packaged at "business name" followed by the address. I think this is a fair solution at this point, I would rather the laws be changed to allow PO box or dropped all together. I think as a customer I trust an item more with an address on the back, so I'd probably keep an address of sorts on the back even so. Knowing where something comes from gives a light comfort and an initial judgement of quality.

*Someday I hope to have a place of business separate from my home. Then I'd love to have my address on, so people can come see how things are done and buy products if desired.
 
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Moody Glen, just so you know, your lawyer could be subject to disciplinary action for advising you to break the law.

JStar, that is incorrect. Federal law supercedes state law, states can be more stringent but not less so. You are correct that as long as you are just making and selling soap, that does not fall under FDA regs, but it DOES fall under the Consumer Protection Act and is subject to Fair Labeling, and that also requires you to list the physical address or be listed in a directory.

Look, folks, comply with the law or choose to take the risk and don't comply. I just think it is important to anyone that reads this thread to understand the law so they can make an informed decision for themselves, and the fact is that if you are selling soaps or cosmetics at all you must list the address of your place of manufacture or primary place of business on the label or in a directory. Period.

eta: anywhere within the US, that is!
 
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