In November of 2012, I blogged about the Citizen Petition filed with the FDA by the Handcrafted Soapmakers Guild (now known as the Handcrafted Soap & Cosmetic Guild). The blog was about the current regulation of requiring a home address on the label of cosmetic products. The petition requested that the FDA allow a PO Box address on the label, in place of a physical home address. Many small business owners run their business in their home and some are concerned that placing a home address on the label of a product introduces personal risk. Replacing the business address with a PO Box would eliminate this risk.
UPDATE 9/19/2017: The FTC has updated regulations concerning business name and address. The NEW regulation says the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource. Read more here.
Since November of 2012, the HSMG filed an Amendment of Citizen Petition with the FDA on November 6, 2014. You can find the amendment here. This document briefly recaps the past events, including the response on February 1st, in which the Acting Director of the Office of Cosmetics and Colors stated they were unable to reach a decision. The amendment also presents new information, including the decision to change the name of the Handcrafted Soapmakers Guild, to the Handcrafted Soap & Cosmetic Guild.
Two years later, the Handcrafted Soap & Cosmetic Guild received a final response to the petition. The FDA denied the petition. You can read the final response from the FDA here. Bottom line, the FDA did not agree that a PO Box address would be a suitable alternative to a street address. The response reads:
“We disagree that allowing the listing of a PO Box on labeling in lieu of street address would be an acceptable amendment to 21 CFR § 701.12(d). In considering whether listing a PO Box is a suitable alternative to listing a street address, we must consider the definition of “principal place of business,” and its applicability to the use of a PO Box in lieu of a street address in this instance. “Principle place of business” commonly refers to a location where the corporation’s chief executives, head office or headquarters of a business can be found.”
While it is disappointing that the petition was denied, there is good news. In the response, the FDA states the street address may be omitted from the label if the business name is listed in a current telephone or city directory, including online directories. In the response, the FDA goes into detail regarding the various types of appropriate directory listings of phone numbers which include yellowpages.com and localpages.com. The response reads:
“Telephone directories are published both in print and online, and a listing in either would satisfy the option under 21 CFT 701.12(d) to list a street address in a current city directory or telephone directory, if the street address is not included on the product label.”
If you’re looking for more information on labeling your products, check out the blog posts about labeling cold process soap, lip balm and lotion.
What does this mean for your labeling? You may omit the street address from your label if your phone number is listed in an appropriate directory (including online directories). For many small business owners, this is a simple way to meet the FDA’s new requirements. You can find the Handcrafted Soap and Cosmetic Guild’s summary of the events here.
Q & A via the Handcrafted Soap & Cosmetic Guild:
- Do I have to list my street address in the online listing?
Answer: The letter we received from the FDA states “Telephone directories are published both in print and online, and a listing in either would satisfy the option under 21 CFR 701.12 (d) to list a street address in a current city directory or telephone directory if the street address in not included on the product label.” Therefore, we interpret this to mean that the street address is required in the online and/or print listing. - Does this cover soap too or just cosmetics?
Answer: This is from the FDA and applies to cosmetics and cosmetic labels. That being said, soap can either be classified as a cosmetic or as a consumer commodity depending on how it is formulated and marketed. When soap is made with it’s non-volatile portion being from the alkali salts of fatty acids and there are no cosmetic claims being made on the label, brochures, website etc, about the product (i.e.. moisturizing, deodorizing) is considered true soap and is regulated by the FTC as a consumer commodity not the FDA as a cosmetic. Therefore, the regulation mentioned in the FDA letter 21 CFR 701.12 (d) would not apply.
What do you think of the new developments in this matter? Personally, I feel it’s a step in the right direction. I’m glad there is now an easy alternative to placing a home address on the product label.
So I am a little bit confused. Maybe you can help or point me in the right direction. So I understand that the FDA requires the home address on product label (if the home is the business). Is that just for the labels? I ask this because I just started my home based business so everything has my home address on it, but I want to get a PO Box for shipping purposes, is this ok? This way I can label my products with my home address (omitting the street number), but use a PO Box to ship. Thank you
Hi Pamela!
This ruling is for labeling purposes! So, you’ll want to list your home address on your labels, but you can list your PO Box as your shipping address. 🙂
-Kelsey with Bramble Berry
Umm I’m not sure how, but Blistex tubes use a P.O. Box. address. Maybe because the claims classify it as a OTC drug due to the ingredients. BTW the FDA website says that if it includes cocoa butter then it has active ingredients, and as another poster said, falls under much stricter rules. If it contains active ingredients, it’s considered an OTC drug. A way around this is to not use the ingredients listed with medicinal properties on the FDA website. You can’t legally claim moisturizing, treat chapped skin etc. without it being labelled an OTC drug. That’s why commercial lip balms have “Drug Facts” on the packaging. Everyone knows lip balm is not “medicine,” but that’s how they categorize it. I actually just read all this today, but you have a very good and MUCH SHORTER lol summary of cosmetic requirements. I guess it just wouldn’t apply when considered both a cosmetic and a drug… Be careful.
The difference between products that are cosmetics and drugs can be a bit confusing! For instance, products that claim to treat chapped lips or lip balms that have SPF in them are considered a drug and are regulated that way. However, moisturizing is a tricky one. It claims to beautify the skin rather than treat or cure it, so that term can be used for cosmetics! You can read more about the difference between drugs and cosmetics here: https://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/
As for cocoa butter, I don’t believe it is considered an active ingredient. According to Marie Gale, “There IS a monograph for using cocoa butter at 50% – 100% as an active ingredient for a skin or lip protectant. Using it at that rate and claiming the product actually PROTECTS the skin or lips causes the product to be a drug. In order to be marketed as such it would need to follow the regulations for Skin Protectant Drug Products for Over-The-Counter Human Use, covered in 21 CFR 347, AND the manufacturer would need to be registered with the FDA as a drug manufacturer and follow all the required good manufacturing guidelines for drug manufacture (which are in regulation).”
Read more in her blog on the subject: http://www.mariegale.com/more-on-lip-balm/
So, as long as your cocoa butter is used as a smaller amount and the lip balm isn’t marketed as a lip protectant, it should be fine. To be 100% sure I would recommend contacting the FDA! They can tell you more about cocoa butter. Find their contact information here: http://www.fda.gov/AboutFDA/ContactFDA/default.htm
Marie Gale’s book, Soap and Cosmetic Labeling, has a lot of helpful information as well: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx
Also, I’m not sure why Blistex is allowed to use a PO Box! Because their products are sold as a drug they will have different regulations. For handmade cosmetics, the label will need a street address. Hope that helps! 🙂
-Kelsey with Bramble Berry
The responses received from the FDA refer to “corporations” and “corporate entities”. I would bring this to their attention as it appears that their current sets of guidelines are geared toward corporate entities and as such, would not apply to home based businesses that are sole proprietorships. Corporate law and denominators do not apply to an S/P.
An alternative to listing a PO Box would be to list the street address of the location where the box was located, indicating the Box # as a Suite # (ex: PO Box 45, Anytown, State, Zip would thus translate to: 123 Main St., Ste. 45, Anytown, State, Zip).
I was looking at your instructions on labeling lip balm and I came across something in the comments of which I wasn’t sure you were aware. Perhaps you have changed what you or your staff members have said because the law might have changed between then and now, but you were telling people that if they added the word ‘moisturizing’ to their products that they would have to follow OTC labeling. According to the FDA a cosmetic is anything that are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (http://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074201.htm). In fact, they mention that something intended to moisturize is a cosmetic, it says, “Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.” If I read everything correctly, for something to be a drug something must claim to heal a specific condition, such as a moisturizer that helps reduce eczema breakouts or whatnot. Anywho, I just wanted to see if you had that information updated because I noticed a lot of people asking about it and them being told not to put Moisturizing when that really is considered a cosmetic label. You can correct me if I am wrong and point me to the information that I can read on it. I began my degree in chemistry, and still tutor it often so I am very familiar with the terminology if the resource might seem complicated. Thank you very much.
Anna
Hi Anna!
You are correct! Moisturizing is considered a cosmetic term. Thanks so much for catching that! I’m going to work on updating those comments to clear that up. 🙂
-Kelsey with Bramble Berry
Wow I am so sorry that America has a full set of blinkers on as far as safety. Coudl you not take it as a human rights issue? Since women are predominantly the soap makers (sorry men folk!) could you not promote lack of safety as womens issues? And that the lack of thought into personal safety is in direct violation of violence against women? I don’t know. It seems absolutely MAD though! Hopefully something can happen. That is abolutely rediculous.
I’m glad we don’t have these issues here! But so very happy to support American Soapmakers in their cause! It’s so very important to have the right to privacy and safety.
Hi Janine!
Thanks so much for your thoughtful comment! We think personal safety is really important, and we will continue to advocate for soapmakers.
I would recommend sharing your thoughts with your local representatives! 🙂
-Kelsey with Bramble Berry
I have noticed that Brambleberry uses something like “Not available to the public” on their address, isn’t that an option for everyone else too? I realize that doesn’t stop the address from being out there, but it does tell most people that it’s not a storefront, so no they shouldn’t go looking for it.
Hi Alisha!
That may be an option for you! That way your address would still be on the label, but people would know it’s not a storefront. 🙂
-Kelsey with Bramble Berry
Hi All-
For some reason I was under the impression that we could list our PO Box. Anyway, out of curiosity, I went to my main Yahoo home page online and did a search for my new business name. YIKES!!! Due to how one files for an LLC in Washington, my mailing and street address both come up under my business filing. Well, one way to look at it is that I have an online presence! I will have a very serious chat with our post office.
Hi Nancy!
I’m so glad this post was helpful for you! Hopefully you can get that online listing straightened out. 🙂
-Kelsey with Bramble Berry
You would think that with advent of social media that they would accept the listing of an address on things like Facebook for an address- I know that is has to be a public listing like what is deemed appropriate, like the whitepages.com etc. But I to live in a rural area and get people want g to “see” how I make soap all the time. I don’t like that people can just stop by if they want by writing down my address from a label.
Hi Lorie!
Having people stop by can be a personal safety issue, which is why we supported the PO Box exception. Talking to your local representatives about this issue may be something to consider. 🙂
-Kelsey with Bramble Berry
Sometimes it’s better to ask forgiveness than it is to seek permission. Just don’t bother with a home address. The odds of anyone complaining about this – and to the FTC at that, and them following up on it – are likely to never, ever happen. If it ever comes to that, plead ignorance and deal with it at that juncture. Call the State Department and file a human rights complaint that you’re being economically discriminated against. That the law is intended for large corporations with commercial manufacturing premisses and not someone making a bit of soap at home and selling them at markets and fairs.
As others have mentioned, not only is it a personal safety issue, it’s financial as well. The more information crooks have about you the easier it is to commit identity fraud, rob your home, etc. Unless a judge orders me to comply specifically I’ll be ignoring the FTC on this bit of nonsense for now.
Hi Zapp!
We were really hoping the FDA would allow a PO Box address on labels because we feel personal safety is incredibly important. If you feel the same way, we would encourage you to speak to your local representatives. 🙂
-Kelsey with Bramble Berry
All of this information is interesting and compelling. All I can say is, I safely make and appropriately label my products – however my address is irrelevant to my products and won’t be on my labels.
Hi Michael!
So glad you found the information interesting! We find it really important to educate our readers so they are informed when making decisions for their business. 🙂
-Kelsey with Bramble Berry
ALERT. This is ALL bad news. Soap makers are all sliding under the FDA radar as it is. What most of us are doing could be deemed FDA illegal. The Guild has hooked up with the costmetic industries? Whose bright idea was that? Let’s just draw more attention to those of us that are making soap at home and not in an FDA approved space. Come on gals, we don’t want to call attention to ourselves. What’s the deal with the POB’s. My address, is my address. My business name is simply not on my packaging. I use my name and my address. Simple. My business name and address does not appear anywhere in public. Quit it. This can only backfire. Shush!
Susan,
In early 2013, The Handcrafted Soapmakers Guild took a member vote to change the object and purpose of the association to include not only handcrafted soapmakers but also handcrafters of cosmetics. It was widely recognized in the industry that soapmakers often made other products, such as, lotions, creams, scrubs, etc. Furthermore, the HSCG’s member benefit General & Product Liability Insurance already covered these types of products so it made sense to allow not only handcrafted soapmakers, but crafters of cosmetics as well into the membership. Finally, it also made sense for our advocacy efforts, as soap itself could either be classified as a consumer commodity or a cosmetic in the U.S..
I am unclear as to what you mean by “an FDA approved space” for making handcrafted soap and/or cosmetics. FDA does not prohibit the manufacture of soap and/or cosmetics in a home, nor does FDA have any language that defines an approved space specifically. GMP (Good Manufacturing Practices) Guidelines should be followed by anyone that is making soap and/or cosmetics regardless of where they chose to make them. Here is the link to the checklist for GMP: http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm2005190.htm
Hi Susan,
Thanks for your comment. I agree this isn’t good news and we were really hoping for a different answer.
As far as making cosmetics go you just need to follow Good Manufacturing Practices (GMP) to comply with the law. In general those are the things you do to be clean and organized in your manufacturing process anyway. the good news is that most small soapmaking businesses are thriving and following existing law. Lela Barker made a wonderful online class laying out GMP if you want help in implementing those guidelines. https://www.brambleberry.com/GMP-Good-Manufacturing-Practices-Master-Class-P5607.aspx
We can all be proactive and work on these issues together to ensure that there is a vibrant, thriving small business economy that gives consumers a choice in which soap and cosmetic products they buy. I hope you can see that we are working to ensure that our customers can safely and legally sell their products now and in the future.
This issue really hits home for me because I’ve actually been in the position everyone fears when they discuss this. I’d like to tell you about it. We are self-employed and have an online business. We do not have a storefront, we do all business online. One day I was in the shop (next to my home) and was working when the dogs started barking like crazy and someone drove up. Peeked out to see who it was and it wasn’t anyone we knew. I went out to see what they wanted and it was an older male on a motorcycle, rough looking, wanting to buy something from us. Again, we do not have a retail store, we do markets and we do online sales and that’s it. We’ve never done business out of our home and don’t plan to. However, he had heard of our products online and wanted to buy from us so he drove to the city where we live and went to the post office. When he asked about our address they gave him directions right out to the house and that’s how he ended up in my driveway unannounced. He let himself through the gates into the driveway despite my objections, and muscled his way inside the shop. The dogs were going crazy barking and I was terrified (I trust the instincts of our animals, and they weren’t the only ones having a bad feeling about the situation). He was a large man and could have easily overpowered us (at the time it was just me and my mother in law). He was very pushy and aggressive and we were home alone at the time which scared me too. I tried to answer all of his questions (to get him to go away) and make him aware of the fact that we don’t do business out of our home that we do online sales only, but he refused to leave. I can’t tell you how scared I was, trying to hold it together and not totally freak out. Hubby showed up and he left quickly afterwards but I still to this day wonder what he would have done if hubby hadn’t showed up unexpectedly. Just thinking about it makes my heart race. That is the sort of thing they are opening people up to with this rule. Since then I’ve decided the safety of my family is more important than what they deem important. The previous story is not the only time something like this has happened. One time a couple showed up to my house at 8:30 pm wanting to see what we had and ask questions. They ended up staying for two hours, I just couldn’t get them to leave (they didn’t want to buy they were just curious and wanted to see what was going on). I needed to be at home getting my stuff done but instead I was outside in the cold in a possibly dangerous situation to satisfy someone’s curiosity. People just don’t get the hint… when you say you have to go they just keep right on talking. So now I’ve had a total of three strangers show up at my house unannounced and uninvited. I won’t put up with it anymore. Now I list my PO Box whether they like it or not. I am a very visible presence online and anyone can find me EASILY. There is no reason to require a physical home address. I sincerely thank you from the bottom of my heart for championing this. It’s a very dangerous situation, one that needs to be remedied. I know I’m not the only one that appreciates you standing up for us and addressing this issue. I am confident the rules will change in time, but nothing happens overnight! Until then, I’ll continue to list my PO Box because frankly, my family’s safety is just more important than some random rule a pencil pusher put in place.
I live in rural south Texas, and it really is a different mindset around here. Whether or not that is a “good” thing is a different debate! 😉 The above story is scary, but illuminating. DO NOT give away your personal power or authority to anyone, ever. Yes, we are in business; yes, we want to be helpful. People with questionable motives KNOW this, and will take advantage of it. Bottom Line: ANYONE who shows up at your home unannounced is trespassing. If a polite comment about not doing business from home; here’s my card and look me up online, doesn’t do it, shut the door and call 911. Don’t let people in. If they shoulder their way in, they have committed a “home invasion”. Respond accordingly. Turn the dogs loose, dial 911, LEAVE the property to stay safe, or get out your firearm (Texas!) A lot of people won’t like my mindset, but safety, not niceness should be a primary concern. I am also concerned about a local PO giving out info and directions (!) to a home w/o knowing the inquirer. I would think that violates privacy laws. At the least, let your local Post Master General know in writing that your info is NOT to be given out. And let your local LEOs know what’s happened, too. Our supplies and property are valuable, but not more than our lives and safety.
Oh, trust me… we had a VERY serious conversation with the post office employees. This has happened twice now, (one other time previous from the above example) under two different post masters, and both times I had a serious conversation with them and made them understand how terrifying it was to be put in that situation. They are nearly all women so I think they understand now. They were just trying to be helpful, they knew we were in business for ourselves and honestly just wanted to help. They didn’t stop and think about what they were doing, but did have good intentions when they did it. It won’t happen again or I’ll go higher than I already have. And yes, you are correct. It is a privacy invasion and is highly against post office rules. If I didn’t know them as well as I do (daily trips to the post office for years, we know each other very well) I would have pursued it further than I did. It honestly scared me to death and I didn’t react the way I wished I would have at the time. I wished I’d been more firm but when you’re put on the spot its hard to react the way you should when you have that “run” instinct screaming at you like I had at the time. I too live in the deep south and around here men have a lot less respect for women, so standing up and saying “GO” doesn’t necessarily have the effect it would if a man were saying it. So honestly I don’t know if it would have done much good even if I had been firmer with him. Notice I said he left almost immediately after hubby came home… that says a lot to me.
Hi Delina!
Oh my gosh, that sounds so scary! We’re glad to hear you’re OK. Thank you so much for sharing your story.
Experiences like yours are why we wanted to change the requirements. If you feel the same way, we encourage you to contact your local representatives and let them know.
-Kelsey with Bramble Berry
What a shame, I was really hoping this would be approved! I’d agree about the address listing if it was made in a factory or warehouse, not a residental location. I know the odds of someone showing up at your door is slim to none but it’s still a concern. Knowing the manufacturing location doesn’t help anyone! I guess I’ll have to speak to the politicians here in WA about this!
The odds of someone showing up are a lot higher than you would think. Its happened to me three times now. One was, IMO, a very dangerous situation I just happened to escape without harm due to hubby unexpectedly showing up.
Hello!
We were hoping it would be approved as well. We encourage everyone to talk to their local representatives about this if they feel the same way!
-Kelsey with Bramble Berry
How about a follow-up post on how to get your address listed in print or online? 🙂
Hi Joyce!
Thanks so much for your suggestion! In the response, the FDA talks about appropriate directory listings of phone numbers which include yellowpages.com and localpages.com. You may want to contact those sites to find out more. 🙂
-Kelsey with Bramble Berry
Here are some suggestions for you for how to look more into this:
http://smallbusiness.yahoo.com (currently $29.99/month)
http://www.localpages.com (powered by Yext.com – currently $16/month for entry level)
http://www.yellowbook.com (powered by hibu.com – charges vary)
http://www.yellowbook360.com (powered by hibu.com – charges vary)
http://business.thewebmap.com/ (powered by prweb.com – charges vary)
Have a great day!
I knew that we didn’t have to list the full address on the label if our address and business name show up in a local listing. However, I don’t see why it’s necessary for the public to know where we sleep. Do online businesses that are not considered to have a physical location required to puts the owners home address on their websites? I don’t believe they do. It’s just more incentive to add rent to the price of my goods so that I can move my production to studio. If the studio gets robbed, fine, but, I don’t want any threats to my home where my children sleep.
Hi Becky,
That’s exactly why we supported the Soap Guild in asking for an exception in the first place. Unfortunately, they disagree. You should contact your Senator and House Representative and let them know this is not OK with you.
This requirement is for all manufacturers of products. So you are correct that if an online business is just re-selling products, they don’t have to list their actual physical address anywhere. Unless they are sending out marketing emails – then their address must be listed in each email as part of the CAN-SPAM act.
So to be clear the label needs to read
ABC Business
Any City, Any State Zipcode
Phone Number
Website
If this is not correct and you post how the correct version should look?
Hi Crystal,
There is no requirement for listing a phone number or web address. But many people do list those because it’s good marketing – makes it easy for your customers to re-order.
You only have to list your full address if you are NOT listed in a public directory (in print or online). If your address is listed under your company name in a phone directory then your contact info can just list the business name and the city and state.
~Amber