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A Surprise Visit from the FDA

Filed Under: Business Musings

Every small business, no matter the industry, must adhere to rules and regulations. The soap and cosmetics industry is no exception. Even the smallest of soapy and cosmetic businesses must comply with the FDA in terms of labeling, manufacturing practices, claims and more. If you’re a beginner or micro producer, it’s easy to fall into the trap of feeling the rules don’t apply to you because your business is so small. However, it is important to remember that the FDA enforces their rules and regulations; they expect even the smallest of businesses to comply with them. These rules are in place to benefit both your business and your customers by ensuring safety, purity of ingredients, transparent labeling, cleanliness and more.

Recently, a small soapy business friend had an unexpected knock on their door. When Robin of River Country Soapworks opened the door, she found an FDA inspector at her doorstep. Robin had not been reported to the FDA, but the inspector came across her website and noticed several problems with the way products were described. Specifically, Robin described a scent as “medicinal,” and stated that tea tree and lavender essential oils contained antibacterial properties. For even more background, Kenna of Modern Soap Making shared Robin’s story here.

aa2db734bbc04927b61580984ad5b5b4.image.750x501__72610.1438300865.1280.1280Robin of River Country Soapworks creates beautiful and high quality products. Shown here are her lovely wedding favor soaps.

I contacted Robin personally in April of 2015 to find out more about her experience. As a business owner myself, I immediately sympathized with Robin’s situation. To receive a surprise visit from a government official must have been nerve-wracking! Specifically, I asked her more about what the FDA inspector needed from Robin in order to get in compliance. Below is what Robin shared with me about her experience.

“The amount of money spent has been nothing compared to time and effort on both my husband’s and my part, getting ready and meeting the expectations of the inspector. Lots and lots of time. First though let me tell you what I actually spent. So you understand, I make soap in my garage. We converted the garage and I have my office, a stove, pouring tables and cutting area along with storage of raw materials and a drying room. I spent maybe $350 on more shelving, non-breakable sleeves for the over head lights and certified scale calibration that has to be done once a year. After the second inspection she noticed light bulbs over the desk, in the drying room and other area of the garage. I have to buy the metal cages for those lights. We also had to come up with some sort of raised platform that I could place my five gallon buckets on while making soap. You can not put molds etc. on the floor. They have to be raised up off of it.

work room 6The FDA inspector required Robin to store all molds and buckets in her work space to be raised off the floor. 

As far as time preparing and making corrections to what I was doing, I know I’ve spent at least a month doing that. Since one of the requirements is keeping batch logs, I utilized the Soap Maker program and spent the time necessary to inventory all my raw materials and figure out how to track with it. Then trying to figure out how the batch log system works and tracking down lot numbers from suppliers. I need a FIFO [First In First Out] system on my finished goods too. All raw materials needed to be totally off the floor so bulk oils had to be shelved. Right now there is nothing on the floor and when I make soap – I use the raised platform. The inspector also wanted to watch me make soap but I didn’t have anything going on so she watched how I packaged up an order. The next time she comes I will have to make soap for her as part of the inspection.

I was told that they will take a detailed look at my batch log system the next time they come out. I was not 100% done with working through that, and was actually struggling with it in some areas. She was kind enough to make suggestions on how to manage it which simplified things for me. I was also told I need to have a written procedures manual done which would include procedures on receiving, production, distribution, complaints and recalls.

For packages going out to businesses, I need to have a label on the outside of the shipping box that has my logo and address on it along with phone number. Ninety percent of my work is wholesale. Everything going out needs a batch number assigned. All bulk finished product leaving needs a label with my logo and address on it placed on the outside of the box. I am 90% of where they want me to be right now. Once I get the batch log system finished, and the procedures manual along with the cages for the light bulbs I will be good to go. I will be inspected once a year from now on.

work room 2Robin’s work space now includes plenty of shelving for molds and other tools and ingredients. 

I know people have said that I was turned in to the FDA but that is not the case at all. The inspector found me on an internet search and decided to come an visit. At the time she saw two items on the website that had to be corrected. One was where I was trying to describe a fragrance and in the description of the scent said it had a “medicinal” smell to it. Another was where I said in the description for my Lavender & Tea Tree lotion bar that both lavender & tea tree have antibacterial properties. Both of these had to be changed and I did it right when the inspector was sitting at my kitchen table.

Part of the inspection includes checking your website for errors and your social media and they do this before every visit. This second time she saw a board on my Pinterest for herbs and a couple of the pins had to be taken down. You can have nothing connected with your business that people might interpret as a drug claim. So all social media outlets are checked. My impression (and from what I was told) is the first visit is an introductory visit. They ask for some corrections and come back to make sure you did the corrections, and then any other issues that need to be corrected are presented and you are brought up to speed a little at time. In my case she was very happy I took her seriously and I am close to being totally where she wants me to be. I just know I need to be prepared for annual visits.“

. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Thank you so much Robin for opening up about your experience! I think there are a few crucial takeaways from Robin’s story. First, it’s important to remember that nobody turned Robin into the FDA. The FDA inspector found Robin on the internet and decided to visit her based on claims made on her website. If you’re looking for more information on how to describe your products, check out the Understanding FDA Cosmetic vs. Drug Claims post.

Another important takeaway is the majority of the changes that the FDA inspector needed pertained to Robin’s soaping setup. All her raw materials needed to come off the floor and overhead lighting required non-breakable sleeves. Robin’s scales also need to be calibrated once a year. Records of her batches required proper maintenance and packages shipped to businesses needed labeling on the box with her logo, address and phone number. Robin was not fined or penalized. Instead, the FDA agent seemed happy to help her get to proper compliance. Many of these issues are taken care of under GMP (Good Manufacturing Practices). If you want to learn more about GMP, we have a class for that.

It’s true that there may be plenty of small businesses that don’t follow the rules set by the FDA. But breaking the rules does not help the soap and cosmetic industry. Kenna of Modern Soap Making said it best in her post sharing Robin’s story, “If we don’t like the rules, we need to work together to change them by advocating for our industry. Outright ignoring the rules and regulations will not make them go away!”

If you want to stay up to date to changes in the soap and cosmetic industry, join the Coalition of Handmade Entrepreneurs to take receive updates via email and learn how you can become involved. I started the Coalition to support small businesses in the industry; click here to learn more about the COHE.

If you’re feeling a little overwhelmed and slightly worried about GMP (Good Manufacturing Practices), an incredibly valuable resource is the Good Manufacturing Practices book written by Marie Gale. It’s full of information regarding production and manufacturing, and how to get your operation in FDA compliance. Marie’s website is another great place to start!

Robin also used Soap Maker 3 to help get her inventory in order. Soap Maker 3 is a software program that helps create and save recipes, track inventory, produce invoices and more. It’s a valuable tool for any business owner.

BOOK97Good Manufacturing Practices written by Marie Gale is a wonderful resource for understanding GMP. 

If you’re looking for even more information on FDA regulations, the you might find the blog posts below helpful. If you are ever unsure about the rules and regulations, take the time to read the FDA’s website. Thanks again to Robin for taking the time to chat with me and share her story!

Understanding FDA Cosmetic vs. Drug Claims
Understanding INCI Names on Cosmetic Labels
Using Botanical Names in Ingredients Lists
Update: PO Box Label Petition
How to Label Cold Process Soap
How to Label Lotion
How to Label Lip Balm

 

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138 Comments

  1. I am so happy I found this article. I’m fairly confident that I’ve been “shopped” by the FDA on Etsy recently. I had a gentlemen with a very new profile contact me asking if my perfumes could ward off evil spirits, or if I had a scent that would bring a woman closer to him. I told him that all my perfumes are for is to make women smell good. I had to tell him 3 times. He would say “So you’re telling me you don’t have a scent for…..?” It was the weirdest correspondence I have ever had with a prospect. Weird enough for me to know it was likely a trap. I run my bath and body business on the side, but have worked in marketing and sales for various medical device companies throughout my corporate career. I know the FDA will “shop” vendors on trade show floors, as it happened to myself and several colleagues. They try to get vendors to say things off-label to catch them. Be careful if you get any weird messages, or conversations at trade shows like this.

  2. So we can say that our product cleans, beautifies, and moisturizes the skin. What about saying that a salt or sugar scrub exfoliates dead skin which IS what it does & it’s pretty obvious. Can I say it “polishes the skin” instead if I can’t use the word “exfoliate”? In my eyes, exfoliating & polishing are considered beautifying and not a cure to some skin issue. You’re just cleaning off the dead skin which is hiding the fresh skin, right? It’s kind of like saying you’re cleaning your skin of oil your body naturally produces to reveal what’s underneath. I would assume it would be fine to say those things. But I just want to be sure. If we can’t say “unclog pores”, which I interpret as cleansing, then I don’t want to make an incorrect assumption about saying “exfoliating or polishing”. My head hurts trying to figure this out. Thanks in advance for your reply!

    • Exfoliating and polishing are just fine to use for cosmetics, as they are beautifying the skin. You can also say the scrub cleanses, moisturizes, etc. If you claim your product exfoliates to help cure acne, exfoliates and has anti-aging benefits, etc., that would be a drug.

      I would definitely recommend Marie Gale’s book, Soap and Cosmetic Labeling. The FDA regulations can definitely be overwhelming and confusing, but Marie’s book breaks it down in a really easy to understand way: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx

      -Kelsey with Bramble Berry

  3. This is all well and good for people who sell pink strawberry soap that smell and look pretty and not much else, but for those of use who have worked with herbs and essential oils and have actually been trained and certified, it is ridiculous. Herbs do have healing properties, essential oils do have anti-bacterial, anti-viral healing properties as well. It is spitting in the face of quality formulations. This involves expensive organic or wild-crafted ingredients and to say “just say they clean” is a gross insult. The FDA is worried about natural options to Drugs, so they want to make it impossible to get information to consumers about the benefits of natural options. As I said if all you do is make “pretty” soap, I am not surprised that you do not have a problem with this. It is funny that the FDA does not become involved with all the chemical poisons you get in those “pretty” soap and body care products – synthetic fragrances, colorants, emulsyfiers, preservatives, the list goes on. But to say something natural can actually help someone is dangerous? Please.

    • Hi Misty!

      Cosmetic and drug regulations apply to all skincare, whether it’s made with natural essential oils or synthetic fragrance oils! However, if the ingredients are claiming to have healing properties, they need to be regulated as a drug instead of a cosmetic: http://www.fda.gov/Drugs/default.htm

      I would encourage you to talk to your local representatives about how these regulations affect you and your small business. Let them know what you would like to see happen. That can really make an impact.

      This form is really helpful for talking to your local representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

      COHE, or the Coalition of Handcrafted Entrepreneurs, was started by Anne-Marie and others to advocate for small business owners. I would recommend checking it out as well.

      COHE: http://www.coalitionofhandcraftedentrepreneurs.com/

      -Kelsey with Bramble Berry

    • Exactly. My thoughts exactly and I couldn’t have put it better . I’m working on a huge apothecary project and I’m looking to team up with some like minded individuals . Do you mind me asking where you are located ??

    • Amen. You are so right, Misty. I don’t know if we can ever successfully fight the FDA, however. I have no answers, but I agree with your comments.

  4. Insider perspective: I was qualified to be an OSHA inspector, but the unreasonable people I worked with do not care the cost or whether or not regulations are reasonable for the situation. I cannot work for OSHA because I have a little friend in my head saying, ‘What you would be doing is wrong, especially when bigger, costlier, and more dangerous violations merely get warnings, and someone was certainly paid off.’ Just… Wow. This is absolutely crazy. I can tell you for certain that she was simply an easier target. I have worked in manufacturing facilities where OSHA, the FDA, and other organizations could have come in and shut them down should they know what was going on. Obviously, as an employee, it would not be to my benefit to financially harm the company who was helping me put bread on the table, especially when I knew that certain regulations do more harm to employees than good. This wasn’t about ‘consumer safety,’ this was about employee X needing to strengthen an evaluation by appearing productive. Any one with any moral compass referred to those particular agents as ‘brown-nosers’. I see the eval write up now: ‘Inspector Evans brought 65 handmade soap manufacturers into compliance with manufacturing regulations, protecting over 325,000 consumers from dangerous caustic chemicals, and saving the US over an estimated $3,000,000.00 in unnecessary medical expenses. Inspector Evans has proved to be a highly valuable asset to our team. Highly recommended for advancement as soon as possible to the position of blankety-blank.” I sorely wish that this was merely narcissism.

  5. I came across this website while researching soap making. I have a small farm and plan to make soaps, scrubs etc using some of the dried herbs I will have. I’ve run a small business before and work as a healthcare provider so I know about those ‘pesky’ government regulations all too well. I just got the GMF and labeling practices books in the mail today. I’ve only flipped through them and I could tell immediately they’re well written and succinct. I was intimidated after reading this article, but feel good about jumping into soapmakingnwoth thia guidance. Thanks for the recommendations and willingness to help others succeed!

    • Oh that’s so great to hear Penny, I’m glad you’re feeling good about jumping into soapmaking! Marie Gale’s books are very helpful and make the process less intimidating. Thanks for your sweet comment. 🙂

      -Kelsey with Bramble Berry

  6. Hi! I just want to make sure I understand this correctly.

    If I make a charcoal soap, if I just label it has “Activated Charcoal Round” with a list of ingredients, batch #, and an expiration date… that is OK per the FDA correct?

    As long as I don’t say “Charcoal is great for acne prone skin and also helps calm eczema”, I can sell that bar per FDA standards. Is this correct?

    • Hi Sarah!

      That is correct! Technically, if your soap is just labeled as soap and only claims to cleanse, you don’t technically need to label it. However, we highly recommend labeling it so your customers know what’s inside. Listing the batch number and an expiration date is a great idea as well. 🙂

      So, you can sell your product as soap and just say that it cleanses. Or, you can say it’s moisturizing, hydrating, etc. That makes it a cosmetic and is regulated as such. As long as it doesn’t claim to treat anything, you don’t have to follow drug regulations.

      That can be kind of confusing, so simply put – we recommend labeling your soap with ingredients, net weight size and your address. The batch number and expiration date is not required by the FDA, but I would recommend adding it because it is Good Manufacturing Practices. Let me know if that makes sense! 🙂

      Read more about labeling your soap here: https://www.soapqueen.com/bath-and-body-tutorials/cold-process-soap/how-to-label-cold-process-soap/

      -Kelsey with Bramble Berry

  7. This is why I am going back through all of my site information as well as periodically going through my records to make sure every batch record is there. When you’re in a hurry or you are distracted, it’s easy to forget the small details. The Good Manufacturing Practices book that Bramble Berry offers is very helpful and what I used to get started on record keeping and general operations. I usually put batch numbers on my soaps which I label as LOT No. and I put that near the expiration dates on my labels. So, pretty much, I periodically audit myself to make sure I didn’t forget to record something. I know I need to go back through my websites and make sure my descriptions are in compliance. It’s easy to forget that you can’t use the terms antibacterial, antifungal, or anything else regarding the specific medicinal and healing properties of essential oils. That really puts a damper on things, but I’d rather make sure that I’m in compliance before rather than get a surprise visit and not be prepared.

  8. I’m confused by this post now, even after reading all of the comments and responses. If we make labeled soap to sell on the internet and at craft fairs – even if it’s just a hobby and not a full-time job – are we subject to being inspected once a year? Or was she only picked for this because she has a full-scale business? Was there any way she could have avoided being picked for inspection? I’m not sure what the takeaway is other than that we should sign up for COHE to fight this overregulation (which I have done). I’m not sure if we need to be registering our hobby with the FDA and be ready for a surprise inspection OF OUR HOME.

    My one big takeaway, I guess, is label your stuff carefully.

    • Hi Phil!

      Sorry for any confusion! FDA inspections are pretty rare. This is the first one I’ve heard of in my two years of working here. The inspector came across her website and noticed several problems with the way products were described. I believe you can also be reported to the FDA by a third party.

      The takeaway from this post is that it’s important to label and describe your products according to FDA regulations. So, if you’re selling your products as cosmetics, they can’t have any medical claims. Read more about labeling your soap here: https://www.soapqueen.com/bath-and-body-tutorials/cold-process-soap/how-to-label-cold-process-soap/

      As long as your products are labeled correctly, you shouldn’t be inspected. We also think it’s important to note that the FDA was willing to work with Robin and she wasn’t fined or penalized. So, in the very rare event of an inspection, the FDA seems like it’s willing to work with people to help them reach compliance. 🙂

      -Kelsey with Bramble Berry

      • I just started selling my soap within the last couple of months and honestly I am completely intimidated by the FDA regulation terminology..so much so that I am rethinking starting a soap business. Every time I think I understand it seems like I read something that contradicts what I just read. I know this sounds stupid but this has caused several anxiety attacks. lol Is there something out there that breaks the regulations and terminology down into laymen terms? Like maybe even dumb blonde terms? (That would be what I need!) Any help would be much appreciated! Thanks!

        • Absolutely! Marie Gale’s book on Soap and Cosmetic Labeling is amazing: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx

          It goes over the rules step by step in a way that’s easy to understand. We highly recommend her book! Another option is to contact FDA.gov. If you’re finding conflicting information, they can help clear it up for you. 🙂

          Marie Gale’s book on Good Manufacturing Practices is helpful too: https://www.brambleberry.com/Good-Manufacturing-Practices-P5580.aspx

          -Kelsey with Bramble Berry

          • I sympathize with Dara, Kelsey. I have been on soap making Facebook groups since I first read this, and there are plenty of soapers who are confused about regulations as it concerns their hobby. I’ve seen this very article passed around a lot since I first commented back in August, and most people misread it as “the FDA is gunning for you, keep your head down, or better yet just don’t sell your soap in the first place.” Of course the article points out FDA’s good naturedness and that it is right to protect consumers. But I’d hate for folks to stop supplying their families and communities with beneficial natural products (especially in a market full of synthetic, harmful chemicals) because they think their hobby is likely to be subject to strict government oversight. It’s simply not the case.

            These kinds of articles, in the future, should disclaim that 1) this is very rare for small soap businesses to be targeted and usually because of mislabeling, and 2) while 100% GMP is ideal, it is not necessary for weekend hobbyists with limited space and funds.

          • Thanks so much for your feedback! We tried to make it clear that inspections are very rare, and that Robin wasn’t fined or penalized. The FDA was willing to work with her to make sure she was in compliance. We also recommend getting Marie Gale’s book on Good Manufacturing Practices and trying to follow as many of the suggestions as possible for your business. Then, as you continue to grow and can get a dedicated soaping space, you’ll be well versed on how to set it up. We’ll definitely keep your suggestions in mind for future FDA posts. 🙂

            Good Manufacturing Practices: https://www.brambleberry.com/Good-Manufacturing-Practices-P5580.aspx

            -Kelsey with Bramble Berry

          • I’m closing my sugar scrub business that I just opened this year as I type as the tax assessor paperwork is too overwhelming for me. If I had a dedicated room in my home where I could run my business (and not scattered throughout my home) it might help me keep track of property and supplies without overwhelming me.. Plus, the lab costs for ‘safety substantiation’ that the FDA requires is killing my profit margin. I figured I have to make a giagantic batch (vs. small batches) of a sugar scrub to help distribute the lab testing cost of $62 for each batch tested…and that would only be (1) scent!! I don’t mind complying with rules, but how in the world can a (mostly) 1-girl small home-based operation afford any of this? How many of the Etsy sellers are lab testing there products ?? It’s hard to compete cost-wise with those not following the regulations. It’s just not fair. I love my product and am so sad to leave it, but I’m stuck for now.

          • I’m sorry to hear that Michelle. I would definitely encourage you to contact your local representative and tell him how these regulations are affecting you. This form is really helpful for talking to your local representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

            COHE, or the Coalition of Handcrafted Entrepreneurs, was started by Anne-Marie and others to advocate for small business owners. I would recommend checking it out as well.

            COHE: http://www.coalitionofhandcraftedentrepreneurs.com/

            -Kelsey with Bramble Berry

  9. I came across this article and it was very informative, but tell me does every one who makes soap to give as gifts or sell have to seek permission from FDA or is it that you just make sure you abide by the rules and requirements?
    Is there a license for selling handmade soap?

  11. Hi all!

    I used to make and sell through Longs Drug Stores in California. I learned years ago about the FDA. I am retired now. I would not want to be in love with this as a business. All the regulations can be quite taxing. Most business owners learn that there is not a set time for them to be involved in their work. Even if they work from 9 to 5, after those hours, they are still thinking about work while making dinner, checking the kids homework or while they are just trying to relax. Having a business is something you do every waking minute. For those of you that are really into this, take your time getting established. Grow slow and steady. Best of luck to you all. I love dropping by the bazaars and craft show tables and buying your soap. I only make soap as gifts. That’s it for me!

    • Owning a small business does take dedication and hard work! It’s also very rewarding. Thanks for supporting local crafters Annette. 🙂

      -Kelsey with Bramble Berry

  12. I’m sorry I don’t get this or maybe I was raised with good moral values. First, I find a garage (that is not finished out with special flooring and cabinets) unsanitary and molds on the floor… really? I don’t care how small of a place you have, not to keep things clean and stored properly in any handmade industry makes me question why someone is in business if they don’t take pride in what they do. To me these are just fundamentals of any business. As far as descriptions in products I have serious problems with the FDA interfering. First of all, all herbs have specific chemical properties, these include antibacterial, antiviral, etc. There are some that should not be used for regular use and how you combine them is also important to know. How the FDA can legally come in and state you can’t say this is bizarre to me cause for over a hundred years there weren’t any problems in doing so. As long as you aren’t claiming a cure for something I don’t see what the issue is. This political red tape that has a motive, and I assure you it’s large companies that don’t like small business competition cause they are doing this with all types of businesses which is why they pay big bucks for their lobbyists in the White House. I find it seriously infringes on the freedoms this country stands for. It is funny that Brambleberry now is speaking for the entire handcrafting industry to set regulation when I remember years ago, you were just like me and the rest, a handmade small business that seems to now kind of make me think you have intentions of controlling this industry standards which makes me a bit nervous cause this is a living for many of us and the constant over-regulating of small business is eventually going to crush all of us if you people don’t wake up to what this is really about. I kind of feel like I’m being led into the lions den and I haven’t done anything wrong. I do know that over-regulation took over half my business away from me here in Florida (I’m down to just M&P soap now, must have a separate manufacturing facility to produce shampoos, lotions, etc. with each item getting inspected and licensed-bill passed in 2007) which if they place these same regulations on the rest of this industry most of you will not be in business any longer cause the startup costs will be beyond what you can afford. Don’t you find it interesting that our representatives are busy these next two days trying to pass the “Dark Horse” Act which basically will allow companies the right to hide what is in our food and what our food really is, but they are now knocking on small handmade soap businesses doors cause you described soap as antibacterial and the fact is… Tea Tree is antibacterial!!!!! That is a fact guys. So we put it in our soap, but don’t describe it as such. Personally, if you saw what farmers are spraying on your food today or tampering with micro organisms that make it harder for the human body to digest food and it IS causing many harmful diseases from the very necessity you and I need to survive and I won’t tell you the issues with our drinking water; yet there is no one at the FDA knocking on these doors. Flint Michigan has had serious water contamination for two years and not one plumber has been called to change one single pipe. Florida has Big Sugar polluting several waterways and where’s the FDA? This just blows my mind that we even have to discuss this anymore. I don’t recognize my country at all and it saddens me that this is the road we are going down cause it is only going to get worse and it’s harmful to all of us who are below the big business line which is right where they need to keep us. Good luck cause I believe you don’t budge on this issue and the nit picking needs to stop. If you keep thinking you can work out a deal, we are all done and this is just silly. In my entire life I have not known anyone with any major issues from soap outside of a skin rash and then the answer is you just don’t ever use it again… it is that simple. If the product is bad it won’t last long on the market, this is when you report it to your local city agencies, and those who make really bad product will get sued. This industry regulates itself and has for years; why do you think we need it regulated more and why does our congress think so… chiching$$$$… that’s why. People are getting overly paranoid. My advise to everyone in the handmade industry is if you want this to end then take some care in how you do your business because these people are going to hand pick the worst to support the bills they want passed. I will say I am glad Brambleberry reports and give information on all this and I have been a long time customer of theirs and will remain cause I love their products, but I do get concerned that even Brambleberry doesn’t speak fully on what I feel that our law makers are not allowing in the freedom the soap industry should have in producing their products and once you take this away with certifications and the like you strip us of having that freedom my grandparents had. This should be an enjoyable business venture not a regulation nightmare. I watched this happen in the interior design industry and now you have to come from an upper society to even be successful in the industry unless your just the lucky 1% who fell on Gods grace. You no longer can make a reasonable living now and this also happened in the fitness field. We have a serious problem here and the playing field is becoming rigged to fill select pockets and this should scare everyone in this country who is trying to survive. This takes from ALL of our freedoms and places limits on those who can’t afford and we all deserve a chance to survive and prove our worth. The end result will be very wide gaps between rich and poor, so fight for your freedom by making sure who you vote for is protecting it cause right now those in power are trying to take it away. Read between the lines cause saying something is not actually doing it. Hammer those representatives that are placing unreasonable limits on small business with letters of concern and make sure you address it towards a specific law or bill or they won’t take your correspondence seriously.

    • Hi Lisa – Thank you so much for being such a long time supporter. I appreciate your thoughts on this important matter. I also notice that you started your thoughts with a commitment to safety and cleanliness and following GMP; I am 100% in agreement on that. It is so important that we manufacture safe products in a clean environment to ensure batch purity and consistency of batches. In Florida, you have state laws to follow to. I would really recommend finding your representative and asking to meet with them in person to talk to them about your feelings. You can find your representative here: http://lookup.coalitionofhandcraftedentrepreneurs.com/ Fax them, email them, call them and then meet with them in person, with a bar of your properly labeled handcrafted soap. Tell them how you manufacture it, the care you put into your ingredient sourcing, your thoughtful product formulation and then explain what it means to you and your family to have this as a source of income, creativity and pride. Close with your thoughts on regulation and then see what they say. I’m wondering if they’ve ever met a handcrafted soapmaker; maybe you’ll be the first! =) Keep me posted on how it goes for sure and if you haven’t signed up for updates from COHE, definitely do so you can be in the know about potential legislation, bill movement etc: https://www.coalitionofhandcraftedentrepreneurs.com/join-us/ Happy Soaping, Anne-Marie

    • This has ruined my day too!! Actually…the past two months! I just spent a fortune on jars, labels, ingredients, brochures, etc. I have worked endlessly on recipes…balms, salves, creams, lotions. And of course, these items are not unique if I can’t at least state what the heck they are used for! Seriously, what is the point of homemade at all now??!!!
      My ancestors have been making home remedies for a hundred years…but I can’t tell anyone that?!! Sounds ridiculous.

      So before I give all this up and cry over the waste of money and time, I have a couple of questions.
      If I make a salve with arnica infused oil, I can’t say that it is for muscle aches?
      If I make a cream with candelula infused oil, I can’t claim the properties of the candelula? Like anti-inflammatory? Or that candelula is great for diaper rash?
      I can’t say that something works for bug bites or stings? That an herb that I use has antibacterial properties?

      I’m not trying to make crazy claim on my products, but come on…these are simple, OLD, facts.

      Thanks to anyone who helps answer my questions.

      • Hi Robin!

        If you say your products help with muscle aches, diaper rash, etc., the FDA considers it a drug claim. A drug is anything intended to diagnose, treat or prevent disease, or affect the functions of the body. This post has more information on the difference between a drug and a cosmetic: http://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/

        To sell your products with those claims, they will need to be tested and regulated under the FDA drug requirements: http://www.fda.gov/Drugs/default.htm

        I am sorry you are frustrated with the FDA regulations. I would definitely recommend talking to your local representatives about how you feel. Let them know how it affects you and your business, and what you would like to see happen. That can really make an impact.

        This form is really helpful for talking to your local representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

        COHE, or the Coalition of Handcrafted Entrepreneurs, was started by Anne-Marie and others to advocate for small business owners. I would recommend checking it out as well.

        I’m sorry again for any frustration Robin. I think talking to your local representatives would be a great idea – let them know what these regulations do to your business.

        -Kelsey with Bramble Berry

      • I believe that you are able to say – I find this product very useful when I have muscle aches and pains, or, *said oil* has been used for centuries for aches and pains. This is information I received when I did my certification for aromatherapy. I also make soaps, lotions etc.

        • Hi Janine!

          Saying the product is useful with muscle aches, or that it has been used for muscle aches in the past, can imply that the product is a drug. The FDA is rather strict about the difference between drugs and cosmetics. If the product is intended to diagnose, treat, prevent disease or affect the function of the body, it is considered a drug. This is the case even if it is implied rather than said directly. You can read more about cosmetics versus drug claims here: http://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/

          And read more about the regulations for drugs on the FDA website: http://www.fda.gov/Drugs/default.htm

          -Kelsey with Bramble Berry

      • I have seen many items that have hanging tags or papers that will explain the origin of the product or active ingredient. This way you could still explain the beneficial uses for your item by telling its history. You would not be making a claim only educating people.

        • The FDA is fairly strict about product labeling. So, even if you’re implying the product treats something and your customer thinks it does, they may consider that a drug and require you to sell it as such. We recommend being super careful and saying the product only cleans the skin, or moisturizes, beautifies, etc. That way your customers know it is only intended for cleansing and not for treating any disease or condition. 🙂

          -Kelsey with Bramble Berry

          • I have seen product labeling that follows with, “these claims have not been approved by the FDA” and other ways of wording which do allow the product to be described in a manner which explains its healing properties… treats sore muscles, is antibacterial, etc.

          • Even putting that warning on there, if your customers think your products treat or cure something, they will be considered a drug. We always recommend erring on the side of caution. It’s best to stick to cosmetic terms like hydrating and moisturizing. That way your customers know it is only intended for cleansing and not for treating any disease or condition. 🙂

            -Kelsey with Bramble Berry

    • Lisa, thank you so much for typing what I was thinking! I have little to add, except that if I can’t do something without following someone else’s rules, it’s the same as having to get permission – especially when said permission can be revoked by the same. And it hurts a little for this site to support such infringements. Stings the heart.

      • Bramble Berry supports Anne-Marie and her COHE organization to make changes to the laws that govern the handmade cosmetic industry to make sure that consumers are safe and small business can thrive. But in the meantime, we want to make sure that our readers know and understand the law and guidelines as they now stand so you can make informed choices about how you run your business and that was the purpose of this post. For more information about COHE and how you can get involved check out this site: http://www.coalitionofhandcraftedentrepreneurs.com/

  13. This was a rather overwhelming article….it was my understanding that a number of things mentioned were NOT going to be required for a small business that makes under a certain amount each year…that a group had tried to lobby a new set of rules in Washington D.C. that pertained to the small soap and cosmetic businesses and these laws were supported by large manufacturers like Proctor and Gamble, and others who made cleansing bars and lotions. (Gee…wonder why!) From what I understand the proposal did NOT pass, and things like keeping detailed records for EACH batch made, and handed in each month (not to mention a number of other requirements with this proposal) would not be necessary for a business . (Of course sanitary practices, etc. are required!) If we as small soap makers, who can’t afford to hire even another person to take care of all of the paper work, etc. YOU say that this FDA person said is required, (especially for a tiny home business), the soap maker won’t have time to actually make the soap! SO, even though it’s usually mentioned in their videos that certain oils, etc are said to have healing properties, or are natural anti-fungal, or naturally antiseptic, you can’t actually claim this anywhere….even if you have a disclaimer on your site, or remind the video watcher that you’re not making any medical claims, and that what you’re saying is that ” it may help relieve some of the symptoms of….” So Soaping 101, Essential soaps, and so many others who are making videos are not doing this correctly? I have no problem with keeping oils, buckets, and molds off the floor. Mine have never been ON the floor, but always on shelving…I don’t make my soap in the basement or in a garage…I just use my kitchen for making the soap, and my dining room with three shelving units and the covered table for drying, on cooling racks. Everything is kept cleaned and I spray a LOT of alcohol , especially on surfaces when I am making my soap…and I always wear gloves when handling the soap, too. The gal showcased here has a much bigger operation than I have…much bigger. Although it is called a “small business”, I look at this as more of a craft in my case, but what you’re saying here is that there are overwhelming expectations even for the really small businesses. Now I have to decide whether I want to continue making soap, which I really enjoy, and try to tackle all of the extra paperwork, and worry the entire time, or just quit, and unfortunately waste a lot of great butters, oils, etc. This has kind of ruined my day…and maybe more. 🙁

    • Hi Sousonne!

      The FDA regulations can be a bit overwhelming for sure. I would definitely recommend talking to your local representatives to tell them how you feel. Let them know how these regulations affect you and your business, and what you would like to see done differently. Your feedback can make a difference. This form has tips for how to talk to them: http://www.coalitionofhandcraftedentrepreneurs.com/action/

      Last year, there were two bills introduced to try and reform cosmetics regulations. When those bills were introduced, Anne-Marie and several others formed the Coalition of Handcrafted Entrepreneurs (COHE) to advocate for small business owners. One of the bills, H.R. 4075, has exemptions any manufacturer operating out of their home and also provides an exemption for any business making less than $1 million in revenue. We are very excited about that bill, as it’s better for small businesses in the handcrafted industry.

      COHE will continue to monitor and advocate for small businesses. I would definitely recommend becoming a member so you can see all the developments the bill is making: http://www.coalitionofhandcraftedentrepreneurs.com/join-us/

      -Kelsey with Bramble Berry

    • This has ruined my day too!! Actually…the past two months! I just spent a fortune on jars, labels, ingredients, brochures, etc. I have worked endlessly on recipes…balms, salves, creams, lotions. And of course, these items are not unique if I can’t at least state what the heck they are used for! Seriously, what is the point of homemade at all now??!!!
      My ancestors have been making home remedies for a hundred years…but I can’t tell anyone that?!! Sounds ridiculous.

      So before I give all this up and cry over the waste of money and time, I have a couple of questions.
      If I make a salve with arnica infused oil, I can’t say that it is for muscle aches?
      If I make a cream with candelula infused oil, I can’t claim the properties of the candelula? Like anti-inflammatory? Or that candelula is great for diaper rash?
      I can’t say that something works for bug bites or stings? That an herb that I use has antibacterial properties?

      I’m not trying to make crazy claim on my products, but come on…these are simple, OLD, facts.

      Thanks to anyone who helps answer my questions.

      • Hi Robin!

        If you say your products help with muscle aches, diaper rash, etc., the FDA considers it a drug claim. A drug is anything intended to diagnose, treat or prevent disease, or affect the functions of the body. This post has more information on the difference between a drug and a cosmetic: http://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/

        To sell your products with those claims, they will need to be tested and regulated under the FDA drug requirements: http://www.fda.gov/Drugs/default.htm

        I am sorry you are frustrated with the FDA regulations. I would definitely recommend talking to your local representatives about how you feel. Let them know how it affects you and your business, and what you would like to see happen. That can really make an impact.

        This form is really helpful for talking to your local representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

        COHE, or the Coalition of Handcrafted Entrepreneurs, was started by Anne-Marie and others to advocate for small business owners. I would recommend checking it out as well.

        I’m sorry again for any frustration Robin. I think talking to your local representatives would be a great idea – let them know what these regulations do to your business.

        -Kelsey with Bramble Berry

  14. Hi everyone I loved this post although I found it a little scary but extremely informative, thank you Robin for sharing. I am just starting out and only do Bath Bombs, Truffles and lotion bars. I was going to try to set up a website and get LLC but am not sure if this pertains to Mee or is this only for Soap?

  15. Thank you so much for posting. This was an incredible eye opener and a wealth of information.
    I am keeping this email in my BB file so I can go back to it and keep doing updates if needed one step at a time.
    I am truly grateful she shared her story. I hope people do realize she was not reported. I personally would feel good about ordering from her knowing she was FDA approved.

    • You’re welcome Vanessa, I’m glad this post was helpful for you! Thanks so much for reading and for commenting. 🙂

      -Kelsey with Bramble Berry

  16. I was in the food industry for over 30 years and in a position where I dealt frequently with the FDA. They actually used some of my facilities to train new inspectors on how GMPs should be followed. They are a group of very knowledgeable people who are there to help you. They are not “out to get you” or impose fines. Their focus is to make sure anything coming from our soap kitchen is safe to our consumers and to keep us out of trouble…exactly the same things we want! I can honestly tell you I never met an inspector who did not teach me something valuable.

    Now, the be aware portion….Their visits are always unannounced. Be honest and straightforward but don’t point all the bad things out. Answer only the questions asked. If it is a yes/no question, say “yes” and stop. Don’t try to fill the silence with babbling of volunteering information over eagerly. It can get you into trouble. It is a good policy to have a condensed version of the GMPs posted somewhere in your work area. This shows you are aware and serious about you business. At the end of the inspection, feel free to ask “hypothetical” questions or questions concerning the report and how best to fix them. They will not tell you what to do (they aren’t allowed to consult) but they can say “I’ve seen this successfully done at another place where they filled the requisite successfully by …..”. They will not share information about you or your business by name to a competitor. They will not go outside the realm of GMPs in discussions…ie, your formulae are safe with them. They can look at these but you are not required to give these to them to remove from your facility.

    Hope this helps relieve any angst in dealing with them as a government representative. They truly are helpful in improving our business.

    Doc

    • Thanks so much for sharing your tips! I think they’ll be really helpful for fellow small business owners. 🙂

      -Kelsey with Bramble Berry

    • Absolutely, we were really excited she shared her story with us so we can share it with you! 🙂

      -Kelsey with Bramble Berry

  18. I’m impressed with how positively the small-time soapers are taking this story. It’s important to manufacture things in a clean environment and to label things properly, so that consumers can make informed choices, and it seems most of us are doing that. But the idea that we will all have to comply with all sorts of government regulations, (the same regulations that big manufacturing corporations adhere to), is going to take a lot of the fun out of small-time soap making. Cottage industry makes me think of a cottage (or garage or kitchen) where someone is handcrafting with love and creativity rather than anxiously adhering to safety regulations. Oh, well. Inevitable, I guess. Sigh.

    • Hi Heather!

      I would definitely recommend talking to your local representatives about how you feel! Let them know how it affects you and your business, and what you would like to see happen. That can really make an impact!

      This form is really helpful for talking to your local representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

      COHE, or the Coalition of Handcrafted Entrepreneurs, was started by Anne-Marie and others to advocate for small business owners. I would recommend checking it out. 🙂

      -Kelsey with Bramble Berry

  19. I’m not a soap maker, but I do buy from a lot of local artisans, so this is interesting.

    My first impulse if I happened to be inspected like this would be to immediately call a lawyer who’s well versed in FDA regulations. It seems like it would be easy for a single agent to overstep their bounds and require you to make changes or upgrades that aren’t technically necessary. That’s not to say they’d do it intentionally or to be a pain. It could be well intentioned… They might just have a much more stringent interpretation of the regulations than someone who’s just following the letter of the law.

    And unless you (as a business owner) happened to know all the regulations by heart, you’d never know when the agent was correct and when (or if) they were overstepping their authority.

    Seems like in some cases, the cost of an attorney could offset and even reduce the cost of compliance. But then again, I have no idea if that’s accurate because I’m neither a lawyer or the owner of a food/drug/cosmetics business.

    Sooo… thoughts? If a small soapmaker gets a knock at the door, should she call a lawyer?

    • Hi Josh!

      The good news is Robin wasn’t fined by the FDA! She did spend around $350 for updated lights and shelving. In this case, FDA inspector was basing her suggestions off Good Manufacturing Practices: https://www.brambleberry.com/Good-Manufacturing-Practices-P5580.aspx

      You can definitely call a lawyer if you like! An attorney who knows the ins and outs of FDA regulations will be able to provide you with advice and guidance about what to do next. 🙂

      -Kelsey with Bramble Berry

      • Thanks so much for posting this article, I see a couple things I need to improve on. I would not have known these things had you not posted what happened during the inspection, so thanks for looking out for us Bramble Berry!

        I do want to make a comment – I do craft shows and have noticed a new group of soapers/lotion makers coming on the scene who say they use “all essential oils” but have scents like cucumber – and who also say their products are “all natural” and who sell lotions – yikes. I also visited a store in an indoor flea market and the owner said her products were “all organic” even her lotions – which were not refrigerated and came with a little spoon so that you use the spoon and not your hands. The spoon was out in the open air. I think with practices like these – they are begging for inspections and truly need them because consumers need to be protected from their products. I am hoping that these businesses fall by the wayside so the long term businesses who do their best to be honest and protect their customers don’t get lumped in with this new trend. I am all for all natural if it can be safely done.

    • I would find a lawyer unnecessary unless I knew I was being totally negligent in following any of the requisites. If you read the GMPs, follow them to the best of your abilities, and are trying to improve then the FDA visit can really be used to your advantage. Light bulbs…do you really want the potential of glass in your products? To assure it isn’t get the coated bulbs that don’t break apart when dropped. Do you want your products to have dirt in them? Of course set them off the floor on a pallet or rack…something easily cleaned under…and cover your ingredients with lids. Want your product to be consistent every time? Then you have to have your scales calibrated. Most of this is common sense.

      If you read the GMPs, follow them to the best of your abilities, and are trying to improve then the FDA visit can really be used to your advantage. Use it as a means to improve your processes. Ask the inspector what are the best practices they’ve seen in our industry.

  20. I absolutely love the post and I already have the book on good manufacturing practices. Very valuable information that I can use. However, as much as I like to try to have everything on computer, I am finding it very daunting to search for a good software for equipment management and for accounting. Do you have any recommendations for such software? I find the soapmaker3 does not provide a section for inputting equipment, nor does it have a good accounting feature on it. And if it is not too personal, what software do you guys use or wished you used from the start of your company?

    • Hi Vivian!

      Thank you, so glad you love the post! For accounting purposes, we love using QuickBooks. We use that for our accounting needs. Find out more about QuickBooks here: http://quickbooks.intuit.com/online/

      They have an online version that’s really great for small businesses. 🙂

      -Kelsey with Bramble Berry

  21. Amazing article and great references! What about those products I see that are labeled “these statements have not been evaluated by the FDA….not intended to diagnose, treat, cure, or prevent any disease. Not intended to replace seeking medical attention for concerns”. Is this their way of saying “I can’t prove this product will soothe your burn/cut/scrape”. I often see on essential oil blogs claims about antibacterial properties and then “for educational purposes only. Statement not evaluated by the FDA”. Is this acceptable to the FDA?

    • Hi Kate!

      Even with the warning, it may be confusing to customers. For instance, if a soap label says it will cure acne but the fine print says it hasn’t been proven to cure acne, it is a bit misleading. To be on the safe side, we recommend only using terms like “moisturizing” if you want your soap to be classified as a cosmetic. If you want it to be classified as a drug, it will need to be tested and regulated by the FDA.

      Read more about the difference between cosmetics and drugs here: http://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims

      This book on labeling soap by Marie Gale is really helpful as well: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx

      -Kelsey with Bramble Berry

    • The reason most of those disclaimers are put on products is so they are not classified as drugs which would have to be tested and regulated by the FDA as stated in the other response. Also depending on information on a label it can be classified as making a claim and you have to have the relevant testing to back up that claim. The other reason many items, websites, blogs etc. have “for educational purposes only” is that if you make certain recommendations or if it sounds like you are diagnosing, treating or curing then you can be in legal trouble for practicing medicine without a license. This is the FDA world in which we have to operate.

  22. “For packages going out to businesses, I need to have a label on the outside of the shipping box that has my logo and address on it along with phone number.”

    Can someone please point me to this reg? I always like to see the original text rather than what gets retold, and this is the one I can’t find a reference for.

  23. Love reading these updates! I was so fascinated by the process when I read the original story on Modern Soapmaking – it’s great to see a little more background.

  24. Can the FDA come after a minor who makes and sell soap if they are not following all the regulations? I’m 14 so that’s why I’m asking. I am currently working on making sure everything is up to standard.

    • Hi Madisyn,

      I know this is an older post and you may not see this reply, but hopefully it helps someone.

      Kelsey stated that the rules apply “apply to everyone who sells soap, regardless of age,” and that is correct; what was not said is that if that someone is under 18, the consequences of those rules will be applied to that someone’s legal guardian(s).

      So I am hoping that your parent(s) or guardian(s) are knowledgeable about your soap-making endeavors. Hopefully they are, and are even assisting. Just please be aware that if you get that knock on the door from the FDA, it won’t just be you called on the carpet for non-compliance.

      I think it would be great for you to look into the COHE that Kelsey has linked a few times, and get involved in it to help drive awareness for the issues facing our industry. By the time other people are entering college, you’d already have a great education in not only business and the rules and regulations required to stay in it, but also in how to talk to our legislators and how make a difference in our local and federal government 😉

  25. I make my soaps, lotions, butters, lip balms and working on face cleansers, serums, toners & creams in my kitchen. Before I got sick w MS I used our 2nd bedroom, after my diagnosis plus I developed narcolepsy our daughter gave up her job and moved home to be here when her daddy works so now everything is in the kitchen some on shelves and some in totes. But we also use the kitchen for food prep. Is that a nono or is it okay as long as everything is stored separately which is how I have it now. We also have our dogs food bowls down in the kitchen, our poor little 900square ft home is full to the seams and then some. It’s a perfect little home for my husband and I. But w our daughter and finally the gift the Drs said she’d never have her 19mth old daughter were full and w the baby we had to remove my stuff from her bedroom becuz the baby has to Ckout everything and somethings wasn’t safe. We bought extra cabinets and an island that’s completely dedicated to my business plus I have a burner I use for heat M&P and my oils so my stove isn’t used. The only thing I use on occasion is my frig for specific oils and the freezer for stubborn M&P. Help I need some advise. Sandra

    • Hi Sandra!

      In Marie Gale’s book, Good Manufacturing Practices, she says you can use your kitchen for soaping if need be! The kitchen should only be used for production when you are making your recipes. Don’t do any food preparation at the same time. That is to help prevent any lye or fragrance contamination. Then, clean every surface well and store the soaping items before making food. 🙂

      I would definitely recommend checking out Marie Gale’s book! It has tons of information on how to follow GMP, and it’s easy to read and understand: https://www.brambleberry.com/Good-Manufacturing-Practices-P5580.aspx

      -Kelsey with Bramble Berry

  26. Great article! I love the idea of the Soap Maker 3 software. Is there any chance this software will be compatible with Apple products soon?

  27. great info, thanks. As a consumer looking up FDA is important to me for my own safety. I want to know all ingredients of soap as I have allergies. As a medical support person I cringe from “medicinal powers” “known to help some in (fill in the blank)” I see adverts for dandruff, dry skin, reduces inflammation and I quake. Every one of these statements fall under FDA rules as have been explained to me. Am I wrong? Every craft fair has ” expected results in the properties of their soaps” Isn’t that when FDA rules? If “handmade soap” is the only label I have to ask for ingredients due to allergies this includes fragrances which I don’t think falls under FDA (does it?) and would love to see it on the label. Maybe the soaper isn’t under FDA but “just soap” falls under somebodies guidelines if you sell it. A friend makes soap for Christmas gifts, no sales, when a soap gifted friend was in E.R. due to reactions the soap was tested and found that changes occur in some ingredients if not used within a specific amount of time and since there was no info regarding dates the soap was tested, a court became involved and no excuse was good enough. Soaper lost and investigators showed up. FDA said comply or desist. She insists “only soap” isn’t under FDA rules. The court said otherwise. She still makes soap, gives it to friends who quietly throw it out. She cannot be the only one who has made a mistake and been held responsible for it. Now, I only buy from boutiques and still I wonder.

    • You are correct about medical claims. If a product claims to help dandruff that’s a medical claim and that product needs to be tested to prove it actually helps with that condition. Whereas if a product says it’s moisturizing – that’s not claiming to cure a medical condition so it would only be considered a cosmetic. Both of those products are covered by the FDA, but they have different guidelines. If a product contains fragrance – it doesn’t automatically make it a cosmetic. So not all products with fragrance are regulated by the FDA.

      While it’s true that real soap that is just for cleansing isn’t regulated by the FDA – it’s not correct that it’s totally unregulated.
      True soap falls under the Consumer Product Safety Commission (CPSC) and although they don’t require you to label your soap ingredients, you do need to do it if your product is potentially hazardous.

      None of the recipes we test and blog about have ingredients that would be become hazardous after a certain amount of time – so I’m really curious what your friend puts in her soap!
      Finally, I just want you to know that I have been using handmade soap made by our customers, Anne-Marie and from our test lab for the last 10 years and I’ve never had an issue like that nor have any of my co-workers.

      For more info about the difference between soap and cosmetics I recommend Marie Gale’s blog and books (which we proudly carry – links above).

      Hope this helps to ease your concerns around handmade soap. Please let us know if you have any other questions.
      Happy Soaping!

      • thank you so much now all my questions are answered. I want to tell you a reality that should be common knowledge to everyone ….. if you add extra lye for any reason you are not following a formula. The hospital test showed there was a 20 percent addition of lye that made the soap too harsh. I am allergic to lye in high dosage in anything that comes in contact with my skin. I am sure soapers know that Lye doesn’t play well with others unless the correct amount is used and is stabilized. If you leave that soft weird bar on a shelf to dry forever you can recut and it looks like a bar of soap. It is not. It is just weird. If you use ingredients that have expired shelf life it becomes weird as well. I was given that due to old ingredients, too high a lye content and time to practically ferment (my words) anyone can show a skin allergy if they have sensitive skin (which is why I use soapers soaps). It is rare only in that nobody brings the stuff they last used on their skin to the ER so it can be tested. That is why I am following the Soap Queen tutorials since I cannot make anything with lye myself. It has to be a melt and poor and add good stuff. What I am taking away with me is that if you want to make soap, etc, for sale you should make yourself knowledgeable of FDA and cosmetic regs. If you have questions contact either or and they will help you. Never assume you are too small a business or that the regs don’t apply to you or that you can fly under the radar. Keep it clean, follow formularies, use fresh ingredients, do not cross contaminate your working surfaces and apply what you learn and will continue to learn. Thanks again.

  28. This was great article – but distressing. I work in my kitchen still – and it will be a long time before I have the ability to set up a whole “area” devoted to soaping. My sells are very small as are my batches. I will just keep following the rules on labeling and storage, etc., and hope for no surprise visits. I clean things “religiously” before using so it is just the fact that I am not able to set up in a pre-defined space like Robin’s that worries me. 🙁

      • Hi Sherry and Susan!

        When you’re very small and just starting out, these regulations can be intimidating for sure. I would recommend getting Marie Gale’s book on Good Manufacturing Practices and trying to follow as many of the suggestions as possible. Then, as you continue to grow and can get a dedicated soaping space, you’ll be well versed on how to set it up. 🙂

        Good Manufacturing Practices: https://www.brambleberry.com/Good-Manufacturing-Practices-P5580.aspx

        I would also recommend talking to your local representatives! Let them know how the regulations affect you and what you’d like to see instead. 🙂

        Our Coalition page has a great form for talking to your representatives: http://www.coalitionofhandcraftedentrepreneurs.com/action/

        -Kelsey with Bramble Berry

    • Hi Laurie, I’m so glad you found this post helpful. We are very grateful that Robin shared her story with us 🙂

      -Amanda with Bramble Berry

    • Hi Mary!

      We are so grateful that Robin was willing to share her experience as well! I’m glad you enjoyed the post.

      -Amanda with Bramble Berry

  32. Great article – lots of commonsense items I didn’t even really think about b/c I’m just starting out. But it is good to get into the habit early, so hopefully when my business grows, it will just be part of my process.

    • Hi Jill!

      Absolutely! Glad you found this article valuable. The rules and regulations can be a little tricky; luckily there are a lot of great resources and information out there to help 🙂

      -Amanda with Bramble Berry

    • Hi Amy and Shauna!

      Good question. Soap is defined in its own special category by the FDA. According to the FDA website, a product is defined as soap when:

      1. The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
      2. The product is labeled, sold, and represented solely as soap [21 CFR 701.20].

      If the product meets these requirements, it is regulated by the Consumer Product Safety Commission, not the FDA. If you claim your soap does anything to beautify or alter ones appearance, it is then considered a cosmetic and is regulated by the FDA. For example, if you say your soap moisturizes the skin, it is considered a cosmetic.

      So in this case, Robin’s soap was actually considered a cosmetic because she made claims that defined it as such. In addition, Robin sells lip balms and other cosmetics. To read more about the differences between drugs, soap and cosmetics, I would recommend checking out the blog post below. It’s full of great information! In addition, I would recommend looking at the FDA’s website for Cosmetic Laws and Regulations. I’ve included that link below as well 🙂

      Understanding FDA Cosmetic vs. Drug Claims:
      http://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/

      Cosmetic Laws and Regulations:
      http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/default.htm

      I hope that helps 🙂

      -Amanda with Bramble Berry

    • Hi Jennifer!

      Good question. If your product meets the definition of soap, the product is regulated by the Consumer Product Safety Commission, not the FDA. Soap is defined in its own special category by the FDA. According to the FDA website, a product is defined as soap when:

      1. The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
      2. The product is labeled, sold, and represented solely as soap [21 CFR 701.20].

      If your product meets the definition of a cosmetic, then it is regulated by the FDA and will need to meet the requirements and regulations regardless of the type of cosmetic product it is. I would recommend looking at the GMP Guidelines/Inspection Checklist below. I’ve also included their page with more information about the inspection of cosmetics.

      GMP Guidelines/Inspection Checklist:
      http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm2005190.htm

      Inspection of Cosmetics: http://www.fda.gov/Cosmetics/ComplianceEnforcement/ucm136455.htm

      In the GMP Guidelines/Inspection Checklist, there is a section labeled “Records” that goes over the type of control records that need to be accounted for. If you have any specific questions, I would highly recommend contacting the FDA. We have done so several times, and they do respond to emails 🙂 You can find their contact information in the bottom right corner of their Cosmetic homepage. I’ve included the link to that below 🙂

      FDA Cosmetics Homepage: http://www.fda.gov/Cosmetics/default.htm

      I hope this helps!

      -Amanda with Bramble Berry

  36. I don’t sell my soap, so I’m just curious. A few years back Anne-Marie mentioned that she was meeting with legislators to try to influence them to not make too strict of rules for small soap making businesses. At that time they were talking about making soap makers that sold under a certain amount each year exempt from the new regulations. Are these the new regulations and do they apply to everyone who sells soap, or just certain categories of income producing businesses. Just wondering.

  38. I also had a visit from the FDA…at a trade show! He came into my booth and told me that they saw I had listed “Tea tree” as anti-bacterial on my website, and that was a no-no. Put the fear of the US Government in me that day, that’s for sure!

  40. Soap Maker 3 states Win8. Not everything that worked on 8 will work on 10. Is SM3 going to be made Win10 compatible?

    • If you’re making soap even to give away, you should use good manufacturing processes so you’re not giving away something that’s potentially tainted.

      • Yes I realize that, I’m not making soap in a dirty bathtub or something. I understood that soap didn’t even require labeling, although I do label mine. I am not a business, I don’t have a web site or an on-line store. I am only a crafter, I sell at craft fairs, mostly around the holidays. However I do follow good manufacturing processes and I keep batch logs of what I make.

      • Another post said you do not have to be FDA approved if you are selling only soap. Now I’m confused…..

        • The confusion is that if you’re not making claims and make only soap and nothing else – meaning, you say “Handmade Soap” and that’s all you say and you follow good GMP and ingredient usage, the FDA does not oversee you. The Federal Trade Commission oversees soap that does not have ingredient labels or claims.

          Not every product marketed as soap meets FDA’s definition of the term. FDA interprets the term “soap” to apply only when

          the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
          the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

          Products that meet this definition of soap are regulated by the Consumer Product Safety Commission disclaimer icon (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.

          Here is more information on that: http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm

          That said, most soap does have ingredient labels and most entrepreneurs in the bath & body space sell other things (like lotions, lip glosses, bath fizzies and more) so they fall under FDA jurisdiction.

          If you want to keep up on any federal legislation proposed for the bath and body industry, sign up for free updates here:
          http://www.coalitionofhandcraftedentrepreneurs.com/

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