A Surprise Visit from the FDA

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.

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

Robin 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.

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

The 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.

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

Robin’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.

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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.

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

Good 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