In discussions about the rules and regulations around selling handmade bath and body products in Facebook groups and soapmaking forums, I see it time and time again. Usually, someone asks for advice on how to comply to the rules. A stream of fantastic responses give recommended resources, advice, and input.
Unfortunately, in the mix, there are always some who think they are too small to really matter. A handful of soapmakers who think that because they don’t make a living from their craft, they shouldn’t have to foot the bill to comply with the rules. Or some soapmakers who think that the FDA (or other regulatory organization) is just too big and they are so small, that they won’t even bother with their small time operation. And even more dangerously, they recommend that others follow in their footsteps: ignoring the regulations set forth to govern our businesses.
Yes, I may be a goody-two shoes who follows the rules to the best of my ability. I do my best to comply with FTC guidelines about sponsorships, product endorsements, and reviews. I try my hardest to follow the FDA cosmetics regulations when creating tutorials and recipes to ensure that anyone who uses them will also be in compliance with the information I give. I won’t write about how amazing ingredient XYZ is for such and such medical problem, or claim a recipe here on Modern Soapmaking will cure a disease.If you choose to fly under the radar, don't expect any help from the control tower. Click To Tweet
The truth of the matter is that the FDA is not too big to enforce the regulations, and no soapmaker is too small to blip up on their radar. Yes, they really are paying attention.
Last fall, a soapmaker found out for herself that the FDA does pay attention to small businesses, like yours and mine. I talked with her a bit to to find out what happened, so we could both help other soapmakers see the light.
One Soapmaker’s Experiences with Cosmetics Regulations Enforcement
Robin of River County Soapworks makes handmade soap and other bodycare products, like lotion, lip balm, and lotion bars. She had done her best to research and comply with all applicable regulations on her own, using the FDA as a resource and following closely along with Marie Gale’s book, Soap & Cosmetic Labeling. Her labels on her products were completely up to spec, thanks to all that hard work.
As of last fall, Robin was in the process of working through Good Manufacturing Practices (GMP) compliance. Again, she had turned to Marie Gale’s expertise and was using her book, Good Manufacturing Practices for Soap & Cosmetics Handcrafters, to work through it. However, she just hadn’t finished the process to be 100% compliant quite yet.
One early morning in October 2014, there was a knock at her front door in the rural area where she lived. She had been going about her life as usual, folding laundry in her pajamas, preparing for a day of working from home in her converted garage turned soap studio and homeschooling her son. At the door, she found an FDA inspector flashing a badge, and asking to see her operations. She later learned that the first inspection visit is always unannounced, and if you work from home, they’ll allow you to make an appointment in the future.
Despite other soapmakers’ claims that the FDA will only take notice of you if you get reported for adverse effects or medical claims, Robin hadn’t been reported by anyone at all. The inspector had said she was looking at websites online, came across River County Soapworks online, and noticed two products that sat in a problem area for regulatory compliance. On one product, Robin had used the word “medicinal” to describe a soap’s fragrance and in another product, she had mentioned that both tea tree and lavender essential oil had antibacterial properties. The inspector drove two and a half hours from Tacoma, Washington to conduct the inspection at Robin’s studio on these two errors alone.
The inspector took the time to review Robin’s website with her, and explained what she could and couldn’t say. The inspector conducted a walk-through of Robin’s studio, looking at how raw materials were stored, what overhead lighting was being used, and the scales and equipment she was using. It’s not unusual for the inspector to ask to see manufacturing processes in action, but Robin was allowed to explain her soapmaking process rather than demonstrate it, since she was so shocked to be in the midst of the inspection. The inspector took three product labels with her, and ensured Robin understood that this was an introductory visit. She made it absolutely clear to Robin that she was there to help her get in compliance.
Robin wasn’t fined or otherwise penalized for her mistakes, and was given a few days to change the two issues on her website. She also had a list of other compliance issues to tackle, including:
- Putting non-breakable sleeves on the overhead lighting in the shop.
- Raising all raw materials off the floor.
- Having her scales calibrated once a year.
- Making a platform to put soap buckets onto when making soap.
- Starting to keep batch records of her production.
Robin did her best to correct the issues, but struggled with how to maintain batch records. Luckily (depending on how you look at it!), Robin was scheduled for a follow-up visit this past summer. This time around, she was able to make an appointment and didn’t have the surprise of a knock on the door in the early morning.
At the follow-up visit, the inspector made sure Robin was aware that she was happy with the progress, and even helped her work out the kinks in batch recording. During that second visit, the inspector noted a few more areas to work on, including:
- A few lights over her desk and in the drying room needed cages.
- A Standard Operating Procedures (SOP) Manual needed to be written to address the processes of receiving, production, packaging, distribution, and complaints/recalls.
- Packages shipped to customers in plain kraft shipping boxes needed to have a label on the outside with her logo, company name, and contact information.
- A Pinterest board Robin had compiled about herbs needed to be removed as some pins (links to other websites) indicated medicinal use.
Robin is confident that she will have her ducks in a row for her next visit, and hopes to completely check out in compliance. It’s been a long process for her, but she isn’t ever going to be done: she expects an annual visit from an inspector for as long as she is in business.
The Truth About Cosmetics Regulations & Compliance
Despite what other people might say, the FDA and other regulatory organizations are not out to get you. They are there to enforce the laws passed in your country, state, or city. By manufacturing and selling your products in the locations governed by them, you agree to be in compliance. Their goal isn’t to put you out of business, and as Robin learned, they may even try to help you.
While following good manufacturing practices and labeling products correctly may seem daunting, it’s our responsibility as business owners to follow the rules and regulations in place. The truth of the matter is that it’s not impossible for any of us to follow the regulations to the best of our ability, nor is it impossible for us to access the resources out there to make that happen.
And 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!
Here’s Robin’s takeaway advice for other soapmakers:
Take it seriously.
Even if you only make some soap, lip balm, lotion bars, etc., in your kitchen to sell at a farmer’s market, you must follow FDA guidelines and you can have the FDA show up on your front step.
I don’t know of many people that only sell soap and only label as just soap. Most of us make cosmetic claims on our soaps, in addition to making other products.
I know there are many, many sellers out there not following the rules and it is frustrating because there isn’t a level playing field. However, the FDA knows this, too. What my inspector told me was, it doesn’t matter what everyone else is doing, and she is right.
I was even asked for referrals of other makers in my area. They are looking.
Resources for Regulatory Compliance & Advocacy
While I’m happy to encourage regulatory compliance, and work hard to advocate for our industry, I’m not an expert by any means. However, there are plenty of resources available:
- The FDA’s Website: All of the regulations are plainly available via the FDA’s website, and a treasure trove of resources can make compliance easier, including guidance documents, labeling guides, fact sheets, and so much more.
- Marie Gale: Marie Gale has dedicated years to educating the handmade soap and cosmetics industry in regulatory compliance, including books like Soap & Cosmetic Labeling and Good Manufacturing Practices, articles, and more. Her website alone houses enough information to get you started.
- Lucky Break Consulting: Lela Barker has developed a comprehensive GMP program to help you get in compliance. She offers a live version occasionally directly through Lucky Break Consulting, as well as an independent study class via Bramble Berry.
- Coalition of Handcrafted Entrepreneurs: Anne-Marie of Bramble Berry and Soap Queen heads up the COHE, which she formed to support small businesses in the soap and cosmetic industry. COHE works hard to advocate for small manufacturers like us, and it’s easy to get involved by signing up for the newsletter.
- Handmade Cosmetics Alliance: Debbie May of Wholesale Supplies Plus established the HCA to seek to preserve the freedom to buy or produce and sell handmade soap & cosmetics in the USA. Again, it’s easy to get involved, just visit the HCA website.