Why No One is Too Small to Follow the Labeling Rules & Cosmetics Regulations

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.

The Importance of Following the Rules & Cosmetics Regulations
The Importance of Following the Rules & Cosmetics Regulations

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.

[bctt tweet=”If you choose to fly under the radar, don’t expect any help from the control tower.”]

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:

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23 Responses

  1. Kenna!

    Thanks for the upbeat update on “labeling and manufacturing compliance.” Every time I think I’m finally in compliance, and ready to do a little soap, potions, and lotions retailing, I go back to Marie Gale’s books, or read something like your article. While my initial response is to mentally freak out and feel defeated, it is good to know that I’m closer to compliance.

    Thank you for all your hard work and the awesome content!

    Leela

  2. “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.”
    I have NEVER heard that the logo has to be on the shipping box and that the companies name and address on the shipping container. Nor can find in the fda regulations that it mentions the direct mail shipping containers needing that at all outside of if the product itself not having a label on it needs the info in the box avail online etc (off label packaging)

  3. While I agree that the FDA regulations are mostly for safety, there are still state laws in effect that in my opinion have no reasoning behind them besides hindering small businesses and making money for the state. I live in Florida. In Florida to be able to manufacture ANYTHING that isn’t soap including scrub, lotion, bath bombs, or anything to do with bath or body products you have to get a permit that is $800 every two years. You also have to pay $150 for an inspector to come out to where you manufacture your product and they are very picky. They take pictures of things like water bottles anywhere in the building, hand written notes, inventory, etc. You also cannot reside in your place of manufacture meaning you must rent or own an entirely separate space than your home that will pass inspection. Many of the laws are very unclear and vague but trying to get any type of clarification can leave you holding on the line for a very long time or directed to eight different departments because nobody knows the answer.

    Besides the $400/year it costs to have your permit, you also have to register each individual product in each variation to the state which comes out to $30 each every two years. Do you sell ten products? That’ll be $300 every two years to register alone.

    It’s very nice in this story where the FDA worked with a small business to become regulatory, but in Florida this doesn’t happen. You simply get fines and/or cease and desist letters and they shut you down. I would venture to say that if everyone was held to the regulations within this state many of them would not be in business. Many small businesses are home based which would not fly. Many of us cannot afford to rent a space other than my home to manufacture in. I do not think personally that home based businesses are unsanitary or hurt the product in any way. Considering you can sell food that we literally consume with less regulation, again, this seems like a massive overkill.

    I originally had big hopes for myself and getting into soaps, scrubs, lip balms, lotions, etc. After doing all of the research regarding laws in my state I can really only afford to make and sell soaps. I have to be careful if I am doing melt and pour since some of these cross over in the FDA guidelines and are considered a ‘cosmetic’ which means all the prior stuff I mentioned. I follow FDA regulations on everything. I have a very sanitary environment where I create, I label accordingly and do not make any claims or use ingredients in the names of my soaps. I am very safe with my ingredients and my products are 100% safe (as far as I have tested and experienced) but I cannot sell them without having at least $950 in startup to get the permits/inspection, a whole new rent payment on top of what I already pay for housing, $30 per product to register every two years. I am young and I work from home which was why I got into making bath and body products in the first place. It would literally be cheaper for me to rent a space in another state and fly there to make my products to sell back home. That’s how ridiculously expensive and difficult it is for anyone to touch anything other than SOME kinds of soap in Florida.

    I’m not saying that I condone anyone not adhering to these policies, but I am saying that I understand why and I admit I have weighed out the risks myself though I did not choose to take them. There have been a couple proposed bills to redefine this ridiculous regulation but they have all died within the senate. Why is charging $800 for a permit going to make a product better or safer? What does home made soaping do to this stuff that makes it necessary to rent an entirely separate space? I’m not saying this stuff shouldn’t be regulated, but if this stuff was ONLY regulated by those federal laws that make sense such as labeling regulations or practicing good manufacturing practices then I would understand compliance being called into question. Again, if everyone was held by the ‘standards’ of my state I believe a vast majority would not be currently in business or been able to take off enough to keep up with such a hefty cost to stay within the law.

    1. Thank you so much for your comment. I live in FL and wanted to make soap to sell at my home. I had no idea that it would be so expensive.

    2. Amish Chickweed salve maker- 6 years in prison because of labeling or licensing infractions?! On Chickweed salve? Charged with “conspiracy & fraud! and 11 other felonies??” OUTRAGEOUS ! Jury was either misinformed, info was withheld or jury is without common sense. This does not appear to me to be about making products safe for the public. Who’s next? Isn’t the soaping community large enough to begin/have an advocacy group to stand against such unreasonable over-reach?

      1. Gail,
        I hear your frustration, but that’s not the whole story.

        Sam Girod refused to let government officials inspect his premise, made threats, and committed numerous other legal infractions.

        Making herbal salves for your own use (I do) is one thing. Making and marketing them as drugs is another. People are hurt by false drug claims, whether it be physical injury from an unsafe product or not seeking other treatment because they believe illegal marketing.

        The United States Federal Food, Drug, and Cosmetic (FD&C) Act has been in place for decades. And new, needed regulation changes are likely in the near future. Thankfully, industry advocates have been working for years to make those as favorable to small businesses as possible.

        Personal opinions and beliefs about government oversight aside, there are rules to conducting business, and it is each business owner’s job to know and follow them, and to advocate legislative change through the proper avenues.

        Whether through willfulness or ignorance, this guy didn’t follow the rules. He doesn’t get a free pass any more than I would if I didn’t know I needed to pay taxes or if I just decided not to.

    3. Just so I am clear, you do not need a permit to sell certain types of soaps in Florida? I would assume you would still need a business license to sell, but nothing special after that?

  4. Thanks for the resources, experiences and advice, all. I am starting my business, and there is so much to know! Thanks, Kenna!

  5. Great reminder. I am working through my list to finish now! Question Kenna, have you heard of “getting GMP certification”for your facility? I was told that there was a process for this, but I am clueless.

  6. I am just getting started on preparing to start a soap biz. I am reading Gale’s excellent book. I very much want to follow all the rules but I’m wondering, if I ammaking soap inmy kitchen do I have to have cages over all my kitchen lighting? And inthe office/curing room as well? Thank you for this enlightening discussion.

    1. Hey Maralee,
      While GMP are currently voluntary in the US for cosmetics, we urge you to follow guidelines as closely as practical. Some home-based makers follow the spirit of this guideline by installing (practically) unbreakable lightbulbs or covers, rather than cages.

      Also, as new legislation is being discussed some have proposed writing GMP guidelines specific to home-based businesses. Make sure your reps know your concerns and if this would be helpful for you. (Checkout the advocacy groups listed in the article to help keep on top of what’s being proposed.)

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