After I decided to start selling my homemade soap I began researching any rules and regulations I could find. One of my main questions was “do you need FDA approval to sell soap?”
You do not need FDA approval to sell soap. As long as your soap meets the definition of true soap, and is meant only for cleansing, it is governed by the Consumer Product Safety Commission (in the US).
However, if your soap makes any medicinal claims or does not qualify as “true soap” – then it is governed by the FDA.
This was pretty confusing for me when I first started so let me break it down a little bit.
Let’s start with a summary of how the FDA defines soap.
How the FDA Defines “Soap”
To be considered “true soap” by the United States Food and Drug Administration, it needs to meet the following three criteria:
- Core Components: To be defined as true soap, and not require FDA oversight, it has to be primarily comprised of “alkali salts of fatty acids”. That’s just the technical description of what you get when you combine fats or oils with lye. Lye is the alkali and plant oils and animal fats provide the fatty acids part of the equation.
- Cleaning Agent: To qualify as true soap it can only use the alkali salts and fatty acids as its cleaning agent. This means that it cannot use any type of synthetic detergent. If synthetic cleaning agents are used, your soap is no longer true soap. It is now considered a cosmetic and will be regulated by the FDA
- Intended Use: The final requirement to meet the standards of true soap and be sold as such, is that the soap must be marketed for use only as soap – as a cleaner It must also be labeled with the intent of being used purely as soap.
How Oil and Lye Make Soap
The “alkali salts of fatty acids” are a natural result of the saponification process. Saponification occurs when an alkali, such as lye, is combined with a liquid to form an alkali solution. In soap making, this typically means adding a specific amount of lye to a specific amount of water or other liquid such as wine or beer. That is part one.
The second part is to mix the oils and the lye solution together. A natural biochemical reaction occurs that uses the lye to convert oils into the salts. The liquid evenly distributes the dissolved lye. Most of the excess water evaporates out over time.
Soap Labeling Rules
Labeling your soap properly is extremely important. In the Unites States it is the measure of how your soap is categorized for federal oversight and legalized sale.
The US uses a distinction between soaps, detergents, and drugs to determine how your product will be sold. If it is simply soap – and makes no other claims than cleaning – it may qualify as “true soap”. There’s a bit more to it than that, which was explained above. See “How the FDA Defines “Soap”” above for more detail. In the meantime…
If your soap product is marketed or labeled indicating any sort of medicinal properties, it is now considered a drug. In other words, if you state or advertise that your soap does, so much as kill germs, it is now considered a drug.
Although the word “soap” can still be used on a label, it will now be subject to FDA regulations and oversight when sold in the United States.
Heads Up!
Be very careful about any claims made regarding your soap. This really boils down to intended use. Even stating something such as it is a moisturizing bar or deodorizing bar, makes your soap into a cosmetic.
By the same terms, stating that your soap is antibacterial or meant to assist with skin conditions, makes it considered a drug. It is then under the FDA’s purview.
Links to FDA and Consumer Product Safety Commission
There is no better place to get information like this, than from the source. That said, following are links to the United States Food and Drug Administration website and Consumer Product Safety Commission website.
The links will take you specifically to the pages that answer questions regarding the regulation of soap in the United States.
How to Label Soap for FDA Compliance
How to properly label soap could not only be an entire blog post, it could be an entire book. In fact, there is an excellent book on the topic written by Marie Gale. Soap & Cosmetic Labeling
In the meantime, let me give you the short and sweet explanation of what needs to appear on your soap label. Following is the bare minimum needed on soap that qualifies as “true soap” by FDA standards.
FPLA Soap Labeling Minimum Guidelines
In the United States, true soap labeling regulations are governed by the Fair Packaging and Labeling Act. Following is all that is required of true soap, by FPLA:
- Product Name
- This can be considered the brand, type, “flavor”, or a combination. For example, I make a bar of “Oatmeal, Milk & Honey” soap that goes by that exact name. This is the identifier used on the label.
- Net Weight
- This should be final weight of the fully cured bar at time of purchase. Knowing that even cold process soap cured for several months can still continue to lose water weight, it is best to use a the weight you expect the soap bar to be when it is purchased and optimal for use.
- Name of Manufacturer/Maker
- This might be your personal or company name depending on how your business is set up. If you are incorporated or have an LLC, it is preferable to use that name because your insurance and any legal protection is likely associated with the business entity.
- Address of Manufacturer/Maker, Distributor or Packager
- For most small companies all of these addresses will be the same. All you need is one address on the label.
- Designation of “Soap” is the only “ingredient” required
- If your product qualifies as “true soap” you only need to list soap on the label as an ingredient. The reason is explained below.
Why Individual Ingredients are Not Needed on True Soap Labels
Again, there are excellent informational resources that provide chapters of information on how to properly label soap. However, to give you a two-minute answer, just use the list of items above and you will be fine.
As far as why all the separate ingredients are not needed when labeling true soap, this is because the term “soap” qualifies as an Out of The Pot ingredient.
“Into The Pot” and “Out of The Pot”
There are two ingredient listing options for labeling true soap. You can either list what goes into the pot, or what comes out of the pot.
Personally, I list all ingredients that go into the pot on my soaps. What this means is that I list every ingredient including all the oils, liquid, lye, and any additives whatsoever. Some people choose to list what comes out of the pot instead.
Due to the FDA’s definition of true soap, you can summarize those Out of The Pot ingredients simply as ”soap”. Otherwise you would be listing the results of soap, after saponification.
There is no need to go into a lot of detail here. In short, most of your Out of The Pot ingredients would be scientific names that tend to sound a bit overwhelming. This, again, is simply my opinion and why I choose to include what goes into the pot.
Why Don’t I Just Say Soap?
The reason I opt for including all ingredients that go into the pot is because I personally like to know what I am using as a consumer. Not only do I know that the ingredients I put into my soap are high-quality, I am very proud of that. There’s no reason to keep this information to myself.
Here is an actual soap label before being applied to one of my company’s packages. The two sides fold over so ingredients are shown on the side of the box. This is indicated by the red dashed lines that I added for reference.
FDA Acceptance Summary
I realize there is a lot to this so let me provide a quick summary.
If your soap qualifies as “true soap”, as defined by the FDA, then the FDA does not govern its production and sale.
To be considered “true soap” it must meet the guidelines provided above. As a reminder, these are:
- Core components must be “alkali salts of fatty acids”. These are the results of saponification that occurs when fats/oils and an alkali solution, such as lye water, are combined in the correct quantity for specific durations.
- The cleaning agent must be limited to the “alkali salts of fatty acids” mentioned above.
- Its intended use must be as a cleaner only. Additionally, it must be made as for use as soap. There can be no medicinal or cosmetic claims in order to qualify as true soap.
>>> Get The Inside Edge
Now that you know you CAN sell your soap, let’s help you sell it. There are multiple posts on this site to help with this. Here is a good place to start: Where and How to Sell Handmade Soap.
Happy Soaping!