Soap labeling rules: United States

In the United States, a bar of handmade soap can be one of three things in law: soap, regulated by the Consumer Product Safety Commission; a cosmetic, regulated by the FDA; or a drug, which is a different world entirely. Provided the bar is real soap, what decides it is not what you make but what you say about it.

The exemption has two conditions

The Federal Food, Drug, and Cosmetic Act excludes soap from the definition of a cosmetic, and 21 CFR 701.20 says what counts. There are two tests, and both must hold:

1. The chemistry. "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 those compounds. In plain terms: it has to be real soap, made from fats and lye, with nothing else doing the cleaning. Add synthetic detergents and you are out.
2. The representation. The product is "labeled, sold, and represented only as soap".

Nearly every handmade bar passes the first test without trying, because that's what saponification produces. The second is the one that gets lost, and it gets lost on the label, in the Etsy listing, on the shelf card at the fair. "Only as soap" is a narrow phrase. It means the product is presented as something that cleans, and nothing more.

What a claim does to your product

Categories per the FD&C Act and 21 CFR 701.20; the examples are illustrative rather than a list FDA publishes. Note that the claim doesn't have to be on the wrapper: a website, a sign, or a caption can all be "representing" the product.

Two things follow that are worth sitting with. First, once the bar passes the chemistry test, none of this is about your recipe. The same bar is soap or a cosmetic depending on the words next to it, which means the decision is free to reverse and free to get wrong. Second, the cosmetic route is not a disaster. Plenty of makers deliberately go there because they want to describe what their soap does. It just has to be a decision rather than an accident, because the obligations that follow are real.

If it's true soap: what the label must show

Soap that keeps the exemption falls to the Consumer Product Safety Commission as a consumer product, and its labeling rules come from the Fair Packaging and Labeling Act, as the Federal Trade Commission applies it in 16 CFR Part 500. Three elements:

• An identity statement, saying what the product is. "Soap" does it.
• The net quantity of contents, in both US customary and metric units, on the principal display panel: in the bottom 30% of it (panels of 5 square inches or less are excused from that placement), running parallel to the base the package rests on, in type no smaller than 1/16 inch on the smallest panels and larger on bigger ones (16 CFR 500.6 and 500.21). Whether the scale you weigh the bars on must itself be certified is a state question; the scales comparison covers it.
• The name and place of business of the manufacturer, packer or distributor.

No ingredient list is required. You may include one voluntarily, and many makers do because customers expect it; if you do, it has to be truthful and not misleading, but you are not bound to FDA's naming and ordering rules. "Saponified olive, coconut and palm oils" is fine where a cosmetic would need every ingredient named separately, by the name 21 CFR 701.3 requires, in descending order. That's the single biggest practical difference between the two regimes.

If it's a cosmetic: what changes

Everything above, plus FDA's rules under 21 CFR Part 701:

• A full ingredient declaration, mandatory, in FDA's naming conventions and in a prescribed order (21 CFR 701.3), as worked through below.
• Net quantity under FDA's rule instead of FTC's. 21 CFR 701.13 sets the same placement and type sizes as for soap (bottom 30% of the principal display panel, parallel to the base, no smaller than 1/16 inch, larger on bigger panels), and requires a clear space at least the height of its own lettering above and below it.
• Only FDA-approved color additives, used within their approved conditions. This rules out a number of things soapmakers reach for.
• A contact for adverse event reports on the label. Since December 29, 2024, MoCRA has required every cosmetic label to carry a US address, a US phone number, or electronic contact information such as a website, through which the responsible person can receive adverse event reports (21 U.S.C. 364e). True soap is not covered by this.
• Adverse event reporting and safety substantiation under MoCRA, covered below.

On the figure itself rather than its formatting: the weight has to be true when the bar is sold, and a curing bar keeps losing water for months. The bar count calculator works out what a bar will weigh once cured, and makes the case for declaring a weight you're certain of.

What an ingredient declaration looks like

Ingredients go in descending order of predominance, by weight of what went into the batch, not what comes out of it. Here is our classic bar, at 1,000 g of oils with a 3% fragrance load, in the order the regulation requires:

Weights from the lye calculator's arithmetic for the classic bar: 1,000 g of oils, 5% superfat, a 33% lye solution and 3% fragrance. The names are the English common names FDA asks for: its ingredient-names page says it does not accept "Aqua", "Parfum" or a Latin botanical name as a substitute, though it does not object to one in parentheses after the English name, as in "Sweet Almond (Prunus Amygdalus Dulcis) Oil". The small print under each is the international INCI name, from the site's oil table. Written out, the US declaration reads: Olive Oil, Coconut Oil, Palm Oil, Water, Sodium Hydroxide, Castor Oil, Fragrance.

Two surprises in that list. Water is only fourth, where people expect it first because that is where it sits on a lotion. And 701.3's convenience (anything at 1% or less may be listed in any order after the ingredients above 1%) is no help to a soapmaker: the smallest thing in this batch is fragrance at 2.0%, so every line has to be in strict order anyway. A colorant or a pinch of an additive would be the first ingredient that shortcut ever touched.

Where MoCRA fits, and where it doesn't

The Modernization of Cosmetics Regulation Act of 2022 was the biggest change to US cosmetic law in eighty years, and it caused a good deal of alarm in the handmade community. The first thing to know is the simplest: MoCRA regulates cosmetics, and true soap is not a cosmetic. If your product holds the 701.20 exemption, MoCRA is not your law.

If you are selling a cosmetic (which includes any soap with a moisturizing or deodorizing claim on it), then it is, and the shape of it is this:

• Facility registration and product listing, and the good manufacturing practice rules MoCRA directs FDA to write, both carry a small-business exemption (21 U.S.C. 364h): average gross annual US cosmetic sales below $1 million (adjusted for inflation) over the previous three years. That covers most handmade businesses.
• The exemption does not cover everything. Safety substantiation, adverse event reporting and labeling requirements, including the adverse-event contact on the label, apply regardless of size. The exemption is about paperwork, not about responsibility.
• Certain categories are excluded from the exemption entirely: products that regularly come into contact with the mucus membrane of the eye, injected products, products intended for internal use, and products meant to alter appearance for more than 24 hours. Soap is not among them.

A few things that are not true

• "The FDA approves cosmetics." It does not. There is no pre-market approval for cosmetics in the US. The responsibility for a safe, properly labeled product is entirely yours, which is precisely why the labeling rules matter.
• "Natural" and "organic" are regulated terms. For cosmetics, FDA has no definition of either. "Organic" is meaningful only through USDA certification of the agricultural ingredients.
• "Handmade means exempt." Scale has nothing to do with the soap-versus-cosmetic question. A one-person operation selling six bars a month is subject to exactly the same classification test as a factory.
• "It's fine, everyone words it that way." Widespread practice is not a defense, and the phrasing on other makers' labels is not evidence that those labels are compliant.
• "These rules are roughly the same everywhere." They are not. In the UK and EU there is no soap exemption at all. Soap is a cosmetic, which means a safety assessment by a qualified assessor and notification before sale. If you ship abroad, that is a different page and a much higher floor.

Print this checklist