Soap labeling requirements: true soap, cosmetic or drug

Soap labeling: which rules apply to your bar

Soap labeling starts with one question: is the product true soap, a cosmetic, a drug, or a cosmetic and a drug at once? The answer decides which federal agency regulates it and what the label must say. FDA's own soap FAQ says that if your product meets FDA's definition of soap, it is regulated by the Consumer Product Safety Commission (CPSC), not by FDA.

The Federal Food, Drug, and Cosmetic Act specifically excludes soap from its definition of a cosmetic. That exclusion is narrow. FDA notes there are very few true soaps on the market, and that many detergent products are marketed as “soap” but are not true soap. Most handmade bars that are sold with scent, skin or health claims end up under FDA cosmetic or drug rules, even when the maker uses lye.

This page covers federal rules in the United States. States and cities can add their own rules for home businesses and product sales, so check with your state and local authorities as well. It is general information, not legal advice.

What counts as true soap under 21 CFR 701.20

FDA's definition of soap sits in 21 CFR 701.20. The regulation says the term applies only when The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties come from those compounds, and when the product is labeled, sold, and represented only as soap. FDA's soap FAQ breaks this into three conditions, and all three conditions must be met.

1. What it is made of. The product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
2. What cleans. Those salts must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap.
3. How it is sold. It must be labeled and marketed only for use as soap.

A bar that fails any one of the three is a cosmetic, a drug or both. In those cases FDA says You can still use the word “soap” on the label, so the word itself is never the problem. The ingredients and the claims are.

CPSC adds one more point in its soap guidance: under the MoCRA definition of a cosmetic product, may classify the product as a cosmetic even if no cosmetic claims are made. Adding ingredients known for cosmetic effects can move a lye soap into FDA territory even if the label makes no claims.

Is soap a cosmetic? How claims change the rules

Soap is a cosmetic when its intended use goes beyond cleaning. FDA's cosmetics labeling guide defines a cosmetic as a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Intended use comes from what you say about the product, on the label and in your listings.

FDA's soap FAQ gives the claims that move a bar out of the soap category. Purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body make it a cosmetic. Claims about killing germs, or treating skin conditions, such as acne or eczema make it a drug. A drug soap must comply with the regulations (called “monographs”) for certain categories of non-prescription drugs, and you will need to register your firm and list your products with FDA.

Words like natural and organic do not change the category. FDA says do not have definitions for “natural” or “organic.” The same rules apply whether the ingredients come from plants, animals, minerals or a lab.

CPSC soap labeling requirements for true soap

CPSC regulates true soap, and its business guidance says CPSC does not have specific requirements for soaps. Soaps fall under the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA). CPSC also states that CPSC does not oversee any requirement to list the ingredients of a soap on the label, and that true soaps under its jurisdiction do not need to follow FDA’s requirements.

The label rules switch on only when the soap is a hazardous substance under the FHSA. In that case it must bear precautionary labeling. CPSC notes that such labeling for standard soap is uncommon and usually reserved for strong degreasing soaps that could cause eye irritation. A cautionary label then includes:

• A signal word, as CPSC's list puts it: Signal word.
• Statements of the principal hazard, and the common or chemical name of the substance; CPSC says these soaps must identify the substance responsible for the hazard.
• The name and place of business of the manufacturer, packer, distributor, or seller.
• Statements of precautionary measure to follow, plus Instructions, when appropriate, for special handling and storage.
• When appropriate, first aid instructions.
• The statement “Keep out of the reach of children” or its practical equivalent.

Soap made for children is a separate case. Soaps primarily intended for children 12 years of age or younger are children's products. They must bear a permanent tracking label and be tested for total lead content by a third-party, CPSC-accepted laboratory, and makers must issue a Children’s Product Certificate (CPC).

A true soap with no hazard still benefits from a plain label: a name for the product, your business name and the weight help buyers and markets. Those are good practice for true soap, not a CPSC rule.

FDA soap labeling requirements for cosmetic soap

If your bar is a cosmetic, FDA labeling rules apply in full. FDA's soap FAQ says it is make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled. 21 CFR 701.20 gives bar soap as an example: a cosmetic bar must carry an accurate statement of the weight of the bar in avoirdupois pounds and ounces.

The label has two areas. The principal display panel (PDP) is usually the front panel of the label of the outer package. Other panels are information panels. The table lists each required element and where it goes, from FDA's cosmetics labeling guide.

Ingredient declarations are required only on the label of the outer container of cosmetics customarily sold at retail. If a bar sits in a box or wrap, the outer wrap carries the list. For products sold by mail, FDA's guide says direct mail cosmetics may utilize off-package ingredient labeling, with a notice in the package and a copy sent on request.

How to label handmade or melt and pour soap

Example: a lavender bar sold online and at a weekend market, wrapped in a paper band. The steps work the same for cold process, hot process and melt and pour soap.

1. Read the base and your claims

   For melt and pour soap, read the ingredient list of the base you bought. If it lists synthetic detergents, it’s a cosmetic, not a soap. Then read your own label and listing: a word like moisturizing or a scent claim makes the bar a cosmetic.

2. Decide the category

   A lye soap with no detergents and no cosmetic or drug claims can be true soap under CPSC. Anything else follows FDA cosmetic or drug rules. If you are unsure, CPSC says firms may wish to contact the FDA for guidance whether their products fall under FDA’s jurisdiction.

3. Put the identity and weight on the front

   For a cosmetic bar, name the product on the paper band's front panel. Add the net weight in avoirdupois pound and ounce with the term "net weight" or "net wt."; grams may additionally be stated also in the metric system. The weight goes within the bottom 30% of the PDP of the outer container, and that location rule is waived for PDPs of 5 square inches or less.

4. List ingredients on the back

   List each ingredient in descending order of predominance, and declare scent compounds as "fragrance" and "flavor." if you prefer. Put the list on the outer band or box, since ingredient declarations are required only on the label of the outer container of cosmetics customarily sold at retail.

5. Add your name and address

   Print your business name and an address that must include the street address, name of the city and state, and the ZIP code. The street address may be omitted if the firm is listed in a current city or telephone directory. If someone else makes the bar for you, use wording such as "Manufactured for ...", "Distributed by ...".

6. Check your listings match

   The claims in your shop listings count toward intended use. A listing that says the bar clears acne makes it a drug, even if the paper band says only soap.

Do I need a license to sell soap?

FDA does not license soap or cosmetic makers: its small business fact sheet says FDA does not license cosmetics firms, although state or local authorities may require licensing or have other requirements. Cosmetic products and their ingredients do not need FDA approval before sale either. FDA's soap FAQ says Neither the product nor its ingredients need approval by FDA before they go on the market, except for any color additives it contains.

Cosmetic soap does fall under MoCRA, which requires registration and listing of cosmetic product facilities and products with FDA. FDA's MoCRA page says the law exempts certain small businesses from GMP, registration, and product listing requirements, although those exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products on FDA's list. A drug soap is handled under drug rules: you will need to register your firm and list your products with FDA.

Licenses for the business itself come from your state, county and city. The SBA says license requirements and fees vary based on your business activities, location, and government rules. It also notes that zoning ordinances can still apply even to home-based businesses, so check with your city planning office before you sell from home.

Where Nation fits

Questions about soap labeling