Is handmade soap a cosmetic? US labeling rules for soap (CPSC vs FDA)

In the US, a bar is regulated as "soap" by the Consumer Product Safety Commission only if it is mainly fat-and-alkali soap, gets its cleaning from that soap, and is sold only as soap. Claims such as moisturizing or deodorizing make it a cosmetic, regulated by the FDA, and claims to treat skin conditions or kill germs make it a drug. Cosmetics have specific label requirements; true soap has far fewer.

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The three-part test for "soap"

The FDA's definition (in 21 CFR 701.20 (definition of soap)) treats a product as soap only when all three are true (FDA: Frequently asked questions on soap):

  1. What it's made of: mostly alkali salts of fatty acids, the material you get when oils react with lye.
  2. How it cleans: the cleaning comes from those salts. Synthetic detergents mean it isn't soap in this sense, even if the label says "soap".
  3. How it's sold: labeled and marketed only as soap.

Products that meet the definition are regulated by the CPSC, not the FDA (FDA: Frequently asked questions on soap).

Words that change the category

CPSC adds a caution: under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a product containing ingredients commonly recognized as cosmetic may be treated as a cosmetic even without cosmetic claims, and it suggests asking the FDA if you're unsure (CPSC: Soap business guidance).

If it's true soap (CPSC)

  • CPSC has no soap-specific labeling rules. A soap that meets the definition of a hazardous substance needs precautionary labeling, which CPSC says is uncommon for ordinary soap (CPSC: Soap business guidance).
  • Soap made mainly for children 12 and under is a children's product, with third-party lead testing, a tracking label and a Children's Product Certificate (CPSC: Soap business guidance).
  • If a bar is labeled for cosmetic purposes, 21 CFR 701.20 says it must meet the cosmetic rules, including a net weight statement (21 CFR 701.20 (definition of soap)).

If it's a cosmetic (FDA)

Outside the US

How Soap Ledger helps

Soap Ledger keeps the records behind a label (recipe versions, batches, lot numbers and ingredients) and prints batch labels with codes. It does not decide whether your product is soap, a cosmetic or a drug, and it does not certify a label as compliant.

Try it in the lye calculator. The lye calculator lists every ingredient by weight, which is where an ingredient list starts.

Sources

Written for Soap Ledger in our own words. Numbers in the examples are calculated by Soap Ledger's engine when the page is built. Last updated .