Buy a full case and the price per unit drops automaticallyRequest a sample
AccountCart0
All ContainersBottlesJarsCaps & ClosuresPumps & SprayersTubs & PailsJugsDroppersTinsTubesAccessories
Industries
Learn
Soap, cosmetic or drug

Staying exempt on purpose

Updated

On this page5

The exempt position is available and it is narrower than the marketing makers often want. Choosing it deliberately is the only way it survives.

A real choice with a real cost

Exempt soap is the lightest regulatory position in this estate: no ingredient declaration, no MoCRA registration, no cosmetic labeling requirements.

The cost is that you may say almost nothing about what the soap does.

Which is a genuine trade rather than a free win, and it is why makers often should look hard at the cosmetic route before choosing this one.

What you get

A simpler label: identity, net quantity, and your name and place of business under the Fair Packaging and Labeling Act.

CPSC rather than FDA as the regulator.

No INCI list, which for a soap maker means not having to explain Sodium Olivate to customers who asked for olive oil soap.

And no registration.

What you give up

Moisturizing. Nourishing. Gentle. Softening. Deodorizing. For dry skin. Good for eczema.

Every benefit statement about what the bar does to a person.

Which is most of the vocabulary the category sells on, and is why the exempt position is harder to hold than it looks.

Holding it

Write the permitted language once and use it in every place: wrapper, website, listing title, listing category, market sign, sample card, and the sentence you and anybody helping you says out loud.

Audit the listings, not just the labels. The condition says labeled, sold and represented, and the listing is representation.

Review whenever a new product, a new marketplace or a new person writing copy arrives.

And be honest about whether you are actually holding it. A maker who cannot resist the word moisturizing is a maker who should be labeling as a cosmetic and complying properly, which is an entirely respectable answer.

References

21 CFR 701.20. FDA interprets "soap" to apply only to articles where the bulk of the non-volatile matter consists of an alkali salt of fatty acids, the detergent properties are due to those alkali-fatty acid compounds, and the product is labeled, sold and represented only as soap. ecfr.gov
US Consumer Product Safety Commission. Soap Business Guidance. Products meeting the FDA soap exemption fall to CPSC rather than FDA, with labeling under the Fair Packaging and Labeling Act and the Federal Hazardous Substances Act where relevant. cpsc.gov
Fair Packaging and Labeling Act, and the consumer commodity requirements: a statement of identity, a net quantity of contents and the name and place of business of the manufacturer, packer or distributor. ftc.gov
US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). How intended use, established by claims, decides which of the three a product is. fda.gov
Written from the federal regulation and FDA and CPSC guidance named on each page, not from a laboratory or a legal practice. Whether a particular product and a particular label make exempt soap, a cosmetic or a drug is a determination about your product, and this is not that determination.