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What goes wrong

The product was misclassified

Updated

On this page9
The classification is about the customer, not the formula, and that is where it goes wrong.

How it happens

A cleansing balm is wiped off with a cloth and the maker reasons that it is not rinsed. An in-shower body treatment is marketed as leave-on and customers rinse it anyway. The paragraph follows the use.

The honest test

Will customers rinse it off. Not whether the instructions say to, and not what the category convention is. If they will, treat it as rinse-off rather than arguing the margin.

Toothpaste shows the drafting intent

The statute includes toothpaste in the term rinse-off cosmetic expressly, which tells you the reading is practical rather than narrow. Toothpaste is rinsed because people rinse it, and the statute says so.

And a dual-use product should be treated as the stricter one

A scrub that doubles as a mask, or a cleanser marketed for both, is simplest to formulate as rinse-off throughout. The alternative is two formulations or an argument.

The consequence is not symmetrical

Treating a leave-on product as rinse-off costs you one ingredient choice. Treating a rinse-off product as leave-on is a prohibited act. The asymmetry argues for the conservative classification.

Which is why plastic-free across a range is tidy

One decision for every product, no classification question, and a claim that works across the whole line. For most makers that is the proportionate response.

Record the classification per product

Rinse-off or leave-on, with the reason. It is one word in the formula file and it is the thing a later reviewer will ask about first.

Write the classification down, in one word

Rinse-off or leave-on, in the formula file, with the reason. It is the first thing a reviewer will ask and the first thing anybody will have forgotten. One word, dated, beside the formula version it belongs to, so that a reformulation visibly reopens it.

References

21 U.S.C. 331(ddd), which prohibits the manufacture or the introduction or delivery for introduction into interstate commerce of a rinse-off cosmetic containing intentionally-added plastic microbeads, defines a plastic microbead as any solid plastic particle less than five millimeters in size intended to be used to exfoliate or cleanse the human body or any part thereof, and provides that rinse-off cosmetic includes toothpaste. law.cornell.edu
Written from federal statute and from measured catalog data, not from a formulation bench. Whether a particular particle is a plastic microbead within 21 U.S.C. 331(ddd) is a question about that particle and its purpose. Nothing here is a determination about a specific exfoliant or a specific formula.