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The claim check, before anything is published

Updated

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Three questions, run over everything you publish. Any one of them can change your regulator.

One: does it mention microorganisms at all?

Germs, bacteria, viruses, microbes, or a percentage killed. If none of those appear and nothing implies them, you are almost certainly making a plain cleaning claim and no agency is involved.

Two: if it does, is it for skin or a surface?

Skin puts you in front of FDA as an over-the-counter drug; a surface puts you in front of EPA as an antimicrobial pesticide. There is no third answer and the product can be in both if it is sold for both.

Three: does an image or a name carry the claim?

Germ illustrations, clinical imagery, a product name containing a word like shield or defense. The overall impression is what counts, and names are the hardest thing to change later.

Check beyond the label

Website, listings, advertising, stall signage, emails and replies to customers. The label is the part that gets reviewed and the rest is where the claims actually are.

Keep the list, and date it

Every claim, where it appears, and when it was approved. It is the same register the supplements and sun properties describe, which is not a coincidence: three different statutes, one failure mode.

Decide who may publish

The common breach is somebody being helpful in a reply. Agreeing in advance who writes about the product, and what the standard answers are, is part of the control rather than an administrative nicety.

Run it again when anything changes

A new variant, a seasonal campaign, a new marketplace listing or a supplier whose copy you reused. Each reopens the question, and the check costs minutes against a pulled listing in the middle of a season.

Hand sanitizer answers all three at once

It is for skin, it is about microorganisms, and it is a drug. If that is the product, the check is over and the question becomes whether you want to be in the drug regime at all.

References

21 CFR 310.545, which covers consumer antiseptic hand wash and body wash drug products as over-the-counter drugs and names active ingredients not generally recognized as safe and effective for that use, including triclosan and triclocarban, as of September 6, 2017. law.cornell.edu
United States Environmental Protection Agency, What are Antimicrobial Pesticides?, defining them as substances used to destroy or suppress the growth of harmful microorganisms on inanimate objects and surfaces, with over 4,000 registered products. epa.gov
21 CFR 701, Cosmetic Labeling, for the products here that are cosmetics rather than drugs or pesticides. law.cornell.edu
Written from federal regulation, not from a formulation bench. An antiseptic wash is an OTC drug and a surface disinfectant is a pesticide, and a plain soap is neither until it makes a claim. Nothing here clears a specific label.