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Claims

Skin or surface decides the agency

Updated

On this page8
One sentence, two regulators, and what decides it is what the product is used on.

On skin, it is a drug

An antiseptic hand wash is an over-the-counter drug product. 21 CFR 310.545 covers consumer antiseptic hand wash and body wash drug products directly, which puts germ-killing claims for skin squarely in FDA territory with everything that implies.

On a surface, it is a pesticide

EPA defines antimicrobial pesticides as substances used to destroy or suppress the growth of harmful microorganisms on inanimate objects and surfaces, and has more than 4,000 registered. A dish soap claiming to sanitize a countertop is making that claim.

Which means the use instruction can change the agency

A soap that says it cleans hands is a cosmetic. The same soap suggesting you also wipe down the counter with it, and claiming germ reduction there, has made a pesticidal claim. The product never changed.

The words that trigger it

Antibacterial, antimicrobial, sanitizes, disinfects, kills germs, kills 99.9 percent of anything. These are not descriptive adjectives in this context; each one is a regulated claim pointing at one agency or the other.

Plain cleaning claims are fine

Cleans, washes, removes grease, cuts through grime, leaves dishes streak-free. All true, all sellable, none of them a drug or pesticide claim. The honest version of this product is easier to sell than makers expect.

Check everything, not just the label

A website, a listing, a market stall card and a reply to a customer all carry claims. The label usually gets reviewed and the rest usually does not, which is where these problems live.

A product sold for both is in both regimes

A soap marketed for hands and worktops, with germ claims for each, is making a drug claim and a pesticide claim at the same time. That is a harder position than either alone and it is reached by accident more often than on purpose.

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
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.