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Insect repellent

What an exempt product may not say

Updated

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The minimum risk exemption comes with a condition that takes away the most commercially valuable claim a repellent has.

The condition

A minimum risk product may not claim to control disease-transmitting organisms or disease-carrying insects. Not ticks and Lyme, not mosquitoes and the diseases they carry, not any formulation of that idea.

Why the line is drawn there

Because a claim about disease vectors is a claim people rely on to protect their health in a specific way, and the exemption exists precisely because these products have not been through the data review a registration requires. The strongest claims are reserved for the products that were assessed.

What is left to say

That it repels mosquitoes, that it is made from listed botanical ingredients, how long it lasts if you can support that. Those are real and sellable, and they are not the same as implying protection from illness.

Implication counts here as it does elsewhere

Naming a disease alongside the product, using imagery that evokes one, or publishing a customer story about avoiding illness all make the claim without the sentence. This is the same lesson the supplements property arrives at from a different regulation.

It applies to everything you publish

Website, packaging, market stall signage, social posts and replies. A clean label and an enthusiastic blog post is the common shape of this failure, and it is the blog post that is quoted.

If the disease claim is the product, register it

For a maker whose whole proposition is tick protection, the exemption is the wrong route and the honest answer is registration or selling a registered formulation. Choosing the exemption and then making the claim anyway is the worst of both.

Distributors and retailers say it for you

A shop listing that adds a disease reference to an exempt product has made the claim on your label’s behalf. Supplying approved copy and checking listings periodically is the only practical control.

References

40 CFR 152.25, Exemptions for pesticides of a character not requiring FIFRA regulation, including the minimum risk exemption: active ingredients named with their percentage by weight, inert ingredients by their designated names, company name and contact information, and no claim to control disease-transmitting organisms. law.cornell.edu
United States Environmental Protection Agency, Find the Repellent that is Right for You, which explains that a registration number means the company provided EPA with technical information on the safety of the product and its effectiveness. epa.gov
Written from federal regulation, not from a formulation lab. A sunscreen is an OTC drug and an insect repellent is a pesticide, and both carry requirements that a cosmetic does not. Nothing here clears a specific label, and the difference between a cosmetic claim and a drug claim is narrower than it looks.