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The line

Pesticide or animal drug

Updated

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The cleanest jurisdictional line in this library, and it is written into the definition rather than agreed between agencies.

The pesticide definition

Any substance or mixture intended for preventing, destroying, repelling or mitigating any pest, plus plant regulators, defoliants, desiccants and nitrogen stabilizers. Broad, and squarely covering a flea and tick product that acts on the pest.

And the exclusion that follows it

The term shall not include any article that is a new animal drug, or that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use, or that is an animal feed bearing or containing a new animal drug.

So the food and drug law takes precedence

If the article is a new animal drug, it is not a pesticide for FIFRA purposes at all. That is an unusual drafting choice and it is what makes the line clean rather than negotiated.

What a new animal drug is

Any drug intended for use for animals other than man whose composition is not generally recognized among experts qualified by scientific training and experience as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling.

Which is a labeling-dependent definition

The conditions in the labeling are part of the test. So two products with the same composition and different labeled conditions of use are not automatically in the same position, which is worth sitting with.

A drafting detail worth noticing

FIFRA cites section 321(w) for the new animal drug definition and that definition now sits at 321(v). The published text carries a footnote about it. The substance is unaffected and it is a reminder to read the current section rather than the cross-reference.

And a third possibility: neither

A shampoo, a coat conditioner or an ear cleaner that makes no pest, antimicrobial or therapeutic claim is not a pesticide and not a drug. That is where most of what this shelf can honestly serve sits.

References

7 U.S.C. 136(u), the FIFRA definition of pesticide, which covers substances intended for preventing, destroying, repelling or mitigating any pest and then excludes any article that is a new animal drug within the meaning of the Federal Food, Drug, and Cosmetic Act, or that has been determined not to be one by regulation, or that is an animal feed bearing or containing a new animal drug. law.cornell.edu
21 U.S.C. 321(v), the definition of a new animal drug: any drug intended for use for animals other than man whose composition is not generally recognized among qualified experts as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling, with a pre-1938 saving clause and provisions for minor species and minor uses. law.cornell.edu
Written from federal statute, not from a veterinary bench. Which regime a specific product falls under is a determination about that product, and state feed and drug programs run alongside the federal ones. Nothing here is a registration, an approval, or advice on a particular formulation.