Label Review Training: Module 3: Special Issues, Page 39
Section 8: How should I review labeling claims?
Efficacy-Related Claims
Even though registrants/applicants must conduct efficacy studies, EPA only routinely requires the submission of these studies for certain types of products. As discussed in Module 1, EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health.
The following table provides examples of acceptable and unacceptable efficacy claims.
| Acceptable | Unacceptable |
|---|---|
| The terms “microbiocide,” “microbicide,” and “microbiostat” on a non-public-health product if the claim indicates that the product does not provide public health protection. | The terms “microbiocide,” “microbicide,” and “microbiostat” on a public health product. |
| The term “biocide” on a non-public-health product if the directions for use or other statements make clear the types of organisms to be controlled. | The term “biocide” on a public health product, because it implies that the product can kill all living organisms. |
True, non-misleading claims regarding the effectiveness of a product against target pests. For example:
|
Exaggerated or misleading claims regarding the effectiveness of a product against target pests. For example:
|
Terms that describe a specific level of efficacy and that are standard EPA-accepted claims, when data support their use. For example:
|
Terms that describe a specific level of efficacy but that are not supported by data. |
Terms that function only to define a use site and that are not themselves claims of heightened efficacy, provided that such terms are not used in a manner that is misleading. For example:
|
Implied claims of heightened efficacy of a pesticide product by itself or as compared to another product or device. For example:
|
| The claim of “new” if the product is of new composition and has been approved for a period of six months or less. | The word “new,” if it is part of the product name of record. |
Words or phrases that imply a product possesses unique characteristics because of its composition. For example:
|
|
Claims that are inconsistent with efficacy established by testing. For example:
|
|
Claims of efficacy based on an unsubstantiated, or improbable site/pest relationship. For example:
|
Resource
For more information about efficacy-related claims, see Chapter 12, Section VII of the Label Review Manual.
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