Determining If Insect Repellent Skin Patch Products Must Be Registered Under FIFRA
Certain skin patch products that claim to repel insects are required to be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), while others are exempt. This fact sheet describes how to distinguish between these two categories.
Skin Patch Products Regulated as Pesticides
Skin patch products that claim to repel or mitigate insects are pesticide products. Unless otherwise exempted from registration under 40 C.F.R. §§ 152.20, 152.25, or 152.30, pesticide products that are intended to prevent, destroy, repel or mitigate a pest must be registered under FIFRA.
An example of an insect repellent skin patch that would require registration under FIFRA is a skin-applied patch impregnated with vitamin B sold or distributed with claims to repel insects. Such claims are pesticidal claims. Vitamin B is not on the minimum risk exempt active ingredient list; therefore, the sale or distribution of any such product requires that it be registered as a pesticide.
The fact that the vitamin B repellent chemical is expected to spread from the patch through the skin does not exempt the product from being a pesticide regulated under FIFRA. FIFRA Section 2(u) does not limit the definition of pesticide based on mode of action of the substance, or the mechanism of dissemination of an insect control pesticide.
A vitamin B patch would be considered to be a “biochemical pesticide” when used to repel insects because the active ingredient is naturally occurring and has a non-toxic mode of action. A patch containing only biochemical pesticides would be eligible for registration using a reduced set of data requirements, as described in 40 C.F.R. part 158 subpart U.
Regulatory Exemptions That May Apply to Some Skin Patch Products
At 40 C.F.R. § 152.25(f), EPA has published a list of chemical substances deemed to pose minimal risk and that are, therefore, exempted from the requirement to register under FIFRA. It is possible that producers may market certain of these exempt substances as having insect repellent properties. As an example, we are aware of skin patches on the market that contain citronella (a pesticide exempt under § 152.25(f)) as an active ingredient. A patch that contains only active ingredients exempt under § 152.25(f) would be exempt from the requirement to register under FIFRA, provided that it meets the other requirements listed in § 152.25(f) (i.e., that the label list the name and percentage (by weight) of each active ingredient and the name of each inert ingredient, and that any inert ingredients in the product (including the patch material) be listed in the most current inerts List 4A. (10 pp, 52k, about PDF). Read more about minimum risk pesticide requirements.
Another regulatory exemption that may apply to some skin patch products is that devices are not required to be registered under FIFRA section 3. The regulation published at 40 C.F.R. § 156.500 defines devices and lists the FIFRA requirements applicable to devices, including labeling requirements, establishment registration and reporting, and record keeping. An example of a patch that could qualify as a device would be one that uses a sticky substance to trap flies that land on a person wearing the patch. This kind of product would be exempt from the registration requirement but would be subject to the other provisions of FIFRA as described in § 152.500. Read more about pest control devices.
Producers of unregistered skin-applied insect repellent patches should consider the preceding information when deciding whether their product must be registered under FIFRA. There can be serious consequences for sale and distribution of an unregistered pesticide. The Agency has the authority to take appropriate enforcement action where unregistered products make pesticidal claims. These include, but are not limited to:
- issuing notices of warning;
- stop sale, use, or removal orders (SSURO); and,
- civil and criminal penalties.
If you have questions regarding whether your products are subject to registration, we encourage you to seek further information from one of the following: