On Oct. 4, 2017, the U.S. Food and Drug Administration (“FDA”) finalized guidance to clarify jurisdiction over the regulation of mosquito-related products. Both the FDA and the EPA regulate products intended for use in or on animals. The FDA is charged with protecting the public health by ensuring that animal drugs are safe and effective, while the EPA is charged with protecting human health and the environment by ensuring that registered pesticide products, when used according to their label instructions, result in no unreasonable adverse effects to man or the environment. Given their overlapping jurisdictions and the increasing focus on mosquito-borne diseases such as Zika, the FDA and the EPA issued the guidance to clarify the regulatory oversight of mosquito-related products.
The new FDA guidance clarifies that mosquito-related products intended to prevent, destroy, repel or mitigate mosquitoes for population control purposes are regulated as pesticide products by the EPA pursuant to the Federal Insecticide, Fungicide and Rodenticide Act. In contrast, mosquito-related products that are intended to prevent, treat, mitigate or cure a disease (including by an intent to reduce the level, replication or transmissibility of a pathogen in mosquitoes) will be regulated by the FDA pursuant to the Federal Food, Drug and Cosmetic Act.
The new guidance lists the following examples of mosquito-related products that will be regulated by the FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans.
- Products intended to prevent mosquito-borne disease in humans or animals.
The guidance also lists the following example of mosquito-related products that will be regulated by the EPA: products intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle or by interfering with their reproduction or development).
The FDA and the EPA recommend that companies seeking to register and manufacture mosquito-related products consult with the agencies early in the process to address any jurisdictional questions or concerns. The final Guidance for Industry #236 “Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products” can be accessed here.