Last week, FDA and the EPA issued guidance for industry regarding each agency’s respective jurisdiction over mosquito-related products. With the emergence of the Zika virus and the urgency in countering the spread of mosquito-borne diseases taking on new prominence, the agencies acknowledged that “novel mosquito control technologies have gained greater attention as an element of [vector control]; however, there has been some confusion with respect to FDA’s and EPA’s respective jurisdiction over mosquito-related products.” Key points of the guidance include the following:
- Mosquitoes fall within the statutory definitions of “drug” per the FD&C Act and “pest” per the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
- In 1975, Congress amended FIFRA’s definition of “pesticide” in FIFRA to exclude any article that is a “new animal drug,” within the FD&C Act. Since then, EPA has required registration, as pesticides, articles that control the mosquito population by killing them or interfering with their reproduction.
- Given this history, with the new guidance, FDA is clarifying that the phrase “articles (other than food) intended to affect the structure or any function of the body of man or other animals” in the FD&C’s drug definition does not include articles intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes.
- Examples of New Animal Drugs regulated by FDA include products intended to reduce the virus/pathogen load within a mosquito or products intended to prevent mosquito-borne disease in humans or animals.
- Examples of Pesticide Products regulated by EPA include products intended to reduce the population of mosquitoes (for example, by killing them or interfering with their reproduction).
This guidance potentially applies to a wide variety of products, including those produced through biotechnology. One point that is not addressed in the guidance but that is of interest to industry is that the Federal Trade Commission also has jurisdiction over the advertising of insect repellent products. Last year the agency issued warning letters to companies making Zika-related claims.
As mosquito-borne disease spreads, mosquito-related products will proliferate. Companies will need to determine at the outset which agency or agencies have jurisdiction to ensure compliance.