*Topically applied products for control of fleas and ticks, other than those with systemic action, and* flea and tick collars currently fall within the purview of the Federal Insecticide, Fungicide, and Rodenticide Act, which is administered by the Environmental Protection Agency. Before EPA registers a pesticide product for marketing, research data must be submitted to show that the product is effective for the intended use and is safe when used according to label precautions and restrictions. Unfortunately, there are some individual animals and breeds that may be unusually sensitive to certain pesticide chemicals or the collars per se, so there are numerous complaints. The instructions provided with these *products* usually provide instructions as to what should be done if *problems* occur. Articles registered by the EPA have an EPA registration number listed on the label.
*Products containing a pesticide which are the responsibility of EPA contain EPA registration numbers on the label, and inquiries regarding such products or complaints should be referred to the Regulatory Division Office of Pesticide Programs, Environmental Protection Agency (EPA), 1921 Jefferson Davis Highway, Arlington, VA 22202, the nearest EPA regional office or advise the inquirer to contact them directly.*
If labeling of these articles contains claims for conditions other than for fleas, and other external parasites, they may be drugs subject to regulation by the FDA under the Memorandum of Understanding between FDA and EPA (CPG 7155b.08).
*Material between asterisks is new or revised*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.