WASHINGTON — Manufacturers of spot-on flea-and-tick products have six months to make labeling changes, according to a new directive from
the Environmental Protection Agency, to address increasing adverse events associated with the misapplication of these products
by pet owners.
The new requirements are outlined by EPA after reviewing more than 1,000 comments collected since spring 2010 over safety
concerns about the misapplication of spot-on flea-and-tick products.
The comment period was launched around the same time EPA announced sweeping changes to the way spot-on products are approved,
monitored and labeled. The changes followed a more than year-long safety review of spot-on products by a panel of veterinary
experts. The panel was commissioned to help EPA understand why adverse events were increasing, with the number of reported
incidents jumping from 28,000 in 2007 to 44,000—including 600 deaths—by 2008.
EPA said it would work with manufacturers to change product labels to address health risks to cats from canine-labeled products
that have been misapplied.
The labeling changes will clearly identify spot-on products for dogs or cats by adding the word "dog" or "cat" in or in close
proximity to the product name. The appropriate species will be repeated throughout the directions, EPA says, and it has issued
guidance on the font size as well. Images of cats and dogs must be featured on the product labels. And canine-labeled products
would also include specific warnings about use on cats.
EPA also is asking manufacturers to add more information about possible adverse effects associated with spot-on products.
Products will now instruct users to consult a veterinarian or the manufacturer in case of an adverse event.
EPA has not adopted the suggestion of several groups, such as the American Veterinary Medical Association and the Companion
Animal Parasite Council, to mandate greater involvement by veterinarians in the use of spot-on products. EPA says it lacks
the authority to require pet owners to purchase pet pesticides only from veterinarians, although the agency does recommend
pet owners consult their veterinarians on the use of any flea-and-tick treatments.
AVMA also recommended that EPA align its adverse event reporting with the U.S. Food and Drug Administration and the Veterinary
International Conference on Harmonization. More specifically, AVMA says FDA should receive adverse events though FDA's new
MedWatch portal to make adverse event reporting easier for veterinarians. EPA stated it is looking into such a program, but
adds that regulatory changes relating to reporting requirements could take several years to complete.
EPA did not see reason to conduct a separate study on inert ingredients in spot-on products—another request submitted through
several comments. It did note, however, that it would no longer allow the use of any inert ingredients that have suspected