News from the FDA on the use of Spot-on Flea and Tick Products and their safety.
Pet owners need to be cautious about using flea and tick products safely, says Ann Stohlman, V.M.D., a veterinarian in the Food and Drug Administration’s (FDA) Center for Veterinary Medicine. “You need to take the time to carefully read the label, the package insert, and any accompanying literature to make sure you’re using the product correctly.”
Regulation of Flea and Tick Products
Flea and tick products for pets are regulated by either FDA or the Environmental Protection Agency (EPA).
FDA is responsible for regulating animal drugs; however, some products to control external parasites come under the jurisdiction of EPA. FDA and EPA work together to ensure adherence to all applicable laws and regulations. In general, flea and tick products that are given orally or by injection are regulated by FDA.
Before an animal drug is allowed on the market, FDA must “approve” it. Before a pesticide can be marketed, EPA must “register” it.
Both agencies base their decision on a thorough review of detailed information on the product’s safety and effectiveness provided by the manufacturer or other product sponsor. The sponsor must show that the drug or pesticide meets current safety standards to protect
the animal people in contact with the animal the environment
The sponsor must also show that the drug or pesticide produces the claimed effect, and the product must carry specific labeling so that it can be used according to the directions and precautions.
After a product is allowed on the market, manufacturers are required by law to report any side effects of their flea or tick products to the regulating agency.
Caution with Spot-On Products
In spring 2009, EPA noticed an increase in pet incidents being reported involving spot-on pesticide products for pets. EPA received a large amount of bad pet reaction information reported to the companies that hold registrations for these products. EPA formed a veterinarian team with the Food and Drug Administration’s Center for Veterinary Medicine (CVM) and Canada’s Pest Management Regulatory Agency (PMRA) to review this information. The team studied incidents involving cats and dogs, looked at the ingredients, studied labeling, and discussed data needs for the future to improve analyses and regulation.
Based on its analysis, EPA determined that some changes need to be made in how spot-on products are regulated, how companies report data on pet incidents, and how packages are labeled for cats, dogs, and size of animals to ensure the safety of these products. Based on reported incidents, EPA also concluded that many but not all pet incidents took place because the products were misused.
In September 2011, EPA required the following actions in response to the analysis of spot-on treatments:
Requiring manufacturers of spot-on pesticide products to improve labeling, making instructions clearer to prevent product misuse, including repeating the word “dog” or “cat” and “only” throughout the directions for use and applicator vial, and detailed side effect language. Requiring clear marking to differentiate between dog and cat products and more precise label instructions to ensure proper dosage per pet weight. Restricting the use of any inert ingredients that EPA finds may contribute to incidents. Launching a consumer information campaign to explain new label directions and to help users avoid making medication errors.
Spot-on flea and tick products can be effective treatments, and many people use the products with no harmful effects to their pets. EPA does not advise pet owners to stop using spot-ons, but asks them to use caution and make informed decisions when selecting treatment methods.
EPA advises pet owners to
*carefully follow label directions and monitor their pets for any signs of a bad reaction after application, particularly when using these products for the first time *talk to a veterinarian about responsible and effective use of flea and tick products
When to Treat
It’s best to treat your pet at the beginning of flea and tick season, says Stohlman. The length of flea season, which peaks during warm weather months, varies depending on where you live. “It can last four months in some places, but in other places, like Florida, fleas can live all year long,” says Stohlman. And fleas can live inside a warm house year-round no matter where you live.
Ticks are found in some places year-round. The Centers for Disease Control and Prevention report that in most parts of the United States, the greatest chance of infection by a tick bite is spring and summer.
Tips for Using Flea and Tick Products
Read the label carefully before use. If you don't understand the wording, ask your veterinarian or call the manufacturer. “Even if you’ve used the product many times before,” says Stohlman, “read the label because the directions or warnings may have changed.” Follow the directions exactly. If the product is for dogs, don't use it on cats or other pets. If the label says use weekly, don't use it daily. If the product is for the house or yard, don't put it directly on your pet. Keep multiple pets separated after applying a product until it dries to prevent one animal from grooming another and ingesting a drug or pesticide. Talk to your veterinarian before using a product on weak, old, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown signs of sensitivity to flea or tick products. Monitor your pet for side effects after applying the product, particularly when using the product on your pet for the first time. If your pet experiences a bad reaction from a spot-on product, immediately bathe the pet with mild soap, rinse with large amounts of water, and call your veterinarian. Call your veterinarian if your pet shows symptoms of illness after using a product. Symptoms of poisoning include poor appetite, depression, vomiting, diarrhea, or excessive salivation.
Do not apply a product to kittens or puppies unless the label specifically allows this treatment. Use flea combs to pick up fleas, flea eggs, and ticks on puppies and kittens that are too young for flea and tick products.
Wash your hands immediately with soap and water after applying a product, or use protective gloves while applying.
Store products away from food and out of children’s reach.
Reporting Problems
Keep the product package after use in case side effects occur. You will want to have the instructions available, as well as contact information for the manufacturer.
To report problems with spot-on flea or tick products, contact the National Pesticide Information Center (NPIC) at 1-800-858-7378. To report problems with FDA approved flea or tick drug products, contact the drug manufacturer directly (see contact information on product labeling) or report to FDA's Center for Veterinary Medicine on a Form FDA 1932a. If your pet needs immediate medical care, call your local veterinarian, a local animal emergency clinic, or the National Animal Poison Control Center at 1-888-426-4435. The NAPCC charges a fee for consultation.
