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Label Instructions Tightened on Flea & Tick Control Products For Pets
Current as of: November 2002
Resources
- Questions On Pesticides?
National Pesticide Information Center (NPIC) 1-800-858-7378
Additional Information
Due to safety concerns stemming from use of two flea and tick control products for cats and kittens, EPA is announcing that the Hartz Mountain Corporation has agreed to enact measures to reduce potential risks to pets from using these products. EPA sought this agreement due to concerns over safety issues based on thousands of adverse effects incidents investigated by EPA. Under this agreement, Hartz will implement a product recovery, label improvement, and consumer education program for two pesticide products:
- Hartz Advanced Care Brand Flea and Tick Drops Plus for Cats and Kittens (EPA Reg. No. 2596-148)
- Hartz Advanced Care Brand Once-a-Month Flea and Tick Drops for Cats and Kittens (EPA Reg. No. 2596-151)
On This Page:
- What action is being taken?
- How do consumers identify the affected products?
- What should I do if I have the affected products in my home?
- What other measures did Hartz agree to take with regard to these two products as conditions of their amended registrations?
- What prompted this action?
- How will Hartz implement the recovery, repackaging, and relabeling program for the affected products?
- What are the reported adverse health reactions associated with exposure to these two Hartz Advanced Care flea and tick products?
- What are the active ingredients in these products?
- When did EPA first become aware of any problems associated with the use of these two Hartz products?
- Does EPA require pesticide companies to report adverse effects or other problems associated with their product(s)?
- What additional information is EPA requiring to continue evaluating the safety of the affected pesticides?
- What additional measures is Hartz taking to ensure consumers are aware of the new labeling requirements and the exchange policy?
- Has EPA completed its review and regulatory activities with regard to these two products?
- How do I report adverse health reactions associated with these and/or any pesticide products?
- What action has been taken?
- Hartz Advanced Care Brand Flea and Tick Drops Plus for Cats and Kittens (EPA Reg. No. 2596-148)
- Hartz Advanced Care Brand Once-a-Month Flea and Tick Drops for
Cats and Kittens
(EPA Reg. No. 2596-151). - to conduct a consumer education program, which will include point-of-sale brochures, Web site information, and direct mail campaign to pet owners, pet stores, and veterinarians on the new safety improvements.
- to submit an additional animal safety study conducted by an independent laboratory and to submit additional quarterly reports specific to cats, summarizing allegations of toxic or adverse incidents.
- How do consumers identify the affected products?
- What should I do if I have the affected products in my home?
- What other measures did Hartz agree to take with regard to these two products as conditions of their amended registrations?
- new directions for "spot-on" treatment only (limiting application to a single spot applied to the base of the cat's head);
- new precautionary statements to better inform consumers of the additional signs of individual animal sensitivity that may occur after use of these products;
- new labels will include clear statements indicating that:
- these products should not be used on debilitated, aged, medicated, pregnant or nursing animals, or animals known to be sensitive to pesticide products without first consulting a veterinarian;
- animals should be observed after application of these products for any of sign(s) of sensitivity; and
- if there is sensitivity, animals should be treated immediately by bathing with mild soap, rinsing with large amounts of water, and consulting a veterinarian.
- What prompted this action?
- How will Hartz implement the recovery, repackaging, and relabeling program for the affected products?
- What are the reported adverse health reactions associated with exposure to these two Hartz Advanced Care flea and tick products?
- What are the active ingredients in these products?
- When did EPA first become aware of any problems associated with the use of these two Hartz products?
- Does EPA require pesticide companies to report adverse effects or other problems associated with their product(s)?
- What additional information is EPA requiring to continue evaluating the safety of the affected pesticides?
- What additional measures is Hartz taking to ensure consumers are aware of the new labeling requirements and the exchange policy?
- Has EPA completed its review and regulatory activities with regard to these two products?
- How do I report adverse health reactions associated with these and/or any pesticide products?
EPA is announcing that the Hartz Mountain Corporation has agreed to enact measures to reduce potential risks to cats and kittens from using two flea and tick products. Under this agreement, Hartz will implement a product recovery, label improvement, and consumer education program for two pesticide products:
Hartz is required to recover, repackage, and re-label currently available stock. The relabeled products, which will start appearing on store shelves over the next several months, will include stronger precautionary statements and use directions. EPA is also requiring Hartz:
Every registered pesticide product has an EPA registration number on its packaging. The EPA registration number is 2596-148 for the Hartz Advanced Care Brand Flea and Tick Drops Plus for Cats and Kittens and 2596-151 for the Hartz Advanced Care Brand Once-a-Month Flea and Tick Drops for Cats and Kittens. In addition, please review the use directions on the product. The affected product will specify a stripe-on application, while the new products (once available) will specify a spot-on application.
Consumers are encouraged to contact Hartz to either exchange the affected products for relabeled ones, or receive a refund for the purchase price. If you have any unused products, or portions of these products, you may contact the Hartz Mountain Corporation toll free at 1-800-275-1414 for instructions on how to exchange the product or obtain a refund from Hartz.
Hartz will begin, within the next 60 days, to recapture and replace their old product packages and will only sell and distribute products with new labeling which specifies the "spot-on" treatment (applied to one spot at the base of the cat's head only) to reduce the opportunity for the cat to lick and ingest product. Hartz will repackage and re-label these products with labels that will contain changes to include:
Hartz will conduct a Consumer Education Program about the proper use of these products. The program will be directed at audiences including veterinarians, pet product stores, large retail stores, pet magazines, and users of Hartz products. This program will include the dissemination of educational materials through point-of-sale brochures, Hartz's Web site postings, and a direct mail campaign. These materials will include Hartz's toll-free number [1-800-275-1414] for product questions as well as flea and tick questions.
This action is being taken following EPA's investigation into thousands of adverse effects incidents over the past two years. To reduce such incidents and the potential risks associated with the affected products, Hartz is strengthening the safety precautions and alerting consumers on steps they can take to better protect their cats when using these products.
On November 19, 2002, all shipments of these two products as "stripe-on"
treatments ceased. As soon as new product bearing the approved amended
labeling is available, but no longer than 60 days from November 19th,
Hartz is expected to provide its customers with a replacement kit
that will include packaging that can be used to return any existing
stocks to the company, with courier costs prepaid by Hartz and a credit
to the customer for each package of the product that is returned.
For some customers, Hartz may arrange for retrieval of existing stocks
and delivery of the replacement product by Hartz personnel or someone
contracted by Hartz. Each kit should contain a reminder to the customer
that Hartz is committed to replacing the product or refunding the
purchase price to any consumer who wishes to return the product for
any reason and that retailers can return such products to Hartz for
credit. For Hartz customers making new orders, the replacement kit
will also include the product with amended labeling, and a brochure
to be made available to consumers at the point of sale. Hartz will
provide EPA with monthly reports containing the amount of product
returned to Hartz, including returns by customers and consumers as
well as the amount of new product shipped for replacement.
Incident reports ranged from minor adverse effects including skin irritation or hair loss at the application site and salivation to more serious effects on the nervous system, such as tremors (twitching of muscles) and, in some circumstances, severe full body tremors (convulsion). Unfortunately, in some cases, death has also been reported.
Hartz Advanced Care Brand Once-a-Month Flea and Tick Drops for Cats and Kittens contains 85.7% phenothrin, a synthetic pyrethroid that kills adult fleas and ticks. Hartz Advanced Care Brand Flea and Tick Drops Plus for Cats and Kittens contains 85.7% phenothrin, 2.9% methoprene. Methoprene is an insect growth regulator that interrupts the insect's life cycle by killing the eggs.
The Agency first began receiving preliminary and initial reports of adverse effects to cats associated with these products in May of 2000. In March of 2001, EPA found the number of adverse incident reports and effects to be mounting and promptly began evaluating and investigating these incidents. EPA requested full incident report documentation from Hartz, consulted with veterinarians, and interviewed affected pet owners. Following a thorough evaluation of the incident reports and other information available to the Agency, EPA began working with Hartz to reduce such incidents and the potential risks associated with these products.
Section 6(a)(2) of FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act) requires registrants to report any studies, incidents, or other information indicating adverse effects associated with pesticides. If at any time after the registration of a pesticide the registrant has or becomes aware of any information regarding unreasonable adverse effects, the registrant must submit this information to the Agency for its evaluation.
While the Agency believes that these changes in application method and labeling will better protect cats and kittens under the amended product registrations, EPA is also requiring Hartz to submit an additional companion animal safety study conducted by an independent laboratory within 12 months of the amended registration. Also, along with the already required quarterly reports of allegations of toxic or adverse incidents, Hartz is required to submit separate reports of allegations of incidents involving cats and, for the next two years, to submit details of the serious incidents in three categories of severity along with the clinical signs alleged.
Hartz is conducting the product exchange, which will include accepting returns from consumers; conducting a consumer education program, including point-of-sale brochures, postings on its Web site, and a direct mail campaign to pet owners, pet stores and veterinarians; and modifying its individual applicator tube labeling to contain contrasting label language that is legible and will include the product name and a statement to "read entire label before use."
EPA will continue to review these products, using the results of the companion animal study, any additional incident reports submitted, and other information available to the Agency to determine whether further regulatory action is warranted. EPA reminds consumers to always read the entire product label and labeling before using any pesticide product and only use pesticide products in accordance with their label/labeling. Keep products in their original containers, together with all labeling and packaging, and out of the reach of children.
If you and/or your pets have experienced adverse health reactions
to pesticides, you should report those reactions to your local Poison
Control Center, physician or veterinarian. Another option is to contact
EPA by telephoning the National Pesticide Information Center (NPIC)
on 1-800-858-7378, seven days a week excluding holidays, from 6:30
AM to 4:30 PM Pacific Time - or fax them on (514) 737-0761 - or send
them email at npic@ace.orst.edu.
You should also report adverse health reactions involving cats and/or
kittens that are associated with these products to the Hartz Mountain
Corporation by calling 1-800-275-1414.