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Questions & Answers: Label Instructions Tightened on Flea & Tick
Control Products for Pets
November 2002
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)
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. The following Questions and Answers have been developed
in an effort to provide consumers with information about the actions being
taken.
- 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?
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 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).
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:
- 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.
For specific information regarding the product recovery and label
improvements, consumers may contact Hartz by calling 1-800-275-1414.
- How do consumers identify the affected products?
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.
- What should I do if I have the affected products in my home?
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.
- What other measures did Hartz agree to take
with regard to these two products as conditions of their amended registrations?
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:
- 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.
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.
- What prompted this action?
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.
- How will Hartz implement the recovery, repackaging,
and relabeling program for the affected 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.
- What are the reported adverse health reactions
associated with exposure to these two Hartz Advanced Care flea and tick
products?
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.
- What are the active ingredientsin these products?
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.
- When did EPA first become aware of any problems
associated with the use of these two Hartz products?
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.
- Does EPA require pesticide companies to report
adverse effects or other problems associated with their product(s)?
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.
- What additional information is EPA requiring
to continue evaluating the safety of the affected pesticides?
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.
- What additional measures is Hartz taking to
ensure consumers are aware of the new labeling requirements and the
exchange policy?
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."
- Has EPA completed its review and regulatory
activities with regard to these two products?
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.
- How do I report adverse health reactions associated
with these and/or any pesticide products?
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.
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