Meetings with Registrants of Pet Spot-on Products

In order to advance the EPA's efforts to mitigate adverse effects from spot-on products used on pets, we have been meeting with the producers, or registrants, of the products to discuss product-specific mitigation. We announced our intention to hold product-specific mitigation meetings in our March 2010 public release and committed to providing the public with information on those meetings. This Web page follows up on that commitment.
 
The following information is available on this page:
 
 

Summary of Meetings We Held with the Product Registrants

The Agency met with representatives from the companies for one to one-and-a-half hours to begin discussing product-specific mitigation measures for the registrants' pet spot-on products. The objectives of the meetings for each of the companies were similar:

  • to discuss registrants' views and actions on EPA's reviews of their products and the general mitigation proposal,
  • to hear the registrants' mitigation proposals and actions;
  • to discuss EPA's product-specific mitigation measures, and
  • to discuss the next steps.

In each of these meetings, the registrant began by making a presentation on its analysis of its own product incidents, any label changes made to date or proposed, and other steps the registrant is taking to either reduce incidents or aid EPA'’s review of these products and mitigation efforts.

The Agency then asked any questions it had on the registrant's presentation. Next, the Agency and the registrant discussed the Agency's own mitigation plan specific to the registrant and its spot-on registrations. Such mitigation plans included, but were not limited to:

  • further increasing the number of weight ranges and having appropriate pictures of the weight ranges;
  • repeating the word "dog" or "cat" throughout the instructions on the packaging,
  • having species, age, and weight ranges clearly labeled on all packaging; and
  • having specific cat warning on all dog products.

The product-specific mitigation plans are based on the generic proposal provided below; however, each product was individually considered. Finally, the representatives and the Agency discussed the next steps in the mitigation process.

The meetings were productive and the registrants were receptive to the Agency's mitigation proposals. Some registrants were proactive, beyond the Agency's proposals, in their efforts to stem adverse incidents. One company for example, has begun listing all ingredients on its packaging, including inert ingredients. Many of the registrants are making significant changes to their registration, and the Agency commends their effort in addressing this significant problem.

In the registrants' presentations, most spoke of their efforts to educate the public on how to safely use their products and on an expanded post-market surveillance system. Most importantly, all the registrants expressed their concerns about the incidents and their desire to work with the Agency in order to protect pets.

Generic Pet Spot-On Mitigation Plan:

EPA has developed a list of generic mitigation measures to reduce adverse incidents. Each registration will be reviewed on a case-by-case basis to determine whether these measures are appropriate and adequate for the product.

Below is a table that explains the Agency's generic pet spot-on mitigation plan. This plan includes label improvements that the Agency indentified as generally necessary across the pet spot-on products. This table will be used to guide label changes on a product-specific basis.

Generic Pet Spot-On Mitigation Table

Purpose of Mitigation Action
(from public Mitigation Plan)
Mitigation Actions
Cat Products Dog Products
To address dosing concerns Companies should provide additional directions for use, especially on the largest product size, on what to do for very large animals.

Companies should consider lower weight limits as well.

Companies should provide additional directions for use, especially on the largest product size, on what to do for very large animals.

Companies should consider lower weight limits.

To address concerns about cat exposure to dog products Brand names: Companies should increase the size of the word “cat” to the same size as the brand name

Directions for use: Companies should repeat the word "cat" throughout the directions for use.

Pictures: Companies should place large, clear pictures of the appropriate species on the front panel.

Separate registrations: Split any registrations with cat & dog uses into two registrations.

Brand names: Companies should increase the size of the word "dog" to the same size as the brand name

Directions for use: Companies should repeat the word "dog" throughout the directions for use.

Pictures: Companies should place large, clear pictures of the appropriate species on the front panel.

Separate registrations: Split any registrations with cat & dog uses into two registrations.

To address concerns about cat exposure to dog products

(Cat warning language)

N/A Cat Warning:
  • A cat prohibition icon is needed on the front panel in a box at the same size as any marketing icons
  • The background of the box containing the cat prohibition icon must be yellow with black text
  • The cat prohibition icon on the back panel must be in a yellow box with black text. Text must read as follows:
    • Permethrin-, cyphenothrin- and phenothrin-containing products:
      DO NOT USE ON CATS -- MAY BE FATAL Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your veterinarian immediately.


    • Other products
      DO NOT USE ON CATS Keep cats away from treated dogs for 24 hours. If applied or ingested, contact your veterinarian immediately.
To address concerns about label clarity Brand Names: See Second Row

Other warnings: Companies should use the word "ONLY" when referring to cat size and age. In addition, this must appear on the front panel. Examples:

  • "For use ONLY on cats 9 lbs and over"
  • "For use ONLY on cats 8 weeks and older"

Weight/Age Restrictions: Ranges must appear on product vials.

Brand Names: See Second Row

Other warnings: Companies should use the word “ONLY” when referring to dog size and age. In addition, this must appear on the front panel. Examples:

  • “For use ONLY on dogs on dogs larger than 16 lbs”
  • “For use ONLYon dogs 8 weeks and older"

Weight/Age Restrictions: Ranges must appear on product vials.

To address product-specific concerns Side effects: Companies should list potential side effects in plain language on product label based on incidents most commonly seen. This must appear on the back panel, not only a package inserts, so consumers can make choices based on potential side effects.

If any commonly seen side effect would warrant veterinary care, registrants must provide instructions on what to do (e.g., in case of x, contact veterinarian immediately and report incident to company at 1-866-xxxx)

Note: For consumer ease the Agency is considering standard terminology.

To address uncertainties about inert ingredients The Agency is considering limiting products to one basic CSF as a condition of registration.

Standardized adverse event reporting

Contact Information: Companies should add language to the phone number block providing a number to call I"f your pet is experiencing an adverse event" and instructing users to contact their veterinarian, when warranted.

Potential conditions of registration - The Agency is considering requiring that quarterly enhanced incident reports and an analysis of the incidents be submitted as a condition of registration. Enhanced reporting must include weight range of product used and weight of animal.

Standardized sales reporting

Potential conditions of registration - The Agency is considering requiring that quarterly sales information be submitted as a condition of registration.

To bring data requirements in line with FDA's requirements for similar products (companion animal safety studies; premarket clinical trials; and post-market surveillance)

Protocols. The Agency is requesting that future companion animal safety studies be discussed with the Agency prior to submission

Potential conditions of registration - The Agency is considering making pet spot-on registrations (new and existing products when approving amendments) time-limited to expire two years after the product is released for shipment. This could allow for post-market surveillance of the incidents for these products before the guidelines are revised to include pre-market clinical trials.

Next Steps

The Agency will be continuing to communicate with the pet spot-on registrants as needed to further implement label changes and other actions described in the Agency's mitigation plan. This may include additional meetings and letters to the registrants. The Agency will continue to update this web page with any changes to the mitigation plan and notable accomplishments.

Additional Information

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