Bayer Animal Health Working with EPA to Stop Distribution and Sales of Counterfeit Advantage®

Bayer Animal Health Continues the Fight to Stop Unauthorized Sale of Advantage®

SHAWNEE, Kan. (March 5, 2004) – Bayer HealthCare LLC’s Animal Health Division welcomes and applauds the Environmental Protection Agency’s (EPA) efforts to stop the distribution and sales of counterfeit Advantage®, a leading flea control product for dogs and cats. Yesterday’s announcement is the result of a lengthy investigation conducted in collaboration with Bayer that was initiated by Bayer in a meeting with EPA more than 20 months ago.

EPA has ordered retailers and distributors in a number of states to stop selling counterfeit Advantage products which falsely contain EPA registration numbers and labeling for Advantage. The counterfeit Advantage products are packaged in retail cartons designed to look similar to legitimate products registered with EPA. In some cases, the product may not have the proper packaging or instructional leaflet to ensure proper usage. In addition, the consumer cannot be assured that the dosage is correct for the animal pictured on the retail carton.

“Protecting the well-being of animals is Bayer Animal Health’s first priority, and we have been working diligently with EPA and the veterinary profession and its leadership to stop counterfeiters,” said John B. Payne, President and General Manager, North America, Bayer HealthCare LLC, Animal Health Division. “EPA’s actions are another important step in keeping America’s pets safe,” he added.

Stopping Unauthorized Sales of Advantage
Bayer has taken aggressive actions to stop unauthorized sales of Advantage and against companies that violate its sales policy, which specifies Advantage products are sold only through licensed, practicing veterinarians with a doctor-client-patient relationship.

“Our sales policy protects consumers and their pets from counterfeit products and we will aggressively enforce our policy and take legal action wherever appropriate,” said Payne. “Our policy is based on the belief that veterinarians possess the most in-depth knowledge about their clients’ pets and can offer them personalized information about the application and proper use of Advantage products.”

The company has issued warnings to non-veterinary retail outlets selling counterfeit Advantage products, resulting in the removal of these products from stores’ shelves.

Consumers who have purchased Advantage from a source other than a licensed, practicing veterinarian and who may have concerns regarding the products authenticity can go to
www.epa.gov/pesticides/factsheets/petproduct.htm to review information that will show how to identify legitimate products.

Bayer has taken additional steps to ensure pet owners are getting their Advantage products from the best source, their veterinarian. Bayer’s Partnering with the Profession program helps ensure products are sold by veterinarians and not by third parties through the program’s inventory management, tracking and distribution capabilities. Also, in the past, Bayer has partnered with the American Veterinary Medical Association to educate veterinarians and consumers nationwide regarding Bayer’s policy to sell its products only through licensed, practicing veterinarians.

EPA is advising consumers who have purchased counterfeit Advantage products not to use them and instead dispose of them in accordance with any local disposal guidelines. EPA’s website (www.epa.gov/pesticides/factsheets/petproduct.htm) has more information regarding the actions they are taking in identifying counterfeit products.

Bayer Animal Health advises consumers of the following risks associated with purchasing Advantage products from unauthorized vendors:

·  Only authorized veterinarians have the accurate information and latest training on the appropriate use of Advantage products.

·  Counterfeit Advantage products are not subject to quality control standards for labeling, shipment and storage.

·  Any time a product is not purchased from a licensed veterinarian with a doctor-client-patient relationship there is a risk that the product is counterfeit, and may not be effective.

For more information visit www.nofleas.com or call the Bayer Animal Health customer care center at 1-866-459-3771 from 8 a.m. to 5 p.m. CST, Monday through Friday.

About Bayer
Best known for its flagship product, Bayer Aspirin, Bayer HealthCare is a subgroup of Bayer AG with annual sales amounting to some 10 billion Euro. It is one of the world’s leading, innovative companies in the health care and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceutical divisions. More than 34,000 employees work for Bayer HealthCare worldwide.

Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance the well-being and quality of life by diagnosing, preventing and treating disease.

Bayer HealthCare’s Animal Health Division, the maker of Advantage® Topical Solution and K9 Advantix®, is a worldwide leader in parasite control and prescription pharmaceuticals for dogs, cats, horses, cattle and poultry. U.S. operations for the Animal Health Division are headquartered in Shawnee, Kan.


Questions and Answers Regarding EPA’s Actions to Stop Counterfeit Advantage®

What action has EPA announced?

EPA, in cooperation with its state and regional regulatory partners, and with the full support of Bayer Animal Health has ordered retailers and distributors in a number of states to stop selling counterfeit Advantage flea control products, which falsely contain EPA registration numbers and labeling for Advantage.

The counterfeit Advantage products were unlawfully imported and packaged in retail cartons designed to look similar to legitimately registered products. In some cases, the product applicators may not have the proper child-resistant packaging or instructional leaflet to ensure proper usage. In addition, the consumer cannot be assured that the product dosage is correct for the animal pictured on the retail carton.

Why is EPA taking this action?

EPA, which regulates all such products sold in the United States, took this action to protect consumers and to ensure the products they purchase will meet U.S. product guidelines. Without having the proper registration neither EPA nor consumers can be assured of what is being sold and purchased. So, the use of counterfeit products may put the treated pet at risk.

Bayer Animal Health and the EPA are advising consumer who have purchased counterfeit Advantage products not to use them and dispose of them in accordance with any local disposal guidelines.

What is Bayer Animal Health doing to Stop Sales of Counterfeit Advantage?

Protecting the health and well-being of animals and their owners is Bayer Animal Health’s first priority and that is why we have collaborated with EPA on this lengthy investigation that started more than 20 months ago.

In addition to supporting EPA’s actions, Bayer has taken an aggressive action to stop unauthorized sales of Advantage including issuing warnings to non-veterinary retail outlets selling counterfeit Advantage products, resulting in the removal of these products from the stores’ shelves.

Bayer has developed an innovative program for the industry to ensure pet owners are getting Advantage from the best source, their veterinarian. Bayer introduced Partnering with the Profession to help ensure Advantage products are sold by veterinarians and not by third parties, through the program’s inventory management, tracking and distribution capabilities. Bayer also is working with the American Veterinary Medical Association (AVMA) to educate veterinarians nationwide regarding the sale of illegal Advantage products.

How will I know if this affects me?

Bayer Animal Health exclusively sells Advantage flea control products through a licensed, practicing veterinarian with doctor-client relationship. Consumers who purchased their Advantage from such veterinarians should not be concerned about the authenticity of the product.

Our policy of selling Advantage only through a licensed, practicing veterinarian with a doctor-client relationship protects consumers and their pets from counterfeit products. This policy ensures the Advantage products they purchase from their veterinarians are legitimate and contain the necessary packaging and information for their proper usage.

Consumers who have purchased Advantage from a source other than a veterinarian and who may have concerns regarding the products authenticity can go to EPA’s Web site at www.epa.gov/pesticides/factsheets/petproduct.htm to review information EPA has provided to identify legitimate products and they can call Bayer's Customer Care Center at 1-866-459-3771 from 8 a.m. to 5 p.m. Central Standard Time, Monday through Friday.

What Advantage products are potentially affected by this action?

According to EPA, the counterfeiters may have used some Advantage brand names and legitimate EPA registration numbers on their counterfeit products to deceive consumers and they are listed below.

·  Advantage 10 for Dogs (EPA Reg. No. 11556-117)

·  Advantage 20 for Dogs (EPA Reg. No. 11556-119)

·  Advantage 55 for Dogs (EPA Reg. No. 11556-120)

·  Advantage 100 for Dogs (EPA Reg. No. 11556-122)

·  Advantage 9 for Cats (EPA Reg. No. 11556-116)

·  Advantage 18 for Cats (EPA Reg. No. 11556-118)

How can I determine my Advantage is authentic?

Consumers who purchased their Advantage from veterinarians should not be concerned about the authenticity of the product.

According to EPA, the counterfeit packaging can be difficult to distinguish from legitimate products. To determine if the product you have purchased is legitimate, check to see if it meets the following criteria. If the product fails any one of these criteria, it most likely is an illegitimate product and should be disposed of properly.

1.                 The only way to determine a legitimate Advantage product from a counterfeit product is by examining the actual applicator tubes that are inside the carton. Since the directions for use on the retail carton (outer box) and instruction leaflet of the legitimate product and the counterfeit product are identical, check the language that is printed on the applicator tubes. The legitimate Advantage products all contain applicator tubes that are printed in English. The most obvious sign of a counterfeit product is that the applicator tubes are printed in a foreign language (most likely French or German).

2.                 The legitimate applicator tubes include EPA Registration Number, the signal word WARNING, and the child hazard warning (Keep Out of Reach of Children). Counterfeit applicator tubes may lack this information.

3.                 Legitimate applicator tubes will also include a reference statement that refers users to the main labeling for directions for use and will include the manufacturing company’s name (Bayer). Counterfeit applicator tubes may lack this information.

4.                 Legitimate applicator tubes will contain an active ingredient statement that agrees with the active ingredient statement on the retail carton (9.1% imidacloprid). A counterfeit product may have an active ingredient statement that differs (such as 10%).

What should I do if I have counterfeit Advantage?

First, do not use the product. Second, contact the place of purchase for a refund. Third, dispose of the product in accordance with any local disposal guidelines.
For further information or to report counterfeit products, consumers can go to EPA’s Web site at www.epa.gov/pesticides/factsheets/petproduct.htm. Consumers can also call Bayer’s Customer Care Center at 1-866-459-3771 from 8 a.m. to 5 p.m. Central Standard Time, Monday through Friday.