Counterfeit Advantage and Frontline: Issues and Risks by Stacy Pober (17 March 2004) The Environmental Protection Agency (EPA), Bayer Animal Health, and Merial recently issued press releases about a recent investigation that found that "counterfeit" versions of Bayer Advantage and Merial's Frontline were being sold to consumers. This issue recently came up on VETMED, an email discussion list that I moderate. Because there seemed to be a lot of speculation among pet owners about this issue, I decided to look into the matter a little more thoroughly. The EPA documents and company press releases, [see references at end] have been very vague regarding any specific problems that have come up with the counterfeit versions of these products. For example, they do not mention whether any pet has been harmed by a counterfeit version of either of these products. One of the problems here is the many meanings that the EPA and manufacturers have given to the word "counterfeit". Most of us think of a counterfeit as something that is a bogus, imiation version of something. And indeed, a counterfeit drug may be one that is completely different than the genuine article. However, the EPA and the companies that make Advantage and Frontline also consider a product counterfeit if it is the exact same chemical as the genuine one, but if it was was manufactured, labelled and originally sold by the manufacturer for use in another country. For example, Bayer Advantage is made and sold in France. However, if a U.S. retailer imports the French product, relabels it in English and sells it to U.S. consumers, the company and the EPA consider that to be a counterfeit. The recent joint EPA/Merial/Bayer investigation was focussed on the retail sale of these pesticides. In some cases, the retaillers had relabelled the products to indicate U.S. origin, and then resold them to consumers in pet stores. But there has been another source for 'gray market' versions of Frontline and Advantage. Some American consumers have found it cheaper to purchase these from foreign internet or mail-order vendors than from their veterinarians. These products are not purchased for resale, and according to the purchasers who have posted to some of the email lists, the imported products are shipped to them with the original Australian labelling. My specific questions about this were whether there have been any pets harmed by counterfeit Advantage or Frontline. I also wanted to know if there were cases where a different pesticide was used in a counterfeit version, or where the correct chemical was used but the dosages were significantly higher or lower than the label indicated. I did a little research and contacted Bayer, Merial, and the EPA on 3/15/2004. 1) BAYER ANIMAL HEALTH I called the Bayer Animal Health customer line and spoke to "David" and "Andrea". (It seems that the drug and chemical company phone reps are just like Cher and Madonna in that they go by one name only. I tried to get last names so that I could cite my sources more specifically but I had to give up on that. They seem dismayed at the idea they might be identified by surname. ) Here is the information from Bayer: Advantage is sold in Australia, but K9 Advantix is NOT. Advantage is legitimately sold only through vets in all areas of the world. It is not, however, a prescription item. As far as they were aware, the problem with the counterfeit Advantage was that it was not legitimately labelled for use in this country. They knew of no cases where the active ingredient was not correctly indicated on the label. 2) MERIAL I called the Merial customer line and spoke to "Melanie". According to Melanie: Frontline and Frontline Plus are manufactured and sold in Australia, the U.K., and France. Merial only sells Frontline through vets, though it is not a prescription item. According to Melanie, some counterfeit Frontline or Frontline Plus had incorrect dosages that differed from the label claims. Either the amount in the vial was for a different size of dog than indicated or it was for the wrong species, such as a cat dose in a vial labelled for a dog. Melanie could not point to any documentation for the cases of counterfeits that had incorrect dosages. The company press release does not make this claim and neither did the EPA announcement of the results of their investigation. 3) ENVIRONMENTAL PROTECTION AGENCY (Keep in mind that these are not drugs, they are pesticides, so the EPA's pesticide program has the primary regulatory authority over them.) I spoke to Kit Farwell, DVM, from the EPA's Office of Pesticide Programs, Health Effects Division. The Bayer Animal Health rep is the one who referred me to Dr. Farwell when I asked for specific information on what was wrong with the counterfeit product. However, from what Dr. Farwell told me, he was not directly involved in the counterfeit Frontline/Advantage testing.] Dr. Farwell was unaware of any cases of counterfeit Frontline or Advantage where the active ingredient was not correctly listed on the label for the product. The case of Australian Frontline which he had heard of had involved product labelled for use in another country, but sold illegally in the U.S.. He promised to look into this and get back to me. I also tried to contact the EPA spokesperson named in their recent press release on this issue. He is away this week and the two spokespeople substituting for him did not have the requested information. One of them promised to get back to me with an answer, but so far, this hasn't happened. If I hear anything significant from Dr. Farwell or the EPA spokesperson, I will post the info to the VETMED list. SUMMARY: From the reading I did and calls I made, here's my conclusions: Retailers buying Frontline or Advantage from foreign sources and relabelling them to indicate U.S. origin are breaking the law. There's good reason to question whether such retailers are trustworthy sources for these products. Any store relabelling products to indicate EPA approval for illegally imported stock is, to put it mildly, ethically challenged. These retailers are putting false EPA approval statements on the labels. If they are doing this, they might be putting other misstatements on the labels, such as incorrect dosage information. I was unable to independently verify the Merial rep's citation of "wrong dosage" imported Frontline. Still, I personally would not buy product that has been relabelled. As a consumer, I have a basic expectation that the company selling me a product has put a label on it that is factually correct. I don't want to deal with someone who's cutting this particular corner. However, the question of consumers who are directly purchasing their Frontline or Advantage overseas is a separate issue. This is probably a very low risk choice. Most likely, you will get the product you expect. As with any purchase, it's best to try to deal with reputable firms. Sometimes, the least expensive source is not the most reliable one. Any pesticide sent to the U.S. is supposed to come under the regulatory oversight of the Environmental Protection Agency even if it bears the original label from its country of origin. Thus, it may be technically illegal for consumers to purchase Frontline or Advantage from overseas sources without obtaining an EPA permit. Still, the Advantage or Frontline sold in Australia is basically the same product as the Advantage and Frontline sold in the U.S.A.. Even the manufacturer's reps admit this, though they referred to such illicitly imported products as "counterfeits". As one VETMED subscriber pointed out, the major drawback of using directly imported versions of these products is that the manufacturers will disclaim all responsibility if a problem arises. However, a few years back, I purchased a bad batch of Advantage through my veterinarian. It didn't harm the dogs - or the fleas, for that matter. It didn't do anything at all. Bayer would not make good on their guarantee in that case, even though I had purchased it from my vet. So, it's not been my experience that the manufacturers will stand by their product even when the consumer follows their rules. (I still would use Advantage if the need arose - subsequent purchases did work as expected.) I can't definitively say that no counterfeit versions of these products have harmed pets. However, I feel relatively confident that if this had happened, the EPA and the manufacturers would be happily sharing that information with the public. If I hear of any significant information about this, I will post it to VETMED. References: EPA FACT SHEET - Retailers and Counterfeit Pet Products http://www.epa.gov/pesticides/factsheets/retailerfactsh.pdf EPA: Counterfeit Pesticide Products for Dogs and Cats. Information for Consumers http://www.epa.gov/pesticides/factsheets/petproduct.htm EPA: Counterfeit Pesticide Products For Dogs and Cats Found - Retailers Ordered to Stop Sales http://yosemite.epa.gov/opa/admpress.nsf/b1ab9f485b098972852562e7004dc686/aa19074f36966bd085256e4d0062ceca?OpenDocument Merial Assisting with US EPA Actions Announced Against Counterfeit FRONTLINE Packaging http://www.frontline.com/epa/ Bayer Animal Health Continues the Fight to Stop Unauthorized Sale of Advantage® http://www.nofleas.com/Press-Release.asp Copyright 2003, S. Pober, Golightly Greyhounds, roo (at) raingoddess.com This article was originally posted to the VETMED list. For information about VETMED, see: http://raingoddess.com/vetmed/vetmed.html