NAD Recommends Novartis Modify, Discontinue Certain Claims for ‘Sentinel’ Flea-Preventative

Finds Company can Support ‘Integrated Approach’ to Flea Control

New York, NY – June 28,  2012 – The National Advertising Division has recommended that Novartis Animal Health modify or discontinue certain performance and comparative claims for Sentinel Flavor Tabs, a flea-prevention medication for dogs.

NAD is an investigative unit of the advertising industry’s system of self-regulation and administered by the Council of Better Business Bureaus.
The claims, which appeared in a detailer provided to veterinary professionals and on the advertiser’s website, were challenged by Elanco Animal Health, the maker of a competing flea-prevention product – Comfortis – which contains the ingredient spinosad.
The challenged claims included the following:

•    “Spinosad does NOT prevent fleas from laying eggs.”
•    “A new study has shown that viable fleas hatch from eggs collected from dogs treated with spinosad.  That can mean an ongoing flea problem in your clients’ homes and big problem for you.”
•    “Comfortis experienced ‘product failure,’ and ‘[o]ver a 3-month period, spinosad consistently failed to prevent the development of adult fleas.’”
•    “Your flea control product is only as good as its efficacy.”
•    “In this Study, lufenuron was 100 % effective at preventing the development of adult fleas.  Spinosad was not.”
•    “Sentinel (milbemycin oxime/lufenuron) Flavor Tabs kill fleas before they become adults.” “One Tablet … Total Protection.”
•    “Flea treatments are typically adulticides, (i.e., products that kill adult fleas), but they are only temporary solutions to a larger problem.”
•    “Adult fleas represent just 5% of a flea infestation – the other 95% are the eggs, maggot-like larvae and pupae hiding in and around your home.”
•    “It’s no secret that flea infestations make our pets miserable, but did you know that for every flea you see, there’s probably a much bigger problem hiding in the bedding, carpets, furniture and floorboards of your home?”

Elanco also challenged the accuracy of a chart, purporting to depict the performance of Sentinel, compared to Comfortis.

NAD noted in its decision that that at the “root of the challenge to the comparative claims made by Novartis for its Sentinel Flavor Tabs are two different approaches taken by veterinary pharmaceutical companies for preventing fleas in dogs.”

Elanco manufactures Comfortis and Trifexis, which contain spinosad. The products are approved by the Food and Drug Administration and labeled to “kill fleas before they lay eggs” and prevent flea infestations on dogs for a full month.

The advertiser’s product, Sentinel, contains the active ingredient lufenuron, an insect development inhibitor (IDI) or ovicide that does not kill adult fleas but rather, operates to interfere with the development of adult fleas.  The advertiser recommends an integrated approach to control fleas, by using an IDI together with an adulticide, in order to adequately address the problem of unhatched eggs that may hatch and re-infest dogs when an adulticide is used alone.

In a previous decision involving the same parties, NAD considered claims by Novartis that compared the performance of Sentinel with Comfortis and found that the challenged advertising communicated the unsupported message that “Sentinel is superior to, more effective, or longer lasting than adulticides such as Comfortis and Trifexis,” and recommended that the advertising be discontinued or significantly modified.

In this case, the challenged claims appeared in a different context and are based on different evidence – specifically a study conducted by Dr. Michael Dryden of Kansas State University. NAD determined that the Dryden Egg Study on egg viability was a well-designed, placebo-controlled study conducted by an expert in the field. NAD further determined that the advertiser provided a reasonable basis in support of communicating accurately the results of the study to a professional audience of veterinarians.  However, NAD was concerned about 1) whether the detailer fairly and accurately communicated the results of the study and 2) a conflict between the claims made based on the Egg Study results and FDA’s recognition of the ability of Comfortis (spinosad) “to kill fleas before they can lay eggs.”

Following its review of the evidence, NAD determined that the advertiser provided a reasonable basis for promoting on its website an integrated approach to flea control, although NAD recommended that the advertiser discontinue the characterization of spinosad as a “temporary solution.”

However, NAD determined that the advertiser’s detailer communicated a stronger message of superior efficacy in favor of the Sentinel product over Comfortis. NAD further determined that advertiser’s evidence did not support a superiority message or the claim that Comfortis is ineffective.

NAD recommended that the advertiser discontinue the claim “spinosad does not prevent fleas from laying eggs” and modify the claims in the detailer to avoid express or implied claims that Comfortis experienced “product failure” or is an ineffective product.

NAD also recommended that the chart depicting the results of the Dryden study in the detailer be discontinued.

Novartis, in its advertiser’s statement, took issue with certain of NAD’s findings, but said it will “adhere to all of NAD’s recommendations with respect to the statements and claims in the Detailer.”

Novartis “appreciates the opportunity to participate in this industry self-regulatory process, and also appreciates NAD’s comprehensive analysis of the complex scientific issues,” the company said.