A panel of the National Advertising Review Board (NARB), the appellate advertising body of BBB National Programs, has referred Intervet, Inc. (d/b/a Merck Animal Health) to the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) for failure to comply with its recommendation to discontinue or modify express once-a-year dosing claims for its Bravecto® Quantum injectable flea and tick treatment for dogs.
Merck Animal Health appealed the National Advertising Division's (NAD) (Case #7519) recommendation that Merck Animal Health discontinue or modify its express Bravecto Quantum once-a-year dosing claims, which included claims that a "quick injection" provides "1 full year* of flea and tick protection for dogs" and offers "365 days of protection, all in one dose." The challenger in the case is Elanco Animal Health, Inc.
The NARB panel found that Merck's express once-a-year dosing claims are inaccurate and misleading. While the first FDA-approved indication for the product provides 12 months of protection against multiple tick species in a single dose, the FDA-approved dosing interval to protect dogs from one tick species, the lone star tick, is eight months. The panel concluded that the advertising conveys to veterinarians and consumers that dogs are protected from ticks for a full year regardless of the species, placing the burden on the user to figure out the limits of the broad dosage claim.
Additionally, the panel found that website graphics identifying the tick species covered by the once-a-year dosing claim did not distinguish the lone star tick from others, and that the asterisk used in headlines referring to a statement that Bravecto Quantum also kills lone star ticks for 8 months was not noticeable. Consequently, the NARB panel recommended that Merck Animal Health discontinue the express once-a-year dosing claims or modify them to clearly communicate "up to" one year of protection in the main claim, accompanied by a clear and conspicuous disclosure in close proximity explaining that certain tick species require more frequent dosing under the FDA-approved indication.
The panel noted that it did not agree with NAD that the qualification regarding the lone star tick must be in the main claim, finding that specific recommendation too prescriptive, provided the "up to" language and a clear disclosure are used instead.
In its advertiser statement, Merck Animal Health agreed to use a clear and conspicuous disclosure, in close proximity to the main dosing claim, conveying that Bravecto Quantum should be dosed every eight months when used to target Amblyomma americanum (lone star ticks).
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