Merck Animal Health referred over ‘inaccurate and misleading’ Bravecto Quantum claims

A major pharmaceutical company has been referred to the United States’ Federal Trade Commission and Food and Drug Administration (FDA) over “inaccurate and misleading” dosing claims on one of its parasiticide products.

The National Advertising Review Board (NARB) referred Merck Animal Health to the bodies for possible enforcement action for failing to comply with its recommendation to discontinue or modify annual dosing claims for its Bravecto Quantum injectable flea and tick treatment for dogs, which Merck has argued is unfair.

In a challenge brought by competitor Elanco, the National Advertising Division (NAD) highlighted unqualified claims the product offers “year-long” tick protection in a single dose.

While the product provides 12 months of protection against certain tick species, the FDA-approved dosing interval to protect dogs from the lone star tick is eight months.

‘Respectfully appeals’

In an advertiser statement, Merck stated it will “take NAD’s recommendations” for certain claims into account, but that it “respectfully appeals NAD’s decision in part”.

In its scrutiny of the case, a NARB panel found the dosing claims “inaccurate and misleading” and concluded they convey to vets and consumers that dogs are protected from ticks for a full year regardless of the species, placing the burden on the user to determine the claim’s limits.

The panel also said website graphics identifying the tick species covered by the dosing claim did not distinguish the lone star tick from others, and that an asterisk used in headlines referring to a statement on lone star ticks was “not noticeable”.

Disclosure

The NARB panel did not agree with NAD that the qualification regarding the lone star tick must be in the main claim but recommended it “clearly communicate ‘up to’ one year of protection” with an accompanying “clear and conspicuous disclosure in close proximity”.

In an advertiser statement, Merck agreed to implement the disclosure recommendation.

But it declined to modify or discontinue the main dosing claim, stating it would “require Merck Animal Health to approach tick claims differently than its competitors and unfairly restrict promotion of Bravecto Quantum’s first FDA-approved indication”.

Bravecto Quantum was approved for US use last year; it was first given the green light in Australia and New Zealand in 2023 and in the European Union in 2024.