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FDA issued warning letter over VisionBlue advertising
WASHINGTON — Print ads and a Web site for a formulation of trypan blue were deemed to be “false or misleading” by the Food and Drug Administration, according to a warning letter sent to Dutch Ophthalmic USA by the FDA last month.
The FDA sent the June 28 warning letter to Dutch Ophthalmic regarding promotional materials for its VisionBlue (trypan blue ophthalmic solution) tissue dye. The promotional materials, a “professional journal advertisement” and a Web site, were submitted to the FDA for review by Dutch Ophthalmic Research Center International, the parent company of Dutch Ophthalmic USA.
There is no information in the FDA warning letter indicating whether the ad ever appeared in any publication.
In the letter, the FDA said the ad and the Web site “present numerous efficacy claims for VisionBlue, but fail to communicate any risks with its use.” As such, the promotional materials are in violation of the Federal Food, Drug and Cosmetic Act, the letter said.
DORC raised “public health and safety concerns through [its] complete omission of risk information for VisionBlue by suggesting VisionBlue is safer than has been demonstrated,” the letter stated.
Because the ad and Web site do not present any risk information, the FDA deemed them as “misbranding” VisionBlue. DORC was asked in the letter to “immediately cease the dissemination of violative promotional materials for VisionBlue.”
The company was given until July 13 to respond.