(PRESS RELEASE) On June 15, the American Optometric Association (AOA) officially alerted Facebook to advertisements on its site by Opternative and companies marketing the app-based test found in violation of federal law by the U.S. Food and Drug Administration (FDA). Referencing the social platform’s concerted efforts to crackdown on misleading, deceptive information, the AOA apprised Facebook of the potential public health and safety impact that results from Opternative’s continued advertisement – under its own brand and marketed by 1-800 Contacts – despite an Oct. 30, 2017, enforcement action from the FDA that declared Opternative was in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
The FDA letter (not made public until March 9, 2018) requested the company “immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”
“Given the serious nature of the FDA warning against Opternative, we wanted to ensure that you are aware that your platform is being used to advertise a company that has marketed its app-based vision test without clearance or approval required by the government, in violation of federal law,” the letter, signed by AOA President Christopher J. Quinn, O.D., reads.
Aside from Opternative’s own advertising on Facebook, the company’s device also is being marketed by 1-800 Contacts in advertisements that state their online vision test is “Powered by Opternative.” The AOA requested Facebook take action and investigate.
The FDA’s enforcement action against Opternative reflected the very points that AOA first broached in a 2016 complaint to the FDA regarding Opternative’s lack of a premarket approval (PMA) prior to marketing, and lack of a formal FDA review of the product’s safety and efficacy. As such, Dr. Quinn applauded the FDA enforcement action and called it a major victory for public health and safety.
“The AOA and our member doctors across the country are gratified that the FDA has taken such decisive action to address the urgent health and safety violations we identified, reported and relentlessly followed up on. It is our hope that we are a step closer to holding all companies that would place profits ahead of patient care fully accountable for their actions,” Dr. Quinn said.
AOA Committed to Patient Safety
In light of the FDA’s warning letter to Opternative and without further information from the FDA, AOA encourages the agency to take action should Opternative not follow the directions and requirements stipulated under the FDCA.