Amazon drops noncompliant contact lens sellers

Amazon drops noncompliant contact lens sellers, thanks AOA for diligence

Amazon's marketplace no longer displays noncompliant, decorative contact lens vendors after the AOA alerted the e-commerce retailer to potential violations of federal law and its own medical device policy.

In a Feb. 27 letter to Amazon outing possible offenders, the AOA emphasized that contact lenses-whether corrective or plano-are U.S. Food and Drug Administration (FDA)-regulated medical devices that not only require a prescription from a licensed practitioner for purchase, but also fall under Amazon's own policy for "Medical Devices and Accessories." That policy mandates how sellers must abide by all federal, state and local laws, which in this case, the AOA noted, includes patient protection provisions of the Fairness to Contact Lens Consumer Act (FCLCA).

Per federal law, vendors "may sell contact lenses only in accordance with a contact lens prescription for the patient that is (1) presented to the seller by the patient or prescriber directly or by facsimile; or (2) verified by direct communication."

As the AOA's letter notes: "The contact lenses available for sale on Amazon are sold entirely without a prescription, which we believe is an FCLCA violation." Furthermore, "in addition to sales via (Amazon's) platform raising legal questions related to the FCLCA, the guidance provided by sellers regarding these FDA-regulated medical devices is very concerning."

The AOA's letter goes on to document egregious and inappropriate instructions from vendors, such as "... gently press the contact lens opposite clockwise or counterclockwise turn 30 times [sic], and put in a box for a new care solution ... if you do not use for a long time, please put in the box, soak with care solution [sic], replace the care solution every three days." Such guidance is wholly inappropriate and dangerous, the AOA notes, and proper physician oversight is necessary for medical devices that require a physician's prescription.

In response, Amazon thanked AOA for its diligence and reiterated its own medical devices policy while stating the company will take appropriate action when products are reported for legal non-compliance. As of June 4, those violating posts that AOA first identified and reported have been removed. The AOA will continue to monitor the site and report retailers.

While the AOA is not a regulatory enforcement agency, a central mission of the AOA is to serve as a resource to the public for reliable and current information related to eye care and health care policy.

AOA's patient protection advocacy

Long a champion for patient safety and public health priorities, the AOA continues to take noncompliant and offending businesses to the mat over issues that put Americans' eye health and vision at risk. This includes an ongoing effort to inform federal agency officials and Congress on the need for a crackdown on illegal internet contact lens sellers, especially in light of several noteworthy and concerning examples.

Such was the case in 2018 when the AOA's concerns about the online contact lens vendor, Hubble Contacts, were validated by a Quartz exposé that characterized the business as "playing fast and loose with some basic consumer protections." The AOA had expressed concern with the FDA, Department of Justice (DOJ) and Federal Trade Commission (FTC) related to possible irregularities related to prescription verifications for its contact lenses.

This past year, AOA also filed a complaint with the FTC regarding 1-800 Contacts' naming of its online prescription renewal platform, "ExpressExam." The AOA noted use of the word "exam" might lull consumers into a false belief that they received a comprehensive eye examination for their eye health. Notably, 1-800 Contacts' online vision test now requires consumer acknowledgement prior to use that such service is not a comprehensive eye examination.

Furthermore, the AOA's annual '31 in 31' letter-writing campaign this past October tipped federal authorities to a spurious, California-based vendor selling contact lenses in violation of the FCLCA and Contact Lens Rule. A proposed order filed by the DOJ on behalf of the FTC directed a $60,000 fine and ban on selling contact lenses against Lawrence Duskin, operator of the sites HollywoodColorContacts.com, WorldColorContacts.com and TopModelContacts.com.

While the AOA's contact lens advocacy continues at full-tilt, there's still more that can be done.

Support the AOA's contact lens advocacy

Better documentation of illegal contact lens sales or complications helps the AOA provide better data to policymakers to keep Americans safe. If doctors are aware of an illegal retailer or encounter a patient harmed by illegally procured lenses, here's how to help:

Report a website illegally selling contact lenses
Report an adverse event
related to contact lenses
Report problems
with decorative contact lenses
Report a contact lens seller
with fraudulent or abusive business practices

Report suspected violations to the AOA via aoa.org/StopIllegalCLs, and direct questions to StopIllegalCLs@aoa.org

For more information on illegal retailer or incident reporting, contact the AOA's Director for Coding and Regulatory Policy Kara Webb.

Want to become an AOA Contact Lens and Cornea Section member? Find more information here.

June 19, 2019

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