AOA’s ‘31 in 31’ campaign alerts agencies to alleged violators.

Letter a day, keeping illegal contacts at bay

Contact lens sellers' disregard of federal market laws can ultimately harm Americans, which is why the AOA is making alleged violators aware that such infractions won't go unnoticed any longer.

"Every company we can get to change policy is potentially hundreds to thousands of patients with decreased risks of sight-threatening complications."

This month, AOA will call to task online vendors, brick-and-mortar shops and other hawkers who illegally distribute corrective, novelty or bogus contact lenses without a valid prescription, in clear violation of the Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule.

Every day in October, the AOA will issue a letter to a contact lens seller previously flagged for suspicious business practices or apparent disregard of federal law. This '31 in 31' campaign confronts vendors and informs them of the regulatory requirements related to the sale of contact lenses in the United States.  Copied to both the Federal Trade Commission (FTC) and Food and Drug Administration (FDA), these letters are disseminated to businesses reported to AOA's hotline,

Although not a regulatory enforcement entity, the AOA takes seriously its central mission of serving as a resource to the public for reliable and current information related to eye and vision care, as well as safeguarding patients' eye health. As such, reiterating these violations with the industry enforcement agency, the FTC, will help put these concerns under a federal spotlight.

"This is an incredibly important initiative," says Paul Velting, O.D., AOA Contact Lens and Cornea Section member helping lead the AOA's Watchdog Group on contact lenses. "Now, more than ever, it seems companies are willing to find and exploit loopholes in the FCLCA to make a sale. Every company we can get to change policy is potentially hundreds to thousands of patients with decreased risks of sight-threatening complications."

These letters emphasize FDA regulatory language that not only stipulates all contact lenses are FDA-regulated devices, but also that all contact lenses may only be sold with a valid prescription from a licensed practitioner. In some cases, alleged violators are foreign online vendors, unaware of U.S. law, making the letters all the more pertinent.

"At this point, we believe it is your responsibility to guarantee compliance with federal laws and regulations governing the sale, marketing and distribution of these devices in the United States," some letters read. "We urge you to review these legal and regulatory requirements carefully, and consider the public health risks associated with the illegal sale of contact lenses without a prescription."

Some retailers have turned that appeal into action. Last year's '31 in 31' campaign prompted changes at eight different companies that manifested in revised policies or wording, and visible changes to their websites reflecting the necessity of a valid prescription. 

Unsafe business, contact lens practices put vision at risk

Contact lenses are a safe, effective vision correction option, worn by nearly 40 million Americans. However, there is a reason that all contact lenses-whether corrective or plano-are classified as medical devices, requiring a valid prescription to purchase. Improper wear and care can cause significant, sight-threatening damage. That message is especially important as Halloween nears.

Popular among young adults and teenagers, the use of non-corrective, novelty contact lenses for cosmetic purposes typically balloons around Halloween when online merchants, convenience stores, costume shops and other retailers try passing off the lenses as costume enhancements.

There's nothing benign about illegal procurement of contact lenses, as reflected by how seriously the FDA takes the charge. In 2015, the FDA's Operation "Fright Night" sting operation took down 10 California businesses for selling misbranded contact lenses, while last year, Texas cracked down on 21 San Antonio-area convenience stores for selling novelty contact lenses.

Furthermore, this year, the Department of Justice and the FDA announced a fraudulent vendor of contact lenses was sentenced to four years prison-time and $200,000 in restitution after selling counterfeit contact lenses, some of which were found to be contaminated with a potentially dangerous bacteria.

How to report illegal activity

Have information about a suspected illegal sale of contact lenses? Better documentation on illegal contact lens sales helps make the case for increased enforcement by the FTC. That's why the AOA requests doctors provide reports of illegal sales or contact lens complications to the AOA and the FTC.

If doctors are aware of an illegal retailer or encounter a patient harmed by illegally procured lenses, they should:

  • 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 poor business practices.
  • Email a de-identified case report to to help bolster AOA's advocacy against harmful contact lens practices.

"Every report to is important and helps us stem the tide of increasingly bold and illicit sales tactics," Dr. Velting says. "The Watchdog Group and AOA are doing everything we can to identify the illegal sales of contact lenses. Our efforts would be magnified a thousand-fold if we had every optometrist in the country on the lookout with us."

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

October 4, 2017

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