It launched the ’31 in 31′ campaign.
The American Optometric Association will send letters this month to contact lens sellers “previously flagged for suspicious business practices or apparent disregard of federal law” informing them of regulatory requirements.
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,” the organization said on its website.
It will send one letter each day in October in its “31 in 31” campaign. The letters will be disseminated to businesses reported to AOA’s hotline, StopIllegalCLs@aoa.org, and they’ll be copied to the Federal Trade Commission (FTC) and Food and Drug Administration.
“This is an incredibly important initiative,” said Dr. Paul Velting, 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.”
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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,” AOA stated.
“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.”
According to the organization, last year’s “31 in 31” campaign prompted changes at eight companies that manifested in revised policies or wording, and visible changes to their websites reflecting the necessity of a valid prescription.
AOA noted: “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.”
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AOA requests that 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 StopIllegalCLs@aoa.org to help bolster AOA’s advocacy against harmful contact lens practices.
Read more at AOA
