Fairness to Contact Lens Consumers Act (FCLCA) compliance and contact lens safety
With a growing number of websites and small retailers continuing to illegally offer decorative, non-corrective contact lenses for sale without prescription, doctors of optometry should be diligent in reporting all adverse events associated with such lenses.
Fairness to Contact Lens Consumers Act (FCLCA)
The FCLCA became law on Feb. 4, 2004. The act mandates that eye care practitioners, including doctors of optometry, release contact lens prescriptions to their patients. It also requires contact lens sellers to verify the validity of contact lens prescriptions before releasing contact lenses to consumers. Included below is additional information regarding AOA advocacy regarding the FCLCA, how to report FCLCA violations, and additional resources to assist AOA members with complying with the FCLCA and ensuring contact lens seller compliance.
- Important Fairness to Contact Lens Consumers Act Update for Doctors of Optometry
- Summary of Advisory from AOA General Counsel regarding FCLCS Enforcement Update
- The Contact Lens Rule - Retailer Prescription Verifications and Prescription Requests
- Contact Lens Rule Updates Compliance and Advocacy Checklist
AOA contact lens safety advocacy
Ensuring that contact lenses are used safely by the public—and urging a robust response by federal and state authorities to illegal and improper contact lens sales—is a top priority for the AOA. In addition to efforts to educate consumers, the AOA regularly meets with federal agency officials to urge that more be done to crack down on dishonest internet and unconventional direct sellers, and these efforts are always informed and bolstered by reports the AOA receives from individual doctors from across the country.
Eye care practitioners should report all violations of the FCLCA, including instances in which contact lens sellers fail to comply with the prescription verification provisions of the law. Examples of non-compliance by sellers may include:
- No date and time on faxes.
- Multiple requests for same patient after receiving doctor response.
- Refusal to accept "Rx has expired" as compliant response.
- Selling contact lenses—decorative or corrective lenses—without prescription.
- Ignoring the eight-business-hour response period.
- Substituting lenses.
- Unintelligible recorded messages or other messages not allowing the practitioner a reasonable opportunity to respond.
Click below to report:
- Reporting Unlawful Sales of Medical Products on the Internet
- FTC Complaint Assistant
- Consumer Complaint Coordinators
Please contact CLCS@aoa.org with any questions or concerns regarding the activities of dishonest contact lens sellers or situations in which consumer safety is at immediate risk
Unfortunately, many retailers are illegally selling contact lenses or using regulatory loopholes to circumvent requirements designed to ensure the safety of our patients.
Although the AOA is not a regulatory body or an enforcement agency, we regularly meet with government agencies and policymakers to inform them of illegal business practices and threats to our patients' safety. The more informed we can be, the better we can advocate for improved laws and regulations that that better protect our patients.
Therefore, we encourage you to complete and share the below survey and instructions on how to report illegal and unsafe contact lens sales. For questions or more comments, please contact StopIllegalCLS@aoa.org.
If you are interested in combating illegal contact lens sales, consider joining the Contact Lens and Cornea Section.
The AOA urges you to report adverse events involving novelty contact lenses to the FDA
With a growing number of websites and small retailers continuing to illegally offer decorative, non-corrective contact lenses for sale without prescription, doctors of optometry should be diligent in reporting all adverse events associated with such lenses to the U.S. Food & Drug Administration's (FDA's) MedWatch Safety Information and Adverse Event Reporting Program.
The Federal Trade Commission (FTC) and the AOA last fall jointly launched a public information campaign to increase awareness of the dangers of illegally obtained novelty contact lenses. Several state optometric associations have launched similar efforts over the past year in conjunction with local news media or state officials. As a result, a number of small retailers, mostly along the Eastern Seaboard have been forced to stop selling the lenses, according to state optometric associations.
However, overall, the use of non-corrective novelty contact lenses appears to be growing, particularly among teenagers and pre-teens as the result of the prominent use of cosmetic lenses in popular movies such as the "Twilight" series, and the lenses are being offered illegally by an increasing number of online merchants, convenience stories, costumes shops and other specialty retailers.
Sale of contact lenses—corrective or plano—without prescription is prohibited in the United States under federal law. Both the federal FCLCA and the FTC Contact Lens Rule, which sets down the terms of enforcement for the FCLCA, specifically require non-corrective plano contact lenses, used solely for cosmetic purposes, to be treated as corrective lenses and sold only by prescription. Infractions are punishable by civil penalties of up to $11,000 per violation. Yet, during a meeting with the FDA, AOA Advocacy Group representatives turned over a selection of lenses purchased they had purchased through several websites, all without prescription.
Many small business owners may not yet be aware that it is illegal to sell contact lenses without prescription, FDA officials note.
They also observe that many websites which offer novelty contact lenses for sale without prescription are based outside the U.S. and are therefore beyond their agency's jurisdiction. The AOA Advocacy Group is hoping better documentation on the adverse events associated with illegally obtained novelty contact lenses will encourage the FDA, which has authority over the marketing of health care devices, and the FTC, which has jurisdiction over the retail sales of contact lenses under the FCLCA, to step up enforcement.
The FTC Contact Lens Rule requires drug store and other retailers who offer prescription contact lenses to provide contact lenses only after receiving current prescription information from the prospective purchaser and then confirming that information with the prescribing eye care practitioner. The AOA's Advocacy Group would like the FTC to more stringently apply those rules to both websites and local stores that sell non-corrective novelty lenses.
With illegal sales of novelty lenses apparently increasing, doctors of optometry will soon be seeing more cases of novelty lens-related eye problems—if they haven't already, the AOA Advocacy Group believes.
MedWatch reports were critical in prompting federal officials to take action on fungal eye infection and other contact lens-related health problem over recent years, the AOA Advocacy Group notes.
Information may be reported to the FDA's MedWatch program by phone at (800) FDA-1088, by fax at (800) FDA-0178, online or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Members can access new, template appeal letters to assist in payer denials and patient communications, as well as attend an #AskAOA webinar on addressing payer clawbacks and denials.
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