Report adverse events involving novelty CLs to FDA, AOA urges

With a growing number of websites and small retailers continuing to illegally offer decorative, non-corrective contact lenses for sale without prescription, optometrists should be diligent in reporting all adverse events associated with such lenses to the U.S. Food & Drug Administration's (FDA) MedWatch Safety Information and Adverse Event Reporting Program, according to the AOA Advocacy Group.

The Federal Trade Commission (FTC) and 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, the AOA Advocacy Group says.

Sale of contact lenses - corrective or plano - without prescription is prohibited in the United States under the federal law. Both the federal Fairness to Contact Lens Consumers Act (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 in May of this year, 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 legal 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 CL only after receiving current prescription information from the prospective purchaser and then confirming that information with the prescribing eye care practitioner. The AOA Washington office would like the FTC mores stringently apply those rules to both web sites and local stores that sell non-corrective novelty lenses.

With illegal sales of novelty lenses apparently increasing, optometrists will soon be seeing more cases of novelty lens-related eye problems - if they haven't already, the AOA Washington office 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 at www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.