Regulation of cosmetic contact lenses pursued

March 15, 2005

Washington, DC—The American Academy of Ophthalmology (AAO) has renewed its fight to regulate cosmetic plano contact lenses. A bill introduced in Congress on Jan. 26 would amend the Federal Food, Drug and Cosmetic Act to recognize and regulate both corrective and non-corrective contact lenses as medical devices, regardless of their intended use.

Washington, DC-The American Academy of Ophthalmology (AAO) has renewed its fight to regulate cosmetic plano contact lenses. A bill introduced in Congress on Jan. 26 would amend the Federal Food, Drug and Cosmetic Act to recognize and regulate both corrective and non-corrective contact lenses as medical devices, regardless of their intended use.

Similar legislation was introduced last session and was passed by the House of Representatives by a unanimous vote, but died in a Senate committee. Reps. John Boozman (R-AR) and Henry Waxman (D-CA) are the original co-sponsors of the House bill.

Sens. Michael DeWine (R-OH) and Edward Kennedy are the original co-sponsors of the Senate bill.

"The unsupervised, unregulated, and unmonitored use of contact lenses is a recipe for disaster," said Thomas L. Steinemann, MD, an AAO member and associate professor of ophthalmology at Case Western Reserve University.

Dr. Steinemann authored a case report of six patients treated for complications related to these lenses that appeared in the October 2003 issue of Eye Contact Lens. Two of his patients developed blinding complications, requiring lengthy hospital stays. One 14-year-old patient needed a corneal transplant after wearing cosmetic lenses without the supervision of an eye-care professional. The other patient remains legally blind. In another 11 cases that he documented, three developed blinding complications requiring hospitalization.

Although the FDA has ordered customs officials to detain all decorative contact lenses entering the United States, AAO leaders believe that a legislative fix is the best long-term solution to this problem.

"We are hopeful that we will get the job done in this Congressional session," said Catherine Cohen, AAO vice president for governmental affairs.