January 28, 2005

WASHINGTON – Academy-backed legislation regulating cosmetic plano contact lenses was reintroduced in Congress on January 26 by Reps. John Boozman (R-Ark.) and Henry Waxman (D-Calif.) and Sens. Mike DeWine (R-Ohio) and Edward Kennedy (D-Mass.). The bill, H.R. 371 and S. 172, respectively, amends 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 in the 108th Congress and passed the House unanimously, but was never brought to the Senate floor for consideration.

The Academy initiated efforts to regulate cosmetic plano contact lenses following several reports of teenagers who developed serious eye problems after using nonprescription cosmetic lenses purchased from flea markets, beauty parlors, gas stations and other unauthorized vendors.

“The unsupervised, unregulated and unmonitored use of contact lenses is a recipe for disaster,” said Thomas L. Steinemann, MD, a member of the American Academy of Ophthalmology 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. Dr. Steinemann recently documented another 11 cases, and three of those patients developed blinding complications requiring hospitalization. Dr. Steinemann presented these findings earlier this month at a meeting of the Contact Lens Association of Ophthalmologists.

Most consumers are unaware that contact lenses, even costume lenses not intended to correct vision problems, need to be fitted by an eye care professional and properly maintained. Most of the problems involve bacterial infections and scratches on the cornea. Without supervision, consumers – particularly teenagers – do not properly clean the lenses, fail to remove them before sleeping, (which cause a five-fold increase in the risk of bacterial infection) or share them with friends.

After the Academy provided the Food and Drug Administration (FDA) with several cases detailing adverse affects, the FDA took action, ordering FDA and customs officials to detain decorative contact lenses presented at United States ports of entry that were intended for distribution directly to the wearer, without the involvement of a qualified eye care professional. Some foreign contact lens manufacturers have taken advantage of the ambiguity of the medical device regulation, selling costume contact lenses without the usual regulatory safeguards for medical devices – failing to provide adequate direction on cleaning and maintenance, and dispensing them without a prescription.

There is nationwide concern over this issue. Florida recently declared it a felony to sell any contact lens without a prescription.

“We’re hopeful that we’ll get the job done during this Congressional session,” said Catherine Cohen, Academy vice president for governmental affairs.

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The American Academy of Ophthalmology is the voice for ophthalmologists and their patients in Washington, D.C., and is the world's largest organization of eye physicians and surgeons, with more than 27,000 members.

Reporter Contact: Governmental Affairs, 202.737.6662, or media@aao.org