American Optometric Association Supports Legislation Requiring Regulation of Non-Corrective Contact Lenses

ST. LOUIS -- The American Optometric Association (AOA) applauds the introduction of federal legislation to require that the Food and Drug Administration (FDA) regulate non-corrective, decorative contact lenses as medical devices. The bill, H.R. 2218, was introduced by Rep. John Boozman (R-AR) and Rep. Henry Waxman (D-CA), just several weeks after the FDA began to regulate these lenses as cosmetics, claiming that current FDA law does not allow for continued regulation as a medical device.

According to J. Pat Cummings, OD, president of the AOA, contact lenses that are improperly manufactured or used without appropriate medical supervision can cause serious eye infections and loss of vision.

"The FDA has historically and correctly classified plano or 'zero power' contact lenses as prescription devices since it is necessary for an eye care practitioner to evaluate the ocular health of the patient and the fit of the lens to the eye, just as they would for lenses with power," said Cummings. "We were pleased to have the opportunity to work with Rep. Boozman and Rep. Waxman to bring about this proposed legislation clarifying the status of these lenses. We commend their taking the lead on this important public health issue."

The sale of noncorrective, colored contact lenses in beauty salons, flea markets and gas stations has been reported across the country. Eye care practitioners have called attention to a number of serious injuries, including among young people who are often unaware and uninformed of the proper use and care of contact lenses. Some of these injuries have been the topic of news stories across the country.

The physical and other characteristics of those lenses are identical to corrective power lenses; the only difference is the refractive power. More importantly, the very real health consideration associated with improper fit and wearing of lenses applies equally to both plano and corrective power lenses.

If consumers are able to purchase these contact lenses without a prescription that specifies correct size, some purchasers may obtain lenses that don't fit properly or are too tight, thus reducing the flow of oxygen to the eye's surface and increasing the risk of inflammation and infection. Others may obtain lenses that are loose fitting and therefore could damage the cornea as well as obscure vision by constantly shifting position.

Organizations supporting Boozman and Waxman's bipartisan effort include major professional, patient advocacy, and industry groups. These include the AOA, the American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, Prevent Blindness America, and the Contact Lens Institute. Five House members who are medical professionals are original cosponsors of the legislation.

The American Optometric Association represents more than 33,000 doctors of optometry, optometry students and paraoptometric assistants and technicians in more than 6,600 communities across the country.

Source: American Optometric Association