DeWine Introduces Bill to Regulate Non-Corrective Contact Lenses

DEWINE INTRODUCES BILL TO REGULATE NON-CORRECTIVE CONTACT LENSES

U.S. Senator Mike DeWine (R-OH) today announced the introduction of a bill that would designate all contact lenses as devices and require them to be approved under the Federal Drug Administration's device authority. The bill would apply the medical device requirements to manufacturers and distributors to ensure that all companies are held to the same safety standards.

"This bill is important to help keep our children safe," said Senator DeWine. "With non-corrective contact lenses designated as devices, we can prevent needless eye injuries and infections."

Non-corrective contact lenses, such as decorative lenses that change eye color or have some design on them, are regulated under the FDA cosmetic authority. The FDA does not review cosmetics for safety or effectiveness before they are sold to the public. Therefore, non-corrective lens manufacturers are not required to include directions for use or test lenses for safety problems.

Eye & Contact Lens, a medical journal, describes the cases of six people injured by the sale of unregulated colored contact lenses. Four of these six people reside in the greater Cleveland area, and five of the six were teenagers.

U.S. Senator Edward Kennedy (D-MA) is a cosponsor of the bill.

http://dewine.senate.gov/