DeWine Bill to Regulate Non-Corrective Contact Lenses Passes House of Representatives

Press Release

DEWINE BILL TO REGULATE NON-CORRECTIVE CONTACT LENSES PASSES HOUSE OF REPRESENTATIVES

U.S. Senator Mike DeWine (R-OH) today applauds the House of Representatives' passage of S.172, a bill that would designate all contact lenses as devices and require them to be approved under the Food and Drug Administration's device authority. Senator DeWine's bill would apply the medical device requirements to manufacturers and distributors to ensure that all companies are held to the same safety standards.

"The House's passage of this bill is very timely with Halloween approaching. Each year, so many children and adults use these cosmetic contact lenses as part of costumes, not knowing the potential dangers associated with them. This bill is important to protect healthy sight in our Nation's children and adults, and I am pleased to see the House agrees," said Senator DeWine. "The sense of sight is so important. With this bill, 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.

"By providing the Food and Drug Administration with the regulatory authority over cosmetic contact lenses, we'll prevent countless and senseless eye injuries each year," continued Senator DeWine, a member of the Health, Education, Labor and Pensions Committee.

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 Senate bill, while Representatives John Boozman (R-AR) and Henry Waxman (D-CA) sponsored the bill in the House of Representatives.

The bill now goes to the President for his signature.

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