Optometrist and U.S. Representative John Boozman (R-AR) reintroduced a bill that would give the FDA the power to regulate noncorrective colored contact lenses as medical devices.
All contact lenses have significant effects on the eye and pose serious potential health risks if improperly manufactured or used without appropriate involvement of a qualified eye care professional, the bill says.
Previous legislation had passed the House in the 108th Congress, but stalled in the Senate. Dr. Boozman has high hopes that this bill (H.R. 371) will pass both Houses in the 109th Congress.
In the last session, we made great strides in raising awareness of the problem and worked hard to get the bill passed in the House, Dr. Boozman says.
In April 2003, the FDA announced that it would change the classification of noncorrective lenses from medical devices to cosmetic devices. As a result, the FDA can no longer review the safety of these lenses before they are sold to the public, cannot set good manufacturing practices for manufacturers, cannot require the super- vision of a health care professional, and cannot require that adverse events be reported promptly. Although the FDA has detained imported noncorrective lenses prior to sale, the agency can only protect consumers from dangerous domestic products after the lenses have already been marketed and consumers are at risk.
Optometrists and ophthalmologists have seen significant injuries from the misuse of these lenses and unfortunately, in many cases, it is a teenager who is trying to follow the latest fad. These injuries will continue if we do not close this loophole and regulate colored contact lenses the same way as prescription contact lenses.