Optometrists, Legislators Push For Stronger FDA Oversight Of Contact Lenses
This article was originally published in The Gray Sheet
Executive Summary
Legislation addressing the regulation of decorative contact lenses has a strong chance of being considered this fall when Congress returns from its August recess, according to staffers
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Ophthalmic Devices In Brief
Noncorrective contact lenses: House-passed bill (HR 2218) would provide for the regulation of all contact lenses - including noncorrective plano products - as medical devices. Introduced by John Boozman (R-Ark.) in May, the legislation passed the House Nov. 19 in a voice vote, following referral to the Energy & Commerce Committee before Congress' August recess (1"The Gray Sheet" Aug. 25, 2003, p. 8). A Senate companion (S 1747) sponsored by Sen. Mike DeWine (R-Ohio) was referred to the HELP Committee in October...
Ophthalmic Devices In Brief
Noncorrective contact lenses: House-passed bill (HR 2218) would provide for the regulation of all contact lenses - including noncorrective plano products - as medical devices. Introduced by John Boozman (R-Ark.) in May, the legislation passed the House Nov. 19 in a voice vote, following referral to the Energy & Commerce Committee before Congress' August recess (1"The Gray Sheet" Aug. 25, 2003, p. 8). A Senate companion (S 1747) sponsored by Sen. Mike DeWine (R-Ohio) was referred to the HELP Committee in October...
Non-corrective contacts
Lack of a prescription requirement for non-corrective, colored contact lenses and aggressive marketing tactics by some firms are cited as a threat to public health in a Sept. 15 letter to HHS Secretary Tommy Thompson from Reps. Henry Waxman (D-Calif.) and John Boozman (R-Ark.). The congressmen seek Thompson's support for HR 2218 (co-sponsored by Waxman and Boozman), which would reverse FDA's April decision to regulate non-corrective contacts as cosmetics instead of devices, and ask Thompson to investigate marketing practices for the products (1"The Gray Sheet" Aug. 25, 2003, p. 8). The reps single out 2www.beWild.com for providing the lenses to teenagers without instructions or risk warnings and maintain that "it is imperative that these sales be halted as quickly as possible"...