Just days before Halloween, Congress approved the plano contact lens bill (S. 172). This legislation restores the designation that a plano, or decorative, contact lens is a medical device, not a cosmetic.
The unregulated, unsupervised use of decorative contact lenses has been shown to be extremely hazardous to ones health, says Rep. John Boozman (R-AR), an optometrist and the chief house sponsor of the legislation. By acting before Halloween, Congress is telling parents and young adults that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are used without the appropriate involvement of a qualified eye care professional.
|This colored lens should again be a medical device.|
The FDA historically treated all contact lenses as medical devices. Then in 2003, the agency determined that plano contact lenses worn solely for cosmetic purposesincluding colored contacts and decorative lenseswere cosmetics. Since the FDA does not review cosmetics for safety or effectiveness before sale to the public, the agency could not set good manufacturing processes for these manufacturers or require that consumers be supervised by a health care professional.
Passage of this bill represents an important achievement in protecting the health and safety of U.S. citizens, says optometrist Arthur Epstein, chair of the American Optometric Associations Contact Lens and Cornea Section (CLCS).
Dr. Epstein says the AOA in conjunction with CLCS worked closely with Reps. John Boozman and Alan Waxman (D-CA) as well the American Academy of Ophthalmology and Prevent Blindness America to ensure passage of this legislation. This is a great day for the AOA, the CLCS and most importantly our patients. Optometrists should be proud of this notable accomplishment, he says.
Proponents of the bill expect President Bush to sign it into law in the near future.