To amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.

Mr. Speaker, I thank the gentleman from Florida (Chairman Bilirakis) for yielding me this time.

I also thank the gentleman from California (Mr. Waxman) and his staff for working so hard on this bill. They have really gone above and beyond the call of duty in spending a great deal of time getting this to the situation that we have now. I also thank the gentleman from Florida (Mr. Bilirakis) for his help and the gentleman from Louisiana (Mr. Tauzin).

Today we have the opportunity to close a loophole that has caused harm to many people young and old throughout the country. The loophole is a quirk in the law that allows decorative, plain old contact lenses to be sold without a prescription. Although this may not sound like a big deal, as a practicing optometrist for over 25 years, it is.

There are many cases of damage caused by contact lenses sold without the supervision of an eye care professional. Take, for instance, the case of a 14-year-old girl who purchased a pair of decorative contact lenses from a local video store and received no instructions on how to care for them. She ended up suffering a severe bacterial eye infection, and ultimately had to have a corneal transplant, which is a very significant surgery. Or the 32-year-old man who bought a pair of lenses at the local flea market for a Halloween costume. Again, the customer was provided with no directions at all on proper usage. He was later diagnosed with a corneal abrasion. He had scratched his eye because they did not fit his eye. He was later in a situation that resulted in possible permanent loss of vision.

Unfortunately, there are many, many more people whose vision has been compromised because of this type of contact lens being available to the general public without the supervision of eye care professionals. It is important to know that although adults are affected by the availability of these lenses, our children are the most vulnerable. As all of us who have children know, reason is often overruled by the desire to be fashionable and trendy.

Selling lenses to change one's eye color in video stores, flea markets, hair salons, and gas stations is inviting trouble and, frankly, should not be allowed.

A simple eye infection is the least of problems with unsupervised contact lens use. The worst is it can lead to permanent blindness. Proper care of the lenses and instructions on the correct way to use them are the keys to preventing these afflictions. Consumers are not getting this information from the video store clerk or the gas station attendant.

H.R. 2218 presents a simple fix to a dangerous problem. This bill is not intended to address the complicated legal issues surrounding intended use. The gentleman from California (Mr. Waxman) and I have worked hard to ensure that the language in this bill remains neutral on this question, and I think we have succeeded.

Additionally H.R. 2218 is being endorsed by the health care community, including the American Optometric Association and the American Academy of Ophthalmology, as well as the leading manufacturers in the contact lens industry and consumer protection groups.

Mr. Speaker, I cannot stress strongly enough that unregulated, unsupervised use of decorative contact lenses is extremely hazardous to one's health. H.R. 2218 would simply close that loophole that allows these lenses to be sold unregulated. I would strongly encourage my colleagues to support H.R. 2218.

Mr. Speaker, I thank the gentleman for yielding me this time.

I am very pleased to be able to join my colleagues in urging support for a bill that deems all contact lenses to be medical devices under the Federal Food, Drug and Cosmetic Act; and I thank the gentleman from Arkansas (Mr. Boozman) for his leadership in sponsoring this legislation. Anyone who has any doubts about how significantly contact lenses affect the structure and function of the eye need only spend a few minutes talking with the gentleman from Arkansas (Mr. Boozman), who, by virtue of his professional training, understands these dangers better than anyone else in the House of Representatives.

This bill is urgently needed. All contact lenses pose serious health risks. Lenses the wrong size can deprive the surface of the eye of oxygen. Lenses worn for too long can cause painful ulcerations of the cornea. Lenses that are poorly manufactured or misused can become contaminated and cause vision-threatening infections. Until recently, FDA had the tools to control the risks of contact lenses. They considered all lenses of all types to be Class III medical devices. Using its medical device authority, the FDA required that companies follow good manufacturing standards, obtain approval prior to marketing, report adverse events promptly, and sell their lenses only with a prescription from an eye care professional.

However, under FDA's current interpretation of the law, some contact lenses are now considered cosmetic, nonmedical devices. These lenses, which the agency refers to as decorative lenses, are colored or feature unusual designs. These lenses pose exactly the same health risks as other lenses, yet today these lenses only have to comply with requirements for cosmetics, and there are very few requirements and they are difficult to enforce.

Treating them in this way, I believe, is a recipe for disaster. Lenses sold outside the protections of medical device laws have caused numerous eye injuries. It is critically important that FDA have the ability to stop these dangerous sales as quickly and efficiently as possible. The solution is simple: treat all contact lenses as medical devices. No contact lenses should be classified in the same category as lipstick.

H.R. 2218 would ensure that all contact lenses are treated the same as medical devices. This bill is enforced by professional associations representing ophthalmologists and optometrists, by leading manufacturers and by consumer groups. It is a basic consumer protection, and it is common sense.

Finally, let me say this bill has been written with the understanding and agreement of all parties that it should not be interpreted as either a rejection or a ratification of the legal arguments

underlying FDA's decision to treat noncorrective lenses as cosmetics. For that reason, the bill includes a rule of construction stating that the bill should not be construed as having any effect on any product regulated by the FDA other than the specific contact lenses at issue here. I thank the gentleman from Ohio and the distinguished chairman of the Subcommittee on Health, and I join with every Member who has spoken on this bill in urging support for it.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, colored and patterned contact lenses can be a fun way to express one's sense of style. Noncorrective contact lenses that are manufactured responsibly and worn under the supervision of a qualified eye care professional are useful and a perfectly safe commodity.

For years, the FDA saw it that way too and properly classified colored contact lenses as medical devices. In fact, just over a year ago FDA issued an official notification noting that noncorrective contacts ``present significant risks of blindness and other eye injury if distributed without the involvement of a qualified eye professional.''

But in April, for whatever reason, and we have seen an FDA that has become more and more politicized in the last couple of years, but for some reason the FDA flip-flopped deciding that colored contact lenses were not medical devices and were instead cosmetics. This quiet, but important, policy change opened the door to a new public health threat.

By reclassifying colored contacts as cosmetics, FDA eliminated the requirement that these products be manufactured to exacting standards, that they be FDA approved for safety before marketing, and that they be labeled with directions for safe use. FDA has expressed concern about the safety of noncorrective lenses administered without a doctor's involvement. But FDA's decision to reclassify them in this increasingly politicized FDA, this decision to reclassify them eliminated its authority to require that very involvement.

Despite concerns raised by Members in the House, but more importantly by Prevent Blindness Ohio and other eye health advocates, FDA went ahead with this misguided plan. This bill corrects that mistake by statutorily reclassifying noncorrective contacts as medical devices by statute. This bill was carefully drafted to ensure that this would be its only effect, and it clearly states this change will have no limiting effect on FDA's discretion in classifying other products under the Food, Drug and Cosmetic Act.

H.R. 2218 enjoys bipartisan support in the Committee on Energy and Commerce. The chairman of the Subcommittee on Health, the gentleman from Florida (Mr. Bilirakis), and I have cosponsored this legislation, as have several other colleagues; and I am joined on the floor today by two other leading health advocates, the gentleman from California (Mr. Waxman) and the gentlewoman from California (Ms. Eshoo). I urge my colleagues to join us in supporting this important legislation in protecting the vision and health of American consumers.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to the gentleman from California (Mr. Waxman).

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2218) to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of noncorrective contact lens as medical devices, and for other purposes.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and to include extraneous material on H.R. 2218, the bill now under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in support of H.R. 2218, which amends the Federal Food, Drug and Cosmetic Act to provide for the regulation of noncorrective contact lens as medical devices, and I commend the gentleman from Arkansas (Mr. Boozman) for his work on this legislation.

As the corrective contact lens industry has grown, so has the practice of using noncorrective contact lenses for cosmetic purposes. Currently, there is very little regulation of these lenses. However, all contact lenses have significant effects on the eye and pose health risks if improperly manufactured or used without the supervision of a qualified eye care practitioner. Both corrective and noncorrective contact lenses have been approved as medical devices by the FDA. It just makes sense that the FDA should have the authority to regulate these lenses.

Mr. Speaker, having said that, I would urge all of my colleagues to support this important resolution.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to the gentleman from Arkansas (Mr. Boozman), who is himself an optometrist and certainly has lived with this problem for many, many years and knows the real world, and I thank the gentleman for bringing this to our attention.

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.