Bill C-313 (Historical)

An Act to amend the Food and Drugs Act (non-corrective contact lenses)

This enactment amends the Food and Drugs Act to deem that a non-corrective contact lens is a device for the purposes of the Act. This enactment will ensure that non-corrective contact lenses are subject to the requirements of the Food and Drugs Act.

Food and Drugs Act

[Michael Chong, Conservative, Wellington—Halton Hills, ON]

Mr. Speaker, I am pleased to speak to Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses). I congratulate the member for Sarnia—Lambton for introducing this private member's bill. It is not often that we get a chance to introduce private member's bills. This one is very well thought out. The member is a strong representative of her riding. I remember visiting her five or six years ago. She served for some time as warden of Lambton County and also as mayor of Wyoming in Plympton-Wyoming for 16 years. She has to be one of the longest serving mayors in Ontario. Certainly she is the first mayor to serve as the mayor of Plympton-Wyoming.

Many members from the west may be surprised to learn that the very first commercial oil well ever drilled not just in Canada but in North America was drilled in Oil Springs, Lambton County in 1858. The oil industry and energy industry really started in southwestern Ontario, which is still home to many petrochemical and refinery companies. It is a great area of the world that has produced strong baseball teams, strong farm families, and now a strong member of Parliament who has introduced a very good piece of legislation.

All members in the House would agree that eyesight is a gift and it is not something we should ever take for granted. We would also agree that products we put directly on our eyes should be of high quality and safe to use for those purposes. We would also agree that because our eyesight is so very important, consumers should have the information necessary to make an informed decision about whether or not to purchase the product, and once they have, they should also know how to use that product in a safe way.

For all those reasons, this private member's bill is important legislation. It would help us address a long-standing safety issue related to the sale and use of these products. Cosmetic lenses, also known as non-corrective contact lenses, are used to change the appearance of the eye. They are available in a wide range of colours and designs. They are used primarily to make a fashion statement. Today is Halloween and tonight many Canadian children and adults will either go trick or treating or to a Halloween party. Many people will be wearing costumes. These costumes often include cosmetic lenses.

While I have never used them myself, I have seen them and they sometimes can be disconcerting. I have seen red vampire eyes, yellow cat's eyes, even starry eyes. There is a wide range of cosmetic lenses. They often are purchased over the Internet or at a costume retailer, as opposed to corrective lenses which are purchased at drug stores. Unlike corrective contact lenses, there are no labelling requirements to make consumers aware of the potential health and safety risks, or to provide instructions as to their proper use and care.

Cosmetic lenses are identical to corrective lenses, with one exception. Cosmetic and corrective lenses are used in the same way and pose the same risks to human health. The only difference is that cosmetic contact lenses do not correct vision. Even though these two products pose a similar risk, they fall under two different sets of regulations and regulatory regimes. That is the problem this bill would fix.

On the one hand, corrective lenses are considered to be medical devices and are regulated under the Food and Drugs Act and the medical devices regulations. On the other hand, cosmetic contact lenses are considered to be consumer products and are regulated under the Canada Consumer Product Safety Act. The bill before us today would help to harmonize those two sets of regulations by bringing both cosmetic and corrective lenses under the Food and Drugs Act and the medical devices regulations so that there would be greater clarity for consumers and greater health and safety standards for Canadians. That would mean both cosmetic and corrective lenses would be subject to the same rules for health and safety.

In the last Parliament, our government introduced the Canada Consumer Product Safety Act, which is strong legislation. It came into force earlier this year with support from both sides of the House. It strengthens the product and the protection of health and safety of Canadians by requiring suppliers of consumer products to report any safety-related incidents, including serious injuries or deaths, and to report any recalls or any other regulatory action in other jurisdictions.

As a consumer product, cosmetic lenses are regulated under the new legislation. It means that defective cosmetic lenses could be recalled by Health Canada if they posed an unreasonable danger to human health and safety.

However, while the new legislation will give Health Canada the powers of recall and while it is a much improve regulatory framework under which we will regulate consumer products in Canada, it does have one hole in it. The problem is it does not require companies selling these cosmetic lenses to meet the same labelling and consumer instruction standards. That is exactly what Bill C-313 would fix. It would fix this problem by regulating cosmetic lenses as medical devices under the Food and Drugs Act and the Medical Devices Regulations.

It would also require companies to report problems and provide additional information if Health Canada requested it. It would also ensure that all cosmetic lenses met the same regulatory standards as corrective lenses, in other words, the same standards as class II medical devices. Most important, it would ensure that proper information be contained on the packages to allow consumers to make an informed choice as to whether to buy the product and if they bought the product, what the proper use of the product would be to ensure eye safety.

Bill C-313 would require that cosmetic lenses meet specific labelling requirements, including instructions for use on the product label. It would provide consumers instructions on how to use the product safely and effectively, which would go a long way in reducing the risks associated with cosmetic contact lenses.

It is important to point out one thing. The legislation would, in no way, mandate prescriptions for cosmetic lenses. Whether to require prescriptions for lenses is a decision of the provinces and the legislation would not change that fact.

However, there are two other important aspects of the legislation that are worth pointing out.

The legislation would simplify the Canadian regulatory framework by bringing both corrective and cosmetic lenses under the same regulatory framework, as opposed to the current situation, which is where one is regulated under one act and the other is regulated under another act. This would ensure that both products would be regulated in a similar fashion.

The second thing it would do is harmonize our regulations with our largest trading partner. Since 2005, all cosmetic lenses sold in the United States have been regulated by the Food and Drug Administration. Currently, many Canadian consumers who purchase these products are confused because many of these cosmetic lenses have labels on them that say “FDA approved”. They are confused as to whether they are safe for use in Canada. They are also concerned when they see products that have not been labelled in a similar fashion. The bill would ensure harmonization of cross-border regulations between Canada and our largest trading partner.

I want to once again congratulate the member for bringing forward the legislation. It would allow consumers to continue to have access to high-quality, safe cosmetic lenses. It would simplify our Canadian regulatory framework. It would harmonize the regulations with that of our largest trading partner. Most important, it would require full information be put on the package to allow consumers to make an informed decision about purchasing the product and, once purchased, ensure that consumers would have all the information required in order to use these cosmetic lenses safely.

For all these reasons, I encourage members of the House to support the legislation. I congratulate the member for bringing it forward.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

moved that Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), be read the second time and referred to a committee.

Mr. Speaker, today, I am honoured to speak in support of my private member's bill, Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), in order cosmetic or decorative contact lenses under the same medical device regulations as corrective contact lenses.

I thank the professionals within the eye care community who have contacted my office in recent weeks with their kind words of support for my private member's bill.

Each member in the House today has representatives of the eye care industry in their riding, and I hope members will heed their warnings about the dangers of the incorrect use of decorative contact lenses that we are hearing more about each day in news reports and medical studies.

Bill C-313 has gained the support of three eye care organizations representing various professionals from the eye care industry. The Canadian Association of Optometrists, the Opticians Association of Canada and the Canada Opthalmological Society are important stakeholders in any discussion on eye care related to their profession.

Today, I intend to share medical evidence with hon. members that will show the clear need for the provision sought after by Bill C-313.

Before we discuss Bill C-313 further, I want to take members back to a different time and place, to the autumn of 2007 in the 39th Parliament of Canada. It was during that period that the concerns of eye care professionals from across Canada were first brought to my attention. At the time, I was an active member of the Standing Committee on Health.

There were many concerns that were brought forward to the parliamentarians on that committee, and while all the concerns were important, I was particularly seized by the concerns that were brought to me by the professional eye care organizations in relation to the lack of regulatory oversight on what were called non-corrective cosmetic contact lenses.

It is very easy to break down the main concern brought forward to me all those years ago. A cosmetic contact lens is identical to a corrective lens in terms of its impact on the human eyeball, with the only difference being that it does not correct a sight imbalance.

However, despite the fact that they are identical to a corrective lens, these cosmetic lenses were and, to this day, continue to be free of regulatory oversight similar to the provisions in place for corrective lenses.

It was with this simple fact in mind that I began work in 2007 to further understand the risks of cosmetic contact lenses. We must remember that cosmetic, decorative and plano contact lenses are all referring to the same product. I will use all three terms in my discussion today.

After extensive study, liaising with health researchers and eye care professionals, meeting with our own experts from Health Canada and engaging with the opposition health critics, I developed a strategy that would ensure that Canadians' eye health would be protected. The result was private member's Motion No. 409, which proposed that cosmetic lenses should be classified as medical devices and be regulated accordingly under the Food and Drugs Act.

The actual text of Motion No. 409 read as follows:

That, in the opinion of the House, the Minister of Health should regulate non-corrective, cosmetic contact lenses as medical devices under the Hazardous Product Act or the Food and Drugs Act.

The motion passed unanimously on March 7, 2008, in a fractured minority Parliament, no less, which I believe is a testament to the fact that this is not a political issue. Rather, we are discussing a human health issue that could impact many Canadians, especially our youth, which I will speak to shortly.

Due to the importance of the motion to Canadians' health, I was able to obtain the full support of all the opposition parties and their health critics, in addition to the support of the government and the Minister of Health. Today, I seek that same support from across the aisle.

I was pleased that the government acted upon the unanimously passed motion. It was in 2008 that the Government of Canada, upon advice from Health Canada, introduced my motion as an amendment to the omnibus Food and Drugs Act amendment in the former Bill C-51, which was introduced in April 2008, but which also died on the order paper upon the election in the fall of 2008.

It was unfortunate that having already had my private member's spot used in the 39th Parliament, I found myself near the bottom of the long private members' business list. This meant I would not have the ability to bring this legislative change forward for some time.

Moving ahead to late 2010, now in the 40th Parliament, it became evident that I would possibly have the ability to bring forward private members' business. Knowing that I had unfinished business, I reached out to the professional eye care organizations to begin discussions on the types of legislative remedies that could be brought forward.

My main concern was to ensure that my private member's bill would adequately and fully address the concerns held by myself, other parliamentarians and thousands of eye care professionals across Canada.

Of course, we have had another election since then and, upon being re-elected by the citizens of Sarnia—Lambton, I found myself returning to a new House of Commons in the 41st Parliament. I also found myself near the top of the list for private member's business, meaning that months of research and effort through my office were about to be realized in terms of finally bridging the regulatory gaps that exist for decorative non-corrective lenses.

The culmination of this long process now stands before the House of Commons for debate. With this brief background on my bill now before the House, I would like to discuss Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses), with everyone today.

I can sum up the situation regarding the need for my legislation in one sentence regarding non-corrective cosmetic lenses. National distribution of these products without professional oversight, fitting and training significantly increases the risk of public harm.

The difference between 2007, when I first brought my private member's motion forward, and 2011, is that I now have the peer reviewed medical evidence to back up my claim. Today, we now know that the warnings on cosmetic lenses dating back to October 23, 2000 by Health Canada are, in fact, quite well warranted and now demand a legislative recourse to alleviate the potential harm that could be done to consumers of these products.

To some, it may seem that to deem a decorative lens as a harmful product is somewhat overreaching, yet eye care professionals and medical researchers have shown otherwise. A short list of the complications that could occur due to unsafe handling and wearing an improperly fitted lens in one's eye, along with the lack of professional oversight when these products are initially obtained by the consumer, includes the following: conjunctivitis, corneal abrasions, giant papillary conjunctivitis, microbial keratitis and other forms of bacterial, allergic and microbial infection as specified by the eye care industry.

Already we know that these complications all occur with prescribed corrective lenses, which is exactly why Health Canada regulates the use of these product through opticians and regulatory bodies. What has now been shown as fact through peer reviewed studies is that non-prescribed decorative or cosmetic lenses are much more likely to cause complications to users for a combination of factors, including lack of oversight on the product for the consumer in terms of how to use the product and in terms of the potential quality of the product.

It should be noted that some businesses import cosmetic lenses from parts of the world where production of the device to be fitted into a human eye does not necessarily take the best precautions in terms of the quality of their product, leading to the rise of bacterial infections and microbial issues. These companies make large profits off a consumer base that is woefully unaware of the potential harm they are causing to their own eye sight.

A recent search on the Internet for cosmetic contact lenses Canada brought up over one million hits. The top hits on the search were for several large marketing and distributing companies that sell cosmetic lenses made in certain regions not as well-known as Canada for having strong consumer protection measures. This is extremely concerning and we can be sure that the regulatory oversight that Bill C-313 would provide should help to shed some light on the businesses that are importing and providing these products to consumers with little to no oversight or concern for the consumer of their product.

To date, we have now seen several studies on the issue of decorative lenses and the harm they can cause to consumers. Perhaps the most well-known study in Canada is the human health risk assessment of cosmetic contact lenses conducted by Dillon Consulting Limited, also known as the Dillon report. The final assessment was submitted to Health Canada in September 2003 and it outlined the scientific evidence, which at that point was still being debated by public health officials, that the level of risk associated with the use of cosmetic contact lenses was comparable to that associated with corrective lenses and maybe potentially higher. The main issue here is that corrective lenses are subject to professional monitoring and proper regulatory oversight. Cosmetic lenses are not.

The Dillon report also called for the following risk management strategies: individual screening should take place before a cosmetic lens is sold to a customer; proper fitting should be ensured; adequate instruction on cleaning and sterilization should occur; familiarization with recognition of potential symptoms related to the condition of the eye; and, regular aftercare.

To date, not one of the suggested risk management strategies called for in this report have been adopted, while corrective lenses are strictly defined by Health Canada. With this in mind, we must all ask the question why this has been allowed to occur for so long despite the long-standing pleas of the eye care industry and medical researchers.

To recap our discussions thus far, the main concerns Bill C-313 seeks to redress is that cosmetic or decorative cosmetic lenses are being dispensed without a prescription or fitting from unlicensed vendors. Consequently, uninformed lens wearers are experiencing acute, vision threatening infections and inflammation.

This has now become an accepted fact due to a recent study that appeared in Acta Ophthalmologica, the official medical journal for optometrists and ophthalmologists in Europe. In this study, research conducted at the Department of Opthalmology at Strasbourg University Hospital in Strasbourg, France, clearly indicated that:

Patients who acquire CosCL are less likely to be instructed on appropriate lenses use and basic hygiene rules. Consequently, CosCL wearers are experiencing acute vision-threatening infections.

The study in question focused on a bacterial infection known as microbial keratitis, a common yet preventable infection that can occur in wearers of contact lenses, both corrective and non-corrective cosmetic varieties. This study has shown that wearers of cosmetic lenses were at higher risk, with 79% of the controlled group of cosmetic contact lens wearers suffering from corneal scraping. However, the study showed that only 51% of corrective contact lens wearers suffered similar affects. Meanwhile, more than half of the cosmetic lens wearers who were shown to have suffered corneal scraping were also shown to have serious microbial infection as well in the eye.

The study concludes that the increasingly documented risks of easily accessible cosmetic contact lenses were a serious concern in France where the study took place.

There is no reason to believe that the situation is any different in Canada. The Dillon report of 2003, which, in many ways, served as a groundbreaker on this issue, also came to the same conclusions as the French study in 2011.

Considering the medical evidence that clearly shows the need for the provisions contained in Bill C-313, it is important to note that Canada is at least a decade behind other jurisdictions such as the United States and Europe in achieving proper regulations for cosmetic, decorative or plano lenses.

No matter what we want to call them, it is scientific fact that there are issues with these lenses being improperly sold and used in our nation. The risk was sufficient enough that, in 2000, Health Canada issued a public health warning. In 2003, a human health risk assessment was conducted. In 2008, this House of Commons unanimously agreed with the viewpoint that cosmetic lenses were indeed a risk to Canadian consumers and that we must take action.

Although I have spoken at great length as to the risks of cosmetic contact lenses and, therefore, the need for the provisions of Bill C-313, I will share with the House a quote from Dr. Lillian Linton, president of the Canadian Association of Optometrists, who stated:

This is about people’s eyesight…and in most cases young people’s eyesight! There are daily news stories from around the world about the complications that can arise due to ill-fitting cosmetic lenses or improper use and handling. It is an important vision health issue and the optometrists, opticians and ophthalmologists of Canada are asking for unanimous support from the House, Senate and Health Canada to adopt this amendment and enact it with haste.

I could not agree more with Dr. Linton.

The time has come for us as parliamentarians to join together to support Bill C-313 so that we can ensure that much needed oversight is finally brought forward. In doing so, Canada can reclaim the proper regulatory powers over the importers of these products who so callously flood the Canadian market while doing untold damage to hundreds of thousands of young Canadians' eyes, completely unbeknown to most consumers, unfortunately.

With this in mind, I call on parliamentarians in the House today to stand in support of Bill C-313.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

moved for leave to introduce Bill C-313, An Act to amend the Food and Drugs Act (non-corrective cosmetic contact lenses).

Mr. Speaker, I am pleased to rise today to introduce my bill, an act to amend the Food and Drugs Act. I also want to thank my colleague, the member for Scarborough Centre, for seconding this bill.

The bill would deem non-corrective contact lenses to be a class II medical device. Those who were in the House prior to this session will know that my Motion No. 409 started this work. The bill would continue that work. I look forward to the same unanimous consent as in the last sitting.

(Motions deemed adopted, bill read the first time and printed)