Ophthalmic Devices Panel for the Medical Devices Advisory Committee and the Risk Communication Advisory Committee – Clear Labeling and Potential Risk of Misuse of Peroxide-based Contact Lens Products
Thank you for this opportunity to speak today. I am Samantha Watters and I’m the Director of Communications and Outreach for the National Center for Health Research. Our Center conducts and scrutinizes medical research and patient information, and we then translate that information into plain language so that patients, consumers, media, and policy makers will understand it.
As today’s meeting makes clear, even when the information that consumers need is on the package, they may not read it or understand it. This is especially difficult in a product such as contact lens solution, where the consumers may assume they know everything they need to know without reading any of the directions.
This meeting reflects the fact that the FDA knows it is not enough to require that the risks are listed. It’s essential to clearly explain why or how a product should be used, and in this case, how it is different from other contact lens solutions.
There are many forms of communication that have little to do with the words. FDA is considering ways to make the overall look of product packaging different when the solution contains hydrogen peroxide. We do not think that changing the colors or adding a logo is enough.
Where the products are placed on the shelves in relation to other lens solutions might help, but it might not. Personally, I have used contact lenses on a regular basis, and I didn’t even know that some solutions had peroxide in them. This lack of awareness is certainly a problem, because many consumers don’t even realize they should be carefully looking at the different type of lens solutions to figure out which kind they want.
Unfortunately, most people won’t take the time to read the information on the box, lens bottle, or label carefully. In addition, many people have limited reading skills. That’s why it is important to communicate risk information at the 5th grade or 8th grade level, but also to have warnings that are large and impossible to ignore.
The only way to protect consumers is to restrict this lens solution so it is only available behind the counter, requiring an explanation from the store staff. This behind the counter arrangement works for Sudafed cold medication.
We also suggest that there be fewer bullets, and that the first one be very clear. The sample bullets FDA suggested are not clear and are also repetitious. Instead, these 2 bullets make the point clearly:
- This product contains hydrogen peroxide. It will burn your eyes unless you use the special lens case provided.
- You must use the special lens case provided. It will disinfect your lenses in a way that will be safe for your eyes and won’t hurt them.
Thank you so much for the opportunity to share our Center’s views with you today.