Over-the-counter tears are an oddball category for the FDA. They do not have an approval process. Long ago they established a list of active ingredients (and concentrations thereof) that are considered safe for OTC sales. Any drops that comply can be sold as OTC tears, any that don't, can't. Sodium hyaluronate is not on that list. I don't know what it takes to get something added to the list but I don't think anyone has tried in a long time.
Originally Posted by namoomoo
The Dry Eye Zone