Contact Lenses
This article was originally published in RAJ Devices
Executive Summary
FDA policy change on classification of noncorrective lenses
FDA policy change on classification of noncorrective lenses
The US FDA has relaxed its policy on the regulation of noncorrective contact lenses (also called zero-powered, plano, decorative or cosmetic lenses), while at the same time acknowledging that these lenses can cause a variety of eye injuries1,2. Up until recently, the FDA's policy was to regulate such contact lenses as medical devices, but now the agency has decided that they are cosmetics under the Federal Food, Drug, and Cosmetic Act because they are `articles... applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance'. In an April 2003 Federal Register notice, the FDA supports its new position by stating that `The fact that contact lenses are `devices' in the colloquial sense does not preclude cosmetic status under the act... Moreover, the fact that a product is intended to come into contact with the eye does not make it ineligible for cosmetic regulation... Provided they are not marketed with claims... that they effect physical or physiological change, decorative contact lenses are properly regulated as cosmetics under the act.'
According to the FDA, although only corrective contact lenses are required to comply with medical device regulations, sponsors may voluntarily include noncorrective contact lenses in their pre-market notifications [510(k)] as part of product lines with a range of corrective powers.
Legislation introduced due to concern
As a result of this policy shift, members of the eye healthcare community and congress have expressed concern, arguing that noncorrective contact lenses pose the same risks as corrective lenses and therefore the law should define them as medical devices, making them subject to GMP requirements for sterility and hygiene. To this end, legislation was introduced in the House of Representatives on 22 May 2003 that, if enacted, would require the FDA to regulate noncorrective contact lenses as medical devices rather than cosmetics3.
Background
There have been a number of reports of ocular damage after noncorrective contact lenses were purchased from retail establishments (e.g. beauty salons, flea markets, convenience stores) and worn without a prescription or professional fitting4. In October 2002 the FDA responded by issuing a warning urging consumers to immediately discontinue use of noncorrective contact lenses obtained without a proper fitting and prescription. At that time, an import alert was also issued, instructing FDA and Customs officials to detain all shipments of decorative contact lenses presented at US ports of entry, because it was believed that they were intended for distribution without a prescription or a professional fitting5.
That import alert was revised by the aforementioned April 2003 Federal Register notice, which authorises the agency's officers to detain noncorrective contact lenses at US ports only if they appear to be `adulterated' (e.g. they contain unapproved colour additives or a deleterious substance that could damage the eye). In line with its policy shift, the April 2003 notice also pointed out that eye care professional involvement is not legally required for noncorrective lenses.
References
1. Personal communication with the FDA, 19 June 2003
2.Federal Register, 4 April 2003, 68 (65), 16520-16522;The Regulatory Affairs Journal (Devices), 2003, 11 (3), 189
3. 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, introduced by Rep John Boozman on 22 May 2003
4. FDA Consumer Magazine, January-February 2003, www.fda.gov/fdac/features/2003/103_eyes.html
5.The Regulatory Affairs Journal (Devices), 2002, 10 (4), 351