By Christina Liu, Staff Writer
A retailer in a southern state recently called BxB Magazine about a serious concern. He asked about carrying ¡°cosmetic¡± contact lenses in his store. He took issue with an advertisement for ¡°color¡± contact lenses in a beauty supply trade magazine. He faxed us the ad written in both Korean and English. BxB has made substantial investigation on the federal regulations about cosmetic contact lenses and concluded that these ad phrases were vague and therefore could misguide retailers. Whoever carrying or planning to carry cosmetic contact lenses should read this article in order to avoid possible legal responsibilities.
Do you need a prescription for cosmetic contact lenses? Yes, under the law you need a prescription. This is true even if your lenses do not have any vision correction in them and are used solely for cosmetic purposes. For around two years since 2003, the government classified decorative contact lenses as cosmetic devices rather than medical devices. But in November 2005 that all changed.
The FDA has issued a consumer alert regarding such contact lenses, saying that they "present significant risks of blindness and other eye injury if they are distributed without a prescription by a qualified eye care professional." In late 2004, it was reported that the FDA seized shipments of non-corrective cosmetic lenses, intended for sale without prescription, as they were being imported into the United States.
And in January 2005, optometrist and U.S. Representative John Boozman of Arkansas, concerned about eye problems that consumers have experienced due to poor labeling and packaging of some non-corrective cosmetic lenses sold over the counter, introduced bill H.R. 371 (the Senate version was S. 172). The bills sought to reclassify non-corrective cosmetic contact lenses as medical devices and allow the FDA to regulate the sale of these contact lenses again as it did in the past. The Senate bill passed in July 2005, while the House bill passed in October. President Bush signed them into law in November.
The FDA is on the alert for cosmetic contact lenses being sold in flea markets. Recently flea market vendors in Jacksonville, FL, were warned to stop selling cosmetic contact lenses and were, pending investigation, subject to being charged with a misdemeanor for selling them without state licenses. It has been reported that other illegal sales of cosmetic contact lenses were discovered in gas stations, beauty salons, beauty supply stores and novelty shops.
Facts
BxB strongly recommends retailers to carry cosmetic contact lenses after they check the following facts:
Fact One
Cosmetic contact lenses are also called plano, non-corrective, decorative, or color contact lenses.
Fact Two
Cosmetic contact lenses are now classified as medical devices, and the FDA (Food and Drug Administration) and FTC (Federal Trade Commission) regulate all contact lens sales.
Fact Three
Federal regulations clearly state, ¡°Sellers may provide contact lenses only in accordance with a valid prescription that is directly presented to the seller or verified with the prescriber.¡± Therefore, the seller is violating FDA and FTC regulations by selling contact lenses to consumers without prescriptions.
Fact Four
Sellers must provide consumers with identical contact lenses as those prescribed by the eye care professional. The federal regulations require a prescription to include specific information such as contact lens manufacturer, base curve or appropriate designation, and diameter, if available. It is illegal to provide contact lenses other than specified in the prescription.
Fact Five
According to FTC regulation, contact lens sellers who violate related federal regulations face civil penalties of up to $11,000 per incident.
Procedures
When you decide to carry cosmetic contact lenses, BxB recommends following the procedures below.
You need to verify whether contact lenses are approved by the FDA.
The FDA should approve cosmetic contact lenses. Upon approval, FDA issues a 510(k) number: for an example of 510(k) documentation, see Appendix C below. Note that a 510(k) number is given to each contact lens. It is not applied to all contact lenses manufactured by a certain company. It is best to ask manufacturers or wholesalers to provide you with a copy of the document by fax or mail.
You should ask consumers for a written prescription.
FTC requires that sellers make sure of valid prescriptions. If consumers do not directly present sellers with a valid prescription, the seller must verify its validity with the prescriber. Since verification involves a lengthy process, it is of your benefit to ask consumers for a written prescription. For verification process, see the Appendix D below.
You have no right to alter prescriptions.
According to federal regulations, you must provide consumers with the same contact lenses that were prescribed by their physician or optometrist. It is illegal to offer substitute contact lenses. The regulations allow only one exception, which is that ¡°if the same contact lens is manufactured by the same company and sold under multiple labels to individual providers, the seller may fill the prescription with contact lenses manufactured by that company under another label.¡±
Warnings
According to a report to BxB Magazine, there is a wholesaler who has said that a seller may provide contact lenses to consumers without a prescription as long as the seller obtains a written pledge with signature from consumers that states they will see an eye care professional. It is reported that the wholesaler argues that this post-prescription process is valid under state regulations.
It is obvious that federal regulations precede and overrule any state regulations. BxB is not aware of any state regulations that permit any post-prescription process. Besides, state regulations, being subordinate to federal regulations, become defunct and invalid, once federal regulations govern. Note that federal regulations unmistakably necessitate valid prescriptions prior to provision of contact lenses.
