FTC Staff Sends Warning Letters to Marketers of Cosmetic Contact Lenses

The Federal Trade Commission staff took action earlier this week to increase compliance with the Contact Lens Rule by sellers of non-corrective, decorative/cosmetic contact lenses. In 2003, Congress enacted the Fairness to Contact Lens Consumers Act, which imposed new prescription release and verification requirements on prescribers and sellers of contact lenses. In July 2004, the Commission issued the Contact Lens Rule to implement the Act.
On November 9, 2005, Congress amended the law to state that all contact lenses, including cosmetic or colored contacts, are restricted medical devices. A prescription from a medical professional is required to purchase a restricted medical device. According to the Food and Drug Administration, “[d]ecorative contact lenses present significant risks of blindness and other eye injury if they are distributed without a prescription or without proper fitting by a qualified eye care professional.”

On June 27, 2006, the FTC staff sent 18 warning letters to online sellers of cosmetic or colored contact lens. Most of the sellers to whom staff wrote claim on their web sites that cosmetic contacts are non-prescription or that they do not require a prescription. Such advertising claims violate the Contact Lens Rule. It also appears that most of the sellers to whom the FTC staff wrote may not be verifying that those who attempt to buy cosmetic contacts from them have valid prescriptions. The sale of cosmetic contact lenses without either obtaining a copy of a valid prescription from the customer or verifying his or her prescription information with the prescriber constitutes a violation of the Rule. The letters urge the cosmetic contact lens sellers to review the Rule and revise their practices as necessary to ensure they are complying with its requirements and warn them that violations of the Rule are punishable by civil penalties of up to $11,000 per violation.

Camelia C. Mazard
202-589-1837
cmazard@dbmlawgroup.com