SACRAMENTO – On August 9, 2019, investigators with the California Department of Public Health (CDPH) Food and Drug Branch (FDB) observed a business in Sacramento that unlawfully stocked and was offering for sale misbranded prescription ophthalmic devices known as decorative or cosmetic contact lenses. The contact lenses were misbranded for not meeting the labeling requirements, and for being sold without a written prescription from a licensed practitioner licensed by law to prescribe contact lenses.
“It is potentially harmful for consumers to purchase and wear contacts without a prescription,” said California Statewide Law Enforcement Association (CSLEA) President Alan Barcelona. “CDPH investigators work to protect the public from harm by investigating businesses that sell misbranded lenses and removing them from the market.”
Business and Professions Code 2541(c) defines prescription ophthalmic device as any plano contact lens that is marketed or offered for sale in this state. "Plano contact lens" means a zero-power or noncorrective contact lens intended to change the appearance of the normal eye in a decorative fashion.
Pursuant to the Business and Professions Code 2543 the right to dispense, sell or furnish prescription ophthalmic devices at retail is limited exclusively to licensed physicians and surgeons, licensed optometrists, and registered dispensing opticians. Selling contrary to prescription and dispensing requirements causes the contact lenses to be misbranded.
The contact lenses were marketed as beauty accessories under the names Secret Cosmetic Contact Lens, and Crazy Premium Cosmetic Contact Lens. In total, 123 pairs of misbranded contact lenses were taken off the market.
According to the U.S. Food and Drug Administration, wearing decorative contact lenses could cause serious damage to your eyes, if the contact lenses were obtained without a prescription and from unapproved sources. Contact lenses obtained without a prescription could lead to corneal abrasion, allergic reactions, decreased vision, infection, and blindness.
Among the CSLEA and CAFDI members from CDPH who were involved in investigation were Investigator Bradley and Investigator Lambert.
Consumers can submit complaints regarding the unlawful sale of contact lenses to the CDPH Hotline at (800) 495-3232.