Halloween stores and other retail outlets sometimes sell over the counter contact lenses without a prescription, but many people do not realize this is a crime.
According to Alan Barcelona, president of the California Statewide Law Enforcement Association, retail stores illegally selling contact lenses is a common occurrence. 1 Recently, investigators from the California Department of Public Health (CDPH) and Department of Consumer Affairs (DCA) teamed with the FDA’s Import Operations Branch investigators for “Operation Cat Eyes,” a sting operation that targeted retailers in the Los Angeles area who illegally sold decorative and cosmetic contact lenses. 2
As a result, twelve defendants, including five corporations and seven individuals, are facing federal charges for selling contact lenses without a prescription.
Why is it Illegal to Sell Non-Corrective Contact Lenses without a Prescription?
Wearing contacts can lead to injury or eye infections if you don’t know how to use and take care of them. For this reason, contact lenses are classified as prescription medical devices and are subject to FDA regulations, regardless if they are not corrective lenses. 3
What if the Retailer Didn’t Know it is Illegal to Sell Contacts without a Prescription?
A lot of people don’t realize that all contact lenses, including non-corrective lenses, require a medical prescription. As a retailer, you could be charged with a crime, and possibly sued under the strict liability doctrine, for selling a misbranded or adulterated product, especially if the contact lenses you sell cause injury to someone. 4
Most crimes require criminal intent. In order to be found guilty of a crime, you need to know that you are committing an illegal act. However, the crime of selling contacts to someone without a prescription does not require criminal intent. You could face criminal charges regardless if you knew you were doing something illegal. 5
What Charges Could You Face for Selling Contacts without a Prescription? (21 U.S.C. Section 331)
For selling lenses without a prescription at a county fair, two corporations were charged with the crime of introducing adulterated devices for interstate commerce under 21 U.S.C. Section 331. Halloween and Party Discounters, Inc., which operated a booth at the LA County Fair, and Intertrade Imports, a Florida-based company, allegedly sold contact lenses contaminated with Baccilus cerius, a type of bacteria that causes severe eye infections and can lead to blindness.
Mike Honobach, the owner of Halloween and Party Discounters, and Eunju Savadis, the manager of Intertrade Imports, also face separate charges under 21 U.S.C. Section 331 for introducing adulterated devices for interstate commerce.
Honobach is facing additional charges for sale of misbranded lenses under 21 U.S.C. Section 331. The other eight defendants are facing the same charge. 6
Punishment for Selling Contacts without a Prescription
Under 21 U.S.C. Section 331, selling contacts without a prescription is a misdemeanor. If you are convicted of this federal crime, you could face up to one year in federal prison and up to $100,000 in fines. Corporations that violate this law could be ordered to pay up to $200,000 in fines.
In addition, if adulterated or misbranded contact lenses cause injury to an individual, all parties involved — including the manufacturer, the importer, the retailer, and the store manager — could be held liable under the doctrine of strict liability negligence. 7
Call the Federal Defense Attorneys at Wallin & Klarich
If you or a loved one has been charged with a federal crime such as selling adulterated or misbranded contact lenses, you need the expertise of our team of criminal defense attorneys. At Wallin & Klarich, our federal defense attorneys have been successfully defending our clients accused of committing federal crimes for over 40 years. Let us help you, too.
With offices located in Los Angeles, Sherman Oaks, Torrance, Orange County, San Diego, Riverside, San Bernardino, Ventura, West Covina and Victorville, there is an experienced Wallin & Klarich federal attorney available to help you no matter where you work or live.
Call us today at (877) 4-NO-JAIL or (877) 466-5245 for a free phone consultation. We will get through this together.
1. [https://www.cslea.com/news/article/cdph_dca_investigators_assist_with_operation_cat_eyes ]↩
6. [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm#misbranding ]↩