Naivety is no defense for illegally sold contact lenses that put patients' health at risk. Just ask violators nationwide currently facing repercussions under patient safeguards that AOA diligently champions, especially as the Halloween threat of novelty lenses return to retailers' shelves.
Crackdown on illegal contact lenses
"In many ways, this is a relatively serious offense," remarked U.S. Magistrate Judge Andrew Wistrich at sentencing of a Los Angeles boutique owner this past March. The owner, found guilty on misdemeanor violation of the U.S. Food, Drug and Cosmetic Act, admitted she wasn't aware of illegality when she sold an undercover agent four pairs of contact lenses sans prescription.
But the true affront? Three of those pairs—marketed as Halloween or beauty accessories—were contaminated with sight-threatening pathogens. Were it not for the investigative work of Operation "Fright Night," a sting operation led by the U.S. Food and Drug Administration (FDA) last fall, 10 Southern California businesses might have continued selling such "misbranded" and dangerous contact lenses.
"These products pose a serious danger to unsuspecting Halloween shoppers," commented U.S. Attorney Eileen M. Decker in a U.S. Department of Justice news release. "As required by law, contact lenses should be used only when they are prescribed by a knowledgeable medical professional."
It's law of the land, most recently enforced against 21 San Antonio-area convenience and dollar stores that agreed to pay $50,000 in civil penalties as a settlement with the Texas Attorney General's office this September. Reportedly, San Antonio police determined the stores not only sold novelty contact lenses without prescriptions, but also acquired the products from vendors who allegedly stored the lenses in the back of vans, raising questions about how storage conditions affected the lenses' integrity.
So, too, were the safety of faux contact lenses brought to light when the FDA took down a major, fraudulent online retailer of contact lenses earlier this September. The FDA says Dmitriy V. Melnik, owner of Candy Color Lenses, plead guilty to running an international operation that imported counterfeit and misbranded contact lenses from Asia, and sold them online to tens of thousands of Americans.
Melnik admitted to the FDA that "some of the contact lenses he sold were tested and found to be contaminated with potentially hazardous bacteria."
Unsafe contact lens practices put vision at risk
Contact lenses are a safe and effective vision correction option for nearly 40 million Americans, but there is a reason all contact lenses— whether corrective or decorative plano—are classified as medical devices that require a valid prescription to purchase: When improperly or carelessly worn, contact lenses can cause significant damage.
- 1 in 5 cases of contact-lens-related infections results in corneal damage.
- 99% of contact lens wearers commit at least one unsafe hygiene behavior.
- 1 in 3 contact lens wearers experiences a complication requiring further care.
"As Halloween approaches, we know that people will be tempted to purchase theatrical lenses online," says Jeffrey Sonsino, O.D., AOA Contact Lens and Cornea Section (CLCS) chair. "Unfortunately, many of the online retailers sell lenses illegally and without a prescription. In an attempt to protect patients, we are reporting suspected violators to the FDA and FTC."
AOA stands up against violating vendors
This month, AOA intends to confront offending retailers with a 31 in 31 campaign: 31 letters issued to as many suspicious contact lens retailers across October's 31 days. Copied to both the FDA and U.S. Federal Trade Commission (FTC), these letters are disseminated to businesses flagged by AOA's reporting hotline, stopillegalCLs@aoa.org, and address their alleged violations.
While the AOA is not a regulatory enforcement entity, a central mission of the AOA is to serve as a resource to the public for reliable and current information related to eye and health care policy. As such, reiterating these egregious violations with the industry's enforcement agency, the FTC, will help put these concerns under the spotlight.
"By establishing the email stopillegalCLs@aoa.org, the AOA CLCS has collected hundreds of cases of patients being harmed by illegal online sales of contact lenses," Dr. Sonsino says. "We are working diligently with the FDA and FTC to combat the illegal practices of retailers who import non-FDA approved lenses, gray-market commonly available lenses, or sell to the public without a prescription."
That's why the AOA is proud to support bipartisan, bicameral legislation that would bolster patient safety requirements and increase accountability for the internet contact lens sales industry. The Contact Lens Consumer Health Protection Act of 2016, S. 2777 and H.R. 6157, would reinforce the distinction that contact lenses are medical devices and should be treated as such.
"The Contact Lens Consumer Health Protection Act of 2016 is an incremental, conservative, common-sense approach to improving the Fairness to Contact Lens Consumers Act and the Contact Lens Rule," says Clarke Newman, AOA Federal Relations Committee chair. "It represents good public policy."
He adds, "The answer for sellers and prescribers when addressing these statutes and regulations is simple—follow the law."
AOA offers resources for decorative contact lens campaigns
October is a prime opportunity to reach the public about contact lens safety, which is why AOA has launched a public awareness campaign leading up to Halloween.
Representing a concerted approach to contact lens advocacy, the campaign reminds consumers about the dangers of illegal or improper contact lens use and stresses the importance of visiting their doctor of optometry before seeking decorative contact lenses.
The AOA’s 31 in 31 campaign once again scrutinizes retailers in the contact lens market who sell their patients upstream when it comes to valid prescriptions.
“The number of consumers who have experienced adverse events related to Hubble Contacts is unacceptable,” AOA tells federal regulators and health authorities in appeal for “real action.”
Founded five years ago, the Health Care Alliance for Patient Safety (HCAPS) is making good on its mission to advocate for patient safety and protect the fundamental doctor-patient relationship. The alliance’s advocacy will be recognized with the AOA’s Apollo Award during a ceremony at the 2023 Optometry’s Meeting® June 21-24.