Harmful Loopholes in Contact Lens Legislation

Approximately 45 million Americans wear contact lenses, with the average wearer being 31 years of age.¹ Contact lenses are safe and effective medical devices when prescribed by a licensed optometrist or ophthalmologist.² However, they also present potential risks, including serious eye infections and corneal ulcers, and the risk of infection increases with improper care and use.³ The FDA regulates contact lenses as class II and III medical devices and requires consumers to have a valid prescription from an eye care professional to purchase them. The length of time a contact lens prescription is valid varies among states, but 1 year is most common. Both the FDA and the Centers for Disease Control and Prevention (CDC) advise consumers that contact lenses are not “one size fits all” and that regular comprehensive eye examinations are necessary to ensure optimal eye health with use of these devices.⁴

Even with eye care professionals performing contact lens fittings, evaluations, and education, we see a growing trend of patients purchasing their contact lenses online. According to one survey, 61.7% of respondents who purchased contact lenses online cited cost as the driving factor, and 55.2% said it was simply easier to purchase their contact lenses online.⁵ Another 20.5% reported liking that the contact lenses purchased online arrived sooner than those purchased from an eye care provider.⁵

EXPLOITATIVE PRACTICES

Many online contact lens sellers not only permit consumers to purchase these medical devices using expired prescriptions, but they also allow them to switch to different brands or types of lenses that were not prescribed by their eye doctor. Although these kinds of practices are outlawed by the Federal Trade Commission (FTC), specifically in the Fairness to Contact Lens Consumers Act (FCLCA) and the Contact Lens Rule,^6,7 online sellers commonly exploit loopholes in the current verification process to bypass enforcement of these regulations. One such loophole often employed by online contact lens sellers involves automated robocalls.

Automated robocalls are usually made after hours to an eye care office and leave low-quality recordings; they neglect to include the necessary information to confirm a prescription, which creates barriers for eye care professionals to respond with any corrections. In some cases, optometrists are unable to immediately provide critical health and safety feedback, especially when requests are made regarding an incorrect device or an individual who is not a patient of the doctor.

Some online sellers also use automated robocalls to take advantage of the current passive verification provision of the FCLCA and the Contact Lens Rule, which states that eye doctors have only an 8-hour window to respond before a prescription is automatically verified. By exploiting this provision, online sellers can push contact lens products not prescribed by an eye doctor.

A report from the American Optometric Association (AOA) Health Policy Institute in June 2020 found that, among optometrists who provide contact lens services:⁸

• 89% received prescription verification calls for invalid prescriptions
• 54% received prescription verification calls for an altogether wrong prescription
• 43% received prescription verification calls for someone who wasn’t their patient.

BILL TO CLOSE LOOPHOLES

There is legislation under consideration to counteract exploitation of FTC regulations. US Senators John Boozman (Arkansas) and Tammy Duckworth (Illinois) announced the introduction of bipartisan legislation to make purchasing contact lenses online safer and more secure.² This legislation is supported by the Health Care Alliance for Patient Safety, the AOA, and the American Academy of Optometry. As of March 1, 2022, the bill had 58 cosponsors in the House and three in the Senate. The bill, titled the Contact Lens Verification Modernization Act (HR 3353/S 1784), would prohibit the use of automated robocalls as a method of verifying a prescription. It would also require online contact lens sellers to allow patients to electronically upload contact lens prescriptions and mandate encryption when emailing medical information protected under the Health Insurance Portability and Accountability Act.²

UPDATE ON THE HUBBLE FTC SETTLEMENT

Online sellers are being held accountable for reckless business practices. On January 28, 2022, the FTC reached a $3.5 million settlement with Hubble Contacts. The FTC complaint against Hubble, filed in the US District Court for the District of Columbia, combined allegations of violating aspects of the Contact Lens Rule and engaging in misleading marketing activities related to consumer reviews.

Specifically, the federal complaint alleges that Hubble sold contact lenses online without verifying customer prescriptions, substituted its own brand of lenses for brands originally prescribed by customer eye doctors, and falsely represented that it obtained independent consumer reviews of its products and services, when, in fact, the company compensated for favorable reviews and included reviews written by individuals with direct connections to the company. In 2017, Hubble was found to have contacted certain patients, offering them a free 1-month supply of contact lenses in exchange for a positive review.⁹ One of the reviews was written by Hubble’s own Director of Customer Experience.

This case is the largest fine in the history of Contact Lens Rule violations. In addition to the $3.5 million fine, Hubble must now directly communicate to its customers that “you may have received Hubble contact lenses that were not fit on your eyes or prescribed. The FTC says that [Hubble] may not have properly verified your prescription with your doctor before sending you contact lenses.”¹⁰

TAKING ACTION

Despite the exploitative activities by online contact lens sellers, it is encouraging to see action taken against FTC violations. We as optometrists have the power to influence legislation that would further protect our patients (see What You Can Do). Because contact lenses are medical devices that can lead to significant risks with improper care and use, we must fight to ensure that our patients are getting the best possible chance at maintaining healthy vision when they purchase from online sellers.