EDITORIAL Contact Lens Sales: Will Dysregulation Lead to Deregulation? Julia G. Costantini, BAS and Thomas L. Steinemann, M.D. Eye & Contact Lens In the United States, an estimated 45 million people wear contact lenses, 25% of whom are younger than 25 years old. 1 With the COVID-19 pandemic accelerating a shift from traditional in-ofﬁce visits to telemedicine, patients have turned online to both ﬁll and renew their contact lens prescriptions. This changing landscape has raised discussion about the future of the contact lens industry and, in particular, the possibility of deregulation, that is, purchase without a prescription. 2 Contact lenses have been classiﬁed by the Food and Drug Administration (FDA) as medical devices since 1976: daily wear as class II (moderate risk) and extended wear as class III (high risk). 1 A valid prescription requires an on-the-eye assessment and ﬁtting by a licensed provider, which includes an evaluation of ocular surface health, determination of appropriate speciﬁcations, and instruction on safe wear practices, followed by annual or biannual visits for renewal. 3 Lenses with astigmatic or presbyopic corrections require additional speciﬁcations, whereas gas- permeable, specialty, and hybrid lenses are often custom ﬁt for a patient’s eye. The Contact Lens Rule, part of the Fairness to Contact Lens Consumers Act (FCLCA) enacted by the Federal Trade Commission in 2004, gives patients the freedom to shop for contact lenses from different sellers, thereby promoting market competition. Before its enactment, patients typically bought lenses from their providers, who held the keys to their prescriptions. This practice often resulted in conﬂicts of interest because industry incentives pushed the sale of particular (and potentially more expensive) lenses. The FCLCA mandates that prescribers provide patients with a copy of their prescription and verify prescriptions sent to them by authorized third-party sellers. These sellers may only sell contact lenses to patients with a valid prescription and are not permitted to alter that prescription. Although an important step in the protection of consumer choice, this rule introduces loopholes through “passive veriﬁcation”— a system in which a prescription is assumed to be correct and auto- matically veriﬁed when a provider fails to respond within eight busi- ness hours. This practice allows sellers to inadvertently ﬁll invalid, incomplete, and expired prescriptions. 4 An amendment to FCLCA drafted in 2019 (implemented in March 2021) added further protec- tions to consumer rights (such as requiring patients to conﬁrm receipt of their prescription) but failed to address provider concerns of accu- rate prescription veriﬁcation. Online retailers have jumped at the opportunity to cultivate this emerging market, using direct-to-consumer marketing to draw in wearers with the promise of increased affordability and conve- nience. Misleading advertising such as “skip the trip” encourages patients to bypass licensed providers and promotes the substitution of lenses with a nonprescribed product. 2 Subscription contact lens services, modeled after a similar venture with razors, have also begun to appear. Prioritizing cost, these services rely on older generation material to offer low-price “generic” daily disposable lenses. 5 In addition, despite current regulations against their sale, marketing, and distribution, counterfeit lenses from unlicensed vendors are able to reach this market. 6 Let us take a moment to consider the risks of further deregulation. Obtaining contact lenses without professional guidance has the potential to result in poor lens ﬁt and inadequate patient counseling. According to the FDA, “there are no generic medical devices,” contact lenses included. 1 One size ﬁts all pre- scribing does not exist. Measurements and material properties are not consistent between brands, and thus, identical speciﬁcations may have clinically different ﬁts and performance. In addition, although older generation hydrogels are FDA approved, they are not an equivalent substitution. Ill-ﬁtting contact lenses risk irri- tation, corneal abrasions, and tight lens syndrome, in which the cornea is deprived of oxygen and nutrients. 1 Lack of patient education may leave patients unaware of safe wear habits, increasing risky behaviors such as sleeping, showering and swim- ming in lenses, infrequent replacement, and poor hygiene. It may also delay their presentation for treatment because patients are often uninformed of potential complications or lack an estab- lished relationship with a licensed provider. Both noncompliance and ill ﬁt jeopardize the even more serious complications of microbial keratitis and vision loss. 6 Furthermore, deregulation has the potential to further open the market to unlicensed vendors selling counterfeit lenses. Even with regulations in place, social media platforms easily allow these vendors to reach unsuspecting consumers before detection. These products carry a higher risk of contamination with pathogenic organisms and are often defective or do not match their manufacturing claims. In particular, these sales are associated with a high proportion of corneal infections in younger cosmetic lens wearers. 6 Are there advantages to deregulation? Likely some. Proponents argue that it would increase accessibility, convenience, and affordability of contact lenses. Cheaper lenses may also promote From the Case Western Reserve University School of Medicine (J.G.C., T.L.S.), Cleveland, OH; and MetroHealth Medical Center (T.L.S.), Cleveland OH. The authors have no funding or conﬂicts of interest to disclose.Address correspondence to Thomas L. Steinemann, Division of Ophthalmology, MetroHealth Medical Center, 2500 MetroHealth Drive, Cleveland, OH 44109-1998; e-mail: tsteinemann@metrohealth.org DOI: 10.1097/ICL.0000000000000842 Eye & Contact Lens  Volume 47, Number 12, December 2021 629 Copyright © 2021 Contact Lens Association of Ophthalmologists, Inc. Unauthorized reproduction of this article is prohibited.