In April of 2018, Rodan + Fields, currently considered the number one skincare brand in the United States, was hit with a class action lawsuit related to its Lash Boost eye serum.1,2 The lawsuit alleges that the product’s active ingredient, which claims to grow “lush, longer-looking lashes,” can cause harmful ophthalmic side effects if not used correctly and that such side effects were not disclosed by the company. The ingredient in question is isopropyl cloprostenate, a prostaglandin analog, considered a drug by most ophthalmologists rather than an over-the-counter cosmetic product.3 Common ocular side effects of prostaglandin analogs include conjunctival hyperemia and irritation, iris pigmentation, and lash abnormalities.4 Rodan + Fields Lash Boost eye serum is not the first cosmetic product to be adulterated with prostaglandin analogs to intentionally cause eyelash growth. In 2007, U.S. marshals seized approximately $2 million dollars of Jan Marini’s Age Intervention Eye-lash product whose active ingredient was bimatoprost. Currently, Latisse is the only Food and Drug Administration (FDA) approved treatment for eyelash hypotrichosis and is regulated by the FDA like any other pharmaceutical. Products, such as Rodan + Fields Lash Boost eye serum, are examples of “cosmeceuticals”—an ever-expanding category of cosmetic products that contain an active ingredient and claim drug-like benefits but have none of the oversight such as premarket approval or postmarket surveillance mechanisms that the FDA affords to medical devices or pharmaceuticals. To put this problem in perspective, the authors recently reviewed warning letters sent by the FDA to cosmetic manufacturers and found that there was a 1,450% increase from 2007–2011 to 2012–2017 of letters (an increase from 4 to 62 letters) warning manufacturers against making drug-like claims for their products.5
Whether adulterated or not, however, cosmetic and personal care products can pose harm and have minimal regulation in the United States despite multiple health-related controversies surrounding their use.6 For instance, the FDA has no ability to recall potentially harmful products, and manufacturers are not required to submit adverse event reports to the FDA, in contrast to medical devices and pharmaceuticals. This hampers the FDA’s ability to even identify potential public safety problems with these products. In 2014, in response to 127 reports of severe contact dermatitis and alopecia, the FDA opened an investigation of WEN by Chaz Dean Cleansing Conditioners. It was only then that the manufacturer revealed that it had already received over 21,000 complaints from customers.7 Over 3 years later, the product remained on the market despite class action lawsuits and safety warnings from the FDA.
Many cosmetic products are intended for use around the eye (e.g., mascara, eye shadow, etc.), and ophthalmologists should be aware of their potential safety profile. Some of the first harmful cosmetics were applied directly to the eye. In medieval times, Italian women were reported to use drops of atropine, extracted from the plant atropa belladonna, to increase their attractiveness by dilating pupils.8 Fast forward to the 1930s, eyelash dyes were common practice until they were linked to cases of blindness believed to be secondary to the compound p-phenylenediamine, used primarily in a popular product called Lash Lure.9 Partly driven by this controversy at the time, congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which disallowed adulterated or misbranded cosmetics but otherwise provided the FDA with no regulatory oversight. Since 1938, this initial legislation has changed minimally in spite of continued health controversies.
For instance, the FDA does not have the authority to approve or evaluate the safety of ingredients, save for color additives.10 The Cosmetic Ingredient Review board, an industry-sponsored group, evaluates ingredient safety and provides recommendations. However, to date, it has only deemed 12 ingredients as unsafe compared with the nearly 1,400 that are banned in the European Union.11 This is a particular problem with ingredients used as preservatives. Preservatives are an essential component of many cosmetic products to mitigate microbial contamination, but they are also unfortunately one of the most frequent causes of contact dermatitis.12 The eyelid skin, in particular, is very thin and, therefore, more prone to contact allergy reactions than skin elsewhere on the body. This balance between a proper preservative formulation and the risk of skin irritation leaves microbial contamination as one of the most frequently reported safety issues with cosmetic products. Often, even if a product is contaminated, it poses little risk if intended for use on the skin in healthy adults. However, products meant for use around the eye and on mucus membranes pose an inherent safety risk if these products are contaminated. We recently studied voluntary recalls of cosmetic products from 2002 to 2016 and found that 76% (237/313) of products were recalled because of bacterial contamination.13 Similarly, a study of European recalls due to bacterial contamination of personal care products, found 173 recalled cosmetic products in the European Union from 2005 to May of 2008 with the most common identified organism being Pseudomonas aeruginosa.14
In 2015, Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act intended to provide meaningful oversight of cosmetic and personal care products.15 Among several changes, the bill requires manufacturers to register with the FDA and submit adverse events related to their products. The FDA would also finally have the authority to recall dangerous products and evaluate the safety of ingredients. The bill calls for the FDA to review the safety of 5 ingredients per year with the first proposed 5 ingredients containing 4 compounds that are used as preservatives. These changes would not only allow for earlier identification and removal of harmful products but would also provide guidance for manufacturers in determining safe formations with effective preservatives. Although the Personal Care Products Safety Act has multiple consumer and industry group backers and has received recent media attention from celebrity advocacy, meaningful cosmetic regulatory change is still in limbo. Ultimately, any change to cosmetic regulation should provide for initial practical safeguards to consumers, such as adverse event reporting requirements, while not creating an overly burdensome preapproval system that stifles product innovation.
Until legislative change is achieved, ophthalmologists can play an integral role in public safety. From eye cosmetics adulterated with prostaglandin analogs to those that cause simple irritation, ophthalmologists are the first to identify trends in potentially harmful products. The FDA’s adverse event reporting system for cosmetic products, since currently voluntary, suffers greatly from underreporting.16 Additionally, it has been estimated that only 1% to 3% of all reports are submitted by healthcare providers.17 The public, including healthcare providers, can submit adverse events to the FDA using the MedWatch online reporting system (https://www.fda.gov/Safety/MedWatch/default.htm). Until meaningful cosmetic regulation is passed, these products have the potential to cause harm, and ophthalmologists can help to mitigate safety issues by advocating for cosmetic change through professional organizations and by reporting adverse events of cosmetic products to the FDA database.
3. Horváth ON, Letulé V, Ruzicka T, et al. Periocular discoloration after using a prostaglandin analog for eyelash enhancement: evaluation with reflectance confocal microscopy. J. Cosmet. Dermatol 2016;16:18–20.
4. Camras CB, Toris CB, Tamesis RR. Efficacy and adverse effects of medications used in the treatment of glaucoma. Drugs Aging 1999;15:377–88.
5. Janetos TM, Kwa M, Xu S. Regulation of cosmetics. JAMA Intern Med 2018;178:1000–1.
6. Califf RM, McCall J, Mark DB. Cosmetics, regulations, and the public health: understanding the safety of medical and other products. JAMA Intern Med 2017;177:1080–2.
8. Sirois S, Brisson J. Pupillometry. Wiley Interdiscip Rev Cogn Sci 2014;5:679–92.
9. Shah R, Taylor K. Concealing danger: how the regulation of cosmetics in the United States puts consumers at risk. Fordham Envtl L Rev 2011;23:203–71.
12. Yim E, Nole KLB, Tosti A. Contact Dermatitis caused by preservatives. Dermatitis 2014;25:215–31.
13. Janetos TM, Akintilo L, Xu S. Overview of high-risk Food and Drug Administration recalls for cosmetics and personal care products from 2002 to 2016. J Cosmet Dermatol. In press.
14. Lundov MD, Zachariae C. Recalls of microbiologically contaminated cosmetics in EU from 2005 to May 2008. Int J Cosmet Sci 2008;30:471–4.
15. Feinstein D, Collins S. The Personal Care Products Safety Act. JAMA Intern Med 2018;178:601–2.
16. Kwa M, Welty LJ, Xu S. Adverse events reported to the US Food and Drug Administration for cosmetics and personal care products. JAMA Intern Med 2017;177:1202–4.
17. Katz LM, Valenzuela C, Sadrieh NK. Reporting cosmetic adverse events to the US Food and Drug Administration. Dermatitis 2016;27:236–7.