1Rice University, Houston, TX, USA
2Department of Internal Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA
3Baylor College of Medicine, Houston, TX USA
4Department of Dermatology, McGovern Medical School at University of Texas Health Science Center at Houston, Houston, TX, USA
Conflict of interest:
Rajani Katta is author of a book for the general public on dermatology, and is on an advisory board for Vichy Laboratories.
Evelyne Tantry, Ariadna Perez-Sanchez, Shelly Fu, and Shravya Potula have no conflicts of interest to declare.
Consumers of personal care products must be made aware of the potential pitfalls that arise from current labeling practices and regulations. For example, terms such as “hypoallergenic“, “sensitive skin“, and “baby product” lack legal definitions, and terms such as “fragrance-free“ are frequently misinterpreted. Personal care products are a general category that includes such items as cosmetics, drugs, dietary supplements, and consumer goods. This overview of current US FDA regulations of products in this category reviews pertinent regulatory policies and highlights potential consumer pitfalls when evaluating product labels. In particular, current labeling laws permit the use of language that may be incomplete, misinterpreted, or applied solely for marketing purposes. It is important that consumers understand the meaning of labeling terms, the regulations that govern them, and especially understand the potential pitfalls related to these terms.
personal care products, cosmetics, labeling regulations, fragrance-free, hypoallergenic, sensitive skin, baby products
For consumers choosing among the wide variety of personal care products available, an understanding of current labeling laws and regulations is important. Consumers may be interested in choosing products for sensitive skin, searching for products that are suitable for children, or seeking out products that lack specific allergens. Unfortunately, current regulations limit the utility of many labeling terms to effectively inform the consumer, making it imperative that physicians counsel patients on the specifics of these terms. In this paper, we review areas where consumers may find labels confusing. For each area, we highlight potential pitfalls for consumers when choosing personal care products.
“Personal care products” are not defined by law but rather serve as a general category that can consist of cosmetics, drugs, medical devices, dietary supplements and consumer goods based on the nature of intended use.1 Use of such products may result in allergic contact dermatitis (ACD). Data from the North American Contact Dermatitis Group (NACDG), published in 2018, found that of the top 10 allergens identified by patch testing, nine could be found in personal care products.2 This included six fragrance additives and preservatives, two topical antibiotics (neomycin and bacitracin), and one chemical found in hair dyes (p-phenylenediamine). The treatment of ACD centers on allergen avoidance, and thus an understanding of labeling laws and regulations is critical.
As consumers are faced with a multitude of personal care products, physicians can help by educating them on pertinent regulations and labeling laws. It is important consumers recognize that marketing and safety of personal care products is the responsibility of the manufacturer and is not subject to premarket approval from the US Food and Drug Administration (FDA).3 “Cosmetics”, as defined by the FDA, are any articles intended to be applied to the human body for appearance-altering purposes and include moisturizers, shampoos and makeup.3 ‘Soaps’ fall into a separate category when they are mainly composed of “alkali salts of fatty acids,”4 although the product becomes a “cosmetic” if it contains synthetic detergents or is intended to moisturize or deodorize the body.4
The FDA primarily governs cosmetics and other personal care products through the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and the Fair Packaging and Labeling Act of 1967 (FPLA).3 With these acts, Congress created broad parameters to enable effective regulation of a burgeoning industry. Since their establishment, however, these mandates have not undergone any substantial reform to accommodate the explosive growth of available personal care products.
Table 1 outlines several pertinent regulatory policies that consumers should be made cognizant of when evaluating personal care products. It is vital that consumers recognize that current labeling laws permit the use of language that may be applied solely for marketing, may be incomplete, or may be misinterpreted. Table 2 provides a brief overview of potential pitfalls for the consumer due to current labeling regulations.
|Regulatory Concern||Current Food and Drug Administration Regulations|
|Ingredient safety data and documentation|
Table 1: Overview of current FDA regulations of personal care products
|Labeling Topic||Current Limitations of US Food and Drug Administration Regulations||Potential Consumer Pitfalls Description|
|Uniform ingredient naming|
Table 2: Potential consumer pitfalls when evaluating product labels
Skin and Hair Care Products
Potential pitfalls for consumers when evaluating skin and hair care product labels can be categorized into three broad categories. These include the potential for confusion with marketing terms, labels that are incomplete, and labels that may be misinterpreted.
As many labeling terms lack FDA definitions, they can essentially mean anything a manufacturer decides. The term “hypoallergenic”, for example, is not regulated by law. Therefore, although the term is commonly used in marketing a product, it does not inform consumers about the actual safety of a product.
Similarly, there are no legal standards for qualifying a product as a “baby product.” This may lead to consumer concerns about certain ingredients, as in 2013 when Johnson & Johnson was pressured by consumers to remove formaldehyde and 1,4-dioxane from about 100 of its baby products.5 According to the NACDG, formaldehyde is the fourth most common allergen in cosmetics.2
One study evaluated the use of marketing terms on products. Researchers found that out of 187 cosmetic products, 89% “contained at least 1 contact allergen, 63% 2 or more, and 11% 5 or more” despite being marketed as “hypoallergenic”, “dermatologist recommended/tested”, “fragrance free”, or “paraben free.”6
The lack of regulation involving personal care products marketed and sold as “hypoallergenic”, “baby product”, “natural,” “for sensitive skin”, and other terms is further discussed in Table 3.
|Term||Food and Drug Administration Regulations||Potential Consumer Pitfalls|
Table 3: Marketing terms and regulations
“Free of” Labels
The growing trend among consumers to purchase “free of ” ingredient cosmetics, as evident by growing sales and market shares of these products, has prompted cosmetic companies to address these factors when marketing their products.7
While these labels are technically correct, they often do not highlight information that patients would find useful. For example, the words “paraben-free” are often highlighted on product labels. However, for those who are prone to ACD, the words “free of methylisothiazolinone” (MI) would be more useful. The NACDG publishes a Significance-Prevalence Index Number (SPIN) ranking, which is a weighted calculation that incorporates both clinical relevance and prevalence of an allergen.2 MI had the highest SPIN rating of all allergens tested. It has been banned by the European Commission from use in leave-on products, although it is still used in the US. By contrast, parabens were ranked 48th and had the lowest prevalence of positivity of any major preservative on the North American market. In 2019, the American Contact Dermatitis Society announced that because “[parabens] are rarely problematic as contact allergens, [parabens] have been designated (non) allergen of the year.”8
“Active” Ingredients Listed Separately From Inactive Ingredients
For consumers with ACD, knowledge of all ingredients found in a product is critical. Thus, consumers must be aware that certain product categories separate active ingredients from inactive ingredients. Consumers choosing sunscreens, eyedrops, and over-the-counter medications must be informed to seek out information on both active and inactive ingredients, as sections are separated in these product categories.
Labels That May Be Misinterpreted
Fragrance additives are one of the top causes of ACD,2 but avoidance can be challenging for patients. While product labels may use the terms “fragrance-free” and “unscented”, these terms are frequently misinterpreted by consumers.
- Although the term “fragrance-free” might suggest that a product does not contain any fragrance additives, that is not correct. The FDA defines fragrance as “any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product.” According to that definition, if a fragrance additive is used for another function, then it may legally be included in a fragrance-free product.9 Examples are benzyl alcohol, which may be used as a preservative, and rose oil, which may be used as a moisturizing ingredient.
- Unscented products may contain masking fragrances.
Sunscreen labels are also a common source of confusion among consumers, including the sun protection factor (SPF) value. The SPF is defined as the ratio of the amount of ultraviolet (UV) energy required to produce erythema on skin protected by sunscreen, to the amount of energy required to produce erythema on unprotected skin. Contrary to popular belief, an increased magnitude of SPF value above SPF 30 offers minimal increase of protection from UV rays. Specifically, SPF 30 shields the skin from 97% of UV rays and SPF 50 shields 98%.10
Importantly, SPF values only specify protection against UVB radiation, responsible for sunburns.11 The SPF value does not provide information on protection from UVA rays, which damage the deeper layers of the skin and contribute to skin cancer.12
Marketing claims on sunscreens are also of significant concern.13 Many commonly used claims are neither approved nor regulated by the FDA, including claims such as “dermatologist recommended.”13 Unregulated claims are rampant among sunscreens and advertisements, and sunscreens with more than six of these claims have been associated with increased popularity among consumers.13
Another area of concern relates to GRASE products (generally recognized as safe and effective). While GRASE ingredients are regulated by the FDA, some sunscreens are sold in the form of products that are not considered GRASE, including powders, wipes, towelettes, and insect repellants.26 These product forms have not been extensively studied for their safety and sun protection efficacy.26
Governed by the Environmental Protection Agency (EPA), insect repellents may be required to list active ingredients, but the “EPA does not require a complete declaration of ‘inactive or inert’ ingredients” nor a list of “the identities of inert ingredients on product labels.”27 The label is only required to list the percent composition of inert ingredients.
Furthermore, because only active ingredients require registration for safety and effectiveness, scented inactive ingredients may present concerns for patients with fragrance sensitivity. Case reports documenting insect repellent contact dermatitis have identified various botanical and fragrance chemical ingredients, such as citronellol, lemon oil, eucalyptus oil, and neem oil.28
P-paraphenylenediamine (PPDA) is a common allergen, with the latest data placing it as the 10th most frequent allergen in North America.2 Exposure is primarily via permanent hair dyes.
Although hair dyes in retail stores must list this ingredient, consumers face some challenges. First, unlike other products such as sunscreen, active hair dye ingredients are not required to be highlighted on the label. In fact, active ingredients are typically found as just one ingredient in a long list of chemical names. Second, products that are not intended for retail sale are exempt from ingredient declaration. Products used at a hair salon, therefore, may be exempt from providing ingredients.
In terms of product safety, consumers should realize that FDA approval is not required for hair dyes with PPDA. Regulations divide hair dyes into two categories: coal-tar hair dye (CTHD) and plant or mineral sourced hair dye. Although PPDA is not a coal-tar by-product, it falls into this category. Under FDA regulations there is no need for approval for any of the CTHD.29 Even more worrisome, the FDA cannot take action against a CTHD even if “it is or contains a poisonous or deleterious ingredient that may make it harmful to consumers,” as long as the manufacturer includes a caution statement.29 The only exception is for dyes used in eyelash and eyebrow coloring.
Of the 100+ pages of the FDCA, only two pages discuss cosmetics and personal care product safety. In fact, there is a heavy reliance on safety reporting by manufacturers. Current information from the FDA consists of voluntary ingredient and establishment reporting from companies, along with reports of serious adverse events provided by consumers. Recently, however, there have been efforts to amend the FDCA through the introduction of the Safe Cosmetics and Personal Care Products Act of 2019 and the Personal Care Products Safety Act of 2019. The passage of either bill would increase the regulation of cosmetic labeling and allow the FDA to suspend and even recall the sale of products that cause “adverse health reactions.”30,31
Given the current limitations of federal labeling and safety regulations, it is the responsibility of the consumer to be informed of current regulations and to learn how to accurately evaluate and interpret the information found on personal care product labels.
- U.S. Food and Drug Administration. Cosmetics safety Q&A: personal care products. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/resources-consumerscosmetics/cosmetics-safety-qa-personal-care-products. Accessed August 15, 2021.
- DeKoven JG, Warshaw EM, Zug KA, et al. North American Contact Dermatitis Group patch test results: 2015-2016. Dermatitis. 2018 Nov/Dec;29(6):297-309.
- U.S. Food and Drug Administration. FDA authority over cosmetics: how cosmetics are not FDA-approved, but are FDA-regulated. FDA. Nutrition C for FS and A. Published online March 3, 2005; updated August 3, 2013. Content current as of: March 8, 2021. Available from: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-arenot-fda-approved-are-fda-regulated. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Frequently asked questions on soap. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetic-products/frequently-askedquestions-soap. Accessed August 15, 2021.
- Thomas K. The ‘No More Tears’ shampoo, now with no formaldehyde. The New York Times. Published January 17, 2014. Available from: https://www.nytimes.com/2014/01/18/business/johnson-johnson-takes-first-step-inremoval-of-questionable-chemicals-from-products.html. Accessed August 15, 2021.
- Hamann CR, Bernard S, Hamann D, et al. Is there a risk using hypoallergenic cosmetic pediatric products in the United States? J Allergy Clin Immunol. 2015 Apr;135(4):1070-1.
- Hansen T, Risborg MS, Steen CD. Understanding consumer purchase of free-of cosmetics: a value-driven TRA approach. J Consum Behav. 2012 Nov-Dec;11(6):477-86.
- Fransway AF, Fransway PJ, Belsito DV, et al. Parabens. Dermatitis. 2019 Jan/Feb;30(1):3-31.
- Scheinman PL. Exposing covert fragrance chemicals. Am J Contact Dermat. 2001 Dec;12(4):225-8.
- Paul SP. Ensuring the safety of sunscreens, and their efficacy in preventing skin cancers: challenges and controversies for clinicians, formulators, and regulators. Front Med (Lausanne). 2019 Sep 04;6(195). Available from: https://www.frontiersin.org/articles/10.3389/fmed.2019.00195/full. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Questions and answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. [updated June 23, 2021]. Content current as of: October 22, 2014;. Available from: https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-announces-new-requirements-overcounter-otc-sunscreen-products-marketed-us#Q1_Why_is_FDA. Accessed August 15, 2021.
- Dale Wilson B, Moon S, Armstrong F. Comprehensive review of ultraviolet radiation and the current status on sunscreens. J Clin Aesthet Dermatol. 2012 Sep;5(9):18-23.
- Prado G, Ederle AE, Shahriari SRK, et al. Online sunscreen purchases: impact of product characteristics and marketing claims. Photodermatol Photoimmunol Photomed. 2019 Sep;35(5):339-43.
- U.S. Food and Drug Administration. FDA’s testing of cosmetics for arsenic, cadmium, chromium, cobalt, lead, mercury, and nickel content. Nutrition C for FS and A. Content current as of August 24, 2020. Available from: https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-testingcosmetics-arsenic-cadmium-chromium-cobalt-lead-mercury-and-nickelcontent. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Voluntary cosmetic registration program. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Cosmetics labeling guide. Nutrition C for FS and A. Content current as of August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Allergens in cosmetics. Nutrition C for FS and A. Content current as of November 12, 2020. Available from: https://www.fda.gov/cosmetics/cosmetic-ingredients/allergens-cosmetics. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Cosmetic ingredient names. Nutrition C for FS and A. Published February 4, 2020. Content current as of August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetic-ingredient-names. Accessed August 15, 2021
- U.S. Food and Drug Administration. Center for Veterinary Medicine. Program Policy and Procedure Manual. Guide 1240.4030. Supplemental Policies. Ingredient established names. September 10, 1997. Available from: https://www.fda.gov/media/70119/download. Accessed August 15, 2021.
- U.S. Food and Drug Administration. “Hypoallergenic” cosmetics. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-claims/hypoallergenic-cosmetics.Accessed August 15, 2021.
- U.S. Food and Drug Administration. How to determine if your product is a medical device. Health C for D and R. Content current as of December 16, 2019. Available from: https://www.fda.gov/medical-devices/classify-yourmedical-device/how-determine-if-your-product-medical-device. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Information for manufacturers of baby products. Health C for D and R. P Content current as of August 22, 2018. Available from: https://www.fda.gov/medical-devices/baby-productssids-prevention-claims/information-manufacturers-baby-products. Accessed August 15, 2021.
- Fair L. Are your “all natural” claims all accurate? Federal Trade Commission. Published April 12, 2016. Available from: https://www.ftc.gov/news-events/blogs/business-blog/2016/04/are-your-all-natural-claims-all-accurate. Accessed August 15, 2021.
- Gressin S. Super (un)natural product claims. Consumer information. Federal Trade Commission. Published April 12, 2016. Available from: https://www.consumer.ftc.gov/blog/2016/04/super-unnatural-product-claims. Accessed August 15, 2021.
- United Stated Department of Agriculture. Agricultural Marketing Service. National Organic Program. Cosmetics, body care products, and personal care products. April 2008. Available from: https://www.ams.usda.gov/sites/default/files/media/OrganicCosmeticsFactSheet.pdf. Accessed August 15, 2021.
- U.S. Food and Drug Administration. FDA advances new proposed regulation to make sure that sunscreens are safe and effective. News release dated February 21, 2019. Content current as of February 21, 2019. Available from:https://www.fda.gov/news-events/press-announcements/fda-advances-newproposed-regulation-make-sure-sunscreens-are-safe-and-effective. Accessed August 15, 2021.
- U.S. Food and Drug Administration. Insect repellent-sunscreen drug products for over-the-counter human use; request for information and comments. Federal Register. Published February 22, 2007. Available from: https://www.federalregister.gov/documents/2007/02/22/E7-2890/insect-repellentsunscreen-drug-products-for-over-the-counter-human-use-request-forinformation-and. Accessed August 15, 2021.
- Kullberg SA, Warshaw EM. Summertime dermatitis: when the repellent is the culprit, not the bugs! Dermatitis. 2020 Jul/Aug;31(4):e30-e2.
- U.S. Food and Drug Administration. Hair dyes. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetic-products/hair-dyes. Accessed August 15, 2021.
- Schakowsky JD. Text – H.R.4296 – 116th Congress (2019-2020): Safe Cosmetics and Personal Care Products Act of 2019. Introduced in House September 12, 2019. Available from: https://www.congress.gov/bill/116th-congress/housebill/4296/text. Accessed August 15, 2021.
- Feinstein D. Text – S.726 – 116th Congress (2019-2020): Personal Care Products Safety Act. Introduced in Senate March 7, 2019. Available from: https://www.congress.gov/bill/116th-congress/senate-bill/726/text. Accessed August 15, 2021.