Evelyne Tantry1; Ariadna Perez-Sanchez, MD2; Shelly Fu3; Shravya Potula3; Rajani Katta, MD3,4

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.

Abstract:
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.

Key Words:
personal care products, cosmetics, labeling regulations, fragrance-free, hypoallergenic, sensitive skin, baby products

Background

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 ConcernCurrent Food and Drug Administration Regulations
Ingredient safety data and documentation
  • Under US law, “cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market.”14
  • The FDA does not require cosmetic companies “to share their safety data or file their product formulations with the FDA.”14
  • Participation in the FDA Voluntary Cosmetic Registration Program is voluntary. Companies provide the FDA with the “best estimate of information available about cosmetics products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution”. This information is used by the FDA, as well as “independent, industry-funded” scientific groups, such as the Cosmetic Ingredient Review (CIR), which assesses and reviews ingredient safety data.15
Toxicological testing
  • “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”3
  • Per the FDA, “manufacturers can use whatever testing is necessary to ensure the safety of their products and ingredients.”3 The nature or quality of testing is not specified.
Product recalls
  • The “FDA is not authorized to order recalls of cosmetics” as the process requires “voluntary actions by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective.”3

Table 1: Overview of current FDA regulations of personal care products

 

Labeling TopicCurrent Limitations of US Food and Drug Administration RegulationsPotential Consumer Pitfalls Description
Ingredient listing
  • Per the FDA, products containing fragrance additives that act as a masking agent and are present “at an insignificant level may be considered an incidental ingredient in which case it need not be declared on the label.”16
  • Contrastingly, “certain ingredients may be listed generally as ‘fragrance,’ or ‘perfume,’ without identifying the specific ingredients.”17
  • Ingredient listing is not required for personal care products “distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities.”3
  • Institutional products (such as those used in salons), free samples, and hotel amenities do not require product ingredient listing.
  • Specific fragrance additives are not required to be listed.
Uniform ingredient naming
  • Ingredients must be listed by their “common or usual name.”18
  • Ingredient names can be selected from the International Nomenclature of Cosmetic Ingredients (INCI), United States Pharmacopeia (USP), the National Formulary and the Homeopathic Pharmacopeia of the United States, Food Chemical Codex, the Index Medica, the Chemical Abstracts or the British Pharmacopeia.19
  • The same ingredient may be listed on a label under different names depending on the manufacturer.
Warning labels
  • Personal care products are exempt from displaying warning labels if it is considered to be “adequately substantiated” by either “available test data on its ingredients and on similar products” or “testing appropriate in the light of the existing data.”16 There are no federal standards for what qualifies as ‘appropriate’ testing.
  • Many personal care products are exempt from displaying specific warning labels.

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.

Marketing Terms

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.

 

TermFood and Drug Administration RegulationsPotential Consumer Pitfalls
Hypoallergenic
  • In 1978, the US Court of Appeals for the District of Columbia ruled that the “FDA’s regulation defining ‘hypoallergenic’ was invalid.”20
  • As per the FDA, “there are no federal standards or definitions that govern the use of the term ‘hypoallergenic’” and “the term has no real meaning in the marketplace.”20
  • Companies that manufacture products marketed as ‘hypoallergenic,’ ‘safe for sensitive skin,’ ‘non-allergenic’ or ‘allergy tested’ “are not required to submit substantiation of their hypoallergenicity claims to FDA.”20
  • The term ‘hypoallergenic’ is not regulated by law, and thus, simply means whatever a manufacturer chooses.
  • There is no testing requirement necessary to market a product as ‘hypoallergenic.’
Sensitive skin
  • Presently, “there is no federal standard or definition that governs the use of [phrases such as] ‘for sensitive skin.’”17
  • The FDA instead recommends that consumers refer to the ingredient list, which under the FPLA “requires an ingredient declaration on cosmetic products sold at the retail level.”17
  • There is no federal standard for the term ‘sensitive skin,’ which is purely a marketing term.
Baby products
  • There are no laws explicitly defining what constitutes a ‘baby product’ as they are defined broadly as either ‘cosmetics’ or as a ‘medical device’ (if the product is “intended to cure, treat, mitigate or prevent any illness or disease”).21
  • The only explicit regulation of baby products, in general, is the warning against manufacturers advertising that their products can treat, cure, or prevent the risk of Sudden Infant Death Syndrome (SIDS).22
  • There are no legal metrics for what qualifies a product as a ‘baby product.’
  • Any product can be marketed as a ‘baby product’ and depending on its purpose as a cosmetic or drug, will have varying degrees of labeling regulation.
All natural
  • The FDA does not have any formal regulation, definition or discussion of ‘all natural’ products.
  • The Federal Trade Commission (FTC) reports that there have been incidences when “companies pitched their products as ‘all natural’ or ‘100% natural,’ but included synthetic ingredients.”23
  • Four FTC settlements against the aforementioned companies now prohibit manufacturers from “[mis-stating] the extent to which any product contains natural or synthetic components, [making] misleading claims about ingredients or composition, and [making] deceptive representations about environmental or health benefits.”23
  • Companies are required to provide ‘proof ’ of ‘all natural’ claims. The nature of that proof was not specified by either the FTC or the FDA.24
  • Products marketed as ‘natural’ may still contain synthetic ingredients.
  • Per the FTC, products marketed as ‘all natural,’ suggesting 100% natural composition, cannot contain synthetic ingredients. Products with these claims, however, do not undergo premarket verification
  • No federal standards exist for ‘all natural’ substantiation.
Organic
  • Per the United States Department of Agriculture (USDA), the “FDA does not define or regulate the term ‘organic,’ as it applies to cosmetics, body care, or personal care products.” Rather, the term ‘organic’ is regulated by the USDA for agricultural products through its National Organic Program (NOP, 2008).25
  • ‘Organic’ personal care products are subject to the regulation of both the FDA and USDA.25
  • To be eligible for ‘organic’ certification, a personal care product should “contain or [be] made up of agricultural ingredients, and [be able to] meet the USDA/NOP organic production, handling, processing and labeling standards.”25
  • To be eligible for ‘organic’ certification, a personal care product should “contain or [be] made up of agricultural ingredients, and [be able to] meet the USDA/NOP organic production, handling, processing and labeling standards.”25
  • Alternatively, personal care products “may be certified to other, private standards and be marketed to those private standards in the United States. These standards might include foreign organic standards, eco-labels, earth friendly, etc. USDA’s NOP does not regulate these labels.”25
  • The term ‘organic’ is governed by the USDA, rather than the FDA, even as it applies to cosmetics.
  • The USDA is not the only group capable of certifying organic products. Private companies may also certify organic personal care products under ‘private standards.’
  • Imported ‘organic’ products can be certified using foreign standards.

Table 3: Marketing terms and regulations

Incomplete Labels

“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.

Sunscreens

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

Insect Repellents

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

Hair Dyes

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.

Conclusion

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.

References



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