Labeling Laws for Personal Care Products: Potential Pitfalls for the Consumer

Evelyne Tantry; Ariadna Perez-Sanchez, MD; Shelly Fu; Shravya Potula; Rajani Katta, MD

Skin Therapy Letter. 2021;26(5):1-6.

Abstract and Introduction

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.

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Table 1. Overview of current FDA regulations of personal care products
Regulatory Concern	Current 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 2. Potential consumer pitfalls when evaluating product labels
Labeling Topic	Current Limitations of US Food and Drug Administration Regulations	Potential 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 3. Marketing terms and regulations
Term	Food and Drug Administration Regulations	Potential 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.