Non-adherence to Labeling Standards Can Misrepresent Safety of Ingredients in Cosmetic Cleansers

January 2023 | Volume 22 | Issue 1 | 98 | Copyright © January 2023


Published online December 20, 2022

David A. Mays PharmD MBAa, Adam J. Friedman MD FAADb, James Kennedy MScic, James A. Yiannias MDd, Jill A. Morgan PharmD BCPS BCPPSe

aScientific Engagement Strategies, LLC, Cary, NC
bDepartment of Dermatology, George Washington Medical Faculty Associates, Washington, DC; Department of Dermatology, George Washington School of Medicine and Health Sciences, Washington, DC
cSincerely Chemicals, Melbourne, Australia
dMayo Clinic, Phoenix, AZ
eUniversity of Maryland School of Pharmacy, Baltimore, MD

Abstract
US Labeling requirements for cosmetic products are established by the US Food and Drug Administration (USFDA) and detailed in the Code of Federal Regulations (21 CFR 701.3).1 Over 16,000 cosmetic ingredients names have been documented and ingredient nomenclature resources are recommended by the USFDA for use by manufacturers and suppliers.

Citation: Mays D, Friedman A, Kennedy J, et al. Non-adherence to labeling standards can misrepresent safety of ingredients in cosmetic cleansers. J Drugs Dermatol. 2023;22(1):98-100. 

INTRODUCTION

US Labeling requirements for cosmetic products are established by the US Food and Drug Administration (USFDA) and detailed in the Code of Federal Regulations (21 CFR 701.3).1 Over 16,000 cosmetic ingredients names have been documented and ingredient nomenclature resources are recommended by the USFDA for use by manufacturers and suppliers.2 For cosmetics, ingredients included at > 1% are listed in descending order of concentration within the ingredient declaration section. Ingredients included at concentrations below 1% are generally listed randomly afterwards. Confusion can exist since chemical names are often hard to pronounce, scientific sounding, and technical in nature. As a result, a few non-governmental organizations (NGOs) and retail establishments attempt to help with verification programs and even publish avoidance lists for omitted, verified, or "clean cosmetics" programs.3,4 While this could be beneficial, some manufacturers choose to use more natural and relatable terms to describe ingredients to meet the expectations of these programs instead of conforming to ingredient names as listed in the most recent edition of the International Cosmetic Ingredient Dictionary (INCI), the resource most often used to identify and characterize chemical ingredients in cosmetics.2 The INCI standardizes nomenclature on an international level regardless of language, helps ensure ingredient identification and transparency, and is even cited by some 3rd parties as a requirement of verification programs.5

To evaluate adherence to the INCI, "clean" cleansing products for infants and children were identified online and via an NGO verification program. Products making claims for eczema and atopic skin, claims of natural or organic, and those promoting avoidance of ingredients omitted in Europe were preferentially selected. Ingredient lists were obtained from company product web sites and package labeling then mapped to nomenclature established by the INCI. The addition of common names for botanical ingredients (eg, genus/species) was considered appropriate given ingredient labeling guidance outlined by some NGOs and the INCI standard.5 For those products also receiving a third-party verification, adherence to published standards for naming convention (eg, most recent edition of the INCI) was assessed.

A total of 11 cleansing products meeting criteria were available for purchase at the time of this study. Each ingredient used in the products included in this study was matched to the corresponding INCI. Of the products sampled, 64% failed to completely follow the INCI standard.2 Some products were found to be in non-compliance with the INCI and secondary verification recommendations with the majority of products using a combination of INCI for some ingredients and common names for those more natural sounding. Terminology like "glacial and purified" to describe water, "vegetable", "plant-based", "food-grade", "coconut-based", and "organic" to describe sourcing of ingredients was found within the ingredient declaration section on packaging, a practice that is not recognized as industry standard. In addition, relatable words like "cold-pressed" were added to describe processing. A list of non-conforming labeled ingredients with corresponding preferred INCI and reported action of each ingredient can be found in Table 1.

Of the three products tested which promoted additional third-party verification (ie, EWG verified), two (66%) were found to be in noncompliance.5 An example of an ingredient declaration non-conformance with additional 3rd party verification seal can be found in Figure 1. This may be due to premature use of