Developing Thick Skin: Pediatric Eczema in Vulnerable Communities and FDA Regulation of Cosmetic Products

J Law Health. 2024;38(1):174-195.

Abstract

Eczema is a common yet serious inflammatory skin condition affecting millions of children in the United States. Dark skin and/or African-American ethnicity are risk factors for increased eczema severity, most likely due to systemic racism expressed as lower socioeconomic status, increased environmental toxin exposure, decreased access to adequate medical care, and infrequent implementation of early intervention practices. Skin-directed management of eczema for caregivers is critically important for improving clinical outcomes of children with eczema. Skin-directed management of eczema includes avoidance of allergens and appropriate moisturization of skin, which warrants evaluation of cosmetic products like lotions, creams and oils essential for effective home management of the condition. The Federal Drug Administration (FDA) oversees the regulation of cosmetic products under the Food, Drug, and Cosmetic Act (FDCA). Some over-the-counter (OTC) cosmetic products labeled as eczema treatments may be considered a nonprescribed drug and/or a cosmetic product by the FDA, and allergens generally considered harmful to eczematous skin may be found in both categories of skincare products. OTC products labeled as treating eczema make a concrete medical claim and should be further scrutinized to assess their credibility. The negative ramifications of inadequate skincare for dark-skinned and Black children with eczema can result in significant medical consequences, increased negative clinical and social outcomes and literally thickened skin.

MeSH terms

  • Black or African American
  • Child
  • Cosmetics* / adverse effects
  • Eczema*
  • Humans
  • United States
  • United States Food and Drug Administration* / legislation & jurisprudence
  • Vulnerable Populations
  • White

Substances

  • Cosmetics