Practical and Theoretical Distinctions Between Drugs and Cosmetics
October 1987
in “
Drug Information Journal
”
TLDR The article concludes that products can affect the body without being drugs as long as they don't claim to treat or prevent diseases, except for cosmetic sunscreens.
In the 1987 article by C. L. Hagenbush, the distinctions between drugs and cosmetics as defined by the Federal Food, Drug, and Cosmetic Act were explored, highlighting the challenges in differentiating the two due to overlapping definitions and the evolving nature of the industry. The article reviewed statutory definitions, court cases, and the FDA's regulatory actions, noting that while drugs are recognized for medical use or intended to affect bodily structure or function, cosmetics are for beautifying or altering appearance, excluding soap. It pointed out the practical enforcement discrepancies and the industry's marketing practices that imply therapeutic benefits, which blur the lines between cosmetics and drugs. The FDA's inconsistent regulatory approach, influenced by factors like budgetary constraints and consumer judgment, was discussed, concluding that products can claim effects on the body without being classified as drugs, provided they do not claim to treat or prevent disease, except in the case of cosmetic sunscreens.