How to determine if a product is cosmetics

In March 2025, the US Food and Drug Administration reported the rejection of 53 batches of imported cosmetics. Among them, "other cosmetics" were the most frequently rejected category, especially aerosol products, due to their unique formulation and ingredient characteristics, which make them more prone to regulatory challenges in testing stability during transportation and in proving ingredient traceability. The quantity is 14 batches. In addition, the product types include moisturizers, makeup, oral hygiene products, and hair care products.

Currently, there is no unified definition of cosmetics internationally, resulting in some products being classified differently for regulation in different sales locations. For example, products for removing freckles and whitening, and acne removal are classified as cosmetics in China but as medicines in the United States. On the other hand, for example, cleaning wipes are not considered cosmetics in China but are considered cosmetics in the United States.According to the US law, cosmetics are items used by spraying, spraying, or other methods to clean, beautify, enhance charm, or improve appearance. This definition includes any component of such items, but does not include soap. In 2022, the United States revised some parts of the FD&C Act, where it was proposed that cosmetics are a finished product, a formulation made from a fixed and quantified composition of cosmetic ingredients.

Based on the latest revisions of the US FD&C Act, aerosol products must meet dual compliance standards: first, their usage method (spray application) must meet the functional definition of "cleaning, beautifying, and improving appearance"; second, the propellant and active ingredients in the formula must meet the requirements for quantified finished products. For example, acne spray containing salicylic acid is classified as a cosmetic in China, but in the US, it needs to be declared as an OTC drug, which raises higher requirements for raw material suppliers. Therefore, Wilson established a three-dimensional compliance framework: 1) Ingredient traceability to ensure quantified preparation can be verified, 2) Multi-national data dynamic matching for target markets, 3) Shipping simulation to predict the stability risk of aerosol cans. By integrating the concept of "finished formulations" from the FDA into the research and development phase, it can effectively avoid the risk of returns due to regulatory differences, opening up international markets for innovative aerosol cosmetics such as whitening sprays and sunscreen mousses.

#Aerosol #Compliance #Challenges #Cosmetic #Regulatory #Ingredient #Traceability #Finished #Cosmetic #Formulations