U.S. Food and Drug Administration

Drugs & Cosmetics

A) DRUGS (Human)

According to FD & C ACT, it is banned to attach false or misleading labels on medicine products or to adulterate Drugs, and new medicine products require FDA approval before coming out in the market.
The standards and methods of analysis for Drugs sold in the US are specified in the USP (United States Pharmacopeia). Drugs are categorized into a new medicine, antibiotics, insulin, medicine for research and investigation, prescription medicines, and non-prescription medicines, depending on regulatory purpose.

The services offered by Chemron FDA are as follows:


During an inspection of cosmetics, greater emphasis is put on safety over the quality of the product. The FDA requires supporting documents that evidence the safety and harmlessness of the product while in use. The supporting documents refer to materials collected from animal testing or human testing. The types of animal testing required will depend on the purpose of cosmetics.

If the label of the product indicates that it is cosmetics which can be used for therapeutic or preventive purposes, it may be considered a Drug. In this case, the importer may be subject to penalties and sanctions. Thus, great care should be taken when creating labels.

Chemron FDA handles each individual case by undertaking several safety and functionality testing according to the color or shape and intended use of cosmetics. We also offer services including registration of manufacturers and cosmetics, and registration of cosmetic ingredients in The Cosmetic, Toiletry and Fragrance Association(CTFA).