How long does it normally take and what are the processes of getting products approved by the FDA?
The FDA does not approve products. The two key laws concerning cosmetics marketed in the U.S. are the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act are subject to regulatory action. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. Cosmetic companies are responsible for substantiating the safety of their products before marketing. Failure to do so causes the product to be misbranded, unless the following warning statement appears on the product’s label: “Warning: The safety of this product has not been determined.”1 For OTC products such as sunscreens, antiperspirants and antidandruff shampoos, there are FDA monographs. As long as the monograph is followed, the products can be placed on the market with no specific approval. 2. What makes cert
